Flu Vaccine Clinical Trial - News & Information (Please add information)

[Satyagraha]

It appears as though we should be able to view the database of information they'll be collecting on the results of the swine flu vaccination complications. (This is not specific to swine flu; it has all info about multiple vaccines).

Here's the database.. you have to click through each page, check the box to indicate you 'understand', then proceed to the searchable database:

DATABASE LINK:  http://www.pei.de/cln_116/nn_162428/EN/infos-en/fachkreise-en/pharmakovigilanz-en/adr-database/db-1-en/db-1-node-en.html?__nnn=true

Paul Ehrlich Institute Home Page: http://www.pei.de/cln_116/nn_471508/EN/home/node-en.html?__nnn=true

Information on suspected cases of complications and adverse reactions after vaccinations

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Reports of suspected cases of vaccine complications pursuant to the Infektionsschutzgesetz (IfSG) (German Protection against Infection Act) and suspected cases of serious adverse events after the use of vaccines pursuant to Section 63b Arzneimittelgesetz (AMG) German Medicinal Products Act, for vaccines authorised in Germany

Important notes on these pages
These web pages provide access to reported cases of suspected adverse events following immunisation (AEFI) with vaccines authorised in Germany. They offer help and information for interpreting the data presented. The public link to the "Database on suspected adverse events following immunisation (AEFI)" is intended to serve both the general public and healthcare professionals.

Please read the following carefully. Then tick the appropriate box. Eventually, you will automatically be directed to the "Database on suspected adverse events following immunisation (AEFI)".


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Vaccinations rank among the most effective preventive measures for the protection against infectious diseases. Thus, diseases like diphtheria and polio have been almost completely eradicated in Germany and many other countries as a result of rigorous vaccination programmes. Smallpox has been eradicated world-wide.

Until the start of the 20th century, infectious diseases were considered as the most frequent cause of child mortality. By the turn of the century, approximately 160 children out of 1000 live births still died from an infection such as diphtheria, tetanus, polio, whooping cough (pertussis) or measles by the age of five years. More recent vaccines have contributed to a decline in serious life-threatening infectious diseases in young children.

The same applies to vaccinations for certain groups of adults, as recommended by the Ständige Impfkommission (STIKO) (German Immunisation Commission) at the Robert Koch Institute (e.g. vaccinations against flu [influenza] or tick-borne encephalitis).

In recent years concern over real and alleged risks of vaccines relative to their benefit has grown in many countries including Germany. One reason for this is the fact that most infections that were previously feared have now faded from memory. This situation can be ascribed in part to the success of vaccination.

Thus, very rare or even unproven adverse events have attracted public attention. Declining vaccination rates resulting from these fears may result in a renewed increase of vaccine-preventable diseases.

In the database presented here, the Paul-Ehrlich-Institut has published data on suspected adverse effects which are more serious than the usual accepted list of adverse reactions (suspected vaccine complications, Section 11 IFSG (German Protection against Infection Act)) which have been reported since 1 January 2001 (date of coming into force of the Protection against Infection Act). The database also contains data on suspected cases of severe adverse drug reactions reported to the Paul-Ehrlich-Institut pursuant to Section 63 AMG (Arzneimittelgesetz, German Medicinal Products Act) by the marketing authorisation holder or pharmaceutical company in Germany. The Paul-Ehrlich-Institut also intends to include the earlier data going back to 1 January 1992. Finally, the database also includes reports which the Paul-Ehrlich-Institut received from the Arzneimittelkommissionen der deutschen Ärzteschaft und der Apotheker (Drug Commission of the German Medical Association and Drug Commission of the German Pharmacists), in order to provide a comprehensive overview.

In line with its guiding principles for transparency, the Paul-Ehrlich-Institut intends to give all interested parties the widest access to all relevant data. In doing so, the institute intends to make a major contribution towards improving awareness and facilitating access to information on vaccinations.


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Comprehensive pre-clinical and clinical tests as well as modern manufacturing and testing methods ensure that vaccines marketed nowadays are safe. As a rule, clinical trials performed before granting the marketing authorisation identify the most frequent adverse events and these results are used to evaluate the safety of the product.

Such trials can identify relatively rare adverse events, which occur with a frequency of 1:1,000 – 1:10,000 of all vaccinated individuals. These adverse events will then be included in the summary of product characteristics (SPC) for the vaccine. Only very rare adverse events (<1:10,000) remain unidentified before the marketing authorisation is granted.

Frequency categories for adverse drug reactions
Conforming to European Specifications the following frequency categories are used in the summary of product characteristics:

Very common (more than or equal to 1/10)
Common (more than or equal to 1/100 to less than 1/10)
Uncommon (more than 1/1,000 to less than or equal to 1/100)
Rare (more than or equal to 1/10,000 to less than or equal to 1/1,000)
Very rare (less than or equal to 1/10,000)

Therefore, even after comprehensive clinical trials of vaccines, it is possible that very rare adverse events may be observed for the first time during general use of a vaccine. For this reason, it is particularly important to report suspected cases of adverse events and complications following vaccination.

Adverse events following immunisation and monitoring of vaccine complications after the marketing authorisation has been granted (surveillance)

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In Germany, the obligation to report suspected cases of vaccine complications and adverse drug reactions is laid down in the relevant laws and rules of professional responsibility (Berufsordnung für Ärzte und Apotheker - professional code of conduct for physicians and pharmacists).

The reporting system described in the following sections is called passive monitoring or surveillance in contrast to the active monitoring of adverse events which occurs during clinical trials and observational studies (after granting the marketing authorisation) etc. (active surveillance).

Results obtained from passive surveillance are not suitable for determining the frequency of a particular adverse effect. Passive reports provide warning signals of risk and the opportunity to react to these signals.

Reports in conformity with the IfSG (German Protection against Infection Act)
Pursuant to Section 6 subsection 3 IfSG, any physician or alternative practitioner is obliged to report an adverse event to the local health authority stating the name of the patient if signs of disease occur after a vaccination for which the vaccination might be responsible and if the adverse event is more serious than the usual vaccine reaction.

Pursuant to Section 11 subsection 2 IfSG, the local health authorities in Germany (Gesundheitsämter) are obliged to transmit the reported suspected cases to the competent federal state authority (Länderbehörden) and the national competent authority, the Paul-Ehrlich-Institut. In keeping with the requirements of data protection, these reports have to be anonymised (personal data must be made unidentifiable).

The Paul-Ehrlich-Institut informs the Robert Koch Institute, which is the German authority responsible for infectious disease control. The Robert Koch Institute performs an epidemiological evaluation pursuant to Section 11, subsection 2 IfSG. After registration in the database, the Paul-Ehrlich-Institut evaluates the reports to identify whether the risk-benefit balance of the respective vaccine has changed, and whether action should be taken, for example pursuant to the AMG (German Medicinal Products Act).

The obligation to report these serious suspected adverse events following immunisation was included in the Protection against Infection Act (IfSG) mainly because it would help to initiate investigations by the local health authority (Gesundheitsamt) to clarify the case.

The individuals concerned shall also receive help from the local health authority.

Which vaccine reactions are not subject to the reporting obligation?
Temporary local and expected reactions which can be regarded as reactions of the body to the vaccine.
Signs of disease obviously due to a cause other than the vaccination.
This means that all other suspected cases of vaccine complications are subject to the reporting obligation!

Reporting conforming to the rules of professional responsibility
Pursuant to Section 6 Berufsordnung für Ärzte (professional code of conduct for physicians), a physician is required to notify the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft) of an adverse event that became known to him/her during his/her work. The Drug Commission of the German Medical Association (AkdÄ) is then to transmit the reports received on vaccines to the Paul-Ehrlich-Institut in an anonymised form.

Pursuant to Section 4 Berufsordnung für Apotheker (professional code of conduct for pharmacists) the latter are also obliged to report any suspected cases of adverse drug reactions of medicinal products to the Drug Commission of the German Pharmacists (Arzneimittelkommission der deutschen Apothekerschaft). The Drug Commission of the German Pharmacists is to forward this information to the Paul-Ehrlich-Institut.

Reports pursuant to the Arzneimittelgesetz (AMG, German Medicinal Products Act)

Evaluation of suspected cases of a vaccine complication and/or adverse effect
 
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The Paul-Ehrlich-Institut records in its database all reports of suspected cases of adverse events following immunisation which go beyond the usual vaccine reaction or complication. Each individual report is assessed by a clinical assessor.

