Vaccine overview: Basic information on M59 Squalene Vaccine Adjuvant

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Offline Satyagraha

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Definitions:

MF59 is a Squalene Adjuvant used in Vaccines like the Swine Flu Vaccine

Adjuvants in immunology are often used to increase the protective effects of a vaccine by stimulating the immune system to respond to the vaccine more vigorously, thus providing immunity to a particular disease.

When the body receives a vaccine with the adjuvant, it will react with a greater immune response than it would have otherwise reacted to the vaccine. The reason for this 'overreaction' to the adjuvant-loaded vaccine is that the body 'recognizes' the adjuvants as the 'enemy' because they mimic a natural infection, and stimulate the immune system to attack.

Adjuvants are attenuated, which means that live virus particles with very low virulence are administered. They will reproduce, but very slowly. Since they do reproduce and continue to present the 'enemy' antigen threat beyond the initial vaccination, vaccination boosters are required less often.

These vaccines are produced by growing the virus in tissue cultures that will select (allow) for less virulent strains, or by mutagenesis or targeted deletions in genes required for virulence. There is a small risk of reversion to virulence, this risk is smaller in vaccines with deletions. Attenuated vaccines also cannot be used by immunocompromised individuals.

MF59TM
MF59TM is a sub-micron oil-in-water emulsion of a squalene, polyoxyethylene sorbitan monooleate (TweenTM 80) and sorbitan trioleate.  The MF59 adjuvant was developed by Chiron Corp., a company acquired by Novartis.  MF59 is approved in Europe and is found in several vaccines, such as an influenza vaccine manufactured by Novartis.  It has also been licensed to other companies and is being actively tested in vaccine trials.

Squalene
Squalene is a natural organic compound originally obtained from shark liver oil and a biochemical precursor to steroids.  Squalene is a naturally occurring oil which has been used in the development of vaccine adjuvants, such as the oil-in-water emulsion MF59. In past years, by use of non-controlled and non-validated assays, a claim was made that antisqualene antibodies were detectable in the sera of individuals with the so-called Gulf War syndrome.

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Online TahoeBlue

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http://www.whale.to/vaccines/mf59_h.html
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MF59TM is a sub-micron oil-in-water emulsion of a squalene, polyoxyethylene sorbitan monooleate (TweenTM 80) and sorbitan trioleate.  Squalene is a natural organic compound originally obtained from shark liver oil and a biochemical precursor to steroids. The MF59 adjuvant was developed by Chiron Corp., a company acquired by Novartis.  MF59 is approved in Europe and is found in several vaccines, such as an influenza vaccine manufactured by Novartis.  It has also been licensed to other companies and is being actively tested in vaccine trials. Exploring Vaccines
...
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The three major (squalene containing) Adjuvants are: (to be used in the new vaccines)

MF59 - Novartis
AS03 - GSK
AF03 - Sanofi-Pasteur


Vaccine Adjuvants - GSK

http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10054.htm
GlaxoSmithKline update: A (H1N1) influenza vaccine development
Friday 15 May 2009, London UK & Philadelphia US

- GSK has received orders from several governments aiming to stockpile a new candidate A (H1N1) adjuvanted influenza vaccine as a precautionary measure

- Company to manufacture the new vaccine, once virus seed is made available by the WHO

A (H1N1) influenza candidate adjuvanted vaccine

GSK expects to manufacture a candidate A (H1N1) adjuvanted influenza vaccine once virus seed is made available by the WHO. The first doses of the vaccine are expected to be available four to six months later, subject to regulatory approval.

The vaccine will comprise antigen of the recently isolated A (H1N1) influenza strain and also contain GSK's proprietary adjuvant system AS03
...
To date, GSK has received interest from several governments aiming to stockpile the new candidate adjuvanted vaccine as a precautionary measure.
...
http://www.squidoo.com/swine-flu-vaccine-info

Novartis and the MF59 Adjuvant
Adjuvants are used to enhance the effectiveness and increase the production rate of vaccines. The company Novartis has been researching the use of an adjuvant called MF59, an oil-in-water emulsion made from squalene (a biological precursor to steroids). MF59 has been in circulation in the UK for more than 10 years as part of a Novartis vaccine called Fluad, a flu vaccine for seniors. I am not aware of any adverse reactions reportedly caused by MF59.

This adjuvant was used to create H5N1 pre-pandemic vaccines by Novartis and will likely be included in the new H1N1 vaccine. Though it is currently unlicensed in the US, it is possible that this will not matter.

My question: Since squalene is a precursor to steroids, does it act like a steroid to the immune system? I suppose adjuvants are intended exactly for that purpose-- to artificially enhance the immune response-- but what could be the body's response when the immune system is charged up on unnatural steroids... especially after this steroid response begins to wane?
...
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http://forum.prisonplanet.com/index.php?topic=118137.msg733230#msg733230
the glycoprotein-gp120, a major component of MF-59 vaccine adjuvant, is the same protein fragment isolated from the HIV virus that is responsible for the rapid dementia seen in AIDS patients
...
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AS-03

AS03 contains Sqaulene plus Vitamin-E (Why?) plus Polysorbate-80 (Tween-80) which is another addative that crosses the blood-brain barrier and is thought to create adverse effects (it's in Gardasil)

See: http://infertility.suite101.com/article.cfm/polysorbate_80_causes_infertility

See: http://www.whale.to/v/tween_80.html

Polysorbate-80 is used in pharmacology to assist in the delivery of certain drugs or chemotherapeutic agents across the blood-brain-barrier. What viral, bacterial, yeast, heavy metal or other vaccine containing ingredient need to pass into the brains of our children? Do they belong in the brain?

Is that part of the needed immune response to protect our children from disease? Do vaccine materials pass across the blood-brain barrier with the help of Polysorbate-80?

If so, are there complications from being in the brains of our children? Is this another connection to help us get an understanding of why 1 in 150 children have autism, or 1 in 6 children has developmental/learning disabilities? Aluminum and Vaccine Ingredients: What Do We Know? What Don’t We Know? by Lawrence B. Palevsky, MD, FAAP



http://www.informapharmascience.com/doi/pdf/10.1517/17425240903018863
AS03 is also an oil-in-water emulsion consisting of squalene oil, α-tocopherol and Polysorbate 80 ...

http://www.emea.europa.eu/humandocs/PDFs/EPAR/prepandrix/H-822-PI-en.pdf

What Prepandrix contains:

AS03 adjuvant composed of squalene (10.68 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)

6.1 List of excipients
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
For adjuvants, see section 2.

MF59C.1 : used in FLUAD (flu vaccine for Seniors) no mention of gp-120

There are many variations of MF59(TM) and AS03 (AS04) AF03 ?,  so who knows...

http://wwwapp1.fda.moph.go.th/drug/zone_search/files/FLUAD_2C%2020_45_N.pdf

Importer / Manufacturer: Biogenetech Co., Ltd. / Novartis vaccine Diagnostics S.r.l.
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICAL PRODUCT FLUAD

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

FLUAD is an influenza vaccine. One dose (0.5ml) contains:
Active ingredient: Influenza virus surface antigens (haemagglutinin and neuraminidase),
propagated in eggs, and adjuvant with MF59C.1, of strains:
A/Brisbane/59/2007 (H1N1)-like strain
(A/Brisbane/59/2007, IVR-148) 15 micrograms HA*
A/Brisbane/10/2007/ (H3N2)-like strain
(A/Uruguay/716/2007, NYMCX-175C) 15 micrograms HA*
B/Florida/4/2006-like strain
(B/Florida/4/2006) 15 micrograms HA*
*haemagglutinin
Adjuvant: MF59C.1 which is an exclusive adjuvant (Patent EP 0 399 843 B1): 9.75 mg squalene,
1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, 0.66 mg sodium citrate, 0.04 mg citric acid
and water for injection.
Excipients: Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium
phosphate dehydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for
injection.

This vaccine complies with the WHO recommendations (northern hemisphere) and EU decision
for the 2008/2009 season


http://www.who.int/vaccine_research/documents/Brief_overview_of_use_of_oil-in-water_emulsions.pdf

Brief overview of use of oil-inwater emulsions as adjuvants for influenza vaccines
S. Reed Ph.D. Infectious Diseases Research Institute Seattle, USA

The most advanced o/w emulsion
adjuvants
• Emulsions of oil-in-water.
– AS03 (GSK)
• squalene 10.68 mg, DL--tocopherol 11.86 mg, polysorbate 80 4.85 mg (1)
– MF59 (Novartis)
• squalene 9.75 mg, polysorbate 80 1.175 mg, sorbitan trioleate 1.175mg (2)
– AF03 (Sanofi Pasteur)
• Squalene-containing emulsion (2.5% emulsion)
– Other companies also developing squalenebased
adjuvants
– Each emulsion is different therefore safety and efficacy to be viewed separately !
1) From Prepandrix dossier
2) From Focetrea dossier

Mechanism of action
• Exact mechanisms not yet fully elucidated.
• MF59: Two proposed mechanisms (1)
• Antigen delivery
• Indirect immune potentiation (via JunB and Ptx3) and
APC recruitment and activation.
• AS03: no publicly available data.
• AF03: no publicly available data.

• preclinical studies show reversible inflammatory changes including increase in white blood cells

1) Mosca et al. Proc. Natl. Acad. Sci USA, 2008
...
Theoretical concerns
Anti-squalene antibodies (claimed association with 'gulf-war syndrome')
– Addressed by GACVS (July 2006)
– The Committee concurred that fears of squalene in vaccine inducing pathological anti-squalene antibodies are unfounded. It
did note, however, that the experience of squalene-containing vaccines has been primarily in older age-groups and  recommended that as squalene-containing vaccines are introduced in other age-groups, careful post-marketing follow up
to detect any vaccine-related adverse events needs to be performed.

• WHO Weekly Epidemiological Record on 14 July 2006

Offline phasma

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If they try to stick this in me i will take it off them and get away to my lab to test this damned hing. No way no how is this thing going in me !

Good post !

BUMP!
Things are not what they appear to be: nor are they otherwise - Surangama Sutra

Offline John Bannon

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http://www.whale.to/vaccines/mf59_h.html
Quotes







6.1 List of excipients
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
For adjuvants, see section 2.



6.1 List of excipients
Suspension vial:
Polysorbate 80=Polysorbate 80, which is linked to infertility in mice,

Octoxynol 10=Octoxynol Nonionic surfactant mixtures varying in the number of repeating ethoxy (oxy-1,2-ethanediyl) groups. They are used as detergents, emulsifiers, wetting agents, defoaming agents, etc. Octoxynol-9, the compound with 9 repeating ethoxy groups, is a spermatocide.
    Year introduced: 1994

ThiomersalToxicology

Thiomersal is very toxic by inhalation, ingestion, and in contact with skin (EC hazard symbol T+), with a danger of cumulative effects. It is also very toxic to aquatic organisms and may cause long-term adverse effects in aquatic environments (EC hazard symbol N).[8] In the body, it is metabolized or degraded to ethylmercury (C2H5Hg+) and thiosalicylate.[3]

Few studies of the toxicity of thiomersal in humans have been performed. Animal experiments suggest that thiomersal rapidly dissociates to release ethylmercury after injection; that the disposition patterns of mercury are similar to those after exposure to equivalent doses of ethylmercury chloride; and that the central nervous system and the kidneys are targets, with lack of motor coordination being a common sign. Similar signs and symptoms have been observed in accidental human poisonings. The mechanisms of toxic action are unknown. Fecal excretion accounts for most of the elimination from the body. Ethylmercury clears from blood with a half-time of about 18 days, and from the brain in about 14 days. Inorganic mercury metabolized from ethylmercury has a much longer clearance, at least 120 days; it appears to be much less toxic than the inorganic mercury produced from mercury vapor, for reasons not yet understood.[9]

Risk assessment for effects on the nervous system have been made by extrapolating from dose-response relationships for methylmercury.[9] Methylmercury and ethylmercury distributes to all body tissues, crossing the blood-brain barrier and the placental barrier, and ethylmercury also moves freely throughout the body.[10] Concerns based on extrapolations from methylmercury caused thiomersal to be removed from U.S. childhood vaccines, starting in 1999. Since then, it has been found that ethylmercury is cleared from the body and the brain significantly faster than methylmercury, so the late-1990s risk assessments turned out to be overly conservative.[9] A 2008 study found that the half-life of blood mercury after vaccination averages 3.7 days for newborns and infants, much shorter than the 44 days for methylmercury.[11]


Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)

Potassium chloride (KCl)=Potassium chloride is used as the third of a three -drug combination in lethal injection. Additionally, KCl is used (albeit rarely) in fetal intracardiac injections in second- and third-trimester induced abortions.[2][3]

Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
For adjuvants, see section 2.
When bad men combine, the good must associate; else they will fall one by one

sociostudent

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Adjuvants in flu vaccines this fall ("Damn the data! Full Speed Ahead")
« Reply #4 on: July 19, 2009, 02:46:31 pm »
http://www.newfluwiki2.com/diary/3526/adjuvants-autoimmunity-and-vaccine-safety-in-a-pandemic-vi-squalene-antibodies-revisited

 Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic VI - Squalene Antibodies Revisited
by: SusanC
Mon Jun 29, 2009 at 20:05:25 PM EDT

* part I - First Questions



 A newly published study appears to refute the connection between the presence of anti-squalene antibodies and Gulf War Syndrome, but is it convincing?

First, a quick recap. The US government is stockpiling both antigens and adjuvants for the H1N1 vaccine, in anticipation of possible mass vaccinations in the fall.  Other governments (eg UK, Canada) have placed orders for adjuvanted flu vaccines for the current pandemic.  The use of adjuvants would mean a smaller amount of antigen required per dose, making it possible to vaccinate more people sooner.  Sounds good?  Except that these adjuvants are not yet licensed by the FDA, and their safety continues to be a cause for concern.  

One controversy that refuses to die has its origins in the discovery of antibodies against squalene by researchers in Tulane University in Gulf War veterans, recipients of the anthrax vaccine, and participants in NIH trials who received the squalene-containing adjuvant MF59, all of whom suffering chronic multisystem disorders loosely described as Gulf War Syndrome (GWS).  A recent exhaustive report from the Veterans Administration describes what happened next:

    After its publication, the Asa/Tulane squalene antibody research was criticized by government scientists and panels. Critics questioned the idea that squalene, when injected, acted as an antigen, and whether the assay used had actually detected antibodies to squalene. Within months, however, investigators at Walter Reed Army Institute of Research (WRAIR) published research showing that squalene can act as an antigen and that antibodies could be detected in a model system.

Indeed, the DOD (Walter Reed) results show that squalene antibodies can be detected in a small percentage (7-15%) of normal population, comparable to the results from Tulane (5-16%), thus validating the Tulane tests.  What they did NOT do, however, was to test actual GWS sufferers.  Such an omission is particularly glaring, and the VA report remarked on it, in no uncertain terms:

    Primary Gulf War squalene antibody question unanswered.

    Eleven years after the squalene controversy was first publicly raised, studies have addressed several related questions....The observation from the Asa/Tulane studies that is most relevant to the health of Gulf War veterans, however, has not been further evaluated. Their initial study, reported in 2000, indicated that symptomatic Gulf War veterans had detectable levels of IgG antibodies to squalene, but that healthy veterans did not.This raised a testable hypothesis concerning an objective measure of an immunological abnormality that distinguished ill from healthy veterans. The Asa/Tulane studies may have correctly identified excess rates of squalene antibodies in ill veterans, whether or not they were caused by vaccines, by vaccine contamination, or by clandestine use of an unapproved adjuvant. It is important to determine whether the observed association between squalene antibodies and Gulf War illness is supported, or refuted, by more definitive research.

This story is important because, according to the VA report, GWS affects >25% of Gulf War veterans, and few have recovered.  If squalene-based adjuvants are somehow responsible for (or at least associated with) GWS, and if we vaccinate millions of people as quickly as we can with an adjuvanted pandemic vaccine, the consequences could make the 1976 swine flu vaccine fiasco look like a cakewalk.

Now, after 11 years, the DOD has finally done a study comparing squalene antibody levels in ill vs well military personnel.  The paper is available free at this link Antibodies to squalene in US Navy Persian GulfWar veterans with chronic multisymptom illness: http://www.anthrax.osd.mil/documents/library/PhillipsCJ_%20et_%20al_%20Antibodies_to_squalene_in_US_Navy_Persian_Gulf_War_veterans_with_chronic_multisymptom_illness.pdf

    ABSTRACT: Since the end of the 1991 Gulf War, there have been reports of unexplained, multisymptom illnesses afflicting veterans who consistently report more symptoms than do nondeployed veterans. One of the many possible exposures suspected of causing chronic multisymptom illnesses Gulf War veterans is squalene, thought to be present in anthrax vaccine. We examined the relationship between squalene antibodies and chronic symptoms reported by Navy construction workers (Seabees), n = 579. 30.2% were deployers, 7.4% were defined as ill, and 43.5% were positive for squalene antibodies. We found no association between squalene antibody status and chronic multisymptom illness (p = 0.465). The etiology of Gulf War syndrome remains unknown, but should not include squalene antibody status.

So they examined the serum of ill vs well veterans for squalene antibodies, and didn't find any difference between the two.  Case closed, right?  

Not so fast.  The lesson, as we have learned many times throughout this series, lies in detailed examination of their methodology.  This current study is based on serum collected during an earlier study Increased postwar symptoms and psychological morbidity among U.S. Navy Gulf War veterans, which surveyed active duty personnel among Seabees (Navy contruction workers), who were among the earliest groups complaining of symptoms.  


    In late 1994 and early 1995, epidemiologic teams made three visits to each of the two Seabee Centers. Written informed consent was obtained from each participant. The study included an eight-page questionnaire, and the donation of clinical specimens (sera and whole blood) [3]. The questionnaire was introduced by research staff and self completed by the study subjects. Clinical specimens were preserved at - 70 C. The questionnaire collected information regarding prewar medical history, war exposures, and symptoms occurring for 1 or more months since July 1990.

Since this original survey was only conducted among active duty personnel, there is already some bias because the study excluded those who may have left service due to sickness since the end of the Gulf war in 1991.  That is the first bias.

The current study goes further than that.  It's common in studies to exclude certain subjects for reasons that are relevant to a particular study, but here, the exclusions defy comprehension or logic.  First of all, and most eggregiously,

    Potential subjects were excluded if they reported bad reactions to immunizations or injections,

Look, this study was supposed to discover or refute any relationship between chronic multisystem illness and possible reaction to vaccines containing squalene.  The first thing they exclude is anybody who reacts to vaccines??

There are other exclusions:

   or reported cancer, tumors, lung disease, hepatitis, neurological problems, digestive disease, or psychiatric illness. Additional exclusions included self-report of leishmaniasis, HIV infection or AIDS, malaria, any psychological disorder, sleep apnea, narcolepsy, thyroid disorders, or mononucleosis that resulted in at least a 1-week loss from work or school since age 16. Females were also excluded due to the small numbers of participants


Hmm, I don't know.  This looks like a LONG list of exclusions to me (144 subjects were excluded).  Does it seem like they were keen on INCLUDING those who might actually be sick??   Let's see what they DO include:

    Subjects who reported unusual fatigue and at least three of the additional 38 symptoms listed in Table 1 were defined in these analyses as "ill." Those without any reported symptoms were categorized as "well"

In other words, fatigue is a required symptom (more on the 38 later) in order to be considered as 'ill' in this study,  Here's the problem.  GWS covers a wide range of symptoms, of which fatigue is only ONE of several possible symptom domains, and by no means the most common one.  Many GWS sufferers have a variety of other symptoms but not necessarily 'unusual fatigue', as shown by this table from the VA report.

There are other exclusions, including 371 deemed to be "not well, not ill", in addition to the 144 above, and another 151 for whom there was 'insufficient serum'.

One telltale sign that this study group is NOT representative of GWS sufferers, is that they found only 7.4% of subjects fulfilling their criteria of being 'ill', whereas surveys by other researchers (with 1 exception) consistently show 25-30% excess illness in different study groups:

If you have read thus far, and have gotten thoroughly confused, it's time to start asking whether your confusion is accidental.  The point is, by

   1. artificially excluding vaccination-related issues eg history of reaction to vaccines, or
   2. symptoms commonly found in GWS eg gastrointestinal, neurological, or psychiatric conditions, and
   3. by restricting inclusion criteria to only those with 'unusual fatigue',

the authors have managed to remove a lot of possible cases where the detection of squalene antibodies may be significant.  


Also, the original authors of the 1994 study identified 22 commonest symptoms reported by 5% or more of study participants.  This current study, however, expanded the list of symptoms to 38, including nightmares, crying spells, abdominal pain, swollen glands, asthma, fever, suicidal thoughts, inflammation of the eyes etc.  This expansion of inclusion, of symptoms that were NOT commonly reported by the study subjects, increases the likelihood of subjects being included as 'ill' who are in fact not suffering from GWS but from the normal range of conditions that one would find in any military unit.

Next, we get to the squalene antibody test itself.  Despite ALL of the above, we can still see some associations.    


In the original 1994 survey, 30.2% of deployed and 1.4% of non-deployed personnel reported having received anthrax vaccination.  With the current study, ignoring the authors' grouping of 'ill' vs 'well', and just looking at the deployment status, you'll find that 52% (91 out of 175) of those who had been deployed to the Gulf tested positive for squalene antibodies, vs 39.8% (161 out of 404) of those not deployed.

Is that significant?  Is there a pattern here?  I don't know, I'm not a research scientist, but as a parent who may have to decide whether adjuvants are safe for my kids, I can only say that the way this study was performed, after 11 years of foot-dragging, leaves me with very little confidence that we are anywhere near getting to the truth of the squalene antibody issue.

Finally, in what may be the most significant omission of this whole fiasco, the authors made no attempt to correlate squalene antibody status vs whether the subject reported having received anthrax vaccine. Since the original hypothesis was that these troops may have gotten sick from the vaccine, either because of contamination or because of illicit use of unlicensed adjuvants, wouldn't it be important to discover whether those who received the vaccine were more likely to test positive for squalene antibodies that those who did not?  And, to turn the question the other way round, IF the DOD has found there is NO correlation between someone receiving the anthrax vaccine and testing positive for squalene antibodies, don't you think it would be SO much more confidence-building, if they can PUBLISH such a finding?
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it seems to me these diaries on adjuvant safety
have taken on a life of their own.  When I first started writing about the subject, I never knew the whole thing would grow and grow as it has done.  Those of you who have followed this with me from the beginning, will remember how one question led to another.  Unfortunately, most of my/our questions still have not been answered.  

Since we are now in a pandemic, the question of adjuvant safety takes on another level of urgency.

This diary is the latest where I explore one particular aspect in detail.  Sometime in the future, hopefully soon, I'll probably try and summarize all the findings to date.  Until that happens, and even after that, I have a feeling that this subject will continue to be a work in progress.  Thanks for everyone's patience.

You gotta work the numbers..
by: SusanC @ Mon Jun 29, 2009 at 21:17:52 PM CDT

* part II - Reasons for Concern:http://www.newfluwiki2.com/showDiary.do?diaryId=1758
* part III - The Story of Fluad: http://www.newfluwiki2.com/showDiary.do?diaryId=1768
* part IV - Safety of MF59: http://www.newfluwiki2.com/showDiary.do?diaryId=1772
* Part V - Insights from Immunology: http://www.newfluwiki2.com/diary/3039
* part VI - Squalene Antibodies Revisited: http://www.newfluwiki2.com/showDiary.do?diaryId=3526


Online TahoeBlue

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A nice find composition of Novartis - Focetria (not Focetrea), a H5N1 bird flu vaccine  Notice the name of some of these Bird flu products - "PrePan(Drix)"...

I am still looking at "Sorbitan trioleate" which seems related to "Tween-85"

Yes I was wondering about the need for "Potassium Cloride and Magnesium  salts" - that's not Saline!.

http://www.emea.europa.eu/humandocs/PDFs/EPAR/focetria/H-710-en6.pdf
©EMEA 2007
...
Introduction
Focetria is manufactured with the same process and has the same adjuvant used for Fluad, a trivalent
seasonal influenza vaccine nationally authorised through a MRP for several years in 12 EU countries
and currently on the market. The MF59C.1 adjuvant contained in Focetria and Fluad is an oil-in-water
emulsion, composed mainly of squalene that is an intermediate metabolite in the synthesis of
cholesterol.