To assess the adverse event or vaccine reaction, the following questions must be answered:

Is the information sufficient to assess the causal relationship between vaccination and the suspected adverse event(s)? If not, will further data need to be requested?
Are the symptoms recognised in scientific literature as adverse reactions or vaccine complications?
Are there other vaccines that have shown a similar reaction after administration (analogy)?
Can the adverse effect(s) be explained scientifically, and is there an immunological mechanism by which the reaction can be explained (biological plausibility)?
Are there any signs of a batch related increased frequency of suspected vaccine complications?
Are there other plausible causes for the adverse effects? (previous diseases, adjuvant treatment with medicinal products, international travelling, etc.)
Is the time interval between the vaccination and the onset of the symptoms plausible? (temporal plausibility)
Has the vaccine been administered to the patient before, and did the patient tolerate the vaccination at that time?
Did the same reaction recur after the initial event (with or without re-vaccination)?
WHO criteria
In addition, criteria, set up by the World Health Organisation (WHO) are used for evaluating the reactions. The WHO distinguishes between the following reactions and diseases following vaccinations:

Reactions which are specific for the vaccine.
Reactions triggered by the vaccine, which, however, could also have occurred spontaneously but for which the vaccine caused the first manifestation of the disease.
Diseases caused by faulty production, incorrect dosing, or incorrect use of the vaccine.
Diseases coinciding with but not caused by the vaccination.
In evaluating reports of a vaccine complication and/or adverse effect, it must be borne in mind that the reports concern suspected cases. In view of the large number of vaccine doses administered, diseases may occur in an individual following a vaccination purely by coincidence. However, even these reports are stored in the database, and are therefore contained in the list provided here.

Advantages and disadvantages of passive surveillance

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The advantages of recording reports of suspected cases of vaccine complications and adverse events within the passive surveillance include the simultaneous surveillance of all vaccines enabling us to record very rare events. Furthermore, there is no time limit for passive surveillance: reporting, recording and medical assessment are continuous processes.

All vaccinated population groups are included, even those who were not sufficiently represented in clinical trials conducted before the marketing authorisation was granted, such as patients with rare underlying diseases.

A disadvantage of recording reports of suspected adverse events following immunisation is that it is not possible to estimate their actual frequency. We know that not all adverse events are reported. There are various reasons for such “underreporting”, for example the patient does not consult his physician, or the physician does not establish the connection with a vaccination (for example because the symptoms are ascribed to an underlying disease).

We cannot put a figure to the exact extent of underreporting. However, serious adverse events are reported more completely than less serious adverse events. Experience has shown that serious adverse events are reported more frequently after administration of a new medicinal product than after administration of a medicinal product which has been on the market for a longer period of time. It can be assumed that taken together, more attention is paid to new medicinal products than to well-established ones.

Another difficulty is that the number of doses actually administered, and therefore, the number of exposed individuals, cannot be accurately identified. We can only obtain approximate figures from the number of vaccine doses in the batches released by the Paul-Ehrlich-Institut and/or the number of vaccine doses sold by the marketing authorisation holder/pharmaceutical company.

Some publications refer to a so-called “reporting rate” as the basis for the frequency of reports of adverse events and/or vaccine complications. However, this also involves some inaccuracies. Only a rough estimate of the reporting rate can be given for suspected cases of adverse events/vaccine complications with regard to the total of the vaccine doses administered, if the number of reports and the number of vaccine doses marketed are used as a basis. The overall reporting rate for 2004 and 2005 calculated by the Paul-Ehrlich-Institut was approximately three suspected cases per 100,000 vaccine doses marketed.

Whether an adverse event is causally linked with a vaccination is particularly difficult to assess. Within the spontaneous recording system, it is impossible to collect comparative data on the spontaneous occurrence of a disease in non-vaccinated individuals.

Taken together, the reporting system for adverse events and vaccine complications is one of the most important early warning systems in the field of pharmacovigilance, despite the limitations discussed above.

The spontaneous reporting system can provide valuable signals of rare and previously unknown adverse events, of an increase in the frequency of known adverse events, of batch-related occurrences of particular adverse events, or of changes in the type and severity of known adverse events.

These signals should be verified using other methods, e.g. controlled clinical studies, post-marketing authorisation safety studies and/or epidemiological studies (case-control studies and cohort studies). To identify signals in a timely manner, it is therefore desirable to report adverse effects which occur in temporal connection with the vaccination, even though there may not be a causal relationship.

Reports of suspected adverse events are also required from a consumer protection point of view, since they provide a good method of recognising previously unknown and/or very rare signals of possible risks of medicinal products.

Based on the evaluation of such possible risks, the Paul-Ehrlich-Institut takes the necessary precautionary measures. The health authority of the respective federal state authority (Länderbehörden) will be involved, if required, to initiate necessary measures falling within its sphere of competence.



The following points are important to consider when viewing the data:

The presented data mainly relate to suspected adverse effects. Thus, if an adverse reaction is reported, this does not necessarily mean the vaccine was responsible.
One reported case (suspected case) may include several adverse reactions, e.g. fever, headache, seizure.
The data require medical interpretation and should by no means replace information by your physician on the possible adverse events following immunisation.
The treating physician is best placed to advise on individual assessments of risk and benefit.
Some vaccines are used considerably more frequently than others. The number of cases listed in the database for a particular vaccine therefore does not allow us to draw conclusions as to the relative frequency of adverse events related to that vaccine.
In some cases, more than one vaccine or other medicinal products were administered at the time of the vaccination.
For reasons of data protection, the cases listed do not identify the patients or the reporting person/institution.
The information contained in the database will be updated at regular intervals. It is therefore possible that cases have already been reported to the Paul-Ehrlich-Institut but have not yet been included in the database presented here.
Publication and further use of the data presented
Pursuant to the Gesetz über Urheberrecht und verwandte Schutzrechte (UrhG) (Law on the protection of copyright and certain related rights), the information contained in the database may not be used for public presentations, publications, or similar activities without written consent from the Paul-Ehrlich-Institut.

following immunisation

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Database on suspected adverse events following immunisation (AEFI)
http://52625146fm.pei.de/?ps=9961d62ce30b65f572e933059812fd49

When you click on the above link, cookies will be set on your PC and a new page will open. Please select your language for the database by clicking on the appropriate flag.

Fatal Events
Search results "permant disability"Fatal events following immunisation (Explanation of terminology used in the database)
The following listing shows reports of suspected cases of vaccine complications and adverse reactions after which patients died at different time intervals following one or more immunisations.

When interpreting this list, the reader should note that the Paul-Ehrlich-Institut found in the majority of cases only a temporal rather than a causal connection to the vaccination or vaccinations, after intensive research and thorough investigation. Most of the patients had other underlying diseases at the same time, which were most likely the causes of death. Therefore, the causal relationship in these cases according to WHO criteria is rated as “unlikely”.

Only in exceptional cases could the PEI fail to rule out the possibility that the vaccination(s) may have contributed to the death of the patient. This does not mean, however, that the vaccine(s) actually caused the death of the patient. In these cases, the causal relationship was rated as “possible” according to WHO criteria.

The reports with fatal outcome in infants are mainly cases of sudden infant death (SIDS) or sudden unexpected death in infancy (SUDI). The question of whether there might be a relationship between vaccinations and sudden infant death has been examined thoroughly in comprehensive studies in Germany and other countries. These studies also included modern combination vaccines. According to the present state of knowledge, there is no scientific evidence showing that childhood vaccines cause sudden infant death.

Since the third quarter of 2005, the Robert Koch Institute (RKI) has been conducting a study on deaths in infants and children between 2 – 24 months of age called TOKEN Study (www.rki.de). The purpose of this study is to identify previously unknown factors contributing to early death (e.g. certain circumstances in life, problematic pregnancies and courses of birth, diseases, and medical treatment including vaccinations).

The cases reported to the PEI since 1 January 2001 in which a patient died shortly after a vaccination have been described by the PEI in detail.

Adverse drug reactions in clinical trials before the marketing authorisation

[Satyagraha]

The National Institute of Allergy and Infectious Diseases is conducting trials with the Flu Vaccines.
This is from their website:

http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm

Clinical Trials of 2009 H1N1 Influenza Vaccines
Conducted by the NIAID-Supported
Vaccine and Treatment Evaluation Units

QUESTIONS AND ANSWERS

(Last Update: July 22, 2009)

1.  How many trials are you announcing today, and what is the purpose of these trials?
      
The NIAID Vaccine and Treatment Evaluation Units (VTEU) will soon initiate five clinical trials of two candidate H1N1 influenza vaccines.

The trials are designed to answer three primary questions:

    * Are these vaccines safe in healthy people of various ages?
    * How large a vaccine dose, and how many doses of vaccine, are needed to induce an  immune response that is predictive of protection?
    * Can 2009 H1N1 influenza vaccine be safely administered at the same time or sequentially with the seasonal flu vaccine, and will both vaccines induce protective immune responses?

2. What are the Vaccine and Treatment Evaluation Units (VETUs)?
      
The VTEUs were established by the National Institute of Allergy and Infectious Diseases in 1962. They provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases. An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into vaccine trials and to immunize the volunteers in a safe, effective, and efficient manner. This rapid-response capability is especially important for testing vaccines for emerging public health concerns such as 2009 H1N1 influenza.

3. How many VTEUs are there, and where are they located?
      
There are currently eight VTEUs located at the following sites:

    * Baylor College of Medicine, Houston
    * Children’s Hospital Medical Center, Cincinnati
    * Emory University, Atlanta
    * Group Health Cooperative, Seattle
    * Saint Louis University, St. Louis
    * University of Iowa, Iowa City
    * University of Maryland School of Medicine, Baltimore
    * Vanderbilt University, Nashville

4. What trials are being initiated to evaluate candidate 2009 H1N1 influenza vaccines?
      
The VTEUs will soon begin an initial set of five clinical trials of candidate 2009 H1N1 influenza vaccines. Three of these trials will first enroll healthy adult (18 to 64 years old) and elderly (65 years and older) volunteers. If the vaccines prove safe in those populations, two additional trials of similar design will be initiated in children.


5.  How do I find out more information about the VTEU trials?
      

Detailed information about the trials is available from the NIH www.clinicaltrials.gov Web site. Listed below are the specific links for the initial group of five VTEU trials.

(Note: Links under each Trial will take you to the ClinicalTrials.gov website, where you can learn about the specific trial, including results if and when they get posted.)

   1. Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers. For more information, see NCT00943631.
(See: http://clinicaltrials.gov/show/NCT00943631)

   2. Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of CSL Limited candidate 2009 H1N1 flu vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers. For more information, see NCT00943488.
(See: http://clinicaltrials.gov/show/NCT00943488)

   3. Trial comparing two different strengths (15 microgram and 30 microgram) and one and two doses of sanofi pasteur candidate 2009 H1N1 flu vaccine in healthy children (6 months to 17 years old).  This trial will be conducted only if safety data from the trials in healthy adults and elderly adults show the vaccine is safe. Each of the two groups in this trial will enroll up to 300 volunteers, for a target number of 600 volunteers. For more information about this trial, see NCT00944073.
(See: http://clinicaltrials.gov/show/NCT00944073)

   4. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and elderly adults (65 years and older) volunteers. Each of the four groups in this trial will enroll up to 200 volunteers, for a target number of 800 volunteers. For more information, see NCT00943878.
(See: http://clinicaltrials.gov/show/NCT00943878)

   5. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in primed children (children who have received two doses of seasonal vaccine in one year or are older than 9 years). Each of the four groups in this trial will enroll up to 150 children, for a target number of 600 volunteers. For more information, see NCT00943202.
(See: http://clinicaltrials.gov/show/NCT00943202)


6. Will other sites be participating in these initial five trials?
      
Some of the VTEU have subsites that will join with the VTEUs in conducting these trials. In addition, to allow for rapid enrollment of volunteers and expand the number of trials, NIAID may fund other sites to help the VTEUs conduct future trials of H1N1 vaccines. Those trials are currently under development.


7. Which VTEU sites are leading the initial set of five trials?
      
The lead VTEU sites for these trials are the following institutions:

    * University of Maryland School of Medicine VTEU (Dr. Karen Kotloff, principal investigator) will lead the two trials testing the sanofi pasteur vaccine in healthy adults, elderly, and children.
    * University of Iowa VTEU (Dr. Pat Winokur, principal investigator) will lead the trials testing the CSL vaccine in healthy adult and elderly volunteers.
    * Saint Louis University VTEU (Dr. Sharon Frey, principal investigator) will lead the two trials testing the H1N1 vaccines given at the same time as or sequentially with the seasonal flu vaccine in healthy adult and elderly volunteers and in children.

All eight VTEUs are expected to participate in these five trials.  The priority for NIAID is to enroll these trials as quickly as possible.  In order to optimize quickly enrolling these trials, NIAID wants to maintain maximum flexibility and coverage in assigning specific sites to conduct these trials. NIAID expects to have more definite information over the course of the next week or so about which sites will be conducting which trials as the sites move these protocols through their institutional review boards for approval.


8.  Which candidate 2009 H1N1 influenza vaccines are being tested in the VTEU trials, and why were these two vaccines chosen?
      
This initial set of five VTEU trials will be testing two candidate 2009 H1N1 influenza vaccines: one made by sanofi pasteur (Swiftwater, Pennsylvania) and the other by CSL Limited (Melbourne, Australia). These two vaccines were chosen initially for the VTEU trials based on Department of Health and Human Services (HHS) projections of their initial availability and the need to determine as quickly as possible if unadjuvanted vaccines could induce potentially protective immune responses. In addition, seasonal flu vaccine made by sanofi pasteur is currently licensed in the United States for use in children, which meant that a candidate H1N1 influenza vaccine made by the company would be able to be tested in U.S. children.  Both vaccines also are available in versions made without thimerosal.  Other candidate H1N1 influenza vaccines may be tested in future VTEU trials.


9. How many people will be enrolled in this first set of five VTEU trials?
      
This initial set of five VTEU 2009 H1N1 influenza vaccine trials will enroll up to 2,400 people. For more details about target enrollment, see the specific descriptions of the five study protocols at www.clinicaltrials.gov (specific links are available in the answer to question #5).


10. When will results from these trials be available?
      
In addition to collecting blood samples approximately 3 weeks after each vaccination, these trials are designed also to collect samples a little over 1 week after vaccination to see if there are early indications that some individuals may already have a primed immune system. Preliminary results from these early samples in a subset of the people in these trials are expected to be available a few weeks after the trials begin.


11. How do scientists evaluate the performance of the vaccines in these trials?
      
To evaluate the immune response of the vaccines in these trials, the researchers will look at the level of antibodies induced by the vaccines in the volunteers using two assays: a hemagglutinin inhibition assay (a laboratory test used to measure the amount of antibody present in a sample by determining if the antibody inhibits influenza virus from attaching to red blood cells) and a microneutralization assay (a technique used to determine if the level of antibody in the sample inhibits the virus from infecting cells grown in the laboratory).


12.  How will the safety of volunteers in these trials be ensured?
      
The VTEU study teams will be closely monitoring the health status of all volunteers for any adverse side effects. In addition, a panel of outside experts will conduct an ongoing, close review of the safety data from these trials to spot any safety concerns in real time.


13.  How do these trials fit in with the trials being done by the manufacturers?

The five manufacturers who already produce U.S.-licensed seasonal vaccine are conducting their own 2009 H1N1 influenza vaccine trials under contract with HHS. The VTEU trials are intended to generate clinical data that may be used to inform policy decisions likely to affect the administration of the vaccines.  

For example, the NIAID-supported VTEU trials may evaluate the vaccines in some populations (for example, in children) that manufacturers are not planning to study.

In addition the trials are intended to generate data that are outside a company’s clinical development plan but that may be needed to support licensure or use of the vaccine in special populations or under an Emergency Use Authorization, which may be issued by the Food and Drug Administration to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.  (Note: This is where Squalene comes in...)

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

[Satyagraha]

Emory University: Flu Vaccine Trial Info


Emory begins H1N1 vaccine trials
http://www.wtoc.com/Global/story.asp?S=10877496
Posted: Aug 10, 2009 12:34 PM EDT Monday, August 10, 2009 12:34 PM EST Updated: Aug 12, 2009 9:50 AM EDT Wednesday, August 12, 2009 9:50 AM EST

ATLANTA (AP) - Emory University researchers have started vaccinating adult volunteer participants in the first of several national clinical trials of a new H1N1 vaccine.
The Emory clinical trial will evaluate the safety and immune response to an H1N1 vaccine and help determine how the pandemic and seasonal flu shots should be given to make it most effective. The results of the trial will help determine how to begin a fall 2009 pandemic flu vaccination program.
Dr. Mark Mulligan at Emory says a second study focused on small children and young adults will begin in about a week.
Other trial locations include Baylor College of Medicine, Saint Louis University, University of Iowa, University of Maryland School of Medicine in Baltimore and Vanderbilt University.
(Copyright 2009 by The Associated Press. All Rights Reserved.)

Also see:

http://whsc.emory.edu/home/news/releases/2009/08/vaccinating-volunteers-today-in-h1n1-clinical-trial.html

http://www.npr.org/templates/story/story.php?storyId=111743491

[Satyagraha]

Univ. of Maryland: Flu Vaccine Trial Info

BALTIMORE, Md. (WUSA) -- We know it's coming, but will we be ready?
http://www.wusa9.com/news/local/story.aspx?storyid=89559&catid=189

Researchers at the University of Maryland School of Medicine have just started clinical trials for a vaccine for H1N1 flu. Within a month or so, they hope to know if it is safe and effective, and whether you will need one dose or two.

It's a race against time because experts expect H1N1 to return to North America when we roll into fall and winter. Even if there are no problems, the feds don't expect the vaccine to be ready before mid-October, and we may have already have gotten nailed by then.
"We're in rapid motion here," says lead researcher Dr. Karen Kotloff. She says billions of doses of flu vaccine produced just like this one have been given with very few complications, so she expects it to be safe.
Researchers say they were besieged with so many volunteers willing to take the vaccine that they had to turn many of them away.
Written by Bruce Leshan
9NEWS NOW & wusa9.com

[Satyagraha]

Baylor College of Med: Flu Vacc. Info:

Baylor College of Medicine begins H1N1 vaccine trials
http://www.bcm.edu/news/features/item.cfm?newsID=1497

HOUSTON -- (August 11, 2009) -- Baylor College of Medicine has begun to test the vaccine for the H1N1 (swine) influenza in adults. (Flu experts answer H1N1 trial questions.)
Baylor's Vaccine Treatment and Evaluation Unit is one of eight federally funded centers participating in a series of studies that will help determine the best dose of several experimental vaccines designed to protect against the 2009 H1N1 (swine) influenza.
At BCM, the goal of the study is to determine the reactions and protection responses following immunization with experimental influenza H1N1 vaccine when given with seasonal influenza vaccine. Baylor plans to enroll 200 adults for this trial, which will take place over the next week. Video: One participant's comments.
Baylor will begin a similar pediatric trial Aug. 19, in which 100 children, 6 months to 17 years, will be enrolled.
Those interested in participating in the trial or having their child participate in the pediatric trial should send an e-mail to fluvaccine@bcm.edu for the adult study and H1N1FLUVAX@bcm.edu for the pediatric study. The e-mail should include basic contact information.
In addition to BCM, other sites taking part in the trials include Cincinnati's Children's Hospital, Emory University, Saint Louis University, Seattle Group Health Cooperative, the University of Iowa, the University of Maryland School of Medicine and Vanderbilt University. They will be joined by Children's Mercy Hospital in Missouri and Duke University Medical Center.