Description and Composition of the finished product:
Each 0.5 ml dose of vaccine has the following composition:
Active Ingredient:
HA and NA antigens from the influenza virus
strain recommended by WHO/EU for the Pandemic ≥ 7.5 μg HA
Adjuvant MF59C.1:
Squalene 9.75 mg
Polysorbate 80 1.175 mg
Sorbitan trioleate 1.175 mg
Other Ingredients:
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Thiomersal (included only in multi-dose vials)
Sodium citrate
Citric acid
Water for injections
...
The first production of Focetria with the H5N3 strain was in 1999. The manufacturing process was the
same of the seasonal influenza vaccine Fluad. Successively, Focetria was produced with the H9N2
strain in 2004 and with the H5N1 strain in 2005, with the same manufacturing process approved for
Fluad in 2005.


From 2000, some changes in formulation and manufacturing process were introduced for Fluad and approved through the relevant MRP variations. However these differences, as already demonstrated for the variations submitted for Fluad, do not affect the quality, safety and efficacy of the product.

Thiomersal was previously used in the production of the active substance (as reagent during the process and as preservative at the final stage) and of the finished product (as preservative). Thiomersal was removed in two steps: in the first one it was removed from the active substance and finished product as preservative (remaining as traces); in the second one it was removed completely (in 2003).

Clinical trials performed to compare Fluad formulations (with and without preservative) and of the
stability studies confirmed that the presence of Thiomersal, as a preservative in Fluad, does not have
any impact on the quality, immunogenicity and safety of the product. For that reason, the current
licensed Fluad in pre-filled syringe is a thiomersal-free product
.

Focetria with H5N3 strain was produced before 2003 with the preservative, while Focetria with H9N2
and H5N1 strains were produced in 2004 and 2005 without any preservative.

http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-1.pdf
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
Vaccine Excipient & Media Summary, Part 2
Excipients Included in U.S. Vaccines, by Vaccine

Includes vaccine ingredients (e.g., adjuvants and preservatives) as well as substances used during the manufacturing process, including vaccine-production media, that are removed from the final product and present only in trace quantities. In addition to the substances listed, most vaccines contain Sodium Chloride (table salt).

http://en.wikipedia.org/wiki/Lethal_injection
...
Potassium chloride: stops the heart, and thus causes death by cardiac arrest.
 
http://people.howstuffworks.com/lethal-injection4.htm
...
Toxic agent (not used by all states) - Potassium chloride is given at a lethal dose in order to interrupt the electrical signaling essential to heart functions. This induces cardiac arrest.

http://bluewavecanada.blogspot.com/2008/01/death-penalty-activists-say-potassium.html
...
The last chemical [potassium chloride] is considered to be incredibly painful. The lawyers argue "if the intended dose of thiopental is not injected successfully, or does not bring about general anesthesia, the inmate will experience both the terror and agony of conscious suffocation and the excruciating pain caused by the potassium, but will appear peaceful and unconscious to observers."

Interesting. Potassium chloride is a feticidal agent used to killed unborn children, often in the latter stages of the pregnancy, when there is a chance the baby may survive.

http://www.arthritistrust.org/Articles/Magnesium%20Chloride%20Hexahydrate%20Therapy.pdf
The Art of Getting Well Magnesium Chloride HexahydrateTherapy

Back in 1915, a French surgeon, Prof. Pierre Delbet, M.D., was looking for a solution to cleanse wounds, because he had found out that the traditional antiseptic solutions actually mortified tissues and facilitated the infection instead of preventing it.
He tested several mineral solutions and discovered that a Magnesium Chloride solution was not only harmless for tissues, but
it had also a great effect over leucocytic activity and phagocytosis; so it was perfect for external wounds treatment.
...
He credited the immuno-stimulant activity to the solution for this result, and he tested it in some other patients.
...
Dr. Neveu wasn't discouraged by this and continued to test this therapy in a wide range of diseases. He obtained very good results in:
pharyngitis, tonsillitis, hoarseness, common cold, influenza, asthma, bronchitis, broncho-pneumonia, pulmonary emphysema, "children diseases" (whooping-cough, measles, rubella, mumps, scarlet fever . . . ), alimentary and professional poisonings, gastroenteritis, boils, abscesses, erysipelas, whitlow, septic pricks (wounds), puerperal fever and osteomyelitis.

But the indications for Magnesium Chloride therapy don't end  here. In more recent years other physicians (and I among these) have verified many of Delbet's and Neveu's applications and have tried the therapy in other pathologies: asthmatic acute attack, shock, tetanus (for these the Magnesium Chloride is administered by intravenous injection); herpes zoster, acute and chronic conjunctivitis, optic neuritis, rheumatic diseases, many allergic diseases, spring-asthenia, and Chronic Fatigue Syndrome, (even in cancer it can be an useful coadjuvant.)
...
Those who have kidney problems should be carefully monitored by their family physician, according to the Center for Disease
Control. Dr. Raul Vergini says, that "this is true only for severe renal insufficiency," where an obvious contraindication may exist; but this is also true for all minerals,...

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Offline phasma

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thought this may help in your seach

http://www.chemexper.com/cheminfo/servlet/org.dbcreator.MainServlet?sort=&query=entry._entryID%3D23901&target=entry&action=PowerSearch&from=0&history=off&realQuery=rn.value%3D9005-70-3&format=google2008

Yummy !
I use TWEEN in the lab - i use t to permeablise cell membranrs (basically punch holes in them) so that i can stain them, or induce them to take up specific things they might not other wise take up.

So they want this in the injection site to allow the virus bits to gain access to cells locally.

No thanks !
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Online TahoeBlue

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Yes it appears the Tweens and the Spans are used to disperse the vaccine thru cell membranes...

"Sorbitan Trioleate"  = S-85 = SPAN-85

Found the Chiron (now Novartis) patent for their vaccine process including MF59:

Description of the "Secret Sauce": MTP-PE can't tell whether it's in MF59C.1

http://www.faqs.org/patents/app/20080254065
...

B. Oil-Emulsions

[0050]Oil-emulsion compositions suitable for use as adjuvants in the invention include squalene-water emulsions, such as MF59 (5% Squalene, 0.5% Tween 80, and 0.5% Span 85, formulated into submicron particles using a microfluidizer). See WO90/14837. See also, Podda, "The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine", Vaccine (2001) 19: 2673-2680. MF59 is used as the adjuvant in the FLUAD® influenza virus trivalent subunit vaccine.

[0051]Particularly preferred adjuvants for use in the compositions are submicron oil-in-water emulsions. Preferred submicron oil-in-water emulsions for use herein are squalene/water emulsions optionally containing varying amounts of MTP-PE, such as a submicron oil-in-water emulsion containing 4-5% w/v squalene, 0.25-1.0% w/v Tween 80® (polyoxyelthylenesorbitan monooleate), and/or 0.25-1.0% Span 85® (sorbitan trioleate), and, optionally, N-acetylmuramyl-L-alanyl-D-isogluatminyl-L-alanine-2-(1'-2'-dipalmitoyl-s- n-glycero-3-huydroxyphosphophoryloxy)-ethylamine (MTP-PE), for example, the submicron oil-in-water emulsion known as "MF59" (International Publication No. WO90/14837; U.S. Pat. Nos. 6,299,884 and 6,451,325, incorporated herein by reference in their entireties; and Ott et al., "MF59--Design and Evaluation of a Safe and Potent Adjuvant for Human Vaccines" in Vaccine Design: The Subunit and Adjuvant Approach (Powell, M. F. and Newman, M. J. eds.) Plenum Press, New York, 1995, pp. 277-296). MF59 contains 4-5% w/v Squalene (e.g. 4.3%), 0.25-0.5% w/v Tween 80®, and 0.5% w/v Span 85® and optionally contains various amounts of MTP-PE, formulated into submicron particles using a microfluidizer such as Model 110Y microfluidizer (Microfluidics, Newton, MA). For example, MTP-PE may be present in an amount of about 0-500 μg/dose, more preferably 0-250 μg/dose and most preferably, 0-100 μg/dose. As used herein, the term "MF59-0" refers to the above submicron oil-in-water emulsion lacking MTP-PE, while the term MF59-MTP denotes a formulation that contains MTP-PE. For instance, "MF59-100" contains 100 μg MTP-PE per dose, and so on. MF69, another submicron oil-in-water emulsion for use herein, contains 4.3% w/v squalene, 0.25% w/v Tween 80®, and 0.75% w/v Span 85® and optionally MTP-PE. Yet another submicron oil-in-water emulsion is MF75, also known as SAF, containing 10% squalene, 0.4% Tween 80®, 5% pluronic-blocked polymer L121, and thr-MDP, also microfluidized into a submicron emulsion. MF75-MTP denotes an MF75 formulation that includes MTP, such as from 100-400 μg MTP-PE per dose.
...

New generation vaccines By Myron Max Levine, James B. Kaper, Rino Rappuoli, Michael F. Goodhttp://books.google.com/books?id=POGN-Psdk9oC&pg=PA225&lpg=PA225&dq=%22Sorbitan+Trioleate%22+uses+S-85+SPAN-85+vaccine&source=bl&ots=k1zsbgOU7m&sig=2SXoTf2TYcN5IcyowCTiU7Bkuzs&hl=en&ei=ufZkSvOdAsGGtgevsej_Dw&sa=X&oi=book_result&ct=result&resnum=7

Search MF59C.1 MTP-PE

http://www.aapsj.org/abstracts/AM_1999/2823.htm

MF59: APPROVAL OF THE FIRST NON-ALUM ADJUVANT FOR A VACCINE.
 M Hora1 , J Fang2 , S Tuck3 , V Levi4

1Chiron Corporation, Emeryville, CA, 2Chiron Corporation, Emeryville, CA, 3Chiron Corporation, Emeryville, CA, 4Chiron Corporation, Emeryville, CA
...
Adjuvants based on particulate or cellular materials have been evaluated for many decades. However, none of them have resulted in successful development of a product thus far. To be commercially viable, an adjuvant must have the appropriate pharmaceutical properties (consistent product profile, acceptable shelf life and reproducible manufacturing process) in addition to the desired immunological attributes. We have developed an emulsion adjuvant using squalene, which is a metabolizable oil, having a well defined, submicron particle size distribution and predictable characteristics. This adjuvant, identified as MF59 (or MF59C.1), has been tested extensively in clinical studies with many antigens and can be produced at a commercial scale. Development of an emulsion with a particle size similar to the pore size of the membrane, through which it must be filtered for obtaining a sterile product, posed many challenges to the process scientist. In addition, the formulator and analyst had to stabilize MF59 against degradation of key components to ensure that the adjuvant had a commercially meaningful shelf life. An MF59-adjuvanted influenza vaccine (FluAdÔ) has been fully developed as a commercial product and is on the market in Italy since 1997.

http://www.who.int/vaccine_research/about/2003_novel_adjuvants/en/05_dobbelaer.pdf
...
Adjuvant MF59C.1 is an oil in water emulsion containing squalene as the oil phase, polysorbate 80 and sorbitan
trioleate as co-emulsifiers and a citrate-buffered aqueous phase. Manufactured using a selected ratio of
oil to water that produces a stable emulsion with low viscosity that can be sterilised and easily administrated
by injection.

 Activates dendritic cells at injection site, internalisation and migration to draining lymph nodes
 Strong parenteral but poor mucosal adjuvant


Online TahoeBlue

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Potassium chloride

Can anyone find an article that explains the reasoning behind adding Potassium Chloride to vaccine preparations and post it here...

I assume that Potassium chloride would kill cells at the injection site (nerve cells too?)... I'm just guessing...

Offline phasma

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LL
Potassium chloride

Can anyone find an article that explains the reasoning behind adding Potassium Chloride to vaccine preparations and post it here...

I assume that Potassium chloride would kill cells at the injection site (nerve cells too?)... I'm just guessing...

aLL I know is that potassium chloride is the third drug given during a leathak injection - to stop the heart.
I work in a lab - i worl with cells - i can think of no use for this chemical in cell culture - dave to kill off cardiac cells or nerve impulses maybe.
Things are not what they appear to be: nor are they otherwise - Surangama Sutra

Offline Satyagraha

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This website lists Potassium Chloride as an ingredient in some vaccines, then starts the section by describing how deadly it is!!  I haven't found info on WHY they use this stuff... I have seen articles that describe KCl as a agent used to break through barriers (like blood/brain?) not sure - need to find documentation.


Vaccine Ingredients
Potassium chloride

http://www.novaccine.com/vaccine-ingredients/results.asp?sc=88

1. "Medication Errors: National Findings from the USP Medmarx Medication Error Reporting Program"
"In the last 5 years, insulin, heparin, albuterol, morphine, potassium chloride, and warfarin are consistently in the top 10 agents associated with medications errors and involve both harmful and nonharmful medication errors."
Cousins D, Kagemann L, Hospital Pharmacy Vol 41;5 suppl 1; p82 -- 5/1/2006
http://en.wikipedia.org/wiki/Potassium_chloride


2. "Drug-induced hyperkalemia."

"After reviewing the available data on drug-induced hyperkalemia, we conclude that the situation has not improved since Lawson quantitatively documented the substantial risks of potassium chloride over a decade ago. As discussed, the risk of developing hyperkalemia in hospital remains at least at the range of 1 to 2% and can reach 10%, depending on the definition used…. Readily identifiable risk factors (other than drugs) for developing hyperkalemia are well-known but seem to be consistently ignored, even in teaching hospitals… We remain intrigued by Burchell's prescient pronouncement of over a decade ago that "more lives have been lost than saved by potassium therapy""
Ponce SP, et al, Medicine 64(6):357-70. -- 11/1/1985

3. Adverse Reactions to Potassium Chloride
"Adverse reactions attributed to potassium chloride were reported in 283 (5.8%) patients, the most common being hyperkalaemia. Adverse reactions culminated in the death of seven patients and threatened the lives of a further 21."
Lawson DH, Q J Med 43: 433-440 -- 1/1/1974
http://qjmed.oxfordjournals.org/cgi/content/abstract/43/3/433
The Boston Collaborative Drug Surveillance Programme, Boston University Medical Centre

Reprint requests to Boston Collaborative Drug Surveillance Programme, 400 Totten Pond Road, Waltham, Massachusetta 02154, USA.

Received 5 January 1974 Of 16,048 consecutive patients monitored in a drug surveillance programme, 4921 (31%) received potassium chloride. The major indication for this drug was prophylaxis against electrolyte depletion and the frequency of use varied widely from hospital to hospital. Adverse reactions attributed to potassium chloride were reported in 283 (5.8%) patients, the most common being hyperkalaemia. Adverse reactions culminated in the death of seven patients and threatened the lives of a further 21. Hyperkalaemia was more frequent in elderly patients, in those with uremia, in those who received potassium both orally and parenterally, and in those who died during the monitored admission. In addition, hyperkalaemia was reported significantly more often in patients who received potassium chloride along with diuretics.

The findings suggest that potassium supplements should be used with caution in the elderly, in those with uremia and in patients receiving diuretics. Wide variations in the frequency of potassium use amongst the monitored hospitals suggest that this drug may be used more than is necessary and that a reduction in its use in hospitals might lead to a decreased mortality and morbidity, particularly among elderly individuals.

1Present Address: The Royal Infirmary, Glasgow.

4. Hazards Emergency Overview: CAUTION! MAY BE HARMFUL IF SWALLOWED. MAY CAUSE IRRITATION TO SKIN, EYES, AND RESPIRATORY TRACT.
http://www.jtbaker.com/msds/englishhtml/P5631.htm
Inhalation:Inhalation of high concentrations of dust may cause nasal or lung irritation.
Ingestion: Large quantities can produce gastrointestinal irritation and vomiting. May produce weakness and circulatory problems. May affect heart. In severe cases, ingestion may be fatal.
Skin Contact: Contact may cause irritation or rash, particularly with moist skin.
Eye Contact: Potassium chloride is moderate eye irritant. Redness, tearing, possible abrasion can occur.
Chronic Exposure: No information found.
Aggravation of Pre-existing Conditions: Persons with impaired kidney function may be more susceptible to the effects of the substance.
http://www.jtbaker.com/msds/englishhtml/P5631.htm

==========================================

Here are some vaccines that contain KCl:
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
Influenza (Afluria)
Beta-Propiolactone, Calcium Chloride, Neomycin, Ovalbumin, Polymyxin B,
Potassium Chloride, Potassium Phosphate, Sodium Phosphate, Sodium
Taurodeoxychoalate.

MMRV (ProQuad)
Bovine Albumin or Serum, Gelatin, Human Serum Albumin, Monosodium Lglutamate,
MRC-5 Cellular Protein, Neomycin, Sodium Phosphate Dibasic,
Sodium Bicarbonate, Sorbitol, Sucrose, Potassium Phosphate Monobasic,
Potassium Chloride, Potassium Phosphate Dibasic

Varicella (Varivax)
Bovine Albumin or Serum, Ethylenediamine-Tetraacetic Acid Sodium (EDTA),
Gelatin, Monosodium L-Glutamate, MRC-5 DNA and Cellular Protein,
Neomycin, Potassium Chloride, Potassium Phosphate Monobasic, Sodium
Phosphate Monobasic, Sucrose

Rotavirus (Rotarix)
Amino Acids, Calcium Carbonate, Calcium Chloride, D-glucose, Dextran,
Ferric (III) Nitrate, L-cystine, L-tyrosine, Magnesium Sulfate, Phenol Red,
Potassium Chloride,  Sodium Hydrogenocarbonate, Sodium Phosphate, Sodium
L-glutamine, Sodium Pyruvate, Sorbitol, Sucrose, Vitamins, Xanthan

Zoster (Zostavax)
Bovine Calf Serum, Hydrolyzed Porcine Gelatin, Monosodium L-glutamate,
MRC-5 DNA and Cellular Protein, Neomycin, Potassium Phosphate
Monobasic, Potassium Chloride, Sodium Phosphate Dibasic, Sucrose


NOTE: Vaccine Excipient & Media Summary: the ingredients listed above, are "Excipients Included in U.S. Vaccines, by Vaccine.  They include vaccine ingredients (e.g., adjuvants and preservatives) as well as substances used during the manufacturing process, including vaccine-production media, that are removed from the final product and present only in trace quantities. In addition to the substances listed, most vaccines contain Sodium Chloride (table salt).
"He that would make his own liberty secure must guard even his enemy from oppression; for if he violates this duty he establishes a precedent that will reach to himself."

~ Thomas Paine, A Dissertation on the First Principles of Government, 1795

Online TahoeBlue

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I think we're on to something with Potassium Chloride....
It seems they might be using the Potassium to suspend the virus particles...

This is a "Oral Delivery  - Gene Therapy" article... Geez....
http://www.nature.com/gt/journal/v11/n7/full/3302193a.html

The successful outcome of novel gene therapies and DNA vaccinations largely depends on the development of effective delivery systems
...
In the present study, we found that plasmid DNA can be packaged in vitro into a virus-like particle (VLP) composed of open reading frame 2 of hepatitis E virus, which is an orally transmissible virus, and that these VLPs can deliver this foreign DNA to the intestinal mucosa in vivo.
...
This study demonstrated that an orally administered DNA vaccine encapsulated in an orally transmissible virus-derived VLP induced both mucosal and systemic immunity.

VLPs were pelleted by ultracentrifugation and resuspended in 10 mM potassium-MES buffer (pH 6.2).
...

Proquad with MSG..... and KCl ....

http://www.rxlist.com/proquad-drug.htm
ProQuad* is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses
...
Each 0.5-mL dose of the vaccine contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 meg of potassium phosphate monobasic, 60 meg of potassium chloride; 36 meg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; < 16 meg of neomycin, bovine calf serum (0.5 meg), and other buffer and media ingredients. The product contains no preservative.

Still looking for a document that gives their reasoning...

Offline Satyagraha

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Proquad with MSG..... and KCl ....

http://www.rxlist.com/proquad-drug.htm
ProQuad* is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses
...
Each 0.5-mL dose of the vaccine contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 meg of potassium phosphate monobasic, 60 meg of potassium chloride; 36 meg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; < 16 meg of neomycin, bovine calf serum (0.5 meg), and other buffer and media ingredients. The product contains no preservative.

Still looking for a document that gives their reasoning...

In all the examples, it seems KCl is never the only 'salt' -- always mixed with phosphates and carbonates... a little martini of nasty stuff. In the description quoted above, they write that it contains no preservative. So what's the action of the KCl, and the (who knew...) baking soda?
"He that would make his own liberty secure must guard even his enemy from oppression; for if he violates this duty he establishes a precedent that will reach to himself."

~ Thomas Paine, A Dissertation on the First Principles of Government, 1795

Offline Satyagraha

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I think the KCl is coming in during the production of the vaccine; in trying to isolate the virus ... although they mention potassium tartrate in this excerpt; it might be worth looking it the process used to isolate the virus elsewhere.

From Novel Strategies in the Design and Production of Vaccines (Advances in Experimental Medicine and Biology), by by Sara Cohen (Editor), Avigdor Shafferman (Editor)
P143:
Virus Purification

Crude medium from infected cultures was clarified by centrifugation at 1500g for 30 minutes. The clarified supernatant was then centrifuged at 15000g for 3 hours after a dilution with 2 volumes of cold distilled water. The pellet was reconsitituted in STE buffer (TRIS-HCl 0.01, M; Nacl 0.15 M; EDTA 0.001; pH = 7.4 ) and left over night. After resuspension in 1/10th of initial volume in the same buffer, the preconcentrated virus was deposited on the top of a prepared continuous gradient of potassium tartrate (50% - 10%) in centrifugation tubes. These tubes were then centrifuged at 20000 rpm (80000g) for 18h. The visible opaque bands containing the virus were carefully separated into fractions, which were separately titred after dilution at 1/500 in TRIS-NaCl by the standard hemagglutination technique using chicken or guinea pig red blood cells according to the virus.
"He that would make his own liberty secure must guard even his enemy from oppression; for if he violates this duty he establishes a precedent that will reach to himself."

~ Thomas Paine, A Dissertation on the First Principles of Government, 1795

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I think the KCl is coming in during the production of the vaccine; in trying to isolate the virus ... although they mention potassium tartrate in this excerpt; it might be worth looking it the process used to isolate the virus elsewhere.

Yes! SO it's part of production ... that is not removed....hmmm

www.freepatentsonline.com/4699786.html
Enhanced large scale cultivation of bordetella pertussis cells for vaccine production using lactoglobulin

DESCRIPTION OF THE PREFERRED EMBODIMENT

The incubated agars are inoculated and the organisms are grown at about 35°-37° C. Microscopic examination and purity checks follow all subculturing. The blood agar flasks containing 100 ml of Bordet-Gengou Agar plus 15-25% sheep or rabbit blood are overlaid with 25 ml of Modified CW medium having the following composition:
...
or 25 ml of Modified SS medium having the following composition:

______________________________________  
INGREDIENT GRAMS/LITER  
______________________________________  
L-proline 0.24
Monosodium L-glutamate
10.7
Sodium Chloride 2.5
Potassium Chloride 0.2
Potassium Phosphate Monobasic
0.5
Magnesium Chloride 0.1
Calcium Chloride 0.02
Tris HCl Buffer, pH 7.6 0.05 --M
1.5
Niacin 0.004
Glutathione 0.1
Ascorbic Acid 0.02
L-Cystine 0.04
Ferrous Sulfate.7H 2 O
0.01
Distilled Water qs 1000 ml


http://www.freepatentsonline.com/6656719.html
Serum-free, low-protein media for rotavirus vaccine production

Defined serum-free, low protein media (LPKM), that supports
1) Vero cell growth for up to 20 passages,
2) Vero cell growth on microcarriers and
3) rotavirus production is provided.

Maximum cell densities attained are 60-100% of that in serum-containing medium; the doubling time is equal to that for cells in serum containing medium. Rotavirus titers achieved in LPKM-1 are 50-100% of the serum-containing process. Finally, since LPKM-1 contains no animal-sourced proteins, the problems associated with the serum-containing rotavirus production process (i.e. lengthy wash steps before infection, potential introduction of adventitious agents and lot-to-lot variability) can be avoided; while maintaining nearly equivalent product titers.
...
TABLE 1  
 
Composition of LPKM-1, -2 and-3  
 LPKM-1  LPKM-2  LPKM-3  
Formulation-> Component  mg/l  mg/l  mg/l  
 
INORGANIC SALTS    
Ammonium Metavanadate  0  0  0.00117  
Calcium Chloride/CaCl2  116.6  116.6  116.6   (anhyd.)  
Cupric Sulfate/CuSO4.5H2O  0.00125  0.00125  0.00125  
Ferric Nitrate/  0.36  0.36  0.36  
Fe(NO3)3.9H2O  
Ferrous Sulfate/FeSO4.7H2O  0.415  0.415  0.415  
Magnesium Chloride/MgCl2  28.61  28.61  28.61   (anhyd.)  
Magnesium Sulfate/MgSO4  49  49  49  
(anhyd.)  
Manganese Sulfate  0  0  0.000151  
Molybdic Acid.4H2O  0  0  0.00124   (ammonium)  
Potassium Chloride/KCl  311.8  311.8  311.8  
Sodium Acetate/CH3CO2Na  25  25  25   (anhydrous)  
Sodium Bicarbonate/NaHCO3  1688  3688  3688  
Sodium Chloride/NaCl  7199.5  7199.5  7199.5  
Sodium Phosphate  71  71  71  
Dibasic/Na2HPO4   (anhyd.)  
Sodium Phosphate  70  70  70  
Monobasic/NaH2PO4   (anhyd.)  
Zinc Sulfate/ZnSO4.7H2O  0.43  0.43  0.43  
...

http://www.faqs.org/patents/app/20080213309

[0026]A further object of the invention is a method for preparing alphaviral replicon particles (ARPs) which collectively encode a multiplicity of antigens from a tumor, a tumor cell, pathogen or parasite. The method includes the steps of preparing DNA or cDNA from the tumor, a tumor cell, pathogen or parasite of interest and cloning into the virus/alphavirus replicon nucleic acid to produce a modified virus/alphavirus replicon nucleic acid, introducing the modified viral/alphaviral replicon nucleic acid into a permissive cell, said modified viral/alphaviral replicon nucleic acid containing at least a virus packaging signal to produce a modified permissive cell, culturing the modified permissive cell under conditions allowing expression of at least one helper function and allowing replication of said modified viral/alphaviral nucleic acid and packaging to form ARPs, and desirably contacting the cultured permissive cells with a Release Medium to release cell- and debris-bound ARPs.
...

The Release Medium is an aqueous medium which desirably is from about pH 6 to 9, desirably from about 6.5 to about 8.5, and contains from about 0.2 to about 5 M of a salt including but not limited to ammonium acetate, ammonium chloride, sodium chloride, magnesium chloride, calcium chloride, potassium chloride, ammonium sulfate and sodium bicarbonate.

It is advantageous that when modified alphaviral replicon nucleic acids are introduced into the permissive cells by electroporation, the cells are present in a density of from about 107 to about 5×108 per mL of electroporation mixture.

Offline Satyagraha

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Yes! SO it's part of production ... that is not removed....hmmm

www.freepatentsonline.com/4699786.html
Enhanced large scale cultivation of bordetella pertussis cells for vaccine production using lactoglobulin

DESCRIPTION OF THE PREFERRED EMBODIMENT

The incubated agars are inoculated and the organisms are grown at about 35°-37° C. Microscopic examination and purity checks follow all subculturing. The blood agar flasks containing 100 ml of Bordet-Gengou Agar plus 15-25% sheep or rabbit blood are overlaid with 25 ml of Modified CW medium having the following composition:
...
or 25 ml of Modified SS medium having the following composition:

______________________________________  
INGREDIENT GRAMS/LITER  
______________________________________  
L-proline 0.24
Monosodium L-glutamate
10.7
Sodium Chloride 2.5
Potassium Chloride 0.2
Potassium Phosphate Monobasic
0.5
Magnesium Chloride 0.1
Calcium Chloride 0.02
Tris HCl Buffer, pH 7.6 0.05 --M
1.5
Niacin 0.004
Glutathione 0.1
Ascorbic Acid 0.02
L-Cystine 0.04
Ferrous Sulfate.7H 2 O
0.01
Distilled Water qs 1000 ml


http://www.freepatentsonline.com/6656719.html
Serum-free, low-protein media for rotavirus vaccine production

Defined serum-free, low protein media (LPKM), that supports
1) Vero cell growth for up to 20 passages,
2) Vero cell growth on microcarriers and
3) rotavirus production is provided.

Maximum cell densities attained are 60-100% of that in serum-containing medium; the doubling time is equal to that for cells in serum containing medium. Rotavirus titers achieved in LPKM-1 are 50-100% of the serum-containing process. Finally, since LPKM-1 contains no animal-sourced proteins, the problems associated with the serum-containing rotavirus production process (i.e. lengthy wash steps before infection, potential introduction of adventitious agents and lot-to-lot variability) can be avoided; while maintaining nearly equivalent product titers.
...
TABLE 1  
 
Composition of LPKM-1, -2 and-3  
 LPKM-1  LPKM-2  LPKM-3  
Formulation-> Component  mg/l  mg/l  mg/l  
 
INORGANIC SALTS    
Ammonium Metavanadate  0  0  0.00117  
Calcium Chloride/CaCl2  116.6  116.6  116.6   (anhyd.)  
Cupric Sulfate/CuSO4.5H2O  0.00125  0.00125  0.00125  
Ferric Nitrate/  0.36  0.36  0.36  
Fe(NO3)3.9H2O  
Ferrous Sulfate/FeSO4.7H2O  0.415  0.415  0.415  
Magnesium Chloride/MgCl2  28.61  28.61  28.61   (anhyd.)  
Magnesium Sulfate/MgSO4  49  49  49  
(anhyd.)  
Manganese Sulfate  0  0  0.000151  
Molybdic Acid.4H2O  0  0  0.00124   (ammonium)  
Potassium Chloride/KCl  311.8  311.8  311.8  
Sodium Acetate/CH3CO2Na  25  25  25   (anhydrous)  
Sodium Bicarbonate/NaHCO3  1688  3688  3688  
Sodium Chloride/NaCl  7199.5  7199.5  7199.5  
Sodium Phosphate  71  71  71  
Dibasic/Na2HPO4   (anhyd.)  
Sodium Phosphate  70  70  70  
Monobasic/NaH2PO4   (anhyd.)  
Zinc Sulfate/ZnSO4.7H2O  0.43  0.43  0.43  
...

http://www.faqs.org/patents/app/20080213309

[0026]A further object of the invention is a method for preparing alphaviral replicon particles (ARPs) which collectively encode a multiplicity of antigens from a tumor, a tumor cell, pathogen or parasite. The method includes the steps of preparing DNA or cDNA from the tumor, a tumor cell, pathogen or parasite of interest and cloning into the virus/alphavirus replicon nucleic acid to produce a modified virus/alphavirus replicon nucleic acid, introducing the modified viral/alphaviral replicon nucleic acid into a permissive cell, said modified viral/alphaviral replicon nucleic acid containing at least a virus packaging signal to produce a modified permissive cell, culturing the modified permissive cell under conditions allowing expression of at least one helper function and allowing replication of said modified viral/alphaviral nucleic acid and packaging to form ARPs, and desirably contacting the cultured permissive cells with a Release Medium to release cell- and debris-bound ARPs.
...

The Release Medium is an aqueous medium which desirably is from about pH 6 to 9, desirably from about 6.5 to about 8.5, and contains from about 0.2 to about 5 M of a salt including but not limited to ammonium acetate, ammonium chloride, sodium chloride, magnesium chloride, calcium chloride, potassium chloride, ammonium sulfate and sodium bicarbonate.

It is advantageous that when modified alphaviral replicon nucleic acids are introduced into the permissive cells by electroporation, the cells are present in a density of from about 107 to about 5×108 per mL of electroporation mixture.


So we can imagine that when Pharma companies are "fast-tracking" these vaccines; they're trying to get the maximum yield density, while at the same time keeping the Ph level within range. And you see even more of the toxic ingredients when they are trying to remove the animal blood from the mix. I saw acetic acid somewhere above... so it's fine-tuning going on.
I think you're right suggesting they're not able to get all of the 'release medium' chemicals out... introducing another level of risk. No mention of that however in anything I've seen so far.
"He that would make his own liberty secure must guard even his enemy from oppression; for if he violates this duty he establishes a precedent that will reach to himself."

~ Thomas Paine, A Dissertation on the First Principles of Government, 1795

Offline jflack

  • Member
  • *****
  • Posts: 1,040
    • Survival Communication Equipment
Today I received an email from the National Vaccine Information Center concerning the FDA's approval of the H1N1 vaccine without testing.

"the FDA announced trials for H1N1 vaccines to include previously unapproved adjuvants and that it has already purchased a stockpile of 119,000,000 doses of these untested/unapproved adjuvants (ASO3 oil in water emulsions) to be used When an Emergency Usage Authorization (EUA) is issued by the DHHS."


sociostudent

  • Guest
Today I received an email from the National Vaccine Information Center concerning the FDA's approval of the H1N1 vaccine without testing.

"the FDA announced trials for H1N1 vaccines to include previously unapproved adjuvants and that it has already purchased a stockpile of 119,000,000 doses of these untested/unapproved adjuvants (ASO3 oil in water emulsions) to be used When an Emergency Usage Authorization (EUA) is issued by the DHHS."



It's GSK that makes the ASO3: (Look on p. 6)

http://www.who.int/entity/vaccine_research/diseases/influenza/120209_Robin_Robinson.pdf



Also, there was a journal article in Science Direct about "evaluation of pandemic influenza prototype vaccines in clinical trials". If you want to find it, go to http://dx.doi.org/ and copy/paste in this number/letter combo:

10.1016/j.vaccine.2009.04.059 

Copyright © 2009 Published by Elsevier Ltd.
Conference report
Report of the 5th meeting on the evaluation of pandemic influenza prototype vaccines in clinical trials: World Health Organization, Geneva, Switzerland, 12–13 February 2009
Purchase the full-text article



References and further reading may be available for this article. To view references and further reading you must purchase this article.

Frederick G. Haydena, Wendy A. Howarda, Laszlo Palkonyayb and Marie Paule Kienyb, Corresponding Author
International Activities-Science Funding, The Wellcome Trust, 215 Euston Road, London NW1 2BE, United Kingdom

Initiative for Vaccine Research (IVR), Immunization, Vaccines and Biologicals, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland

Received 18 April 2009;
accepted 20 April 2009.
Available online 9 May 2009.

Abstract

Influenza vaccines are potentially the most efficacious means of mitigating the impact of influenza pandemic and might contribute to the rapid containment of an emerging pandemic virus.

On the 12–13 February 2009, the Initiative For Vaccine Research (IVR) of the World Health Organisation convened the 5th meeting on the ‘Evaluation of pandemic influenza prototype vaccines in clinical trials’ in Geneva. This was a follow-up meeting to the 4th meeting held on 14–15 February 2008 [Girard M, Palkonyay L, Kieny MP. Report of the 4th meeting on the evaluation of pandemic influenza prototype vaccines in clinical trials. Vaccine 2008;26:4975–7], and presentations were made by representatives from industry, academia, and governmental organisations. This year's meeting aimed to update the progress made during the past year on H5N1 and other prototype pandemic vaccines that have undergone clinical trials. A number of vaccine types were covered, including classical egg-derived inactivated vaccines, cell-derived inactivated vaccines, live-attenuated vaccines (LAIV) and vaccines developed using new technologies. The effects of different adjuvants and prime-boosting schedules were important topics, and further data were presented to show that children mount vigorous antibody responses to several H5N1 vaccines. Other subjects presented and discussed were standardisation, and regulatory issues concerning pandemic vaccines.

Keywords: Vaccine; Influenza; H5N1; Pandemic; Clinical trials

Abbreviations: AEFI, adverse events following immunisation; AlPO4, aluminium phosphate; Al(OH)3, aluminium hydroxide; CHMP, Committee for Human Medicinal Products; ECBS, Expert Committee on Biological Standardisation; HAI, haemagglutination-inhibition; LAIV, live-attenuated influenza vaccine; MN, microneutralization; rg, reverse genetics; SRH, single radial haemolysis; TIV, trivalent inactivated vaccine; VLP, virus-like particle
Article Outline

1. Egg-derived inactivated vaccines

1.1. Alum-adjuvanted, egg-derived, split virion
1.2. Alum-adjuvanted, egg-derived, whole virion
1.3. Oil-in-water adjuvanted, egg-derived, split and subunit vaccines

1.3.1. MF59 adjuvant
1.3.2. AF03 adjuvant
1.3.3. AS03 adjuvant

2. Cell-derived inactivated vaccines

2.1. Non-adjuvanted, whole virion

2.1.1. Vero cells
2.1.2. Primary monkey kidney cells

3. Effects of seasonal vaccines or pre-existing immunity
4. Live-attenuated influenza vaccines

4.1. A/Ann Arbor/6/60-based LAIV for prototype pandemic vaccines

4.1.1. Pre-clinical studies
4.1.2. Clinical studies

4.2. A/Leningrad/134/17/57-based LAIV for H5N1

5. Vaccines developed using new technologies

5.1. NS1-deleted intranasal H5N1 vaccine
5.2. Virus-like particle H5N1 vaccine
5.3. Alum-adjuvanted, virosomal influenza vaccine
5.4. Vaxfectin-formulated H5 DNA vaccine
5.5. M2e-HBc hybrid vaccine

5.5.1. rHA H5 protein vaccine

6. Correlates of protection

6.1. Cellular immune responses
6.2. Serological cross-clade reactivity
6.3. In vitro assay methods

7. Prime-boost strategies: potential use of vaccines in the interpandemic period
8. Regulatory issues

8.1. Evaluation of H5N1 vaccine adjuvants and mixed vaccine strategies
8.2. Development of international standards for H5 antibodies
8.3. Regulatory oversight

9. Conclusions
References


Tel.: +41 22 791 35 91; fax: +41 22 791 48 60.


sociostudent

  • Guest
Ok, in case anyone's interested, I just paid over $30 just so we could read about what squalene does to you...

(copied from the pdf) (and this is definitely "fair use"...I think it's fair to know what the nwo is about to try to forcibly inject people with, ESPECIALLY considering the fact that it's never actually been approved in the U.S.--kinda makes you wonder why, huh? Well, this is why. This article was buried in a pay-only journal article site for a reason--they don't want you to know exactly what's bad about the vaccines. They don't really care if you badmouth the vaccines themselves, because the whole autism thing is a friggin strawman compared to the dangers of the adjuvants being put in these shots. I'm not trying to downplay autism or anything, but speaking from someone who's had autoimmune-related kidney and neurological problems, I'd rather at least have some therapy available--like with autism--but autoimmune disorders aren't really something you can make any better, all you can do is slow it down a bit with steroids and drugs that suppress the immune system--but I digress. Back to the horrific, revealing study...)

Dossier: Autoimmunity and Biotherapy
Autoimmunity induced by adjuvant hydrocarbon
oil components of vaccine


Yoshiki Kuroda a, Dina C. Nacionales a, Jun Akaogi a,Westley H. Reeves a,b, Minoru Satoh a,b,*
a Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Florida, ARB-R2-156,
1600 SW Archer Road, P.O. Box 100221 Gainesville, FL 32610-0221, USA
b Department of Pathology, Immunology, and Laboratory Medicine, University of Florida, Gainesville, FL 32610-0221, USA
Received 26 January 2004
Available online 23 April 2004
Abstract
Adjuvant oils such as Bayol F (Incomplete Freund’s adjuvant: IFA) and squalene (MF59) have been used in human and veterinary vaccines
despite poor understanding of their mechanisms of action.
Several reports suggest an association of vaccination and various autoimmune
diseases, however, few were confirmed epidemiologically and the risk of vaccination for autoimmune diseases has been considered minimal.
Microbial components, not the adjuvant components, are considered to be of primary importance for adverse effects of vaccines. We have
reported that a single intraperitoneal injection of the adjuvant oils pristane, IFA or squalene induces lupus-related autoantibodies to nRNP/Sm
and -Su in non-autoimmune BALB/c mice. Induction of these autoantibodies appeared to be associated with the hydrocarbon’s ability to
induce IL-12, IL-6, and TNF-a, suggesting a relationship with hydrocarbon’s adjuvanticity.Whether this is relevant in human vaccination is
a difficult issue due to the complex effects of vaccines and the fact that immunotoxicological effects vary depending on species, route, dose,
and duration of administration. Nevertheless, the potential of adjuvant hydrocarbon oils to induce autoimmunity has implications in the use of
oil adjuvants in human and veterinary vaccines as well as basic research.

© 2004 Elsevier SAS. All rights reserved.
Keywords: Adjuvant; Autoimmunity; Pristane

1. Introduction
The weak immunogenicity of many foreign antigens can
be overcome through the use of adjuvants [1,2]. Although the
precise mechanisms of action are poorly understood, adjuvants
such as Incomplete Freund’s adjuvant (IFA) or alum
have been used for many years in human and veterinary
vaccination [3,4]. Adjuvants also are used routinely in immunological
research
[2]. Squalene (2,6,10,15,19,23-
hexamethyl-2,6,10,14,18,22-tetracosahexane) is a new adjuvant
oil to replace the mineral oil used in IFA and is the main
component of a new adjuvant, MF59, used in human vaccines
[5,6]. It also is present in TiterMax® (Accurate Chemical&
Scientific Co.,Westbury, NY), an adjuvant widely used
in animal research
[7].
A single intraperitoneal (i.p.) injection of pristane
(2,6,10,14 tetramethylpentadecane) induces a lupus-like syndrome in virtually any strain of mouse [8–10] as well as
plasmacytomas [11] or chronic destructive arthritis in susceptible
strains of mice [12] and rats [13].Pristane is derived
from mineral oil, a byproduct of petroleum distillation. IFA
consists of a mineral oil Bayol F plus the emulsifier ArlacelA
[14]. Although the risk of use in human vaccines is considered
minimal [3], i.p. injection of IFA or its oil component
Bayol F [15] induce plasmacytomas in BALB/c mice as does
pristane [11]. IFA or squalene induces inflammatory arthritis
in susceptible mice and rats [14,16], but it was not known
whether they could induce a lupus-like autoimmunity like
pristane. We have recently reported that a single i.p. administration
of IFA or squalene can precipitate lupus-like autoimmunity
in non-autoimmune BALB/c mice
[17,18]. The
induction of lupus-specific autoantibodies by adjuvant oil
may have implications for the immunization of both humans
and experimental animals.

In this article, we will provide an overview of murine
lupus induced by pristane, the induction of autoimmunity by
adjuvant oils IFA and squalene, and the current understanding
of the risk of autoimmunity with vaccination


...

3. Induction of lupus-related autoantibodies by
adjuvant oils

In our recent reports, the autoimmune responses induced
by two adjuvant oils (IFA, squalene) and medicinal mineral
oils were compared with those induced by pristane [17,18].
Three-month-old female BALB/cJ mice received a single i.p.
injection (0.5 ml) of either pristane, squalene, IFA, medicinalmineral oils (MO-F, MO-HT, MO-S from drug stores and
supermarkets) or phosphate buffered saline. Additional agematched
untreated mice were also used as control.

3.1. Cytokines
Intraperitoneal injection of adjuvant oils is followed by
the influx of inflammatory cells such as macrophages,
T-cells, and B-cells and ultimately granuloma formation in
peritoneal cavity [37]. In vivo cytokine production measured
as cytokine levels in peritoneal lavage fluid indicates that
various types of hydrocarbons including adjuvant oils and
medicinal mineral oils induce IL-12, IL-6, and TNF-a [17].
However, the hydrocarbons that induce lupus-related antinRNP/
Sm and -Su antibodies (pristane, IFA, and squalene)
are associated with in vivo
(peritoneal lavage fluid) and in
vitro
(culture supernatant) production of these cytokines, in
particular IL-12, at early (2 weeks–3 months) time points
when autoantibodies develop
[17] (Fig. 1).



3.2. Hypergammaglobulinemia
Pristane, squalene, and IFA all induced hypergammaglobulinemia
of T-cell dependent isotypes IgG1, IgG2a, and
IgG2b.
However, IgG2a increased less dramatically in squalene or IFA-treated mice than in pristane-treated mice.
IgG1 was increased predominantly in the squalene group
[17,18]. The IgG2a/IgG1 ratios increased markedly in
pristane-treated mice and slightly in the IFA group, but not in
the squalene group [17], suggesting that Th1 cytokine production
was less prominent in the IFA and squalene groups
than in the pristane group.
Although medicinal mineral oils
also induced hypergammaglobulinemia, their effects on
T-cell dependent isotypes were less significant compared
with those of adjuvant oils. T-cell independent isotypes IgM
and IgG3 were often dominant in this group, similar to the
effects of silicone oil [38].

3.3. Antinuclear and anti-cytoplasmic antibodies
Antinuclear and anti-cytoplasmic antibodies in sera from
BALB/cJ mice 3 and 6 months after treatment were examined
by indirect immunofluorescence [18]. Representative
staining patterns by sera from mice 3 months after IFA or
squalene treatment are shown in Fig. 2.
Titers of antinuclear
antibodies in the pristane or IFA -treated mice were higher
than those in the untreated mice at 3 months
(P < 0.01 and
P < 0.05, respectively, Mann–Whitney test) [18]. Titers of
anti-cytoplasmic antibodies were higher in pristane,
squalene, or IFA -treated mice (P < 0.01), and to a lesser
degree in the MO-F group (P < 0.05 vs. untreated group,
Mann–Whitney test) compared with the untreated group.

Although the frequency of antinuclear antibodies (1:80 or
higher) was significantly higher than control only in the
pristane group, anti-cytoplasmic antibodies were more frequent
in pristane, squalene, IFA, and MO-F treated mice

than in controls (P < 0.01–0.05 by Fisher exact test) at
3 months
(Fig. 3) [18].
Data at 6 months were similar to
those at 3 months, however, the anti-cytoplasmic antibodies,
which probably reflect autoantibodies to heat shock
proteins [39], appeared to be less frequent than those at 3 months in the squalene or IFA treated group (Fig. 2). This
suggests that the production of anti-cytoplasmic antibodies
may be an early or less persistent response than other
autoantibody responses.

3.4. Anti-nRNP/Sm and -Su antibodies
Autoantibodies in sera from BALB/c mice 6 months after
treatment were examined by immunoprecipitation [17]


(Figs. 4A and 5). In addition to pristane-treated mice, some
IFA or squalene-treated mice
, but not medicinal mineral oil
treated mice, produced anti-nRNP/Sm and/or anti-Su antibodies
[17] (Fig. 4A). Mice treated with pristane produced
anti-nRNP/Sm (15/24, 63%) or anti-Su (13/24, 54%), and
19/24 (79%) produced at least one of these specificities

(P < 0.001 vs. PBS group by Fisher exact test). Although less
frequent than seen in the pristane group, 20% of the IFAtreated
mice and 25% of squalene-treated mice (P < 0.05 and
P < 0.01 vs. PBS by Fisher exact test, respectively) were
either anti-nRNP/Sm or anti-Su positive, in contrast to the
absence of these antibodies in mice treated with medicinal
mineral oils
[17] (Fig. 5).

In western blotting using affinity
purified U1snRNPs [40], sera from IFA-treated mice reacted
with U1-70K protein (Fig. 4B). Other autoantibodies common
in human lupus such as anti-ribosomal P, -Ro, or La,
were not found [17]. Commercially available medicinal mineral
oils (MO-H, MO-F, MO-S) did not induce these autoantibodies
although some MOs induced anti-chromatin and
-ssDNA antibodies more efficiently than IFA or squalene
[18].
The time course of anti-nRNP/Sm autoantibody production
in IFA vs. pristane-treated mice was compared using
ELISA [41] (Fig. 6).

Two mice started to produce antinRNP/
Sm antibodies 2 months after IFA treatment in this
group. The time of onset and levels were similar to those in
pristane-treated mice [8,9]. The titers of anti-nRNP/Sm antibodies
induced by IFA or squalene were as high as 1.28 × 105
by ELISA, comparable to at least some pristane-induced
antibodies [17]. Two squalene-treated mice started to pro-duce anti-nRNP/Sm antibodies at 3 and 6 months, respectively
(not shown).
None of MO or PBS treated mice had
anti-nRNP/Sm antibodies, in agreement with immunoprecipitation
and western blotting data.
It should be emphasized that the anti-nRNP/Sm and
-Su autoantibodies described in the present study are not
low affinity polyreactive natural autoantibodies, which
typically are detectable only by ELISA[42]. They are
mainly IgG, are not detected in pristane-treated nude mice[/color]
[43] and have titers comparable to those in MRL/lpr mice or
SLE patients[17,37]. They immunoprecipitate a highly restricted
group of proteins from crude cell extracts (Fig. 4A)
and are reactive with particular antigens on western blotting

(Fig. 4B).
3.5. IgG subclasses of anti-nRNP/Sm autoantibodies
Since IFN-c plays a critical role in anti-nRNP/Sm antibody
production [21], IgG subclasses of anti-nRNP/Sm antibodies
were examined using ELISAs (Fig. 7)
to see whether
the IFN-c dependent isotype IgG2a is dominant. IgG subclasses
were tested in 7 sets (3 and 6 months after treatment)
of sera from pristane-treated mice, two sets of IFA treated
sera, and two sets of squalene treated mouse sera. All sera
from the pristane-treated mice had IgG2a-predominant antinRNP/
Sm antibodies. One set of IFA treated sera (C) also
had IgG2a-predominant anti-nRNP/Sm antibodies at 3 (C-
3M) and 6 months (not shown). IgG2b was dominant in the
other mouse (D), especially at 6 months (D-6M). Squalene
induced IgG2a anti-nRNP/Sm antibodies in both mice (E and
F). However, mouse F developed high levels of IgG1 antinRNP/
Sm antibodies between 3 and 6 months, consistent
with the increased total level of the IgG1 in squalene treated
mice
[17,18]. Thus, although anti-nRNP/Sm antibodies usually
were mainly IgG2a, other isotypes such as IgG1 and
IgG2b also were produced, especially in IFA or squalene
treated mice, consistent with less intense skewing towards
Th1 in IFA and squalene-treated mice than pristane-treated
mice.