[Satyagraha]

Group Health Cooperative Seattle: Flu Vacc. Info:

August 6, 2009
Group Health begins H1N1 (swine) flu vaccine testing Friday, August 7

UW part of trial may start next week; Seattle Children's Research Institute study in children may start mid-August

Seattle—Group Health Center for Health Studies will start testing an experimental vaccine to prevent the 2009 H1N1 (swine) flu vaccine in a group of volunteer study participants on Friday, August 7.
View our video

Learn about H1N1 (swine) flu vaccine trials from Lisa Jackson, MD, MPH. (4 minutes, 33 seconds YouTube. Also available at www.ghcnews.org)
Watch our video about H1N1 (swine) flu vaccine trials

The study is one of the nation's first clinical trials of an H1N1 flu vaccine. The trials are being conducted at eight federally funded Vaccine and Treatment Evaluation Units (VTEUs) nationwide. The National Institute of Allergy and Infectious Diseases funds the VTEUs.

The VTEUs are helping the nation prepare for the possible autumn 2009 resurgence of H1N1 flu infections. This possible rise may happen at the same time that seasonal flu starts circulating widely in the Northern Hemisphere.

Group Health leads the Seattle VTEU with it research partners, Seattle Children's Research Institute and the University of Washington (UW) Division of Allergy and Infectious Diseases.

"The H1N1 virus has become widespread in the United States and worldwide, causing some deaths," said Lisa Jackson, MD, MPH, senior scientist at Group Health Center for Health Studies and the principal investigator for the Seattle VTEU. "Vaccines have always been a good tool for controlling flu, so we hope that this will be true for the new H1N1 virus, too. If so, it will reduce the risk of serious illness and death from the virus."

For more information about vaccine trials for people age 18 and older, call Group Health Center for Health Studies at 206-287-2061 or toll free 866-883-6772; or call the University of Washington Virology Clinic at Harborview Medical Center at 206-720-4340.

For information about vaccine trials for those age 17 and younger, call the Seattle Children's Research Institute vaccine trials hotline at 206-884-1100.

Generally, healthy adults of all ages are being enrolled in the study. More specific criteria are available on the www.clinicaltrials.gov site at www.clinicaltrials.gov/show/NCT00943488.

Questions & Answers: H1N1 vaccine testing at Group Health Cooperative

How was the vaccine developed?

The U.S. Centers for Disease Control and Prevention (CDC) isolated and characterized the H1N1 virus. Then they produced and distributed a 2009 H1N1 seed virus to manufacturers. From this, the manufacturers developed vaccine pilot lots for testing in clinical trials.

Now the VTEUs are evaluating these pilot vaccines for safety and testing whether they help people develop immunity to the H1N1 virus.

Like the regular seasonal flu vaccines, the new H1N1 flu vaccines the VTEUs are testing do not contain the whole virus. To make the vaccine, the virus is killed and then broken up, so the injection contains only certain parts of the virus. It's possible that the vaccines may cause side effects, such as arm pain or swelling at the injection site or possibly other reactions. But participants cannot get the flu from the vaccine.

What questions are the Seattle scientists trying to answer with this first trial?
In this first trial, they want to learn:

    * Are the H1N1 vaccines safe in healthy people of various ages?
    * How large a dose, and how many doses of vaccine are needed to produce an immune response that can protect against H1N1?

If preliminary data show that the vaccines are safe in healthy adults and healthy elderly people, similar trials in children age 6 months to 17 years old will begin.

Additional trials may look at other questions such as whether the flu vaccine can be administered safely at the same time as the seasonal flu vaccine—or before or after it.

How will the safety of the volunteers in these trials be ensured?

The VTEU study teams will closely monitor the health status of all volunteers for any adverse side effects. A panel of outside experts will also conduct an ongoing, close review of the safety data from these trials to spot any safety concerns in real time.

How will the results be used?

Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the best dosage and number of doses for various age groups.

Data from these trials may also support decisions about immunizations for people in high-risk groups. These groups include: pregnant women; and people with underlying medical conditions, such as HIV, asthma, and diabetes.

How is this first study being conducted?

All study participants will receive two doses of the vaccine three weeks apart. Blood tests three weeks after each vaccination will measure antibodies to the virus. The responses after one dose versus two doses will be compared.

Blood samples will also be collected a little over one week after vaccination to check for any early indications that some individuals may have a "primed" immune system that's already immune to the H1N1 virus.

The researchers will compare the responses among people in different age groups. This may help to determine if older adults have some immunity to the new H1N1 virus, possibly from exposure to similar flu viruses in the past.

When will the results of the trial be available?

Preliminary results from a subset of study participants are expected a few weeks after the trials begin.

How many people does the Seattle VTEU need to recruit for this study?

The Seattle VTEU aims to enroll 268 of the 400 adult volunteers needed nationally. Half of these will be recruited at Group Health and half at UW. If a similar study is to be conducted in children, Seattle Children's Research Institute aims to enroll 120 of the 600 children needed nationwide.

How is volunteer recruitment going?

The response to news coverage of the study has been encouraging. More than 1,000 people have called to volunteer. The study team is currently screening volunteers to find out if they are eligible for the study.

Who qualifies for the study?

Generally, healthy adults of all ages are needed. More specific criteria are available on the www.clinicaltrials.gov site at www.clinicaltrials.gov/show/NCT00943488.

The study involves five visits to the Group Health research facility in downtown Seattle or the University of Washington Virology Clinic near Harborview Medical Center.

What motivates people to be in the study?

The H1N1 flu virus has the potential to cause significant illness worldwide this fall and winter. Many volunteers say they want to help find the best ways to prevent the spread of the flu and protect the health of people in our community and around the globe.

What should people do if they want to volunteer for the studies?

For more information about vaccine trials for people age 18 and older, call Group Health Center for Health Studies at 206-287-2061 or toll free 866-883-6772; or call the University of Washington Virology Clinic near Harborview Medical Center at 206-720-4340.

For information about vaccine trials for those age 17 and younger, call Seattle Children's Research Institute at 206-884-1100.

How are the VTEUs and their research funded?

The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, funds them and their research.

More questions and answers

Which 2009 H1N1 influenza vaccines are being tested in the VTEU trials, and why were these two vaccines chosen?

The initial VTEU trial will be testing two candidate 2009 H1N1 influenza vaccines: one made by Sanofi Pasteur (Swiftwater, Pennsylvania) and the other by CSL Limited (Melbourne, Australia). This first trial at Group Health and UW will look at the CSL Limited vaccine.

These two vaccines were first chosen for the VTEU trials based on Department of Health and Human Services (HHS) projections of their initial availability and the need to determine as quickly as possible if vaccines without adjuvant  (a substance added to boost immunity) could induce potentially protective immune responses. In addition, seasonal flu vaccine made by Sanofi Pasteur is currently licensed in the United States for use in children, which meant that a candidate H1N1 influenza vaccine made by the company could be tested in U.S. children. Both vaccines also are available in versions made without thimerosal, a mercury-based preservative. Other candidate H1N1 influenza vaccines may be tested in future VTEU trials.

How do these trials relate to the trials the manufacturers are conducting?

The five manufacturers who already produce U.S.-licensed seasonal vaccine are conducting their own 2009 H1N1 influenza vaccine trials under contract with the Department of Health and Human Services. The VTEU trials are intended to generate clinical data that may be used to inform policy decisions likely to affect how the vaccines are given. For example, the NIAID-supported VTEU trials may evaluate the vaccines in some populations (like children) that manufacturers are not planning to study. The trials are also intended to generate data that are outside a company's clinical development plan but that may be needed to support licensure or use of the vaccine in special populations or under an Emergency Use Authorization. The Food and Drug Administration may issue such an authorization to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.

How can I get more information about the trials at Group Health?

More details about the current Seattle study in adults are available at:
www.clinicaltrials.gov/show/NCT00943488.

More information about the potential Seattle studies in children is available at:
http://clinicaltrials.gov/show/NCT00944073 and http://clinicaltrials.gov/show/NCT00944073.

More about the VTEUs

The VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns.

Where are the eight VTEUs?

    * Baylor College of Medicine, Houston
    * Children's Hospital Medical Center, Cincinnati
    * Emory University, Atlanta
    * Group Health Cooperative, Seattle
    * Saint Louis University, St. Louis
    * University of Iowa, Iowa City
    * University of Maryland School of Medicine, Baltimore
    * Vanderbilt University, Nashville, Tenn.

Some of the VTEUs have subsites helping them to conduct the trials. Group Health's subsites are the University of Washington and Seattle Children's Research Institute. Co-investigators for the Group Health Cooperative VTEU are Dr. Anna Wald, professor in UW's Department of Medicine, Epidemiology, and Laboratory Medicine, and Dr. Janet Englund, professor of pediatrics in the Department of Infectious Diseases at Seattle Children's Research Institute.  In addition to serving as senior investigator at Group Health Center for Health Studies, the Seattle VTEU's Principal Investigator Dr. Lisa Jackson is a professor in epidemiology at UW, with an adjunct appointment in the Department of Medicine.

Group Health Center for Health Studies
Founded in 1947, Group Health Cooperative is a Seattle-based, consumer-governed, nonprofit health care system. The Group Health Center for Health Studies is Group Health’s research institute. For 25 years, the Center has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.

[Satyagraha]

St. Louis University: Flu Vacc. Info

Swine flu vaccine trials underway at SLU
Posted: Monday, 10 August 2009 1:33PM
Brett Blume Reporting
http://www.kmox.com/Swine-flu-vaccine-trials-underway-at-SLU/4975546

ST. LOUIS (KMOX News)  -- Volunteers are lining up as St. Louis University begins testing possible swine flu vaccines this week.

Lead researcher Dr. Sharon Frey says they had no trouble finding willing participants.

"Our particular site will be enrolling two hundred people into this first trial,"  Dr. Frey said shortly after the first volunteers began receiving their shots Monday.  "We have had a tremendous response."

She says more than 1,000 people responded to the school's call for volunteers.

Nicholas Sarakas was among the first to get a shot Monday morning.

:"I believe I have to go in and get five shots total,"  Sarakas said.  "Two of which are going to be the H1N1 vaccine."

Dr. Frey confirms that each volunteer will receive two shots of the trial vaccine, as well as a shot of the regular flu virus to determine if the two are compatible.

Each volunteer will also get two "placebo" shots to help researchers determine if the real vaccine is working.

"We are asking whether or not one dose of the vaccine is sufficient,"  Dr. Frey explained to reporters who gathered at the Doisy Research Center on the SLU campus.  "Also, what is the amount of the dose."

"And we're also trying to see whether or not it matters if the H1N1 swine flu (vaccine) is given with the regular seasonal flu at the same time."

If all goes well, researchers hope to have an H1N1 vaccine ready for mass production and distribution sometime in October.

[Satyagraha]

Children's Hospital Cincinnati: Flu Vaccine Info:

Cincinnati Children’s is conducting research studies to evaluate the safety of and the body’s response to an experimental Swine Flu (H1N1) vaccine.
http://www.cincinnatichildrens.org/research/trials/current/vaccinations/h1n1-children.htm

Why is this study being conducted?

In April 2009, a new type of flu was found to be spreading across North America and into many parts of the world to the extent that is was called a pandemic. The new flu virus is called 2009 H1N1 flu, or “swine flu.” Since vaccines work well with the common flu, it is thought that an effective vaccine against 2009 H1N1 flu may help to control this pandemic.
Who will be included in this study?

Healthy children between the ages of 6 months and 17 years

What is involved?

    * Your child will be in a study for about 7 to 8 months.
    * The procedures and visits will depend on which study your child is eligible to join. All of the studies include: signing a parental permission and assent form, a medical history, a brief physical exam if medically necessary, temperature, blood draw and receipt of an experimental “swine flu” vaccine.

What are the benefits?

It is possible that your child may receive some protection against infection caused by the H1N1 strain of flu virus. If your child does receive some protection from the H1N1 flu, it is unknown how long this protection will last. The H1N1 flu shot will not protect your child against the seasonal flu. This study may lead to a new way of protecting children from getting H1N1 flu in the future. Your child may not receive a direct medical benefit.

Will I get all the facts about the study?

You will be given a parental permission form and your child an assent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the forms with you and your child and will be sure that all of your questions are answered. Study procedures will not begin until you and your child have signed these forms.
What are the risks and discomforts of the study?

A detailed list of possible side effects will be provided to those interested in knowing more about this study.


What is the pay?

Participants will receive compensation for time, effort and travel.

Who should I contact for more information?

The Gamble Program for Clinical Studies at Cincinnati Children’s
Phone: 513-636-7699
gambleprogram@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave., Cincinnati, OH 45229-3039

[Satyagraha]

Univ. of Iowa: Flu Vaccine Trial Info:

Nothing current on this H1N1 Trial... only this popped up with U of Iowa origin...

http://www.lib.uiowa.edu/hardin/Md/fluvaccine.html

Links to...

    * Flu : Vaccine
      US Center for Disease Control (CDC)
    * Flu vaccine : 2004 - 05
      US Food & Drug Administration
    * Is the flu vaccine a good idea for your family?
      KidsHealth, Nemours Foundation's Center for Children's Health Media



Hardin Library for the Health Sciences, University of Iowa
Please send comments to hardin-webmaster@uiowa.edu
The URL for this page is http://www.lib.uiowa.edu/hardin/Md/fluvaccine.html
Last updated Tuesday, Sep 12, 2006 [flu shot, flu vacine, flu vaczine, influenza vaccine][21391]

 

[Satyagraha]

Vanderbilt U. Flu Vacc Trial Info:

VUMC to conduct early trials of H1N1 flu vaccine
http://sitemason.vanderbilt.edu/myvu/news/2009/07/23/vumc-to-conduct-early-trials-of-h1n1-flu-vaccine.85012
7/23/2009
2:47 pm

The Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU) will participate in the nation’s first studies of an experimental vaccine designed to prevent infections from the 2009 H1N1 influenza virus. Vanderbilt’s VTEU is one of a nationwide network of vaccine units funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The VTEUs are conducting these trials that will recruit volunteers and test the vaccine beginning in August. Vanderbilt’s VTEU is one of just eight in the country, and is one of only two located in the Southeast.

The clinical trials will enroll as many as 1,000 healthy adults and children at 10 centers nationwide to evaluate the safety of the vaccine and measure its ability to stimulate immune responses to the H1N1 virus. The research is a first step toward the U.S. government’s stated goal of developing a safe and effective vaccine against the H1N1 strain of influenza and making it available to the public before the flu season begins in the fall.

Kathryn Edwards, M.D., professor of pediatrics, director of the Vanderbilt Vaccine Research Program, and principal investigator for the Vanderbilt VTEU, will lead the Vanderbilt portions of the trials.

“We are very excited to be a part of such important work. Through the vaccine trials conducted at Vanderbilt, Nashville and Middle Tennessee have played an important role in the development of many vaccines in use today,” Edwards said. “Once again we need the help of Middle Tennesseans to rise to this challenge so we can help the rest of the country.”

According to the Centers for Disease Control and Prevention (CDC), as of July 17, there have been more than 40,000 documented cases of H1N1 influenza in the United States occurring in all 50 states and four U.S. territories, resulting in 263 deaths so far.

“The H1N1 flu outbreak continues its march here in Tennessee and around the globe, achieving global pandemic status by World Health Organization standards,” said Edwards. “The H1N1 outbreak has been declared a public health threat by our government.”

In Tennessee there have been 247 confirmed cases of H1N1 resulting in one death so far. This death occurred at VUMC in early July.

“There is a real urgency to test and approve a safe, effective vaccine by fall. At Vanderbilt we will conduct a series of trials of the H1N1 flu vaccine. The first trial will involve adult participants. Later trials will include children,” Edwards said.

All participants in the trial will receive two doses of vaccine, three weeks apart. The response after one dose versus two doses will be compared. The trials also will evaluate two strengths of the vaccine to determine which strength is required to stimulate an immune response that is most likely to protect people against the H1N1 flu.

The vaccine will be tested in five different age groups. First, researchers will test the vaccine in healthy adult and elderly volunteers. If the vaccines are well tolerated in these groups, then the researchers will begin testing the vaccine in children. Ultimately, as many as 200 adults, 200 seniors and 600 children may be enrolled in the trials.

“The response to the vaccine may vary in different age groups,” said Karen L. Kotloff, M.D., professor of pediatrics at the University of Maryland’s School of Medicine and lead investigator on this study. “This is because young people have not seen a flu virus like this one before. Older adults might have some immunity to the new H1N1 virus as a result of being exposed to similar flu viruses in the past. As a result, older adults might need fewer doses or a lower strength of the vaccine than younger individuals. Learning the responses of different age groups of people to the vaccine will not only tell us the best way to use the vaccine in an individual, but we also learn ways to use the vaccine supply most efficiently to protect the greatest number of people.”

Vanderbilt’s VTEU researchers also will participate in future studies of the vaccine within the NIAID’s nationwide network of VTEUs. Those trials will examine important questions such as how the vaccine works in combination with the seasonal flu vaccine and whether including an adjuvant, which boosts the immune response to vaccines, can make the vaccine work better at lower doses.

The eight VTEU sites participating in the H1N1 vaccine trials include the University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Hospital Medical Center, Emory University, Saint Louis University, Seattle Group Health Cooperative, the University of Iowa and Vanderbilt. They will be joined in these trials by Children’s Mercy Hospital in Kansas City and Duke University Medical Center.