The predominant increase in IgG1 [17,18] and the switching
of anti-nRNP/Sm antibodies from IgG2a to IgG1 as the
anti-nRNP/Sm antibody response develops, as seen in a
squalene-treated mouse (Fig. 7 mouse F-3M, 6M), may reflect
IL-6 overproduction (Fig. 1) during this period
[17].
3.6. Anti-ssDNA and anti-chromatin antibodies
Levels of IgG anti-ssDNA and anti-chromatin antibodies
were tested (ELISA) at 3 and 6 months after treatment [18].
Squalene or IFA did not induce IgG anti-ssDNA antibodies,
in contrast to the significant induction by pristane or mineral
oils MO-F or MO-S (P < 0.01–0.05, vs. untreated, squalene,
or IFA-treated group). Although IFA induced IgG antichromatin
antibodies, the levels were low (~1–10 units com- pared with hundreds to thousands units by MRL/lpr or
NZB/W F1 mouse sera) and squalene did not induce significant
levels of anti-chromatin antibodies
[18]. These data
suggest that different types of hydrocarbons may induce
different types of autoantibodies.

Immune responses induced by pristane, adjuvant oils,
medicinal mineral oils, and silicon oil are summarized in
Table 1. 4. Mechanisms of action of hydrocarbon oil adjuvants
Although the precise mechanisms of action are poorly
understood, adjuvants have been used for many years in
human and veterinary vaccination
[3,4,44]. Adjuvants also
play an essential role in basic research while being called
“immunologist’s dirty little secret”, for without them most
investigations of experimental autoimmunization, would be
impossible
[2,45].
Several recent articles have revisited the mode of action of
adjuvants in an effort to reclassify them based on their potential
mechanisms of action [44,46–48]. Cox and Coulter [44]
classified the modes of action of adjuvants as; (1) immunomodulation
(modification of the cytokine network), (2) presentation
(preserve conformational integrity and present this
to immune effector cells), (3) CTL induction, (4) targeting
(delivery of an immunogen to immune effector cells), and (5)
depot generation. IFA and squalene tested in the present
study are particulate adjuvants, which exist as microscopic
particles and owe at least some of their adjuvant activity to
this property. These water-in oil emulsions mainly act via
immunomodulation and depot effects
[44].
The effects of IFA are somewhat confusing and appear to
have different effects depending on the systems used. Immunization
with an autoantigen in IFA can induce tolerance
while the same antigen in CFA induces autoimmune disease
[49]. While IFA, pristane, squalene, or hexadecane itself
induces chronic arthritis
[12,50], they prevent CFA-induced
adjuvant arthritis
[51]. ....
A recent study using squalene-based adjuvant MF59 emphasized
an importance of macrophage trafficking and apoptosis
and suggested that dendritic cells acquire antigen and
adjuvant by uptake of the apoptotic macrophages
[53]. Another
study showed that adjuvant enhanced survival of bone
marrow-derived macrophages and even induced DNA synthesis

[54]. Recent advances in understanding the biological
functions and ligands of toll-like receptors (TLR) revealed
that many agents considered as adjuvants induce cytokine
production via interactions with TLRs [55]; monophosphoryl
lipidA (MLA) and other lipidA mimetics via TLR4, poly
I:C via TLR3, and CpG DNA via TLR9. Stimulation of
different TLRs lead to dendritic cell maturation and induction
of distinct Th responses [55].
5. Use of hydrocarbon oil adjuvant in vaccines
Squalene-based MF59 and alum are currently the only
adjuvants used in FDA-approved commercial vaccines
[5].
IFA is an effective and relatively safe adjuvant and was used
extensively in the past for influenza, poliomyelitis, and other
vaccines
[3,4]. The side effects appeared to be minimal and
only local side effects such as cysts or abscess formation
were confirmed. Association with autoimmune diseases or
cancer has not been confirmed epidemiologically
[3,56].
However, the risk/benefit ratio was still considered high and
IFA is not currently used for commercial vaccines in healthy
individuals [4]. Nevertheless, IFA still has been actively used
in development of vaccines for patients with aggressive diseases
such as HIV, melanoma, human papillomavirus positive
gynecological neoplasia, and multiple sclerosis
[57].
Squalene is a component of MF59 and other new adjuvants
that have been used as adjuvants in influenza, HBV, HSV,
HIV, and CMV vaccines
[4,6].Both of these have been
widely used in veterinary vaccines as well.


6. Vaccination and autoimmunity
Regarding the effects of vaccination on autoimmunity,
there are two aspects to be considered: the induction de novo
of autoimmune disease, and the exacerbation of existing
autoimmune disorders
[58].
6.1. Vaccine-induced autoimmunity in animals
Various types of autoimmune diseases such as autoimmune
hemolytic anemia, immune thrombocytopenia, and the
immune-mediated polyarthritis syndrome, which usually occurs
between 30 and 45 days after vaccination, have been
reported in veterinary vaccination
[59]. However, only a few
studies had an appropriate control or yielded statistically
significant results. There are few studies specifically examining
autoimmune responses after vaccination. In one, development
of autoantibodies to laminin and fibronectin in the
dog following vaccination, possibly due to contamination of
bovine serum proteins in a vaccine preparation, has been
described
[60].

6.2. Vaccine-induced autoimmunity in humans
Local side effects of oil adjuvants include reactions at
injection site characterized by acute or subacute tissue damage,
or later granulomatous reaction. Diverse autoimmune
diseases such as autoimmune type I diabetes, multiple sclerosis,
and Guillain-Barre syndrome
following vaccination
have been reported, though this has generated much controversy

[61–63].
Older et al. [64] reviewed cases of post-immunization
systemic rheumatic diseases, including SLE, rheumatoid arthritis
(RA), dermatomyositis, polyarteritis nodosa, and Reiter’s
syndrome.
The common characteristics found were (1)
the development of symptoms approximately 1–3 weeks of
secondary immunization when the boosted immune response
is at its peak, (2) except for the limited association of tetanus
toxoid and hepatitis B with RA, the vaccine type and class
(live or killed) bear no correlation with the resultant rheumatic
disease, (3) involvement of multiple or combination
vaccines as well as single agent vaccines are involved
[64].
There are other case reports and retrospective studies on RA,
SLE and other rheumatic disorders that developed after hepatitis
B vaccination [65,66]. Although, no evidence supporting
the association of hepatitis B vaccination and SLE was found
epidemiologically in one study [67], additional studies will
be required.

A rare long-term mortality follow-up study of army recruits
who received influenza virus vaccine with IFA showed
no evidence of increased collagen or allergic diseases
[56].
Despite numerous case reports on vaccination induced autoimmunity,
most epidemiological studies failed to confirm
the association and the risk appears to be extremely low or
non-existent
[63].[ Nevertheless, the possibility that certain
vaccines can induce or exacerbate autoimmunity, at least in a
few susceptible patients, has not been completely ruled out

[62].

6.3. Vaccination in patients with lupus
As in vaccination of healthy individuals, both microbial
products and adjuvants may have effects on autoimmune
diseases. Human and murine lupus are heterogeneous syndromes
affected by both genetic and environmental factors.

In animal models, microbial products such as LPS accelerate
lupus in NZB/W F1 and MRL/lpr mice
[68]. The adjuvant oil
pristane accelerates lupus in NZB/W F1 [34], MRL+/+ (A.
Mizutani et al., submitted), and BXSB (H. Yoshida et al.,
unpublished) mice, but not in MRL/lpr mice, suggesting that
it can trigger lupus in genetically susceptible host or exacerbate
established lupus.
Immunization of SLE patients with pneumococcal
polysaccharide, influenza, recombinant hepatitis B, Haemophilus
influenza type B (HIB), tetanus toxoid, and other
vaccines has been well tolerated in general
[64,69]. In a few
controlled studies on flare of lupus after vaccination in human,
they concluded that there is no difference in flare-up
between vaccinated group vs. control [70,71]. One study on
poliomyelitis vaccine claimed that lupus flare was more
common in the vaccinated group
[72], however, this may
reflect an unusually low frequency of flare in the control
group (no flares in 37 controls for 3-month period) in this
study.Some studied the effects of vaccination on activity of
SLE based on short-term (1–3 months) observation
[73,74].
Although there is no information regarding the duration of
acceptable observation period, 1–3 months may not be long
enough for the purpose, considering that it takes 2–6 months
for adjuvant oils to induce lupus autoantibodies in mice
[8,9,34] and that the oil-induced granulomatous inflammation
can last for years.


(6.4 coming up)

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6.4. Autoimmunity induced by vaccines and adjuvant oils
An important factor to consider in vaccine-induced autoimmunity
is the fact that vaccines contain a microbial
component (or other type of antigens) and adjuvant
[75].
Differentiating adverse reactions caused by these two factors
is often difficult, or it can even be a result of the combination
of both. Nevertheless, the microbial components are generally
considered responsible for adverse reactions and minimum attention has been paid to the potential effects of the
adjuvant component
.
Molecular mimicry of a microbial antigen
in a vaccine and a host tissue self-antigen is often considered
important [61]. Immune complexes also may be
formed following vaccination [61,76], deposit in vascular
endothelium and induce vasculitis
. Induction of cytokines or
shifting cytokine balance may also play an important role.
Predisposing environmental factors such as the dose and time
of vaccination, the age, concurring infections or latent ongoing
autoimmune disease, are also likely to be critical factors

[62]. Like idiopathic autoimmune diseases, genetic factors
also may be important for certain syndrome.

Although adjuvant effects are not usually considered of
primary importance for vaccine-induced autoimmunity, it
has been pointed out that the adjuvants, not the microbial
components of the vaccine, might be responsible for autoimmune
phenomena
[61]. Adjuvant induces polyclonal activation
of B-cells and increased production of natural autoantibodies
or preexisting autoantibodies
[77]. However, the
lupus autoantibodies reported here are clearly not the low
affinity natural autoantibodies suggested by this mechanism
(see Section 3.5). Even in the absence of antigens, IFA or
squalene can induce autoimmunity in animals
, as illustrated
by the development of autoimmune hepatitis in mice injected
with IFA [78] or induction of chronic autoimmune arthritis
by IFA or squalene in rodents[14,16].

The possibility that cytokine shifts toward Th2 might be
responsible for the mysterious Gulf war veterans’ syndrome
has been considered [79]. Some studies focused on possible
immunotoxicological effects of squalene adjuvants and described
the presence of antibodies to squalene among individuals
who received anthrax vaccine, but this is quite controversial

[80].

7. Mechanisms of adjuvant oil-induced lupus

Both IFA and medicinal mineral oils are heterogeneous
mixtures of various hydrocarbons
[18]. There are several
possible explanations for the induction of autoantibodies to
nRNP/Sm and -Su by IFA but not mineral oils
[17]. It is
possible that the emulsifier added to IFA,ArlacelA, enhances
the immune response [50] and contributes to the induction of
autoimmunity. However, the induction of the same set of
autoantibodies by highly purified pristane, squalene [17], and
hexadecane (Y. Kuroda, manuscript in preparation), which
contain no Arlacel A, argues strongly against this possibility.

Another possibility is that the amount of pristane in the oil is
the critical factor. IFA contains 9–67-fold more pristane than
the medicinal oils, but total pristane content of the former
was only 0.17% [18]. Although it is possible that trace
amounts of pristane are sufficient to induce lupus-related
autoantibodies, a more likely explanation is that there are
many components in mineral oil that can induce lupusrelated
autoantibodies. Induction of lupus-related autoanti-bodies by at least three pure hydrocarbon oils, pristane,
squalene, and hexadecane (Y. Kuroda, manuscript in preparation)
supports this possibility
[17,18].
What biochemical characteristic is associated with the
ability to induce IgG anti-nRNP/Sm and -Su autoantibodies
is an important question. It is possible that the ability to
induce lupus autoantibodies correlates with adjuvanticity of
the oil. Intermediate length hydrocarbons (C15–C20) are
shown to have high adjuvant activity [14]. IFA consists
mainly of more inflammatory C15–C25 hydrocarbons compared
with C25–C35 hydrocarbons in MOs [18]. The long
average chain length of MOs may explain the absence of
anti-nRNP/Sm and Su autoantibodies in mice treated with
MOs compared with pristane or IFA.However, another active
adjuvant hydrocarbon, squalene, is a C30 hydrocarbon
[6] yet retains the capacity to promote autoimmunity. Therefore,
it is likely that other physical characteristics such as
viscosity, density, carbon type (i.e. cyclo-, iso-, or straight
carbon), or sulfur content [81] could influence different biological
activities. The identification of factors influencing the
potency of different mineral oil preparations in the induction
of lupus autoantibodies may provide important clues to identify
safe adjuvants.

...
Spontaneous proliferation of macrophages from mice treated with
pristane and other hydrocarbon oils and survival for prolonged
periods in vitro without stimulation (M. Satoh et al.,
unpublished) may be an important feature for autoimmunity.

Aberrant APC functions such as impaired phagocytosis, apoptosis,
proliferation, or overproduction of IL-12 and other
cytokines by activated APCs stimulated by oil adjuvant, may
be a primary pathogenic mechanism in hydrocarbon oil-induced
lupus.

Recent studies indicated that many agents considered as
adjuvants, are ligands of TLRs and induce cytokine production
via TLRs
[55]. In pristane-induced lupus, autoantibody
production was diminished in TLR4 mutant C3H/HeJ mice
[27]. However, it is not known whether the immunological
effects of pristane, IFA or squalene directly involve TLRs.
Further studies on the role of TLRs in adjuvant oil-induced
autoimmunity are under way in our laboratory.

Injection of adjuvant oil induces inflammation and apoptosis
in tissues
[53].Therefore, what is happening in hydrocarbon
oil injected mice can be similar to immunizing animals
with apoptotic cells
[87]. Selection of a highly restricted
set of antigens as targets of autoimmunity due to non-specific
inflammation is another question that needs to be addressed.
Induction of anti-nRNP/Sm and -ribosomal P, specificities
found in pristane-treated mice, by immunization of whole
apoptotic cells has been reported [87]. Modification of certain
self-antigens [88] that occur during adjuvant-induced
inflammation and apoptosis, either as direct or indirect effects
of hydrocarbons, along with genetic factors may determine
the autoantibody specificity.


8. Human exposure to mineral hydrocarbons
Humans are exposed to various types of hydrocarbons by
various routes including, oral (dietary, medicine), inhalation
(air pollution, oil mist in work environment), and cutaneous
(cosmetics, contact with mineral oil in work environment)
[81,89,90].
Excellent reviews on dietary exposure to mineral
hydrocarbons from food-use applications are available
[91,92]. Food contamination can be via a direct route such as
coatings of food products (cheese, fruits, vegetables), grains
de-dusting, confectionary, chewing-gum base, and baking
applications (divider oils, pan-release oils). Mineral hydrocarbons
can also contaminate food indirectly via corrugated
cartons, polystyrene, adhesives, and food-grade lubricants.
The sum of these is estimated 1–2 mg/kg/day (20–50 g/year)
[92]. In addition to hydrocarbons found in foods, many
individual takes pure hydrocarbon oil (medicinal mineral oil)
available at drug stores and supermarkets as an intestinal
lubricant [93]. The standard dose is as much as 15–30 g/day.
It is well known that ingested hydrocarbons are absorbed and
cause lipogranulomas (follicular lipidosis) seen in the liver,
spleen, and lymph nodes of healthy individuals in industrial
countries
[94]. In addition to dietary exposure, oil mist in the
work place, diesel exhaust, gasoline, jet fuel or other petroleum
products, are also common. In particular, health concerns
related to inhalation and skin exposure to jet fuels are
drawing considerable attention recently [90].
Although the risk of vaccination with hydrocarbon adjuvant
in humans appears to be low, at least with the small
quantities of oil administered in vaccines [56], accidental or
deliberate human inoculation of mineral oil is associated
with severe local and systemic effects
[95]. It has been
suggested that individuals injected with mineral or paraffinoil for cosmetic purposes are at increased risk of developing
systemic autoimmunity [96,97], an idea consistent with the
present data in mice.
A possible association between hydrocarbon
exposure and glomerulonephritis and Goodpasture’s
syndrome also has been suggested
[89].
Humans are heavily exposed daily to various types of
hydrocarbons, many of which may have adjuvant activity and
the ability to induce lupus-related autoantibodies. Evaluating
hydrocarbon exposure in each individual is not easy but an
appropriate epidemiological study may help to define the
pathological significance of hydrocarbon exposure.

9. Significance of adjuvant oil-induced autoimmunity
Although less than the frequency observed in pristanetreated
mice, the induction of lupus-related autoantibodies to
nRNP/Sm and -Su in ~25% of IFA or squalene-treated mice
is significant by itself, considering the fact that these substances
are used as adjuvants in human and veterinary medicine
[4,6], as well as in basic immunology research
[2].

Induction of autoimmunity by squalene is of particular
interest since it is an endogenous lipid abundant in serum and
a normal precursor of cholesterol and steroid hormones
[6].
Squalene has been used as a dietary supplement and is found
in cosmetics in Asian countries despite reported cases of
lipoid pneumonia due to its aspiration
[98]. Although generally
considered to be inert, endogenous lipids such as
squalene or intestinal adipose tissue have strong adjuvant
effects in the rat arthritis model
[99]. The present study
clearly showed that the endogenous lipid squalene could
induce lupus autoantibodies in normal mice.
Recent studies
suggest that various endogenous products such as heat shock
proteins can stimulate APCs via TLRs and can work as
adjuvants [55]. How and under what conditions such endogenous
adjuvants cause inflammation or immune stimulation
needs to be addressed in future studies.
Induction of autoimmunity by adjuvants also has implications
in basic research since adjuvants are essential for experimental
immunization
[2]. There are reports of the induction
of autoantibodies to lupus antigens in animals
immunized with peptides or proteins emulsified in Freund’s
adjuvants [100]. A common feature is the “spreading” of
autoimmunity to additional epitopes not carried by the immunizing
peptide. An idiotype–anti-idiotype mechanism has
been postulated as the mechanism of anti-nRNP/Sm antibody
production in another model of lupus in which mice are
immunized with monoclonal antibodies in CFA/IFA [101].
The induction of autoantibodies by adjuvant oil itself (IFA or
squalene) points out the need for caution in interpreting
studies in which antigens emulsified in adjuvant oil induce
the lupus-related autoantibodies such as snRNPs or chromatin.

The detection of autoantibodies suggestive of a systemic
autoimmune reaction has been successful with very few
compounds only, most often in non-conventional strains of
mice [102]. Hydrocarbon-induced autoimmunity is the only
model in which disease specific high affinity autoantibodies
such as anti-Sm and -ribosomal P are induced in a wide
variety of standard strains in the absence of immunizing
antigens. This model should be helpful to study the mechanisms
of autoimmunity and the role of environmental chemicals
in lupus.


10. Immunotoxicity testing of vaccines for
autoimmunity

In addition to the fact that vaccines contain microbial
products and adjuvant, the main challenge in establishing a
predictive safety assessment comes from the fact that vaccines
act through a highly complex, multistage mechanism in
which the vaccine by itself is not the final triggering component
[58].Vaccine induced antibodies or activated T-cells are
the actual effectors. Considering this multi-level interaction
between the organism and the vaccine, five distinct categories
of toxicological effects can be identified and appropriate
investigations need to be designed accordingly. (1) Direct
toxicity of vaccine components, (2) toxicity linked to the
pharmacodynamic activity, (3) the adverse response related
to the activation of pre-existing biological processes, (4)
toxicity of contaminants and impurities, (5) adverse reactions
due to the interaction between the various vaccine
components [58]. In the past, induction of autoimmunity by
vaccines has been hypothesized to relate mainly or exclusively
to the microbial component. However, our data suggest
that the direct or indirect effects of adjuvant need to be
carefully evaluated in vaccine development.

Animal models remain the best option for mimicking the
human situation in toxicological studies, however, a critical
challenge is the identification of the “relevant” animal models.
The species specificity of the immune function is frequently
mentioned as being a major obstacle to safety assessment
of vaccines in animals before proceeding to trials in
man [58]. Responses in animals vary according to genetic
influence and extrapolation to humans is often difficult. IFA
induces adjuvant arthritis in rodents but no association of IFA
and arthritis was confirmed in humans
. Interestingly, the
species specificity of mercuric chloride’s effects on the immune
system illustrates the difficulty in extrapolating animal
data to human [103].
Differences in the effects of vaccine components depending
on the route and dose are additional factors. Aminocarb is
known to have different effects with the strongest effects via
i.p. injection. In contrast, mercuric chloride can induce antinucleolar
autoantibodies in susceptible strains of mice when
given either subcutaneously, i.p., or orally
[104]. Another
limitation in animals is the difficulty evaluating long-term
chronic effects. Some chemicals may have long-term effects
over many years, which may be difficult to evaluate in mice
over 2 years.
It has been pointed out that rare but serious adverse reactions
of vaccination are difficult to detect due to a lack of statistical power
[105]. Even if vaccination in humans is
associated with lupus, it is not clear how long it will take and
what genetic predisposing factors might be involved.A longterm
observation of a large number of subjects like the one
performed in army recruits who received influenza vaccine
containing IFA [56], will be ideal but practically not easy.
The Environmental Disease Study Group of the American
College of Rheumatology (ACR) has suggested an orderly
and staged process based on current paradigms in toxicology,
epidemiology, and epistemology [106]; Stage 1, proposing
the association, Stage 2, testing the association, Stage 3,
defining the disorder, and Stage 4, refining the disorder.
Despite the numerous reports of vaccine-induced autoimmunity,
evaluation of adverse reactions is a highly complex
process. A combination of basic animal research and careful
clinical and epidemiological studies should offer us a better
understanding of the truth in vaccine-induced autoimmunity.


11. Summary and conclusion
Our data suggest that an i.p. injection of adjuvant hydrocarbon
oils, a chronic, non-specific inflammatory stimulus,
can trigger the production of a highly restricted subset of
autoantibodies usually associated only with lupus. This may
help in understanding the significance of human exposure to
hydrocarbons and it also suggests that caution must be used
when adjuvants are used in research studies focusing on
autoimmunity. It will be of interest to examine in the future
how the unremitting, non-specific, inflammation induced by
hydrocarbon oils, generates such a highly restricted subset of
autoantibodies associated with lupus.
The answer to this
question may provide insight as to why the same subset of
autoantibodies is produced by lupus patients.
Acknowledgements
This study was supported by NIH grants R21-AR050661,
R01-AR44731 and AI44074
. We thank Minna Honkanen-
Scott for technical assistance. This material is the result of
work supported with resources and the use of facilities at the
Malcom Randall VA Medical Center, Gainesville, FL.

(References next)


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sociostudent

  • Guest
http://home.att.net/~dstormmom/metcalf.htm

[Submitted courtesy DSNurse]
For Immediate release
Contact Norma Smith/Chris Strow

Congressman Jack Metcalf announced to a House Committee investigating Gulf War illnesses today that he has issued a report stating that squalene, a substance in unapproved vaccine adjuvant formulations, was found in the anthrax vaccine in amounts that could boost immune response---raising the possibility that squalene was used in innoculations given to gulf War era vets. GAO science investigators have documented concerns regarding the use of novel adjuvant formulations in vaccines, including squalene.

Metcalf compiled the report over a three year period, putting together a team led by his special Assistant,Norma Smith. It contains a series of documented conclusions, and an extensive compilation of supporting documents.