For more information on H1N1 vaccine studies at VUMC visit www.vvrp.info or call (615)322-2730. For more information about all clinical trials visit www.clinicaltrials.gov.

Contact:  (615) 322-2730
 vaccineresearch@vanderbilt.edu

[Neo]

Children's Swine Flu Vaccine Trials to Begin

Published: August 18, 2009

Two trials of vaccine against the 2009 H1N1 (swine flu) virus will begin in children shortly, according to the National Institute of Allergy and Infectious Diseases (NIAID).


An independent safety monitoring committee recommended that the trials go forward after reviewing safety data on more than 500 healthy adult volunteers taking part in three H1N1 vaccine trials that started Aug. 7. NIAID accepted the recommendation.


The two trials will be conducted through the agency's nationwide vaccine research network and will evaluate the candidate H1N1 vaccine made by Sanofi Pasteur. The vaccine does not include an adjuvant.


The first trial, led by the vaccine and treatment evaluation unit at the University of Maryland in Baltimore, will evaluate two different strengths of vaccine -- 15 and 30 mcg.

It will include as many as 650 children, ages 6 months to 17 years, who will receive two doses of vaccine three weeks apart.

Other sites taking part in this study will be Vanderbilt University in Nashville, Duke University in Durham, NC, Children's Mercy Hospital in Kansas City, Mo., and Children's Hospital in Seattle.

The second trial will include a similar number of children and will determine whether the H1N1 vaccine is safe and effective when given before, after, or along with the seasonal flu vaccine.

Participants for this study will be drawn from Saint Louis University, which is leading the study, Baylor College of Medicine in Houston, Cincinnati Children's Hospital, Emory University in Atlanta, the University of Iowa in Iowa City, and the University of Texas Medical Branch at Galveston.


The trials are scheduled to be completed in April and June next year, but initial immunogenicity results should be available in the next several weeks, according to NIAID.


Source: http://www.medpagetoday.com/InfectiousDisease/URItheFlu/15583

[livngdedgrl]

Any person who knowingly violates an order of the commissioner or his or her designee, or of a local public health authority or its designee, given to effectuate the purposes of this subsection shall be punished by imprisonment for not more than 6 months, or by a fine of note more than one thousand dollars, or both.
http://www.infowars.com/swine-flu-martial-...husetts-senate/

Will your state be next? Contact your Senator, Representatives!! Don't let them force this squalene filled vaccine on us, on our children. It's bad enough that they're shoving the GM foods at us, the Monsanto and big Pharma taking over and ruining the small farmer, soon there will nothing ORGANIC left, that they are SPRAYING lunchmeats with viruses to PROTECT us, that they flouridate the water we drink, that there are over five hundred different pharmaceuticals and chemicals in our drinking water, in our bottled water as well, and now this H1N1 vaccine filled with squalene, the same adjuvant in the vaccines given to our troops that has caused over ten thousand deaths to date...and they want to give this to my kids??? 
 

[Satyagraha]

Translated from German via Google translate (with some editing from me for clarity):
http://www.berlinonline.de/berliner-zeitung/archiv/.bin/dump.fcgi/2009/0829/wissenschaft/0010/index.html
8/29/09

Johannes Loewer, director of the Paul Ehrlich Institute, interviewed
about the best way, given a large wave of influenza in the autumn

Professor Loewer, experts expect a large pig flu wave in the autumn. Why then?
The (virus) loves cool, damp weather. Like all flu viruses, they are transmitted via droplet infection, they are released via coughing, sneezing or talking, and in the cooler weather (as opposed to dry summer), they transmit a lot faster.

Come mid-October, won't the vaccine be a bit late?
It is of course a race, but I think that we should adopt. I hope that the first batch are already ready in late September and that its ordered 50 million doses will be there in December.

Who should be vaccinated first, those who spread the virus quickly, ie school children, or pregnant women and chronically ill, where the swine flu experience severe and sometimes fatal?
The aim of containing the spread of the pathogen seems to be no longer realistic. The Federal Government is therefore pursuing the strategy to minimize the number of severe cases and deaths. Therefore, in addition to the medical staff, police and fire departments - primarily pregnant women and chronically ill of any age should be vaccinated. This plan is reviewed by the Standing Vaccination Commission of the Robert Koch Institute, currently, the Commission will issue an opinion in mid-September.

In children and pregnant women, the vaccine has not been tested.
The antigen of the virus are not new - and so far there is no evidence that its ingredients could endanger children or pregnant women. Of course there are voices who claim that you should not stimulate the immune system of pregnant women, because it could potentially increase the risk of miscarriage. We will consider this carefully before we test the vaccine on the thousands of pregnant women.  We take the risk that many people could die from the swine flu - and can avoid this by using the vaccination. 

Critics speak of a large-scale trial of the population.
This statement, I can not understand.  The GlaxoSmithKline vaccine ordered will vary according to its manufacturing process, and is not the best vaccine against seasonal flu. And even with small amounts of antigen to build protection, the added adjuvants will enable more people to be vaccinated against swine flu. The adjuvants are all of biological origin: Vitamin E and squalene in vegetable oils, polysorbate is derived from corn. All three substances are contained in many medicines and foods. Incidentally, others come from European countries like: UK, for example, to my knowledge, has ordered 90 million doses.

The waiver (preservative?) contained in the vaccine, mercury-containing preservative thiomersal was removed from vaccines that are intended for children, years ago. This was done as a precaution and was possible because these vaccines are supplied in individual portions. The swine flu vaccine comes in vials with ten doses - because it can be produced more quickly and cheaply.

This means that the manufacturers make this even more (money) from the vaccines?
I do not know how much the drug companies will make money on the vaccine. Above all, it means that health insurance companies and taxpayers have to pay less. Greed can not blame the producers. A double vaccination, as provided for, will cost 28 euros - for a single dose of vaccine against seasonal influenza at the pharmacy, you'll pay around 20 euros. It was also the WHO, which has asked the pharmaceutical companies to develop a vaccine against swine flu. And as for the thiomersal: The name given in a dose volume with a maximum of 12.5 micrograms of mercury is well below the prescribed limit of 96 micrograms per week.

Are there side effects expected with the vaccination?
So far, a few hundred people have been given the new vaccine on a trial basis. In the clinical trials for the vaccine there were several thousand samples. Apart from a slight fever, headache, body aches, as well as local skin reactions - all symptoms that are typical of a stimulated immune system - there were no observed adverse reactions among them.

Whether the dreaded Guillain-Barre Syndrome, an inflammation of the peripheral nerve will occur, we must wait.

Since the disease is extremely rare, were also clinical trials with thousands of people here are not very useful.

Virus researchers still warn again that the swine flu virus could be even more dangerous in the future. If the current vaccine against a killer virus any help?
As long as the surface protein hemagglutinin, H briefly mentioned, is not altered, the vaccine remains effective. Mixing with pathogens of the seasonal flu, which have a variant of the H1, would remain without consequences, because this variant would be covered by the vaccine against seasonal flu.

Anders saw it in a mixture with bird flu viruses: They have the variant H5, against which the vaccines would offer any protection. Fortunately, avian viruses are not currently spread from person to person. To natural mutations, we will need to adapt the vaccine, perhaps next year - this season, it offers sufficient protection.

Even against seasonal flu?
No, because it is caused by other viruses. This year's seasonal flu vaccine protects against influenza B virus and two influenza A strains, an H1N1 variant and a common H3N2 variant. Elderly and chronically ill people should therefore be vaccinated this year against seasonal flu.

Is there enough (seasonal flu) vaccine for it?
Yes, the production was already completed before start of production of the swine flu vaccine was.

Stand for the people then perhaps soon to be the Health snake (not sure how this translates... )?
How will implement the recommendation for vaccination, vulnerable groups have precedence to practical, I do not know. The states are developing similar strategies.

Can the vaccine be ordered in great demand?
The aim is to 80 percent of Germans offer the vaccination. Therefore it would be necessary to order products from GlaxoSmithKline and Novartis also in other batches.

Interview: Anke Brodmerkel

Here's the german version for those who know german. (If you do, please feel free to clarify the google translation further):

Johannes Löwer, Chef des Paul-Ehrlich-Instituts, über den besten Weg angesichts einer großen Grippewelle im Herbst
Herr Professor Löwer, Experten rechnen mit einer großen Schweinegrippe-Welle im Herbst. Warum gerade dann?

Die Erreger lieben kühles, feuchtes Wetter. Wie alle Grippeviren werden sie per Tröpfcheninfektion weitergegeben - im Sommer trocknen diese Tröpfchen, die beim Husten, Niesen oder Sprechen entstehen, viel schneller aus.

Kommt der Impfstoff Mitte Oktober dann nicht ein bisschen spät?

Es ist natürlich ein Wettlauf, aber ich denke, dass wir ihn aufnehmen sollten. Ich hoffe, dass die ersten Chargen schon Ende September bereit stehen und dass die bestellten 50 Millionen Dosen im Dezember da sein werden.

Wer sollte dann zuerst geimpft werden: Diejenigen, die das Virus schnell verbreiten, sprich Schulkinder, oder Schwangere und chronisch Kranke, bei denen die Schweinegrippe erfahrungsgemäß schwer und mitunter tödlich verläuft?

Das Ziel, die Verbreitung des Erregers einzudämmen, scheint nicht mehr realistisch zu sein. Die Bundesregierung verfolgt daher die Strategie, die Zahl der schweren Krankheits- und Todesfälle zu minimieren. Daher sollen - neben dem medizinischen Personal, der Polizei und Feuerwehr - vorrangig Schwangere und chronisch Kranke, egal welchen Alters, geimpft werden. Dieser Plan wird von der Ständigen Impfkommission des Robert-Koch-Instituts derzeit geprüft; eine Stellungnahme wird die Kommission voraussichtlich Mitte September abgeben.

An Kindern und Schwangeren wurde der Impfstoff noch nicht getestet.

Bislang gibt es keine Hinweise, dass seine Inhaltsstoffe - die ja bis auf das Antigen des Erregers nicht neu sind - Kinder oder Schwangere gefährden könnten. Natürlich gibt es Stimmen, die behaupten, dass man das Immunsystem von Schwangeren nicht stimulieren dürfe, da ansonsten das Risiko einer Fehlgeburt steige. Das werden wir sorgfältig prüfen. Wenn wir den Impfstoff vor der Zulassung an tausenden schwangeren Frauen testen, riskieren wir, dass viele Menschen an der Schweinegrippe sterben, die mit einer Impfung hätten gerettet werden können.

Kritiker sprechen von einem Großversuch an der Bevölkerung.

Diese Aussage kann ich nicht nachvollziehen. Der jetzt bei der Firma GlaxoSmithKline bestellte Impfstoff unterscheidet sich hinsichtlich seines Herstellungsverfahrens nicht von den bewährten Impfstoffen gegen die saisonale Grippe. Und die zugefügten Adjuvanzien - sie bewirken, dass schon geringe Antigen-Mengen einen Schutz aufbauen und somit mehr Menschen gegen die Schweinegrippe geimpft werden können - sind alle biologischen Ursprungs: Vitamin E und Squalen stecken auch in Pflanzenölen, Polysorbat wird aus Getreide gewonnen. Alle drei Substanzen sind in vielen Arznei- und Lebensmitteln enthalten. Übrigens gehen andere europäische Länder ähnlich vor: Großbritannien zum Beispiel hat meines Wissens 90 Millionen Impfdosen bestellt.

Das in dem Impfstoff ebenfalls enthaltene, quecksilberhaltige Konservierungsmittel Thiomersal wurde aus Impfstoffen, die für Kinder gedacht sind, vor Jahren entfernt.

Das geschah vorsorglich und war möglich, weil diese Impfstoffe in Einzelportionen angeboten werden. Der Impfstoff gegen die Schweinegrippe kommt in Fläschchen mit zehn Dosen - weil er so rascher und preisgünstiger hergestellt werden kann.

Das heißt, die Hersteller verdienen dadurch noch mehr an ihm?

Ich weiß nicht, wie viel die Pharmafirmen an dem Impfstoff verdienen werden. Vor allem bedeutet es, dass Krankenkassen und Steuerzahler weniger zahlen müssen. Profitgier kann man den Herstellern nicht vorwerfen. Eine zweifache Impfung, wie sie vorgesehen ist, soll 28 Euro kosten - für eine Einzeldosis Impfstoff gegen die saisonale Grippe zahlt man in der Apotheke rund 20 Euro. Außerdem war es die WHO, die die Pharmafirmen aufgefordert hat, einen Impfstoff gegen die Schweinegrippe zu entwickeln. Und was das Thiomersal betrifft: Die in einer Impfdosis enthaltene Menge Quecksilber liegt mit maximal 12,5 Mikrogramm weit unter dem zulässigen Grenzwert von 96 Mikrogramm pro Woche.

Das heißt, mit Nebenwirkungen der Impfung ist nicht zu rechnen?

Bislang ist der neue Impfstoff einigen hundert Menschen testweise verabreicht worden. In den klinischen Studien für die Musterimpfstoffe waren es einige tausend. Abgesehen von leichtem Fieber, Kopf- und Gliederschmerzen sowie lokalen Hautreaktionen - alles Symptome, die für ein stimuliertes Immunsystem typisch sind - waren bei ihnen keine Nebenwirkungen zu beobachten. Ob das gefürchtete Guillain-Barré-Syndrom, eine Entzündung der peripheren Nerven, auftreten wird, müssen wir abwarten. Da die Krankheit extrem selten ist, wären auch klinische Studien mit tausenden Menschen hier wenig aussagekräftig.

Virenforscher warnen immer wieder, dass das Schweinegrippevirus künftig noch gefährlicher werden könnte. Würde der jetzige Impfstoff gegen ein Killervirus überhaupt helfen?

Solange sich das Oberflächeneiweiß Hämagglutinin, kurz H genannt, nicht verändert, bleibt der Impfstoff wirksam. Eine Vermischung mit Erregern der saisonalen Grippe, die eine Variante des H1 besitzen, bliebe folgenlos, da diese Variante vom Impfstoff gegen die saisonale Grippe abgedeckt wäre. Anders sähe es bei einer Vermischung mit Vogelgrippeviren aus: Sie besitzen die Variante H5, gegen die keiner der Impfstoffe Schutz böte. Glücklicherweise werden Vogelgrippeviren bislang nicht von Mensch zu Mensch übertragen. An natürliche Mutationen werden wir den Impfstoff vielleicht nächstes Jahr anpassen müssen - für diese Saison bietet er ausreichenden Schutz.

Auch gegen die saisonale Grippe?

Nein, denn sie wird durch andere Viren hervorgerufen. Der diesjährige Impfstoff gegen die saisonale Grippe schützt vor Influenza-B-Viren sowie vor zwei Influenza-A-Stämmen, einer gängigen H1N1-Variante und einer H3N2-Variante. Ältere und chronisch kranke Menschen sollten sich also auch in diesem Jahr gegen die saisonale Grippe impfen lassen.

Gibt es für sie ausreichend Impfstoff?

Ja, die Herstellung war bereits abgeschlossen, bevor mit der Produktion des Schweinegrippe-Impfstoffs begonnen wurde.

Für den die Menschen dann vielleicht bald vor den Gesundheitsämtern Schlange stehen werden?

Wie man die Impfempfehlung, Risikogruppen Vortritt zu lassen, praktisch umsetzen wird, weiß ich nicht. Die Bundesländer entwickeln zurzeit entsprechende Strategien.

Kann bei großer Nachfrage Impfstoff nachbestellt werden?

Ziel ist es, 80 Prozent der Bundesbürger die Impfung anzubieten. Dafür wäre es nötig, bei GlaxoSmithKline und auch bei Novartis weitere Chargen zu bestellen.

Interview: Anke Brodmerkel

[Satyagraha]

Response after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine —
Preliminary Report
http://content.nejm.org/cgi/content/full/NEJMoa0907413?query=TOC

Published at www.nejm.org September 10, 2009 (10.1056/NEJMoa0907413)

Michael E. Greenberg, M.D., M.P.H., Michael H. Lai, B.Med.Sc., M.B., B.S., M.Med.Sc., Gunter F. Hartel, M.S., Ph.D., Christine H. Wichems, Ph.D., Charmaine Gittleson, B.Sc., M.B., B.Ch., Jillian Bennet, M.Sc., M.P.H., Gail Dawson, B.Pharm., Wilson Hu, M.D., M.B.A., Connie Leggio, B.Sc., Diane Washington, M.D., and Russell L. Basser, M.B., B.S., M.D., F.R.A.C.P.

ABSTRACT

Background
A novel influenza A (H1N1) 2009 virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is urgently needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia.

Methods

This preliminary report evaluates the immunogenicity and safety of the vaccine 21 days after the first of two scheduled doses. A total of 240 subjects, equally divided into two age groups (<50 years and 50 years), were enrolled and underwent randomization to receive either 15 µg or 30 µg of hemagglutinin antigen by intramuscular injection. We measured antibody titers using hemagglutination-inhibition and microneutralization assays at baseline and 21 days after vaccination. The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer.

Results

By day 21 after vaccination, antibody titers of 1:40 or more were observed in 116 of 120 subjects (96.7%) who received the 15-µg dose and in 112 of 120 subjects (93.3%) who received the 30-µg dose. No deaths, serious adverse events, or adverse events of special interest were reported. Local discomfort (e.g., injection-site tenderness or pain) was reported by 46.3% of subjects, and systemic symptoms (e.g., headache) by 45.0% of subjects. Nearly all events were mild to moderate in intensity.

Conclusions

A single 15-µg dose of 2009 H1N1 vaccine was immunogenic in adults, with mild-to-moderate vaccine-associated reactions. (ClinicalTrials.gov number, NCT00938639 [ClinicalTrials.gov] .)