Congressman Metclaf's statement to the House Subcommittee on National Security,Veterans Affairs, and International Relations.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Executive Summary

Congressman Jack Metcalf has issued a report culminating a three year investigation into the conduct of the DOD (Department of Defense) with regard to the possibility that squalene, a substance in vaccine adjuvant formulations not approved by the FDA, was used in inoculations given to Gulf War era service personnel. According to the GAO (General Accounting Office), scientists have expressed safety concerns regarding the use of novel adjuvant formulations in vaccines, including squalene.

The report reveals that the FDA has found trace amounts of scalene in the anthrax vaccine. The amounts recorded are enough to "boost immune response," according to immunology professor Dr. Dorothy Lewis of Baylor University. Therefore, the report concludes that immediate action should be taken to halt the current AVIP (Anthrax Vaccination Immunization Program). It further states that an aggressive investigation must be undertaken to determine the source of the squalene, and the potential health consequences to those who have been vaccinated, both during and after the Gulf War.

The report also documents at length DOD "stonewalling" attempts to resolve this issue, which GAO investigators characterized as "a pattern of deception." The GAO stated the DOD denied conducting extensive squalene testing before the Gulf War, then admitted it after being confronted with the public record. The GAO revealed that DOD officials deliberating deployment of the anthrax vaccine expressed a "willingness to jump out and, use everything:" in discussing experimental vaccines containing adjuvants not approved by the FDA.

GAO also found Peter Collis, DOD official who headed vaccine efforts, refused to cooperate with them. The report states that the DOD has refused to act in good faith upon the GAO recommendation to replicate the findings of a test developed by renowned virologist Dr. Robert Gary of Tulane University, although DOD admitted they could easily do so. The work of theTulane researchers has been peer-reviewed in a scientific publication of high standing.

Finally, the report states that "Congress should take immediate action to review the findings of the GAO and the Armed Services Epidemiological Board, and provide independent oversight for the immediate implementation of their recommendations. "The board called on the DOD to engage in close cooperation with the Tulane researchers.

Congressman Metcalf believes it is clearly within the oversight responsibility of the Congress to get to the bottom of the labyrinth that has become known as "GulfWar Illnesses." We have an obligation to pursue the truth, wherever it may lead us. To do less would be to act dishonorably reward the dedicated men and women who stand between us and a dangerous world, willing to die if necessary to defend our nation.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Table of Contents

Page

1             The Request For Investigation

2             Section One            The Investigation: A Pattern of Deception

7             Section Two            The Stonewalling and Obfuscation

11           Section Three        FDA Testing Reveals Squalene in Anthrax Vaccine

12          Conclusion

13          Footnotes

Appendix 24  -  Appendix 25  -  Appendix 26

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sociostudent

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http://snardfarker.ning.com/profiles/blogs/squalene-a-history-of-vaccine

 
Squalene - A History Of Vaccine Development And The Newest Adjuvant
Posted by Jeff on June 15, 2009 at 11:33am

Fish oil vaccine adjuvant programs bodies for "endless loop of self-destruction"

by The Idaho Observer

It’s a race—will we all be injected with substances that program our own bodies to attack us before or after we realize that the newest weapon in the New World arsenal is our own immune system?

The theory that vaccines prevent the spread of infectious disease is based upon the belief that, by injecting a small amount of a disease into the body, it will develop "antibodies" that will prevent the injected person from contracting the disease against which he had been vaccinated.

The theory is complicated by the fact that attenuated doses of pathogens alone will not initiate an "antigenic response." So, vaccines contain compounds known as "adjuvants" to intensify the body’s immune response.

Traditional adjuvants are alum (aluminum hydroxide), and thimerosal—which is 50 percent ethyl mercury and also serves as a vaccine "preservative."

According to Edda West, "A quick read of the scientific literature reveals that the neurotoxic effects of aluminum were recognized 100 years ago."

The neurotoxic affects of mercury are likewise not a secret and have been documented extensively in the scientific and medical literature since the mid-1800s.

More recently, aluminum has been linked to Alzheimer’s disease and other neurological disorders. Recent medical literature shows that statistically significant numbers of kidney patients and intravenously-fed infants exposed to aluminum suffer neurological complications. Other research shows that pain from muscle diseases is also linked to the presence of aluminum in the body.


Dr. Boyd Haley found that vaccines containing both aluminum and mercury greatly magnify the neurotoxic result of vaccination.

Most people understand that both aluminum and mercury are toxic. It is our body’s reaction to toxic exposure that vaccine advocates measure to determine vaccine efficacy. That elevated levels of mercury and aluminum can cause side-effects worse than the disease is not a consideration for most pro-vaccinators.

The new wave

West, who is director of the Vaccine Risk Awareness Network in Winlaw, BC, Canada, published the comprehensive, well-footnoted article "A Look into the Scary World of Vaccine Adjuvants." The article explains that modern, synthetic or recombinant vaccines are "purer" and less toxic to the body than their live and dead virus predecessors and, therefore, require more potent adjuvants to illicit an immune response. "This has created a major need for improved and more powerful adjuvants for use in these vaccines," the article, Vaccine Adjuvants: current state and future trends, published in the medical journal "Immunology and Cell Biology" stated.

Under this line of logic, alum is scheduled to be phased out and replaced with oil-based adjuvants such as squalene—an essential fatty acid derived from fish.

Squalene

"The most effective adjuvants are formulated with oils but have long been considered too reactive for use in humans. Immunologists have known for decades that a microscopic dose of even a few molecules of adjuvant injected into the body can cause disturbances in the immune system and have known since the 1930s that oil-based adjuvants are particularly dangerous, which is why their use has been restricted to experiments with animals," West wrote.

The following (in italics) is from West’s article. Keep in mind that the FDA determined that squalene was present in varying amounts in specific lots of anthrax vaccine administered to tens of thousands of Desert Storm personnel (without their informed consent). Not surprisingly, tens of thousands of Desert Storm veterans have suffered permanent neurological damage and exhibit symptoms commonly referred to as "Gulf War Illness."

"The classic oil-based adjuvant called Freund’s Complete Adjuvant can cause permanent organ damage and irreversible disease – specifically autoimmune diseases. When scientists want to induce autoimmune disease in a lab animal, they inject it with Freund’s Complete Adjuvant, which causes great suffering and is considered by some too inhumane to even inject into animals.

"Dr. Jules Freund, creator of this oil-based adjuvant, warned in 1956 that animals injected with his formulation developed terrible, incurable conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of MS), allergic neuritis (inflammation of the nerves that can lead to paralysis) and other severe autoimmune disorders.

"Adjuvants can break ‘tolerance,’ meaning they can disable the immune system to the degree that it loses its ability to distinguish what is ‘self’ from what is foreign. Normally, the immune system ignores the constituents of one’s own body. Immunologists call this ‘tolerance.’ But if something happens to break tolerance, then the immune system turns relentlessly self-destructive, attacking the body it is supposed to defend."


For national security

The issue becomes more complicated with oil-based adjuvants that resemble oils found in the human body. West reported that seasoned journalist Gary Matsumoto found evidence to suggest that, "…when an oil is injected, the immune system responds to it not only specifically, but with heightened intensity because the oil adjuvant resembles so closely the natural oils found in the body. A ‘cross reaction’ then happens, sending the immune system into chaos destroying any oils found anywhere in the body that resemble the adjuvant oil. Demyelinating diseases like multiple sclerosis are an example of this destructive autoimmune process."

Matsumoto’s impeccably-referenced and footnoted book is entitled, "Vaccine A-The Covert Government Experiment That’s Killing our Soldiers and Why GI’s are Only the First Victims." West noted that Matsumoto, who was the first journalist to break the story of squalene-containing anthrax vaccine’s link to Gulf War Illness, documented decades of secret medical experimentation on Americans without their knowledge or consent. "The unethical experiments detailed in this book are ongoing, with little prospect of being self-limiting because they have been shielded from scrutiny and public accountability by national security concerns," wrote Matsumoto.

Biological time bomb

Squalene is an oil that is readily digestible if taken orally. However, it behaves much differently when injected. Matsumoto cites data from more than two dozen peer-reviewed scientific papers from 10 labs located in countries all over the world that document how squalene-based adjuvants can trigger the development of autoimmune diseases in lab rats, mice, guinea pigs and rabbits.

Regardless of the known toxic effects on animals and the toxic effects on humans as experienced with squalene-containing vaccines given to Desert Storm personnel, Matsumoto claims, "Squalene adjuvants are a key ingredient in a whole new generation of vaccines intended for mass immunization around the globe."

Among the chronic conditions observed in human and animal test subjects injected with squalene are rheumatoid arthritis, multiple sclerosis and lupus.

In her article, "The Adverse Effects of Adjuvants in Vaccines" (Nexus Magazine Dec. 2000), Australian vaccine researcher Viera Scheibner, Ph.D., lists the autoimmune diseases that have been linked to squalene injections in humans—arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS (amyotrophic lateral sclerosis) also known as Lou Gehrig’s disease, Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhoea, night sweats and low-grade fevers.

But that, believe it or not, is the good news because it merely describes squalene’s experimental contribution to global epidemics of chronic autoimmune dysfunction. Once it becomes a common ingredient in vaccines (already, the squalene-based adjuvant MF59 is a component of the Italian flu vaccine FLAUD), it will be best described as a biological time bomb.

Our own worst enemy

From Edda West: "The immune system does in fact ‘see’ squalene and recognizes it as an oil molecule native to the body. The key is ‘route of administration.’ As Gary Matsumoto says, ‘Squalene is not just a molecule found in a knee or elbow – it is found throughout the nervous system and the brain.’ When it is injected into the body, the immune system sees it as an enemy to be attacked and eliminated.

"As any immunologist will tell you, the way an antigen encounters the immune system makes all the difference. You can eat squalene – no problem as it is an oil the body can easily digest. But studies in animals and humans show that injecting squalene will ‘galvanize' the immune system into attacking it, which can produce a self-destructive cross reaction against the same molecule in the places where it occurs naturally in the body – and where it is critical to the health of the nervous system.’

"This phenomenon is also known as ‘molecular mimicry,’ where the immune system forms antibodies against one of its own structures and will continue to attack the ‘self’ molecule in the body that resembles the one in the germ, or as is the case with squalene, an identical substance that is naturally present in the body. Once this self-destructive process begins, it never stops as the body continues to make the molecule the immune system is now trained to attack.

"Another example involving autoimmune ‘molecular mimicry’ is when the immune system has been sensitized to attack myelin, the insulating fatty coating around nerve fibres which insures the smooth relay of nerve signals. The body would continue to make myelin in order to replenish and repair the protective sheath around its nerve endings. But , says Matsumoto, ‘In the act of doing so, the body immunizes itself against itself, administering over and over again what amounts to a booster dose of something that the immune system now wants to get rid of. This vital constituent (myelin) is now the enemy, and the immune system is now programmed to obliterate it in an endless loop of self-destruction—the process involved in MS (multiple sclerosis), and ALS (Lou Gehrig’s disease).

"Squalene is a kind of trigger for the real biological weapon: The immune system. When the immune system’s full repertoire of cells and antibodies start attacking the tissues they are supposed to protect, the results can be catastrophic," wrote Matsumoto. Dr. Pam Asa concurs with Matsumoto when she stated,"Oil adjuvants are the most insidious chemical weapon ever devised."

West continues, "The main proponents for the use of squalene in vaccines have been the U.S Department of Defense and the NIH. The anti-squalene antibodies found in sick American and British military personnel are evidence that military experimentation has caused an unprecedented health catastrophe in tens of thousands of people onto whom the vaccine was forced and who were denied the right to make an informed decision based on existing scientific knowledge of the dangers of injecting squalene."

Based upon decades of research in animals and humans, once oil-based adjuvants become the most common adjuvant contained in vaccines, there will be no way the pharmaceutical industry will be able to claim mass vaccination is necessary to prevent the spread of infectious diseases—it will be an open declaration of war on mankind. "By adding squalene to their new anthrax vaccine, they did not make a better vaccine, they made a biological weapon," Matsumoto observed.
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sociostudent

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Novartis investigational adjuvanted (MF59) pre-pandemic avian influenza vaccine Aflunov® shows long lasting, broadly cross-prote
Published on 30 April 2009, 03:25 Last Update: 3 month(s) ago by Insciences
Tags: Aflunov H5N1 MF59 Pharmaceutical Science Pre-pandemic avian influenza vaccine Vaccines
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    * - Aflunov® study published in PNAS demonstrated long-lasting immune memory of investigational MF59® adjuvanted pre-pandemic avian vaccine in adults up to seven years after vaccination

          o - Data suggests MF59 provides cross-protection for flu strain variations not contained in initial vaccine formulation (Ok, this is just stupid now....i'm sorry, I'm just lmao at how they've gotten the last, what, 6 YEARS wrong on the flu strain, and they've finally figured out how to get away with not even trying but still sounding "scientific" and like you're really on top of things, lol. Ok, I'm sorry, I'm done. I just think it's kind of f'd up that they're trying to say that the "most insidious biological weapon ever created"--MF59, or squalene, is going to "provide cross-protection for flu strain variations NOT contained in the initial vaccine" and sell even more of their poison)

          o - Other Phase II studies reinforce safety and tolerability of the adjuvanted vaccine in children aged 6 months to 17 years[1] :(

 
Basel, April 30 2009 - A study published this week in the Proceedings of the National Academy of Sciences of the United States of America shows that Aflunov®, the Novartis investigational pre-pandemic avian influenza vaccine formulated with Novartis' proprietary MF59® adjuvant, can elicit a broadly cross-reactive immune response covering all known H5N1 antigenic variants, even when that booster dose is administered six years after the initial priming dose.
 
The data show that the Novartis investigational adjuvanted vaccine elicited a long-lasting immune response that could be rapidly boosted following a single dose of the vaccine. This may provide public health officials additional flexibility to help protect citizens well in advance of an avian influenza pandemic. The study also showed that the adjuvanted vaccine created an immune memory not only against the H5N1 strain contained in the vaccine but also provided cross-protection against several other H5N1 strains.

(Not saying a word, moving on >:(....What's the definition of a snake oil salesman, again?  ::) )
 

"These data reinforce the potentially broad applicability of the MF59 adjuvant [/u]and the role it can play in pandemic preparedness efforts around the world," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "Cross-reactivity is an important element for a pre-pandemic vaccine given that variations are a common feature of emerging influenza strains. We will use these new insights, as well as our strong leadership position in cell based flu manufacturing, as part of our efforts to develop a vaccine against the current swine flu outbreak."

"The findings published about the H5N1 vaccine suggest a way forward for the present swine flu outbreak, " added Rino Rappuoli, Head of Research at Novartis Vaccines. "We are working closely with the World Health Organization, U.S. Centers for Disease Control and Prevention (CDC), PAHO and other government agencies worldwide on developing a strong and effective response to the outbreak."
 
These data are part of several new studies presented this week at the Third International Conference on Influenza Vaccines for the World (IVW) in Cannes, France. Selected Aflunov data were previously presented in September 2008 at ESWI in Portugal, and announced at that time. Aflunov has not been tested on swine flu and has not been approved for sale in the U.S., Europe or other markets. A Phase II study has also demonstrated that Aflunov provided a protective immune response in children as young as 6 months to 17 years of age[1]. It is the first and only -pre-pandemic avian vaccine with a good safety profile and which is effective in building an immune response as early as 6 months of age[3].

( ???A good safety profile??!  ???According to who? Donald Rumsfeld? John Holdren? Bill Gates? Last time I checked, MF59 was one of the most dangerous substances in big pharma's clutches, and it's probably THE worst soft-kill weapon, just because it's so insidious and has gone unnoticed and/or swept under the rug for so long that people aren't even that upset about it even though Novartis and the FDA are admitting right there that it's NEVER been approved by the FDA, and yet they're still trying to shove it down your throat... And where are the 6-mo-old-babies they tested this stuff on? That's horrible...  :( )
 
"To have a pre-pandemic vaccine that can produce a protective immune response in children as young as 6 months of age, as well as seniors is essential," said Timo Vesikari, M.D., Professor of virology and pediatrics and Director of the Vaccine Research Center at the University of Tampere, Finland. "Children are not only at the biggest risk of complications from influenza, but they have been identified as the prime population for spreading the virus to all ages. We need to ensure that they are protected against a potential pandemic, which can strike at any time."
(Um, a healthy diet, plenty of sleep, and frequent hand-washing oughta do it, dontcha think, Timo? Oh wait, my idea doesn't involve a payday for Big Pharma OR the criminal elite eugenicists pulling the strings at the top... ;))

In a third study presented at IVW, Aflunov demonstrated that it could potentially be used to prime the general public against a potential influenza pandemic through a flexible dosing regimen, which would allow public health officials to immunize their citizens by administering the vaccine well in advance of a potential outbreak. The trial showed that a single priming dose of the vaccine was sufficient to develop immune memory in more than 90 percent of healthy adults, which could then be boosted one year later with either the same or a different strain of the avian influenza virus[2].
 
MF59 is the only flu adjuvant in a pre-pandemic program with an established safety profile, supported by more than 10 years of clinical safety data and more than 40 million doses of commercial use in Europe. The adjuvant has been studied in clinical trials involving more than 26,000 people, including children, and has been licensed for use in people 65 years of age and over in the seasonal influenza vaccine, Fluad®, since 1997 in the European Union[4]. Fluad is not licensed for sale in the U.S.
 
Study details
The first study was a Phase II trial that involved 472 subjects aged 6 months to 17 years. The subjects were divided into three cohorts: toddlers 6-36 months of age, children 3-9 years of age and adolescents 9-17 years of age. Each age group was randomized in a 3-to-1 ratio to receive either the adjuvanted pre-pandemic vaccine (Aflunov) or Fluad, a seasonal influenza vaccine. Participants in the adjuvanted pre-pandemic vaccine arm received two 0.5 mL doses. Those in the Fluad arm received two 0.25 mL doses if they were younger than 3 years of age and one 0.5 mL dose if they were 3 years of age or older. Antibody responses were measured using standard hemagglutination inhibition (HI), single radial hemolysis (SRH) and microneutralization antibody response (MN) methods.
 
After the first dose of adjuvanted pre-pandemic vaccine, HI results demonstrated that two Committee for Medicinal Products for Human Use (CHMP) criteria were reached by the adolescent group and one was reached by the toddler and children groups. SRH results showed that all three cohorts fulfilled CHMP for geometric mean ratio and seroconversion. Following the second vaccination with the adjuvanted pre-pandemic vaccine, all three CHMP immunogenicity criteria were met in all three age groups as measured by HI and SRH. Further, 94 percent of toddlers, 92 percent of children and 72 percent of adolescents achieved at least a fourfold increase in MN titer over baseline and 99 percent of all three groups achieved an MN titer of >= 40 - common measures of seroprotection[1].
 
The second study was a Phase II open-label trial that involved participants from 18 to 40 years of age. A subset of 99 subjects received one dose of adjuvanted pre-pandemic vaccine (H5N1 clade 1 [Vietnam]) either three weeks before or after one dose of Agrippal (2007 season). A heterologous (H5N1 clade 2 [Turkey]) adjuvanted pre-pandemic vaccine booster dose, mixed with Agrippal, was administered one year later.

??? ???  ??? ??? (Is this usually how a clinical trial for a vaccine is run? Isn't there usually a control group? They look like they gave some people a mixture of the different vaccines, at different times, so if the patient DID have problems with either vaccine, the doctors wouldn't have been able to really tell which one caused them, would they?)
 
Antibody responses were measured one, two and three weeks later to assess cross-reactivity by HI, MN and SRH and measure seroconversion and seroprotection. After priming, the vaccine gave similar seroconversion (>40 percent) and seroprotection (>40 percent) rates against homologous virus as seen in previous studies three weeks post-vaccination.
All three EMEA licensure criteria were met using both HI and SRH assays[2].
 
Heterologous boosting produced memory immune responses, evident within one week, in more than 90 percent of the subjects. Seroconversion and seroprotection rates were equivalent to those seen after homologous priming[2].
 
Novartis Vaccines commitment to pandemic preparedness
 
Novartis Vaccines is supportive of the WHO's leadership role in global pandemic planning as discussed in the organization's "THE WORLD HEALTH REPORT 2007: Global Public Health Security in the 21st Century." The WHO is a key global hub for pandemic preparedness, ensuring cohesion and coordination among all players involved, including the industry, governments of both developed or developing countries and their populations.

(Well, that actually IS true  ;)  And they have help from the banking families and the nice paramilitary forces they buy with either drug, weapons, or blood money)
 
Novartis Vaccines is working closely with government and regulatory officials worldwide to support pandemic preparedness efforts, including providing vaccines for stockpiling. The company has also been involved in discussions to educate government agencies about the benefits of proactive use of pre-pandemic vaccination in pandemic preparedness planning. The Company also recognizes the importance of pandemic influenza preparedness planning within the business community in an effort to protect the global economy.
With this commitment, Novartis Vaccines is working with business leaders to support their continuity planning for pandemic preparedness.
 
Novartis is the only vaccines manufacturer that has an established, licensed FCC (Flu cell culture) facility which is operating in Marburg, Germany. A second facility, a collaboration with HHS, Department of Health and Humans Services, U.S, is under construction in Holly Springs, North Carolina.
 
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "suggests," "can", "could," "may," "potentially," "will," "expect," "suggest," "potential," "could," "would," "commitment," "preparedness," "planning," or similar expressions, or by express or implied discussions regarding potential marketing approvals for Aflunov or regarding potential future revenues from Aflunov or from other pandemic preparedness efforts. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Aflunov will be approved for any sale in any market. Nor can there be any guarantee that Aflunov or our pandemic preparedness efforts will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

(All of the above means they get to change their mind about pretty much anything whenever they feel like it.)
 
 
About Novartis
Novartis Vaccines and Diagnostics is a Novartis division focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division's products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.

(Yeah, you don't want to be exposed in a humiliating way as being a major eugenics front organization that sells tainted blood overseas like Bayer....notice how we don't even have to try to expose the real criminals anymore, they just kind of expose themselves and we just catch 'em doin it?....lol)
 
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

References
[1.] Anke Hilbert, Elena Fragapane Nicola Groth, Sandrine Tilman, Timo Vesikari. A Phase II, randomized, controlled, observer-blind, single-center study to evaluate the immunogenicity, safety and tolerability of two doses of MF59®-adjuvanted H5N1 influenza vaccine, AFLUNOV®, in subjects aged 6 months to 17 years. Accessed March 24, 2009.
[2.] Angelika Banzhoff, Elena Fragapane, Volker Brauer, Emanuele Montomoli, Chiara Gentile, Anke Hilbert, Sandrine Tilman, Pio Lopez; Novartis AG. M459-Adjuvanted H5N1 Prepandemic Influenza Vaccine Demonstrates Flexible Prime Boosting. Accessed March 23, 2009.
[3.] Timo Vesikari. Aphase II randomized, controlled, observer-blind, single center study to evaluate the immunogenicity, safety and tolerability of two doses of MF59-adjuvanted HF5N1 influenza vaccine, AFLUNOV, in subjects aged 6 months to 17 years. University of Tampere Medical School, Finland. Accessed March 23, 2009
[4.] Ott Gary et al. The Adjuvant MF59: A 10-Year Perspective, Methods in Molecular Medicine., Vol 42: Vaccine Adjuvants: Preparation Methods and Research Protocols

Contacts:
Eric Althoff, Novartis Global Media Relations, +41 61 324 7999 (direct), +41 79 593 4202 (mobile), eric.althoff@novartis.com
Paul Newman, Novartis Vaccines and Diagnostics, +1 (617) 871 7931 (direct), +1 (617) 710 8953 (mobile), paulc.newman@novartis.com

Source: Novartis

Online Jackson Holly

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Thanks sociostudent ... a lot of effort you have put into this ... it's overwhelming, but I am trying to make sense of it.

My 'conclusions' so far is that the 'endgame' with the vaccine op is to disable the immune system in such a way as the organism attacks itself ... kills itself off ... true?

http://forum.prisonplanet.com/index.php?topic=120618.msg751575#msg751575

GOOGLE:  cytokine storm

St. Augustine: “The truth is like a lion; you don't have to defend it. Let it loose; it will defend itself."

sociostudent

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Thanks sociostudent ... a lot of effort you have put into this ... it's overwhelming, but I am trying to make sense of it.

My 'conclusions' so far is that the 'endgame' with the vaccine op is to disable the immune system in such a way as the organism attacks itself ... kills itself off ... true?

http://forum.prisonplanet.com/index.php?topic=120618.msg751575#msg751575

GOOGLE:  cytokine storm



Well, the autoimmune disorders usually end up taking you down in one of two ways (once you get it, and you realize that it's not going away--like, you get the different labs back saying which antibodies you test positive for and at what titer, it just kind of all hits you like, "wow--this really isn't going away"), depending on how the person handles it:

1. organ failure (particularly the kidneys, but other organs can be affected.) This is what usually happens in glomerulonephritis or with Systemic Lupus Erythematosis or Lupus Nephritis.
2. "Wearing down" over a period of 25 years or so, and when a particularly bad bug hits, you go down with it in a matter of days. The body's faulty-wired immune system finally wins the autoimmune battle, from a cytokine storm. This is usually what happens if the autoimmune disorder is relatively mild (no organ damage or impending failure) and stable immunologically,  but persistent in blood tests (like a persistently-high titer of ANA or Anti-Sm antibody with remitting/relapsing of symptoms).

Also, keep in mind that the range of autoimmune disorders is IMMENSE, there's more disorders than I can even remember, and you'd be surprised at what's actually autoimmune (like diabetes)...wow, you know what? I think labtestsonline.org explains it much better than I ever could:

http://www.labtestsonline.org/understanding/conditions/autoimmune.html


Autoimmune disorders fall into two general types: those that damage many organs (systemic autoimmune diseases) and those where only a single organ or tissue is directly damaged by the autoimmune process (localized). However, the distinctions become blurred as the effect of localized autoimmune disorders frequently extends beyond the targeted tissues, indirectly affecting other body organs and systems. Some of the most common types of autoimmune disorders include:

Systemic Autoimmune Diseases

    * Rheumatoid arthritis (RA) and Juvenile RA (JRA) (joints; less commonly lung, skin)
    * Lupus [Systemic Lupus Erythematosus] (skin, joints, kidneys, heart, brain, red blood cells, other)
    * Scleroderma (skin, intestine, less commonly lung)
    * Sjögren's syndrome (salivary glands, tear glands, joints)
    * Goodpasture's syndrome (lungs, kidneys)
    * Wegener's granulomatosis (blood vessels, sinuses, lungs, kidneys)
    * Polymyalgia Rheumatica (large muscle groups)
    * Guillain-Barre syndrome (nervous system)

Localized Autoimmune Diseases

    * Type 1 Diabetes Mellitus (pancreas islets)
    * Hashimoto's thyroiditis, Graves' disease (thyroid)
    * Celiac disease, Crohn's disease, Ulcerative colitis (GI tract)
    * Multiple sclerosis (There is still some debate as to whether MS is an autoimmune disease.)
    * Addison's disease (adrenal)
    * Primary biliary cirrhosis, Sclerosing cholangitis, Autoimmune hepatitis (liver)
    * Temporal Arteritis / Giant Cell Arteritis (arteries of the head and neck)


sociostudent

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Also, the list above is pretty condensed--the TRUE list of ALL autoimmune disorders is here:
http://www.aarda.org/patient_information.php

sociostudent

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http://anthraxvaccine.blogspot.com/2009/07/damn-data-full-speed-ahead.html

Damn the Data! Full Speed Ahead
There are many federal advisory panels, often comprised of those with vested interests. This panel did as expected, calling for precipitous vaccine approval. The Wall Street Journal reports:
http://online.wsj.com/article/SB124839219994977533.html#mod=whats_news_free?mod=igoogle_wsj_gadgv1

    In the U.S., a federal advisory panel said the FDA should move ahead to approve or license the new H1N1 vaccine without waiting to receive data from clinical trials to test its safety and efficacy. The government and vaccine makers plan to start human studies of the H1N1 vaccine in the U.S. in the coming weeks, but the first-look data from those studies won't be given to the FDA until September.

From Gannett:

    But the FDA told its scientific advisers it could finish the red tape of licensing much of that vaccine well before the use-it-or-not decision is made — because it's brewed exactly the same as regular winter flu vaccine, merely using the new swine influenza virus, part of the common H1N1 influenza family, as the chief ingredient. Companies just have to take the normal steps required for each year's regular winter flu vaccine, such as proving the inoculations are manufactured appropriately.

   "Taking the same path now will save some important time because "the virus is ahead of us," said FDA vaccine chief Dr. Norman Baylor. This "is not a rubber stamp. We do need to review some data to give us some comfort that that vaccine will provide some benefit and that it's manufactured properly."

   ... Make no mistake: Vaccines containing immune-system boosters called adjuvants are not candidates for the easier strain-change approval, the FDA said. Flu vaccine with this extra ingredient is widely sold in Europe but never has been sold here, and there's little information about their safety in young children or pregnant women. While both adjuvant-free and adjuvant-added swine flu vaccine is being tested in the U.S. and abroad, using it outside of those studies would require a completely separate government decision.
 
(Sociostudent can't help but interrupt...I'm sorry, but how is the swine flu vaccine with the adjuvant being tested in the U.S., but not getting approval, but still being tested, while saying that we don't use it in this country? Without it's approval from the FDA, it shouldn't, according to the FDA's own words, be eligible for the easier approval.
Looks to me like the adjuvants are going to piggyback in with the vaccines (the FDA will claim they're leaving it out, get everyone happy about it, and then sneak it back in with the patent for the antigen, saying that "the immunogenicity (without the squalene to boost the immune response) could not be accomplished) ; then when people begin to have outbreaks of rashes all over their bodyand 20-year-olds everywhere are feeling like they have the joints of an 80-year-old in a matter of months, and people have allergic reactions to the shot, they can deny any responsibility because they'll point to the "Public Health Emergency Preparedness Act" as their "authority" in deciding to risk hundreds of millions of American lives, and billions of lives worldwide by fast-tracking/baiting and switching with these hardcore eugenics operations RIGHT IN OUR FACE )


FDA appears unwilling, currently, to take the bigger risk of approving novel adjuvants, which have not been tested in at-risk populations,without data. But the risk that our federal regulatory agencies are willing to take is equal to the risk these agencies took in 1976, when no new vaccine adjuvants were used.[b] In 1976, 6-8 times as many Guillain Barre Syndrome (autoimmune paralysis) cases occurred as would have occurred by chance alone, after vaccination.[/b]

Although somewhat reassuring, this is not good enough. Yearly flu vaccines have traditionally been approved each year with very abbreviated testing, compared to other vaccines. Now swine flu vaccine is being pulled through that same loophole, because government officials have a precedent, which makes doing so (bureaucratically) easy.

They need to remember the Guillain Barre precedent also.

Online Jackson Holly

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http://www.youtube.com/watch?v=wHxHmHa9qvs&NR=1


This is an audio file in 8 parts ... must hear ... Patrick Jordan, Jane Burgermeister and more ... SCARY!


~~~~~~~~~~~~~~~~~~

What's Ailing America with Dr. Rebecca Carley, Patrick Jordan, Jane Burgermeister and Dr. Patricia Jordan. 12/07/2009


http://republicbroadcasting.org/ is an excellent online radio station for information and interviews which you would not here on the MSM.


Dr. Rebecca Carley http://www.drcarley.com/


Jane Burgermeister blog : http://birdflu666.wordpress.com/

~~~~~~~~~~~~~~~~~~~~~~~

St. Augustine: “The truth is like a lion; you don't have to defend it. Let it loose; it will defend itself."

sociostudent

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http://www.youtube.com/watch?v=wHxHmHa9qvs&NR=1


This is an audio file in 8 parts ... must hear ... Patrick Jordan, Jane Burgermeister and more ... SCARY!


~~~~~~~~~~~~~~~~~~

What's Ailing America with Dr. Rebecca Carley, Patrick Jordan, Jane Burgermeister and Dr. Patricia Jordan. 12/07/2009


http://republicbroadcasting.org/ is an excellent online radio station for information and interviews which you would not here on the MSM.


Dr. Rebecca Carley http://www.drcarley.com/


Jane Burgermeister blog : http://birdflu666.wordpress.com/

~~~~~~~~~~~~~~~~~~~~~~~



Hey, cool...I'm one of the callers that called the Heritage Foundation guy out on the bird flu on C-Span. Small world, huh? I was really nervous, and he wasn't the coziest person in the world to socialize with to be quite honest, especially when I asked him what he knew about the bird flu --LIVE--being in vaccine material sent to several labs in europe by baxter pharmaceutical in illinois. he totally had no idea what to say, and that's when the brain fart hit, and I didn't know what to say. He then asked which strain it was, and subsequently hung up on me. Oh well...it was kind of productive, at least.

Offline phasma

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Well done anyway !
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Hate brain farts !
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sociostudent

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Found something kinda disturbing while reading this lady's personal research "saga" involving links (or lack thereof) to scientific studies regarding MF59/squalene, experimental vaccines from 1951-1953:
http://www.newfluwiki2.com/showComment.do?commentId=69583

on the subject of using experimental vaccines
on military personnel, here's a sobering study from way back, a follow-up study on 18,000 army recruits vaccinated with an influenza vaccine adjuvanted with incomplete Freund's adjuvant: http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=42120.

Beebe et al, Long-term mortality follow-up of Army recruits who received adjuvant influenza virus vaccine in 1951-1953. Am J Epidemiol. 1972 Apr;95(4):337-46.
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=5015584&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
ABSTRACT: Although studies sponsored by the Commission on Influenza, Armed Forces Epidemiological Board have shown that the effectiveness of influenza virus vaccine can be greatly increased by emulsification in light mineral oil, concern as to the safety of oil-adjuvant preparations has prevented their acceptance for routine use pending definitive long-term testing of both emulsifying agent (Arlacel A) and mineral oil (Drakeol) in experimental animals. In a previous 10-year follow-up study based on Salt's 1951-1953 randomized trials of the adjuvant influenza virus vaccine at Ft. Dix, there was no suggestion of a mortality effect attributable to the adjuvant. In the present study the mortality follow-up has been extended through April 1969, 16 to 18 years after vaccination. The vaccine groups have been compared with respect to all diagnoses listed on the death certificates, autopsy protocols, and terminal hospital records. The findings are essentially negative with respect to malignant neoplasms, allergic diseases, and collagen diseases. In addition, there is no evidence that men known to have had the cystlike reaction at the site of the inoculation, or thought to have had allergic reactions mediated by the adjuvant vaccine, have experienced a higher mortality risk.
This study is instructive for many reasons, although the results look benign on the surface:

   1. This was carried out before the age of informed consent.  But the mind-boggling thing is the fact that they injected 18,000 people in their prime with substances that were still "pending definitive long-term testing"!

   2. The second thing is the number of government agencies involved:
From the Follow-up Agency, Division of Medical Sciences, National Academy of Sciences-National Research Council, and the American Cancer Society. One of a program of medical follow-up studies organized by the NAS-NRC at the request of the Veterans Administration, the Department of Defense, and the Public Health Service, this study was conducted in collaboration with the Commission on Influeza of the Armed Forces Epidemiological board and was supported by Contract DADA17-C-8147 with the U.S. Army Medical Research and Development Command, Washington, D. C.
#

Seems to me everyone had a hand in the game...

# One thing to note is this only compares mortality data.  Assuming that most recruits were in their late teens or early twenties at the time of vaccination, 16-18 years later, they would still be in their prime.  Chronic illnesses would not show up in this comparison.

# Although the gross study results appear to suggest nothing untoward happened to those who got vaccinated with the adjuvanted vaccine, on closer look, something strange emerges.

Although the ascertainment procedures were unbiased with respect to the survey groups, the autopsy percentage was found to be appreciably higher for the adjuvant vaccine (AV) group (48 per cent for AV vs. 36 per cent for C, with p < .01), and the effect of this unexpected and unexplained imbalance is aggravated by a differential in the percentage of autopsy protocols submitted in response to our requests (81 per cent for AV vs. 69 per cent for C, with p = .06).
#

In other words, not only were those who got the adjuvanted vaccine more likely to have had an autopsy at death, for some unknown reason, their healthcare providers were also more eager to present the findings to the investigators.  I wonder why?

# Then there is a small difference in the no of neoplasms (cancers)
Among the groups of special interest here it is only for neoplasia that there is any suggestion (p = .06) that the AV and C survey groups are not homogeneous. An age-adjustment has almost no effect on this outcome, but division of the material into two four-year periods puts the discrepancy largely into the second, viz.:
[/i]

6. Here is IMO the most worrying finding:
There is a significant excess of deaths in the AV group coded to ICD #334, other and ill-defined vascular lesions of the central nervous system,.... There is no hint of such heterogeneity in the death certificate diagnoses, and ICD #334 is almost exclusively an autopsy diagnosis.
#

This is significant for 2 reasons:

  1. ill-defined vascular lesions may be descriptive of what we would now call vasculitic lesions, ie lesions caused by inflammatory changes at the small vessels, which are characteristic of autoimmune responses.  Is there any similarity between that and the rats that were injected with the various oils in this study and developed 'allergic encephalomyelitis'?  I don't know.  But cognitive and neurological symptoms are certainly prominent in Gulf War veterans.

  2. The second important part is ICD #334 is almost exclusively an autopsy diagnosis..  Which means that such problems would not be diagnosed properly, and the veterans may well have been ill but with no proper diagnosis or treatment available.  Was that the reason why more autopsies were ordered when they died?  Or why their docs were more likely to send in their records for the researchers?  It's all speculation, but it's still sobering to consider these implications, IMO.

# One final piece.  There was "a greater number of diagnoses coded to therapeutic misadventures and late complications of therapeutic procedures in the AV group."

   7.

      I wonder why??

      You gotta work the numbers..

by: SusanC @ Tue Oct 16, 2007 at 23:39:54 PM CDT


sociostudent

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 Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic I - First Questions
by: SusanC
Wed Aug 08, 2007 at 23:26:27 PM EDT
http://www.newfluwiki2.com/showDiary.do?diaryId=1560
The world of science is a strange place.  You would have thought that different people working on the same substance, one group set on figuring out how to use it, the other trying to find out how it harms people, will at least have heard of each other and hopefully talked to each other from time to time.  Apparently, that doesn't happen, not in ways that you can take for granted anyhow.

At least the group that is trying to find out about the harmful effects of oil adjuvants did quote the other group, those promoting their use,  in their references, but I suppose it would be too much to expect the latter to volunteer to their readers the existence of the former!

The thing is, if you were looking for possible side-effects of oil-adjuvants like MF59 in vaccine journals or in vaccine conferences, you would not come across the findings (eg induction of autoimmune antibodies) of those researchers who have been doing animal studies on precisely the same substance that would likely have disqualified it from even getting into human trials in the first place!

Let me backtrack a little, and give everybody a bit of background.

We have all heard how our vaccine production capacity is nowhere near enough to produce pandemic vaccines to make a difference to the outcome of a pandemic (at least that is MY definition of what spending all these billions to produce a pandemic vaccine should be about), whether we look at this from the national or global perspective.
 Among many ways of trying to make the small amounts we can produce go further ie dose-sparing techniques, the hottest game in town is adjuvants, substances which when added to a vaccine can make it so much more effective that you only need very small doses, thus instantly creating more with less!  Sounds good, right?

Another bit of background: Under 'normal' circumstances, for any pharmaceutical product or vaccine to get licensed, they have to go through many stages of testing.  The first one is always animal tests, cos unless you have very unusual attachments to animal rights, you don't really want to test something new on humans first thing, do you?  Regulatory agencies such as the FDA have specific requirements that need to be fulfilled before you can even begin human clinical trials, which consist of several phases designed to test efficacy, safety, dosage, etc, everything that they need to know before they can license a product for market.

Now, the case of MF59 is a rather unusual one.  Some of you may remember me writing about it in the old forum, based on the book Vaccine A, by Gary Matsumoto, a NY Times journalist also writing for Vanity Fair, as part of the controversy around Gulf War Syndrome and allegations that the DOD was/is using experimental vaccines including those with MF59 on service personnel without informing them (No consent is needed, apparently, if you are in the military - you gotta take whatever they give you.)  Anyway, I still haven't been able to make heads or tails out of that story, cos I haven't come across definitive evidence one way or the other, so I'm going to leave that well alone for now, and go somewhere else instead.

I'm going to go specifically to Italy in 1992, when the first clinical trials using MF59 adjuvanted influenza vaccines started.  The rationale was that the elderly tend to have poor immune responses to flu vaccines, and they suffer most complications and deaths from flu, so it would make sense to find some ways of enhancing their immune response.  Animal studies then showed that certain oil emulsion compounds had the ability to stimulate and produce enhanced immune responses when given in conjunction with vaccines. At least that is what we are given to understand from reading the (like I said) writings of vaccine scientists, although even then those working on the harmful effects of oil adjuvants had published studies just as prodigiously showing, well, harmful effects.


Be that as it may, the clinical trials went ahead in Italy, with groups of elderly (65 or older) people recruited from the community and duly given the vaccines for three consecutive years, and the results showing enhanced response were duly published.

Let me digress here a little and tell you what I discovered about vaccine safety, or specifically what kind of data from clinical trials would satisfy the requirements and the product be deemed 'safe' for licensing.  Now, this is only what I figured out from the various vaccine papers that I've read; I'm not privy to the exact technical specifications that regulatory agencies require.  It would appear that in most instances clinical trial subjects are monitored for 20-30 minutes at the clinic, then given a list of specified or 'solicited' symptoms that they are supposed to record for the next 7 days.  Sometimes, but not always, they also record 'unsolicited' symptoms, although whether the staff actively 'solicits' such 'unsolicited' symptoms is never quite apparent.


This is all well and good, if we can assume two things to be universally true:
   1. that we know ALL the possible or likely symptoms or reactions that may arise, enough to include them on the list of 'solicited' symptoms, and
   2. that adverse vaccine reactions are bound to start only within 7 days of vaccination and not beyond

(UPDATE I have since learned that the follow-up period is normally longer, 28 days or even more, but the method of follow-up remains the same.)

Well, in the case of swelling and pain of injection sites, for example, that might very well be true.  And if we are testing vaccines that are not too different, conceptually, from the many vaccines that have been in use for many years, such that we pretty much know what to expect (eg we don't expect your hair to turn green), then it would probably work well enough, I guess.

But what if, as in the case of MF59, we are talking about a whole new class of substances for which we had at the time very little data in human subjects, the mechanism of which was specifically designed to elicit enhanced immune responses in the first place, wouldn't it be prudent to ask ourselves how the heck would we know if the immune responses were to become TOO enhanced as to be harmful?And what if the problem that we worry about is a chronic disease that may take weeks or months to manifest instead of days?  After all, if our immune system is supposed to be activated by the vaccine to be able to mount responses against viruses months after vaccination, surely we should also expect abnormal immune responses to persist well beyond the 7 days?

The thing is, excessive response to the degree that is damaging instead of beneficial, specifically the induction of autoimmune reactions, is a lot less common in the elderly than the rest of the population.  In other words, one way to NOT have a particular adverse consequence be pegged with your product is to AVOID the kind of people who are most likely to have such adverse consequences in the first place.  Pick the group that is most unlikely to have problems, particularly since in this instance they are elderly and have all sorts of other health challenges such that it would be easy to say "there were no reports of vaccine-related serious adverse events after the first, second, or third immunization", to quote that first study by Minutello et al 1999.  Make sense?

To cut a long story short, the vaccine Fluad, an inactivated subunit influenza vaccine adjuvanted with MF59, was duly licensed in Italy, and by the quirks of EU regulations, in the EU, for use in the elderly.  And it has been used by now for thousands millions of people with apparently good safety profile.  It has even been used, I'm told, from time to time off-label in younger people when they ran short of the regular seasonal flu vaccine.

You might say, so what's the problem?  The problem is, in the meantime, scientists are finding stacks of evidence in animals that such kinds of oil adjuvants including squalene or MF59 were causing distinctive patterns of autoimmune responses and induction of lupus autoantibodies - antibodies that target the hosts' own cells, believing them to be foreign, thus causing inflammation, tissue destruction, and disease - antibodies that are involved in a host of autoimmune diseases, the most important one being systemic lupus erythematosis or SLE, a very nasty, often fatal, disease which typically appears in young females, black more commonly than Caucasians, and hardly ever happen to men except very occasionally in elderly ones.


NOW let's go back and re-visit the book Vaccine A, that I wrote about in the old forum, on what happened to Gulf war veterans. Specifically, the very unusual finding of large numbers of autoimmune conditions including lupus in previously healthy young men.  As I said, I can't find evidence to prove anything one way or the other, but I did find one study that is particularly intriguing.

I came across this while trying to find information on lupus cos one FW mother on the old forum, the only one that I know of who participated in a clinical trial of adjuvanted H5N1 vaccines, developed symptoms shortly thereafter and was subsequently (as I understand it) diagnosed to be suffering from lupus.  In the process of looking up the literature, I found this review of 5 cases of post-vaccination lupus by Older et al, 1999 which I wrote about here  in the old forum.  Two pieces of information jumped out at me in this review


   1. all five were military personnel who had received vaccinations as part of a required protocol, and
   2. 2 out of these 5 patients, all young, were males.  The normal ratio of female to male cases is 10 to 1, falling to 3 to 1 in the elderly. Simard et al 2007:http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17577298&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

Now I know purists would call these cases 'anecdotal', and they would be right, technically.  But my point is, if we are talking about potentially vaccinating the entire population, or at least a large proportion of the young, surely we need to have a higher degree of certainty that we DO have, in our regulatory processes, the ability to discover such severe adverse consequences, even if they occur but rarely? I once asked this question of a senior scientist/executive of a vaccine company, whether there are processes in the regulatory pathway that allow us to pick up chronic and delayed adverse reactions, and his response took the form of shrugging of his shoulders, more-or-less saying "if the government cannot come up with ways of discovering problems, who am I to help find them, eh?"
Does that keep you awake nights?  It should.  Particularly if you are TPTB.


sociostudent

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 Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic II - Reasons for Concern
by: SusanC
Sun Oct 14, 2007 at 01:26:28 AM EDT
http://www.newfluwiki2.com/showDiary.do?diaryId=1758

The debate on the safety of oil-in-water adjuvants has received renewed attention on flublogia after the revelation and concern (http://www.newfluwiki2.com/showComment.do?commentId=68298) that tptb might be considering adding adjuvants such as MF59 to prepandemic vaccines.  There appears to be a fair amount of misunderstanding or confusion on this subject, and concerns whether all of this is nothing more than internet conspiracy rumor (http://www.singtomeohmuse.com/viewtopic.php?t=1704&postdays=0&postorder=asc&start=0), so I thought this might be a good time to re-visit the issue.

First, some important clarifications and disclaimers:

   1. I have never made the claim nor indeed even suggested that "MF59 caused Gulf War syndrome" (or any other condition, autoimmune or otherwise) , which, as I repeated right from the start (http://www.fluwikie2.com/pmwiki.php?n=Forum.TheMF59Story), is IMO likely to be multi-factorial, even though my original interest and concerns were triggered by the work of Gary Matsumoto on this subject:http://vaccine-a.com/index.html#author
   2. I personally think that the whole ASA (anti-squalene antibody) issue has many red herrings and is only one of the large number of unanswered questions regarding GWS and other similar conditions such as Chronic Fatigue Syndrome and Multiple Chemical Sensitivity, and that multiple vaccinations and environmental exposures created complex etiological combinations that may defy our current reductionistic approaches to causation.
   3. I am a fervent supporter of vaccination - much of the gains of life expectancy and improved quality of life in the past century was due to the control and even eradication of infectious diseases by the use of vaccines.
   4. Vaccines are IMO a critical part of the portfolio of strategies needed to mitigate the effects of an influenza pandemic, as discussed here (http://www.newfluwiki2.com/showDiary.do?diaryId=918) and here (http://www.newfluwiki2.com/showDiary.do?diaryId=1579).
   5. The need for innovative ways to make enough vaccines available to enough people in a pandemic sufficient to make a difference to the outcome (ie morbidity and mortality) is an ongoing and one of my top concerns for pandemic mitigation.  The use of adjuvants is certainly one option, among others, that we cannot and should not take off the table.
   6. While one would always want vaccines to be more efficacious (who doesn't?) and the seasonal flu vaccine is not a superstar in that department, I believe that overall (for individuals as well as communities) the upside far outweighs the downside.  FWIW, in the last few years, I and members of my immediate family have all taken the flu shot, and I do recommend it for everyone who has access to it, barring those with medical contraindications.
   7. Finally, neither I nor any member of my immediate family have, to my knowledge, received any financial benefits from any vaccine company, vaccine-related enterprises/investments/subsidies/re-imbursements etc.  Nor do I have any personal connection (ie beyond professional interaction) with anyone connected to the vaccine industry, or any other industry or profession that might have issues, positive or otherwise, with specific vaccine companies or the industry as a whole.

      Umm, did I cover everything?

      Now, let me outline the issues involved.  For reasons of length, I will split up the discussion and will cover the first 3 issues here, and the rest in part III of this series.
         1. the squalene antibody ASA controversy
         2. post-vaccination lupus in service personnel
         3. animal models
         4. Fluad - the influenza vaccine adjuvanted with MF59
         5. The big picture on oil adjuvants
         6. implications for pandemic/prepandemic vaccine

      I. The ASA controversy

      This is an extremely complex subject with many unresolved issues, way beyond the scope of this forum.  I will summarize the origin of the queries raised, and a few important points.
         1. Findings from first study at Tulane in 2000 http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WFB-45F4JKG-1X&_user=10&_coverDate=02%2F29%2F2000&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=3901958d9eb5846a5b13180d729e6c8f

Antibodies to Squalene in Gulf War Syndrome.:




# This study basically described a laboratory assay that seems to have a high degree of correlation with anthrax vaccination AND development of symptoms, especially systemic ones. The question was raised with the DOD and FDA as to whether military personnel had been given experimental vaccines containing squalene/MF59.
# The FDA reported very low levels of squalene (10-83 ppb, parts per billion) in certain batches of the vaccines tested.  Note that in comparison, Fluad contains MF59 at around 2 parts per hundred.

# A GAO report in 1999 Questions About the Presence of Squalene Antibodies in Veterans Can Be Resolved (http://www.gao.gov/cgi-bin/getrpt?GAO/NSIAD-99-5)states :
We cannot say definitively whether or not Gulf War-era veterans were given  vaccines with adjuvant formulations containing squalene for a number of reasons.  Although DOD officials told us they did not administer such vaccines, they stated they did not have documentation on the process and results of decision-making related to the administration of vaccines at the time of the Gulf War.  Also, some officials involved in the decisions were no longer employed with DOD at the time of our review, and we were either unable to locate them or they declined to be interviewed.
[/i][/b]

# This and other instances of 'obfuscation' (http://home.att.net/~dstormmom/deceptn.htm)cited by the GAO and in a report( http://home.att.net/~dstormmom/metcalf.htm ) by Congressman Jack Metcalfe to House Subcommittee on National Security,Veterans Affairs, and International Relations, added more fuel to the considerable controversies that dogged the AVIP (http://209.200.103.35/AVN/timeline.html), or Anthrax Vaccine Immunization Program (http://www.anthrax.osd.mil/). Nevertheless, the official AVIP site is referenced as source for this WHO statement on the safety of squalene/MF59.:http://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/
# A second study was done by the researchers at Tulane in 2002, this time on Antibodies to Squalene in Recipients of Anthrax Vaccine (http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WFB-468TDD8-3&_user=10&_coverDate=08%2F31%2F2002&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=4ec3ff2aacac020e881b2387483ad632), ie personnel who had participated in the AVIP vaccinations, whether deployed to the Gulf or not.  The results were also analyzed in relation to whether the vaccine received was from one of the lots found to contain traces of squalene by the FDA.


In a pilot study, 6 of 6 vaccine recipients with GWS-like symptoms were positive for ASA. In a larger blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of controls were positive (P  0.05). Further analysis revealed that ASA were associated with specific lots of vaccine. The incidence of ASA in personnel in the blinded study receiving these lots was 47% (8/17) compared to an incidence of 0% (0/8; P 0.025) of the AVIP participants receiving other lots of vaccine. Analysis of additional personnel
revealed that in all but one case (19/20; 95%)
,
  6. There was some controversy around the validity of the assays, although DOD experts did make an initial critique of the 2000 study (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=10816387&ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum), the points they raise were subsequently rebutted by the original researchers.  Subsequent studies on squalene assay (http://www.ncbi.nlm.nih.gov/sites/entrez)were published by DOD researchers.
   7. The point for me, in this whole saga, is not necessarily whether the tests showed that GWS patients had received MF59 adjuvanted vaccine, which to me is inconclusive, but that there appears to be an assay which has incredible correlation to GWS, which AFAIK, has completely eluded experts attempts to document or quantify.  The GAO report did recommend that the DOD do larger scale studies of veterans to determine the extent and implications of such test results, but again AFAIK this has not been done.


II. Post-vaccination lupus in service personnel

   1. Can immunization precipitate connective tissue disease? Report of five cases of systemic lupus erythematosus and review of the literature. (http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WWX-4F2MG9B-1G&_user=3174088&_coverDate=12%2F31%2F1999&_alid=607339907&_rdoc=1&_fmt=summary&_orig=search&_cdi=7142&_sort=d&_docanchor=&view=c&_ct=1&_acct=C000050221&_version=1&_urlVersion=0&_userid=3174088&md5=318ae94d55ab26c9526fe241cbfaca87)

THIS is a much bigger red flag, as far as I'm concerned, the finding in one study of 5 young previously healthy service personnel (including 2 males) developing lupus shortly after receiving vaccinations given by the military.
   2. For reasons that I cannot fathom, the authors did not comment on the occupation of these 5 patients, the single glaring thing they have in common!  In addition, they ascribed the correlation to vaccination only, without making any inquiry as to the specific nature and contents of the vaccines given.
   3. As I wrote here (http://www.newfluwiki2.com/showComment.do?commentId=60629)
          * The overall incidence of lupus varies between a low of 1.4/100,000 in Caucasian americans to 22/100,000 for African Americans.
          * Of these only 1 in 10 are male, which means we need to shift those figures by 1/10, to 1.4/million to 22/million, which are both extremely rare events, for ALL male lupus cases.
          * Out of such rare occurrences of young male lupus patient, we then have to factor in the very rare chance of post-vaccination lupus - a condition so rare that there is no literature on it!
          * But that's for ONE young male post-vaccination lupus patient.  What are the chances of finding TWO such cases?
          * Finally, what are the chances that they are both members of the military?

      Is that all coincidence?  I don't know, you tell me...

   4. To the extent that post-vaccination lupus is so rare (ie routine vaccination does not normally result in such disease) doesn't that beg the question of whether these patients had been given something else other than our regular licensed vaccines?
   5. In this instance, the commonality of their occupation puts them into a unique cohort unlike regular members of the public receiving vaccines. The vaccines THEY received were all from the DOD, which has authority to give mandatory vaccination without informed consent, and, according to this GAO report, (http://www.gao.gov/cgi-bin/getrpt?GAO/NSIAD-99-5)is known by their own admission to have carried out trials of adjuvanted vaccines with squalene.
   6. Clearly something is going on with this kind of 'anecdotal' reports as well as the bigger conglomeration of problems loosely grouped together as GWS.  Are they due to adjuvants?  MF59?  I don't know.  But I believe we ignore these issues to our peril.


III. Animal models
Here I will not repeat what I have already written about before in part  I of this diary, but will add some very recent references to show both the reactogenicity of squalene and similar adjuvants, and their continued use, indeed efficacy, in inducing autoimmune conditions for experimental purposes.

   1. 2000 Carlson The Endogenous Adjuvant Squalene Can Induce a Chronic T-Cell-Mediated Arthritis in Rats:http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=10854227
   2. 2001 Holmdahl Arthritis induced in rats with nonimmunogenic adjuvants as models for rheumatoid arthritis.http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1906311&rendertype=abstract
   3. 2002 Holm The arthritogenic adjuvant squalene does not accumulate in joints, but gives rise to pathogenic cells in both draining and non-draining lymph nodes: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1906311&rendertype=abstract
   4. 2003 Satoh Induction of lupus autoantibodies by adjuvants:http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WHC-48TMCJ6-3&_user=3174088&_coverDate=08%2F31%2F2003&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=3174088&md5=7a02048b9e3ce14191601e4fbe10ca90
   5. 2004 Adjuvant oil induces waves of arthritogenic lymph node cells prior to arthritis onset: http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=15196244#b3
   6. 2004 Kuroda Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VKN-4C7B6GF-3&_user=10&_coverDate=06%2F30%2F2004&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=845247e0c363c204f2172ed01de828ac
   7. 2006 Kuroda Induction of lupus-related specific autoantibodies by non-specific inflammation caused by an intraperitoneal injection of n-hexadecane in BALB/c mice : http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TCN-4HMNG93-1&_user=10&_coverDate=02%2F01%2F2006&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=e07f1d94ced50c40513b4a6bbb5daa8bpandemic

sociostudent

  • Guest
"The equivalent of 'read the fine print' for a scientific paper is 'read the data'.  The interpretation of the data can be skewed by an author to support a larger agenda  Or an author can make mistakes."

Gary Matsumoto, Vaccine A, published by Basic Books 2004, p 134.

In reviewing this whole issue of safety around MF59 and the influenza vaccine, I've come to realize that the biggest challenge, and the commonest pattern that I've come across, is the difficulty of trying to pin down the truth.  In part II, I gave a few examples of statements made or written by scientists and authorities that, on closer scrutiny, do not always support the point they are trying to make.

Because of this, I'm now going to focus on finding out whether and where any discrepancies or misrepresentations might lie, in all the 'evidence' that have been used to support the case that there is no cause for concern.
Maybe there isn't, but I believe we owe it to our children to exercise due diligence, and scrutinize this to the best of our ability.

In this diary, I'm going to cover the adjuvanted influenza vaccines specifically, both the licensed seasonal flu one, and the pandemic vaccines under clinical trials.  Again because of the length, I will have to save the rest of the discussion for another diary!

FLUAD

   1. Fluad is the licensed MF59-adjuvanted vaccine for seasonal flu.  First some basic facts:

          * This vaccine was first licensed in 1997 in Italy.

          * In 2000 it was licensed in the rest of the EU via a European Mutual Recognition Approval mechanism http://www.prnewswire.com/news/index_mail.shtml?ACCT=104&STORY=/www/story/05-24-2000/0001226598&EDATE, ie it did not have to go through more regulatory barriers in other countries once it was approved in Italy.

#

    * It is licensed for those aged 65 and over only. (http://www.novartisvaccines.com/products/influenza.shtml)

    * The company claims variously that between 22 to 30 million doses of the vaccine have been 'distributed'.  That's not the same as the number of doses given, nor the number of people who have received it.  Still, suffice it to say that it's been given to millions by now.http://www.future-drugs.com/doi/abs/10.1586/14760584.6.5.699


http://www.who.int/vaccine_safety/topics/adjuvants/squalene/Jun_2006/en/index.html

# First let's look at the safety profile.  Yes, there is a series of clinical trials for subjects over 65, and the results generally show that the vaccine provides better immune response and protection.  The vaccine tends to cause more local reactions but generally these are considered mild and transient.

# As always, the devil is in the detail.  Let me just show one example.  This particular paper appears at first look to include a very large patient sample, which should give us a sense of comfort, right?
Podda, The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine, Vaccine. 2001 Mar 21;19(17-19):2673-80.http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TD4-42JYTJM-2S&_user=10&_coverDate=03%2F21%2F2001&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=8578b13cb88cbb300f7042cc6bf1b0fb

from the abstract:
"Data from a clinical database of over 10 000 elderly subjects immunised with this adjuvanted vaccine (Fluad®, Chiron Vaccines, Siena, Italy) demonstrate that, although common postimmunisation reactions are more frequent in recipients of the adjuvanted vaccine, this vaccine is well tolerated, also after re-immunisation in subsequent influenza seasons."
[/i]

How exactly was the safety profile determined?  

"All adverse events and specific post-immunisation reactions were recorded during the first 7 days, as well as the adverse events requiring physician consultation during days 7 through 28 post-immunisation."

# COMMENTS:

    * I think we can agree that if we are worried about autoimmune disorders, they may not manifest within this timeframe.

    * These disorders do not tend to have severe acute onset, but as generalized non-specific symptoms such as 'aching all over', which are so common in the elderly it is very likely they would not seek medical advice for them.

    * Whether one seeks physician consultation is also often dependent on socio-economic status as well, and the elderly is hardly the group that can afford to spend money except when absolutely necessary.

# But here's the killer phrase:
There was no difference in the incidence of adverse events possibly related to vaccination occurring between day-0 and day-28.

   4. COMMENT:  It would appear that the investigators have exercised some pre-conceived judgment as to what might or might not be 'possibly related to vaccination'.
      Remember that such adjuvants are a completely different class of substance than vaccines.  We do NOT have extensive clinical experience on their effects in humans.  That being the case, would you not agree that the expecting the investigators to know what symptoms might possibly be related to vaccination is a bit like putting the cart before the horse?

   5. Let's get back to the "10,000 patient" sample question.

          
A large phase IV trial was not included in the safety meta-analysis because the safety follow-up did not include the assessment of common post-immunisation reactions, but only that of adverse events leading to a physician visit within 7 days of immunisation.


     So how many people were ACTUALLY included for "the assessment of common post-immunisation reactions" on days 0-7? 2112 for first immunization, 492 for second, 150 for the third immunization.  Now, I don't know how exactly these numbers work, but I can't see how someone can take part in the 2nd and 3rd immunizations without having been in the first.
      Which means this study evaluated about 2000 patients for the immediate period after vaccination.  Which is still a fairly large number, but hardly the 10,000 shown in the abstract.


   6. So what EXACTLY were the rest of the patients assessed for?  The rest of the 9171-2112=7059 subjects were only assessed for (see above) adverse events leading to a physician visit within 7 days of immunisation.

      In other words, unless you are desperately ill within the first week of vaccination, AND your symptoms pass the test of whether they are 'possibly due to vaccination', any other reaction would not be counted!
      Is this enough to make you feel comfortable about giving such adjuvanted vaccine to your child?  I don't know.  Suffice it to say that autoimmune conditions as well as other syndromes such as GWS or chronic fatigue don't tend to have acute onset, but they can be just as crippling as many other severe illnesses.

   7. Studies in non-elderly subjects.  In comparison, the data on non-elderly subjects is even more scarce, irrespective of how they try to portray the issue.

      The most important one is the one on Fluad, the seasonal vaccine:

          Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults, Frey S, Poland G, Percell S, Podda A. Vaccine. 2003 Oct 1;21(27-30):4234-7.http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TD4-49RCXR6-P&_user=10&_coverDate=10%2F01%2F2003&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=3d5e429d94878701779f69dabe7aafab
          Abstract
          The adjuvanted influenza vaccine FLUAD is composed of subunit influenza antigens combined with the MF59-adjuvant emulsion. The vaccine was developed primarily for use in elderly populations, but non-elderly individuals might also benefit. To evaluate this hypothesis, 301 healthy adults were assigned randomly to receive two intramuscular injections of either FLUAD (150 subjects) or a non-adjuvanted vaccine, Fluzone (151 subjects), in two trials conducted at a 1-year interval. Injections consisted of 15 micrograms per 0.5 ml dose. Vaccine composition was A/Texas/36/91 (H1N1), A/Johannesburg/33/94 (H3N2), and B/Harbin/7/94 for the first injection and A/Texas/36/91 (H1N1), A/Nanchang/933/95 (H3N2), and B/Harbin/7/94 for the second injection. Immunogenicity was evaluated at 28 and 180 days post-immunization. FLUAD was generally well tolerated in healthy adults when compared with Fluzone. FLUAD was associated with increased pain at the injection site after immunization. A statistically significant increase in the incidence of injection-site warmth, chills, myalgia, and analgesic/antipyretic use occurred in the FLUAD group after the first injection but not after the second injection. In both groups, most of these local and systemic reactions were classified as mild. FLUAD was more immunogenic than Fluzone following both injections. After the first injection, statistically significant differences were found in the percentage of subjects with four-fold rises in hemagglutinin inhibition (HI) titers at 28 days post-immunization for the B antigen. After the second injection, the FLUAD group had significantly higher HI titers, a significantly higher percentage with a four-fold increase in titer, and a significantly greater percentage of subjects with titers >/=160 for the H3N2 antigen at 28 days. Only minor immunogenicity differences between the two groups were seen at 180 days. Compared with Fluzone, FLUAD was associated with increased immunogenicity and mild post-immunization reactions in healthy adults. The magnitude of increased immunogenicity in healthy adults was less than that seen in elderly populations.


      This looks pretty straight forward, they injected 150 people aged 18-64 with the regular flu vaccine, and 150 people with the adjuvanted one, fluad.  Fluad appears to cause more mild reactions but also more immunogenic, but this increased immunogenicity is not as marked as in the elderly group, and not sustained at 180 days.  In this and the rest of the studies quoted here, the subjects were followed up in similar ways as the studies on elderly subjects described above, so I'm not going to repeat myself.

      However, given that the purpose of this study is to evaluate safety as well as efficacy in a younger age group, the single most important piece of information missing from the data is the mean or median age of the subjects!  I mean 18-64 is a pretty wide range.  For example, there is a big difference if the mean age is 28 or 58!  But apart from stating this is a study for those aged 18-64, the only other mention of age in the whole paper is this one single sentence:

          The mean age and sex distribution were similar in the two groups.


   8. Other studies on non-elderly subjects that I can find include the following.  I'm including the ages given and the number of people vaccinated, to give you an idea for comparison.  The safety follow-up is pretty similar.

      Safety and Immunogenicity of Nonadjuvanted and MF59-Adjuvanted Influenza A/H9N2 Vaccine Preparations: http://www.journals.uchicago.edu/ucp/WebIntegrationServlet?call=ContentWeblet&url=http://www.journals.uchicago.edu/CID/journal/issues/v43n9/39957/39957.html?erFrom=-523615147925872450Guest&current_page=content
      age 18-34, total 96 subjects, 48 each group.
      MF59-adjuvanted influenza vaccine confers superior immunogenicity in adult subjects (18-60 years of age) with chronic diseases who are at risk of post-influenza complications: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TD4-4N6FM7C-2&_user=10&_coverDate=05%2F16%2F2007&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=a63406df97def6baf75b16938d946a8b

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-439MKF7-G&_user=10&_coverDate=06%2F16%2F2001&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=d64a42c69984d8880b937420ae20a94a

      Mean age 51, 120 given subunit vax with MF59, 118 subunit vax only.
      Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza
      Mean age around 28 years.  32 MF59, non-adjuvanted 33.


sociostudent

  • Guest
So, here's a wrap-up so far:

oil-in-water adjuvant emultion/MF-59/ASO3= SQUALENE
It's GSK that makes the ASO3, and Novartis that makes mf-59(Look on p. 6)




"evaluation of pandemic influenza prototype vaccines in clinical trials". If you want to find it, go to [url=http://dx.doi.org/
and copy/paste in this number/letter combo:

"10.1016/j.vaccine.2009.04.059"  
"...A number of vaccine types were covered, including classical egg-derived inactivated vaccines, cell-derived inactivated vaccines, live-attenuated vaccines (LAIV) and vaccines developed using new technologies. The effects of different adjuvants and prime-boosting schedules were important topics, and further data were presented to show that children mount vigorous antibody responses to several H5N1 vaccines. Other subjects presented and discussed were standardisation, and regulatory issues concerning pandemic vaccines.[/b]






















...or this one's even worse:
"10.1128/CVI.00191-06":
(A whitewash report from Novartis and Chiron that claimed to have injected millions of people with it already, but that that was awesome and not a bad thing at all):
Vaccines with the MF59 Adjuvant Do Not Stimulate Antibody
Responses against Squalene




But, by far, the best article written so far on these issues is this one:

Fish oil vaccine adjuvant programs bodies for "endless loop of self-destruction"
http://snardfarker.ning.com/profiles/blogs/squalene-a-history-of-vaccine
by The Idaho Observer"

It’s a race—will we all be injected with substances that program our own bodies to attack us before or after we realize that the newest weapon in the New World arsenal is our own immune system?

The theory that vaccines prevent the spread of infectious disease is based upon the belief that, by injecting a small amount of a disease into the body, it will develop "antibodies" that will prevent the injected person from contracting the disease against which he had been vaccinated.

The theory is complicated by the fact that attenuated doses of pathogens alone will not initiate an "antigenic response." So, vaccines contain compounds known as "adjuvants" to intensify the body’s immune response.

Traditional adjuvants are alum (aluminum hydroxide), and thimerosal—which is 50 percent ethyl mercury and also serves as a vaccine "preservative."

According to Edda West, "A quick read of the scientific literature reveals that the neurotoxic effects of aluminum were recognized 100 years ago."

The neurotoxic affects of mercury are likewise not a secret and have been documented extensively in the scientific and medical literature since the mid-1800s.

More recently, aluminum has been linked to Alzheimer’s disease and other neurological disorders. Recent medical literature shows that statistically significant numbers of kidney patients and intravenously-fed infants exposed to aluminum suffer neurological complications. Other research shows that pain from muscle diseases is also linked to the presence of aluminum in the body.

Dr. Boyd Haley found that vaccines containing both aluminum and mercury greatly magnify the neurotoxic result of vaccination.

Most people understand that both aluminum and mercury are toxic. It is our body’s reaction to toxic exposure that vaccine advocates measure to determine vaccine efficacy. That elevated levels of mercury and aluminum can cause side-effects worse than the disease is not a consideration for most pro-vaccinators.

The new wave

West, who is director of the Vaccine Risk Awareness Network in Winlaw, BC, Canada, published the comprehensive, well-footnoted article "A Look into the Scary World of Vaccine Adjuvants." The article explains that modern, synthetic or recombinant vaccines are "purer" and less toxic to the body than their live and dead virus predecessors and, therefore, require more potent adjuvants to illicit an immune response. "This has created a major need for improved and more powerful adjuvants for use in these vaccines," the article, Vaccine Adjuvants: current state and future trends, published in the medical journal "Immunology and Cell Biology" stated.

Under this line of logic, alum is scheduled to be phased out and replaced with oil-based adjuvants such as squalene—an essential fatty acid derived from fish.

Squalene

"The most effective adjuvants are formulated with oils but have long been considered too reactive for use in humans. Immunologists have known for decades that a microscopic dose of even a few molecules of adjuvant injected into the body can cause disturbances in the immune system and have known since the 1930s that oil-based adjuvants are particularly dangerous, which is why their use has been restricted to experiments with animals," West wrote.

The following (in italics) is from West’s article. Keep in mind that the FDA determined that squalene was present in varying amounts in specific lots of anthrax vaccine administered to tens of thousands of Desert Storm personnel (without their informed consent). Not surprisingly, tens of thousands of Desert Storm veterans have suffered permanent neurological damage and exhibit symptoms commonly referred to as "Gulf War Illness."

"The classic oil-based adjuvant called Freund’s Complete Adjuvant can cause permanent organ damage and irreversible disease – specifically autoimmune diseases. When scientists want to induce autoimmune disease in a lab animal, they inject it with Freund’s Complete Adjuvant, which causes great suffering and is considered by some too inhumane to even inject into animals.

"Dr. Jules Freund creator of this oil-based adjuvant warned in 1956 that animals injected with his formulation developed terrible, incurable conditions: allergic aspermatogenesis (stoppage of sperm production), experimental allergic encephalomyelitis (the animal version of MS), allergic neuritis (inflammation of the nerves that can lead to paralysis) and other severe autoimmune disorders.

"Adjuvants can break ‘tolerance,’ meaning they can disable the immune system to the degree that it loses its ability to distinguish what is ‘self’ from what is foreign. Normally, the immune system ignores the constituents of one’s own body. Immunologists call this ‘tolerance.’ But if something happens to break tolerance, then the immune system turns relentlessly self-destructive, attacking the body it is supposed to defend."

For national security

The issue becomes more complicated with oil-based adjuvants that resemble oils found in the human body. West reported that seasoned journalist Gary Matsumoto found evidence to suggest that, "…when an oil is injected, the immune system responds to it not only specifically, but with heightened intensity because the oil adjuvant resembles so closely the natural oils found in the body. A ‘cross reaction’ then happens, sending the immune system into chaos destroying any oils found anywhere in the body that resemble the adjuvant oil. Demyelinating diseases like multiple sclerosis are an example of this destructive autoimmune process."

Matsumoto’s impeccably-referenced and footnoted book is entitled, "Vaccine A-The Covert Government Experiment That’s Killing our Soldiers and Why GI’s are Only the First Victims." West noted that Matsumoto, who was the first journalist to break the story of squalene-containing anthrax vaccine’s link to Gulf War Illness, documented decades of secret medical experimentation on Americans without their knowledge or consent. "The unethical experiments detailed in this book are ongoing, with little prospect of being self-limiting because they have been shielded from scrutiny and public accountability by national security concerns," wrote Matsumoto.

Biological time bomb

Squalene is an oil that is readily digestible if taken orally. However, it behaves much differently when injected. Matsumoto cites data from more than two dozen peer-reviewed scientific papers from 10 labs located in countries all over the world that document how squalene-based adjuvants can trigger the development of autoimmune diseases in lab rats, mice, guinea pigs and rabbits.

Regardless of the known toxic effects on animals and the toxic effects on humans as experienced with squalene-containing vaccines given to Desert Storm personnel, Matsumoto claims, "Squalene adjuvants are a key ingredient in a whole new generation of vaccines intended for mass immunization around the globe."

Among the chronic conditions observed in human and animal test subjects injected with squalene are rheumatoid arthritis, multiple sclerosis and lupus.

In her article, "The Adverse Effects of Adjuvants in Vaccines" (Nexus Magazine Dec. 2000), Australian vaccine researcher Viera Scheibner, Ph.D., lists the autoimmune diseases that have been linked to squalene injections in humans—arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS (amyotrophic lateral sclerosis) also known as Lou Gehrig’s disease, Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhoea, night sweats and low-grade fevers.

But that, believe it or not, is the good news because its merely describes squalene’s experimental contribution to global epidemics of chronic autoimmune dysfunction. Once it becomes a common ingredient in vaccines (already, the squalene-based adjuvant MF59 is a component of the Italian flu vaccine FLAUD), it will be best described as a biological time bomb.

Our own worst enemy

From Edda West: "The immune system does in fact ‘see’ squalene and recognizes it as an oil molecule native to the body. The key is ‘route of administration.’ As Gary Matsumoto says, ‘Squalene is not just a molecule found in a knee or elbow – it is found throughout the nervous system and the brain.’ When it is injected into the body, the immune system sees it as an enemy to be attacked and eliminated.

"As any immunologist will tell you, the way an antigen encounters the immune system makes all the difference. You can eat squalene – no problem as it is an oil the body can easily digest. But studies in animals and humans show that injecting squalene will ‘galvanize the immune system into attacking it, which can produce a self-destructive cross reaction against the same molecule in the places where it occurs naturally in the body – and where it is critical to the health of the nervous system.’

"This phenomenon is also known as ‘molecular mimicry,’ where the immune system forms antibodies against one of its own structures and will continue to attack the ‘self’ molecule in the body that resembles the one in the germ, or as is the case with squalene, an identical substance that is naturally present in the body. Once this self-destructive process begins, it never stops as the body continues to make the molecule the immune system is now trained to attack.

"Another example involving autoimmune ‘molecular mimicry’ is when the immune system has been sensitized to attack myelin, the insulating fatty coating around nerve fibres which insures the smooth relay of nerve signals. The body would continue to make myelin in order to replenish and repair the protective sheath around its nerve endings. But says Matsumoto, ‘In the act of doing so, the body immunizes itself against itself, administering over and over again what amounts to a booster dose of something that the immune system now wants to get rid of. This vital constituent (myelin) is now the enemy, and the immune system is now programmed to obliterate it in an endless loop of self-destruction—the process involved in MS (multiple sclerosis), and ALS (Lou Gehrig’s disease).

"Squalene is a kind of trigger for the real biological weapon: The immune system. When the immune system’s full repertoire of cells and antibodies start attacking the tissues they are supposed to protect, the results can be catastrophic," wrote Matsumoto. Dr. Pam Asa concurs with Matsumoto when she stated," Oil adjuvants are the most insidious chemical weapon ever devised."

West continues, "The main proponents for the use of squalene in vaccines have been the U.S Department of Defense and the NIH. The anti-squalene antibodies found in sick American and British military personnel are evidence that military experimentation has caused an unprecedented health catastrophe in tens of thousands of people onto whom the vaccine was forced and who were denied the right to make an informed decision based on existing scientific knowledge of the dangers of injecting squalene."

Based upon decades of research in animals and humans, once oil-based adjuvants become the most common adjuvant contained in vaccines, there will be no way the pharmaceutical industry will be able to claim mass vaccination is necessary to prevent the spread of infectious diseases—it will be an open declaration of war on mankind. "By adding squalene to their new anthrax vaccine, they did not make a better vaccine, they made a biological weapon," Matsumoto observed.



sociostudent

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regarding their comment about children "creating vigorous immune responses", tptb are pushing like hell for the kids to get vaxxed NO MATTER WHAT, most countries are asking for multiple shots, spread apart, which is exactly what's happened with previous "vaccines" that ended up triggering the auto-immune cytokine storm (think "hurricane katrina" is to New Orleans' lower 9th ward = adjuvants, especially the oil-based, to a susceptible immune system that is predisposed to autoimmune disorders)
http://www.prisonplanet.com/12000-u-s-children-to-be-swine-flu-vaccine-guinea-pigs.html


and this one just came out: http://www.daily.pk/7471/flu-is-not-the-biggest-danger-its-the-vaccine/

Flu is not the Biggest Danger it’s the Vaccine
Filed under: World — Tags: flu, swine flu, swine flu Vaccine, Vaccine — Farooq Hussain @ 8:18 am

These are challenging times and we need to stay calm and think things through – not just panic and react. Fear, panic and emotional reaction got us into this mess and it is certainly not going to get us out of it.

We also need to realise – here, now – that we have long crossed the line into a fully-fledged fascist dictatorship. It has hidden itself to most people this far, but it is about to lift the veil.

It is no longer an option to do nothing or passively acquiesce to authority out of fear or apathy. Or, at least, it’s not if we care about our freedoms and, most importantly, those of our children and grandchildren who will have to live almost their entire lives under a global jackboot of sheer, undiluted evil.

The word ‘evil’ is much overused and I don’t say it lightly; but we are dealing with evil in the sense that the word is the reverse of ‘live’. Those behind the conspiracy to cull the human population and turn the rest into little more than computer terminals are anti-life. They have no respect for it and no empathy with those who suffer the consequences of their actions, no matter how appalling.

I have been warning of what was coming for nearly 20 years and it is not ‘coming’ any more – it’s here. No more excuses from anyone, please. We have to deal with it. We have to draw a line in the sand and say no more.

Never was this more important than with the conspiracy to force swine flu vaccination upon the global population. The swine flu virus was created in a laboratory to generate  mass panic with the specific intention of forcing everyone to have the vaccine. Problem-Reaction-Solution. This ‘natural’ swine flu virus apparently contains genes from humans, birds and pigs from several continents.

If you concoct and release a virus and then implement a clearly long-planned mass vaccination programme, there can be only one sensible conclusion: swine flu is not the biggest danger here – it’s the vaccine.

The scale and speed of the planned vaccination programme is insane given that the overwhelming majority of those who have contracted the virus have had very mild symptoms. Dr Peter Holden of the Rothschild-controlled British Medical Association said that although swine flu was not causing serious illness they were eager to start a mass vaccination campaign, beginning with ‘priority groups’. Ugh?? This is not about public health and never was.

Those administering the vaccinations have no clue what is in them or their potential effect. They are just repeaters thinking what they are told to think and doing what they are told to do. Only those at the core of the conspiracy, and those who bother to research it, know what the game is.

‘Get yer flu shot, get yer flu shot, get yer flu shot …’

The Austrian journalist, Jane Bürgermeister, has filed criminal charges with the FBI against the World Health Organization (WHO), United Nations, Barack Obama, a Rockefeller, a Rothschild, and others, over a plot she uncovered to cull the population with a deadly swine flu vaccine.

She said that bird flu and swine flu have been developed in laboratories and released on the public with the aim of mass murder through vaccination. Her filed document is called Bioterrorism Evidence. She writes here about the United States, but what she says applies everywhere:

‘There is evidence that an international corporate criminal syndicate, which has annexed high government office at Federal and State level, is intent on carrying out a mass genocide against the people of the United States by using an artificial (genetic) flu pandemic virus and forced vaccine program to cause mass death and injury and depopulate America in order to transfer control of the United States to the United Nations and affiliated security forces (UN troops from countries such as China, Canada, the UK and Mexico).

There is proof many organisations – World Health Organisation, UN as well as vaccine companies such as Baxter and Novartis – are part of a single system under the control of a core criminal group, who give the strategic leadership, and who have also funded the development, manufacturing and release of artificial viruses in order to justify mass vaccinations with a bioweapon substance in order to eliminate the people of the USA, and so gain control of the assets, resources etc of North America.

The motivation for the crime is classical robbery followed by murder although the scale and method are new in history. The core group sets its strategic goals and operative priorities in secret using committees such as the Trilateral Commission, and in person to person contact in the annual Bilderberg meeting.’

Jane Bürgermeister is a rare real journalist, so much so that she was sacked from her job as European correspondent of the Renewable Energy World website after she filed the charges with the FBI. Renewable Energy? It is their backbone and sense of decency that need renewing, but it shows how controlled everything is.

What Bürgermeister describes in her FBI submission is a summary of what I have been trying to get across in my books and talks for nearly two decades. A cabal of interbreeding families is seeking to impose a global fascist dictatorship of total human control.

Their vehicle is a secret society network structured like a transnational corporation. The operational headquarters is in Europe, in places like Rome, London, Paris, Brussels and Berlin. I refer to this as ‘the Spider’ and it dictates to the global web.

There are subsidiary networks of secret societies in every country that answer to the ‘Spider’. Their job is to control their country’s politics, banking, business, military, media, medicine, and so on, and introduce in their sphere of influence the global agenda dictated by the ‘Spider’. Those on the inner levels of this structure are collectively known as the ‘Illuminati’.

This is how they coordinate between apparently unconnected governments, corporations, media groups etc. The Rothschild and Rockefeller dynasties (the same bloodline) are fundamentally involved in this, as I have long exposed, and they dominate pharmaceutical medicine and government ‘health’ policy worldwide.

The web controls governments, the pharmaceutical industry, or ‘Big Pharma’, the World Health Organisation and  public heath ‘protection’ agencies like the Centers for Disease Control and Prevention in the United States.  In short, they control the entire medical system.

The Illuminati cabal established global bodies like the World Heath Organisation, World Bank and World Trade Organisation to transfer power from the many to the few. Their goal is a world government, world central bank, world currency and world army.

You have to centralise power to impose a global dictatorship and diversity is your worst nightmare. The Illuminati network is behind ‘globalisation’ and the creation of superstate dictatorships like the European Union for this same reason.

Given this essential background, it was no surprise when I saw the list of names and organisations in Jane Bürgermeister’s submission to the FBI:

‘Specifically, evidence is presented that Defendants President Barack Obama, President of the United States, David Nabarro, UN System Coordinator for Influenza,

Margaret Chan, Director-General of World Health Organisation, Kathleen Sibelius, Secretary of Department of Health and Human Services (HHS), Secretary Janet Napolitano, the Department of Homeland Security, David de Rothschild, banker, David Rockefeller, banker, George Soros, banker, and Alois Stoger, Austrian Health Minister, among others, are part of this international corporate crime syndicate which has, marching as one phalanx to carry out their plan of genocide, have developed, produced, stockpiled and used biological weapons to eliminate the population of the United States for financial and political gain.’

Bürgermeister says there is clear evidence that pharmaceutical companies and international government agencies are actively engaged in producing, developing, manufacturing and distributing biological agents classified as the most deadly bioweapons on earth.

She says the swine flu virus was created and released with help from the Rothschild/Rockefeller-controlled World Health Organisation – the very body which then said it was spreading so fast that a pandemic had to be declared.

The symptoms of ’swine flu’ at present are pretty much the same as regular flu and it is easy to call everything ’swine flu’ to increase the official numbers. The British government has announced that people should no longer see a doctor if they have flu symptoms and instead a system of diagnosis over the phone has been introduced without laboratory confirmation. How convenient for fixing the figures:

‘Hello, I’ve got a cold, doc.’

‘I think its swine flu, I’ll tick you off.’

Jane Bürgermeister has filed bioterrorism charges against pharmaceutical giants like Novartis International AG, based in Basel, Switzerland, Baxter AG, based in Austria, and its parent company, Baxter International in Deerfield, Illinois. Guess who is providing much of the swine flu vaccine for mass inoculation – Baxter International and Novartis.

This is the same Baxter International that sent bird flu virus to European laboratories ‘by mistake’ earlier this year and it was mixed with a seasonal flu virus to create a much more dangerous strain.

Last year at least 81 people were killed by Baxter International’s contaminated blood-thinning product, heparin, which was made in China from, among other things, pig intestines. Isn’t pharmaceutical medicine wonderful? The contaminated heparin also seriously injured hundreds of people and it was revealed that the factory of Baxter’s Chinese supplier had never been inspected by either American or Chinese public ‘protection’ agencies.

More than 50 dialysis patients died in 2001 because of faults with Baxter International equipment, and this month Baxter Healthcare Corporation, a subsidiary of Baxter International, reached an out-of-court settlement of two million dollars with the State of Kentucky. Baxter had been caught inflating the cost of intravenous drugs sold to Kentucky Medicaid by as much as 1,300 per cent.

This is clearly a company you can trust and it is now is a major source of the swine flu vaccine that governments across the world want to impose upon entire populations with the most minimal safety checks. The vaccine is being fast-tracked through the regulatory system with safety trials lasting less than a week. The London Times reported:

‘Regulators at the European Medicines Agency said the fast-tracked procedure has involved clinical trials of a “mock-up” vaccine similar to the one that will be used for the biggest mass vaccination programme in generations. It will be introduced into the general population while regulators continue to carry out simultaneous clinical trials.’

My emphasis.

There is no need for ‘trials’ at all, except for public consumption. They already know what is in it and its effect. The drug companies have even been given immunity from prosecution from death or injury from the vaccine in a document signed by Obama’s Secretary of Health and Human Services, Kathleen Sebelius.

Baxter International said it will be shipping swine flu vaccine worldwide by the end of July and the potential profits are fantastic; but this is not primarily about money. It about a long-planned mass-culling of the human population.

We are told that the drug companies and the World Health Organisation have been working at fever pitch to develop a vaccine for the ‘new’ swine flu strain known as H1N1, but … wait for it … Baxter International filed a patent for the H1N1 vaccine on August 28th 2008. Click here to read …

Baxter Vaccine Patent Application US 2009/0060950 A1 says:

‘… In particular preferred embodiments the composition or vaccine comprises more than one antigen … such as influenza A and influenza B in particular selected from of one or more of the human H1N1, H2N2, H3N2, H5N1, H7N7, H1N2, H9N2, H7N2, H7N3, H10N7 subtypes, of the pig flu H1N1, H1N2, H3N1 and H3N2 subtypes, of the dog or horse flu H7N7, H3N8 subtypes or of the avian H5N1, H7N2, H1N7, H7N3, H13N6, H5N9, H11N6, H3N8, H9N2, H5N2, H4N8, H10N7, H2N2, H8N4, H14N5, H6N5, H12N5 subtypes.’

The patent was published in March 2009, a month before the virus was released in Mexico in April, but it was filed seven months before this ‘new strain’ was officially known about. It is the most blatant set-up you could ever see.

The patent includes the following ingredients and toxicity warning:

‘Suitable adjuvants can be selected from mineral gels, aluminium hydroxide, surface active substances, lysolecithin, pluronic polyols, polyanions or oil emulsions such as water in oil or oil in water, or a combination thereof. Of course, the selection of the adjuvant depends on the intended use. E.g. toxicity may depend on the destined subject organism and can vary from no toxicity to high toxicity.’

Nice.

Another Big Pharma corporation involved is Novartis in Switzerland. Chief executive, Daniel Vasella, is a regular attendee of the secretive Bilderberg meetings that I have long exposed in my books. The Bilderberg Group, named in Jane Bürgermeister’s FBI submission, is the creation of the Rothschild dynasty and has been administered for decades by people like David Rockefeller and Henry Kissinger.

It answers to a Rothschild secret society in Britain called the Round Table. This was first headed by the Rothschild agent, Cecil Rhodes, who plundered southern Africa on the family’s behalf. Vasella attended the last Bilderberg meeting last May, just as the swine flu scare was being engineered, and bingo, his company comes up with the vaccine.

I am not saying that people will die in large numbers immediately. This is certainly possible, but it would hardly encourage others to continue to be inoculated. The effects may be immediate in some, probably medium or longer-term in most, to hide the true source of their problem. What we do know is that we are seeing a long-prepared plan for mass vaccination by people who could not care less about the health of the population. That says everything about the real motivation, but only those in the shadows know what the effect is designed to be.

For sure, it will involve targeting the human immune system. Once that has been disabled, it’s over as we see with the immune-destroyer we call AIDS. People don’t die of AIDS, they die of diseases the immune system would normally deal with.

The excellent work of people like the American researcher and author, Patrick Jordan, have exposed the unfolding plan to kill vast numbers of people through engineered viruses and vaccines. He says that they have long perfected vaccines that switch off the human immune system and US troops have often been used as guinea pigs.

Patrick Jordan’s research uncovers a three-vaccine system that the Illuminati have developed. The first inoculation turns off white blood cells (the immune system); the second injects viruses; and the third switches the immune system on again.

In the middle period viruses are expanding around the body, but the person doesn’t feel sick because the immune system is not fighting them. When the immune system kicks in again it unleashes such an assault on the virus cocktail that it kills the body.

This is known as a cytokine storm when the immune system is so overwhelmed that it sends too many antibodies at the same time to infected areas of the body and the body kills itself.

It is also the case that the World Health Organisation has asked for live swine flu virus to be in the vaccine and it is quite possible that they will expand and maybe increase the strength of the virus through the vaccine. The WHO website says:

‘In view of the anticipated limited vaccine availability at global level and the potential need to protect against “drifted” strains of virus, SAGE recommended that promoting production and use of vaccines such as those that are formulated with oil-in-water adjuvants and live attenuated influenza vaccines was important.’

Jane Bürgermeister’s evidence has been supported by Wayne Madsen, a former US Naval Intelligence officer and now an investigative journalist. He said that a top United Nations scientist concluded that the H1N1 swine flu virus has certain transmission ‘vectors’ that suggest the new flu strain has been genetically-manufactured as a military biological warfare weapon. The UN expert believed that Ebola, HIV/AIDS, and the current A-H1N1 swine flu virus are all biological warfare agents. Madsen writes:

‘Past swine flu outbreaks have been spread from pigs to humans, who then passed the flu on to other humans. However, with A-H1N1, there have been no reported infections of pigs. In fact, according to the Centers for Disease Control and Prevention (CDC), A-H1N1 has gene segments from North American swine, bird and human flu strains and a segment from Eurasian swine flu.’

Wayne Madsen also says that his sources confirm that the Centers for Disease Control and the US army recovered the body of an Inuit woman who died in 1918 in Brevig Mission, Alaska, from an outbreak of Spanish flu that killed 100 million people worldwide in 18 months.

Madsen was told that genetic material from the corpse provided the basis for the development of the H5N1 avian, or ‘bird flu’, strain at the US Army Medical Institute of Infectious Diseases laboratory at Fort Detrick, Maryland. This lab was the origin of the anthrax attacks on US Congress and media targets shortly after September 11th in 2001.

All this will sound way out in the Twilight Zone to those new to this sort of information, but what they need to understand is that these Illuminati families are utterly insane. They don’t think like most of the rest of us, so please don’t judge what they would do by what you would do. It’s not the same, because they’re not the same.

The Illuminati plan for the world includes a mass cull of the population and the microchipping of every man, woman and child. Microchips would allow everyone to be tracked 24/7, but it goes much further than that.

Computer technology communicating with the chips has the potential to manipulate people mentally, emotionally and physically. This could be done en masse or individually through the chip’s unique transmitter-receiver signal. Killing someone from a distance would be a synch.

I mention this because, as readers of my books will know, a CIA scientist told me in 1997 that microchips developed in the secret government-military research projects were even then small enough to be injected by hypodermic needles in vaccination programmes. With nanotechnology, no one would know.

The fake swine flu scare of 1976 was a trial-run for what is happening now. These events are planned way in advance and these sick people are extremely thorough in their preparations.

The scare began with the death of an Army recruit at Fort Dix in New Jersey which the government said was caused by ’swine flu’. The recruit was the only death from the virus in 1976, but the government instigated a vaccination programme for all Americans supported by a campaign of outrageous propaganda based, as always, on terrifying people. Click here for an example.

The result was that at least 25 people were killed by the vaccine and hundreds seriously harmed while the Fort Dix recruit was the only death from swine flu -  even if the government was telling the truth about the diagnosis. We are now heading for a re-run on a vastly bigger scale.

The British and American governments have ordered enough swine flu vaccine for the entire population and other countries are following suit. Of course, they are; the ‘Spider’ has demanded it.

It is clear they intend to make vaccination compulsory and threaten parents with losing their children if they refuse to submit to this fascism. Even before that, the pressure on parents to submit to the dictates of the state are going to be considerably increased.

The Rockefeller-dominated Centers for Disease Control (CDC) in the United States have said that children who have never had a flu ’shot’ may need to be vaccinated four times in the Autumn – twice for seasonal flu and twice for swine flu. Making up for lost time, eh? Other children will get three shots – note the three, given Patrick Jordan’s information.

The Rothschild-Rockfeller front-man, Barack Obama, has demanded that his ‘health reform’ bill is passed into law by August, just ahead of mass vaccination. The bill was approved this week by the Senate Health, Education, Labor and Pension Committee and it includes the targeting of parents who do not have their children vaccinated. It authorises the Orwellian ‘demonstration program to improve immunization coverage’. The bill says:

‘Under this program, CDC will provide grants to states to improve immunization coverage of children, adolescents, and adults through the use of evidence-based interventions. States may use funds to implement interventions that are recommended by the Community Preventive Services Task Force, such as reminders or recalls for patients or providers, or home visits.’

‘Interventions’? Home visits? It is one step away from immunising your children by force or having you arrested for refusing to comply. World Health Organisation ‘recommendations’ are binding on its nearly 200 member countries when a pandemic emergency is declared under the International Health Regulations Act of 2005 and WHO pandemic plan of April this year.

Margaret Chan, the WHO Director General, declared a swine flu pandemic when there wasn’t one so these emergency powers would be activated and this lackey of the Rothschild-Rockefeller cabal is going to be recommending compulsory vaccination. She’s virtually done it already. The WHO advisory board on vaccination policy includes executives from … Baxter, Novartis, GSK and Sanofi Pasteur.

Margaret Chan with appropriate logo

Last week Margaret ‘Be Afraid’ Chan warned that a global pandemic of drug-resistant tuberculosis may be imminent with potentially ‘catastrophic consequences’.  She prattled on …

‘The situation is already alarming, and poised to grow much worse very quickly. This is a situation set to spiral out of control. Call it what you may: a time bomb or a powder keg. Any way you look at it, this is a potentially explosive situation.’

Oh, get a life woman. When will TB ‘explode’? As soon as they’ve circulated it sufficiently, I guess.

What is happening now has been planned for a very long time. Builders have been at work for months in a highly-secretive operation at a council building called Westridge, just down the road from me on the Isle of Wight.

The builders themselves have become very suspicious as one group is given plans for one section of the work and then a totally new group is brought in for the next, and so on. No single group sees the whole picture and now people in unmarked white vans are turning up to complete the job.

I had a look through a window near a fire escape after everyone had left and it is clearly an emergency response centre of some kind. The builders were told they had to finish their work by mid-July without fail and, apparently, something similar is happening all over the country.

If you listen carefully, the dark suits tell you what is going to happen. As I said in a recent newsletter, I kept hearing the mantra from different agencies and countries about the dangers of a massive increase in swine flu in the autumn and that is now their target for mass vaccination to really get moving.

Now I am hearing that the virus could become more deadly in the same period and it could well be that they are planning to increase the numbers who die from swine flu to generate more panic and demands to be vaccinated.

We should not forget, however, that ‘normal flu’ kills hundreds of thousands of people a year worldwide. Have no doubt that large numbers of those people will now be officially designated as a death from swine flu, whether they are or not.

It was always going to come to this and aware people need to be strong and come together in collective non-compliance. These crazies want access to our bodies and those of our children for a reason that is nothing whatsoever to do with health.

Most people will line up with their children like good little sheep. They will accept the blatant lies without question and the authorities will use those people to target others who refuse. You will hear nonsense like ‘You are putting my children at risk’.

In fact, it is the programmed people who stand in line who are putting all children at risk. The authorities will claim that those who decline are preventing ‘herd immunity’ when all they have done is withdraw from the herd mentality.

This is a time for like-minded people to come together in mutual support and to prepare a strategy of peaceful non-compliance. There is far more strength in numbers than doing this alone.

We must not succumb to compulsory vaccination, nor pressure from those who lack a mind of their own. If we concede our freedom to stop the state enforcing vaccination upon us and our children, what the hell freedom is left?

Online Jackson Holly

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Socio, you are laying out the evidence for all the world to see, babe.
It is a concentrated attack on especially the children worlwide.
We must get it through to the sheeple:


JUST SAY NO TO GOVERNMENT DRUGS!

St. Augustine: “The truth is like a lion; you don't have to defend it. Let it loose; it will defend itself."

sociostudent

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Does someone want to merge my thread on squalene with this one? We can keep 'em separate if you want, but it's good to have all the info together.