The rapid global spread of a novel influenza A (H1N1) 2009 virus (2009 H1N1) prompted the World Health Organization (WHO), on June 11, 2009, to declare the first influenza pandemic in 41 years.¹ In the Southern Hemisphere, 2009 H1N1 infection has been dominant during the current influenza season.² In the Northern Hemisphere, the incidence of 2009 H1N1 infection is likely to increase substantially during the approaching influenza season, with major public health ramifications. Early availability of safe and effective vaccines is a critical component of efforts to prevent 2009 H1N1 infection and mitigate the overall effect of the pandemic.^3,4

Shortly after the identification of 2009 H1N1, influenza vaccine manufacturers, in conjunction with public health and regulatory agencies, started developing a 2009 H1N1 vaccine.⁵ The sense of urgency was particularly notable in the Southern Hemisphere, where the timing of the pandemic coincided with the onset of winter. Ideally, clinical trials are needed to establish the safety and adverse-effect profiles of the new vaccines and to confirm the optimal dose and regimen.⁶

We undertook a clinical trial in healthy adults to examine the immunogenicity, safety, and tolerability of two different doses of a monovalent, split-virus 2009 H1N1 influenza vaccine (H1N1 vaccine). The vaccine was manufactured with the same procedures that have been used for the production of the company's seasonal trivalent inactivated vaccine. We examined a two-dose regimen of either 15 µg or 30 µg of hemagglutinin antigen, because there was uncertainty as to whether a higher antigen content or a two-dose series might be required to produce a satisfactory immune response. We enrolled equal numbers of subjects 50 years of age or older and below the age of 50 years to explore potential age-related differences in immune response that might result from previous exposure to H1N1 viruses that were displaced from circulation by the H2N2 subtype in the 1957–1958 influenza pandemic.⁷

In the current pandemic, rapid sharing of clinical-trial findings is critical, since such data may assist in the planning of national vaccination programs. This preliminary report includes results that are available to date from our ongoing Australian study in healthy adults after the first of two scheduled vaccinations.

Methods

Study Design

This phase 2, prospective, randomized, observer-blind, parallel-group clinical trial is ongoing at a single site in Adelaide, Australia (CMAX, a division of the Institute of Drug Technology).

The purpose of this study is to evaluate the immunogenicity and safety of two different doses of the H1N1 vaccine in healthy adults between the ages of 18 and 64 years in a two-dose regimen. All subjects provided written informed consent.

The randomization code was prepared by a statistician, employed by CSL Limited, with the use of SAS software (version 9.1.3) and JMP (version 8.0.1) (SAS Institute); permuted-block randomization was used. The randomization code was provided to the vaccine administrator, who was aware of study-group assignments, as a list in a sealed envelope, although all subjects and investigators were unaware of such assignments.

The study was approved by the Bellberry Human Research Ethics Committee (Adelaide, Australia) and was conducted in accordance with the principles of the Declaration of Helsinki, the standards of Good Clinical Practice (as defined by the International Conference on Harmonization), and Australian regulatory requirements. All authors contributed to the content of the manuscript, had full access to all study data, and vouch for the completeness and accuracy of the data.

Vaccine

The H1N1 vaccine, a monovalent, unadjuvanted, inactivated, split-virus vaccine, was produced by CSL Biotherapies (Parkville, Australia). The seed virus was prepared from the reassortant vaccine virus NYMC X-179A (New York Medical College, New York), derived from the A/California/7/2009 (H1N1) virus, one of the candidate reassortant vaccine viruses recommended by the WHO.^8,9 The vaccine was prepared in embryonated chicken eggs with the same standard techniques that are used for the production of seasonal trivalent inactivated vaccine10 and was presented in 10-ml multidose vials with thimerosal added as a preservative (final concentration, 0.01% weight per volume). The two doses were 15 µg of hemagglutinin antigen per 0.25-ml dose and 30 µg of hemagglutinin antigen per 0.5-ml dose.

Subjects and Study Procedures

Healthy, nonpregnant adults between the ages of 18 and 64 years were eligible for enrollment. We excluded subjects with confirmed or suspected 2009 H1N1 infection and those who had received an experimental influenza vaccine during the preceding 6 months.

A total of 240 eligible subjects underwent randomization to receive either 15 µg or 30 µg of hemagglutinin antigen in a 1:1 ratio. An equal number of subjects from 18 to 49 years of age and from 50 to 64 years were included. Each dose was administered intramuscularly into the deltoid muscle. Since the injection volume differed between the two study doses, personnel who prepared and administered the study vaccine had no further involvement in the study.

Safety Assessments

We collected solicited reports of local and systemic adverse events, using a 7-day diary card. All solicited local adverse events were considered to be related to the H1N1 vaccine, whereas the investigator assessed the causality of solicited systemic adverse events. Subjects used a standard scale to grade adverse events during the 7-day period.

Because of the novelty of the pandemic H1N1 strain, we prospectively collected data relating to the occurrence of select adverse events of special interest. These events included several neurologic (e.g., Guillain–Barré syndrome), immune-system, and other disorders. Any adverse events of special interest or serious adverse event was to be reported within 24 hours. A safety-review committee monitored the safety of the study. Stopping rules were in place during the 7 days after vaccination but were not met, and all doses were given.

Assessment of Influenza-Like Illness

Subjects who reported having an influenza-like illness were asked to provide specimens of nasal and throat swabs for virologic testing. An influenza-like illness was defined as an oral temperature of more than 38°C (100.4°F) or a history of fever or chills and at least one influenza-like symptom.

Laboratory Assays

Anti-influenza antibody titers were measured at enrollment and 21 days after each vaccination. The immunogenicity of the H1N1 vaccine was evaluated with the use of hemagglutination-inhibition and microneutralization assays with methods that have been described previously^11,12 (for details, see the Supplementary Appendix, available with the full text of this article at NEJM.org). Virologic testing of nasal- and throat-swab specimens was performed with the use of the protocol of the Centers for Disease Control and Prevention for real-time reverse-transcriptase–polymerase-chain-reaction assay for 2009 H1N1 virus.¹³ All laboratory assays were performed by Focus Diagnostics.

Primary and Secondary End Points

The three coprimary immunogenicity end points after vaccination were chosen according to international guidelines used to evaluate influenza vaccines.^14,15 The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer.
The secondary safety end points were the frequency, duration, and intensity of solicited adverse events during the 7 days after vaccination and the incidence of serious adverse events and adverse events of special interest during the study period.

Statistical Analysis

A sample size of 120 subjects per study group was chosen because it provided sufficient power to assess the primary immunogenicity end points. The primary and secondary end-point analyses were descriptive and consisted of an assessment of the lower confidence bounds of each end point for each study group. On the assumption of a population seroconversion rate of 53%, the study had a power of at least 80% with 120 subjects per group to show the seroconversion rate to be significantly more than 40%. For categorical variables, statistical summaries included counts and percentages relative to the appropriate population. The safety population included all subjects who received a dose of H1N1 vaccine. The population that could be evaluated included all subjects in the safety population who provided serum samples at baseline and after vaccination. The 95% confidence intervals, which were calculated on the basis of the binomial distribution, are provided for descriptive statistics.

Results

Study Subjects

From July 22 to July 26, 2009, we enrolled 240 subjects, who underwent randomization (Table 1 and Figure 1). All subjects received a dose of H1N1 vaccine and were included in the safety population. All subjects provided a blood sample before and after vaccination and were included in the population that could be evaluated. All subjects returned the 7-day diary; there were no withdrawals from the study. Of the 240 subjects, 45.0% reported having received a 2009 Southern Hemisphere seasonal trivalent inactivated vaccine. The proportion of subjects who received the 2009 seasonal vaccine did not differ between the age groups (P=0.24 by Fisher's exact test).


Table 1. Demographic Characteristics of the Subjects.


Figure 1. Enrollment and Outcomes

Immunogenicity

At baseline, 76 of 240 subjects (31.7%) had antibody titers of 1:40 or more on hemagglutination-inhibition assay (Table 2 and Figure 2A and 2C), with no significant differences between either age groups (P=0.21) or dose groups (P=0.68). Similarly, there were no significant differences in baseline geometric mean titers (GMTs) between age groups or dose groups (Table 3). Of note, baseline titers of 1:40 or more on hemagglutination-inhibition assay were observed in 48 of 108 subjects who had received the 2009 seasonal vaccine (44.4%; 95% confidence interval [CI], 35.4 to 53.8), as compared with 28 of 132 subjects who had not received the seasonal vaccine (21.2%; 95% CI, 15.1 to 28.9; P<0.001 by Fisher's exact test).


Table 2. Immune Response after One Dose of the H1N1 Vaccine, as Measured on Hemagglutination-Inhibition (HI) Assay.


Figure 2. Reverse Cumulative Distribution Curves of Antibody Titers in Serum before and 21 Days after a Single Dose of H1N1 Vaccine, According to the Type of Assay.


Shown are levels of antibody titer against the 2009 H1N1 virus on hemagglutination-inhibition (HI) assay before vaccination (Panel A) and after vaccination (Panel B) and in the two age groups in the study (18 to 49 years and 50 to 64 years) (Panels C and D). Also shown are levels of antibody titer against the 2009 H1N1 virus on microneutralization (MN) assay before vaccination (Panel E) and after vaccination (Panel F) and in the two age groups (Panels G and H).


Table 3. Geometric Mean Titers and Factor Increases in the Geometric Mean Titer after One Dose of the H1N1 Vaccine, as Measured on Hemagglutination-Inhibition Assay and Microneutralization Assay.


A single 15-µg or 30-µg dose of the H1N1 vaccine produced a robust immune response in a majority of subjects (Table 2 and Figure 2). Post-vaccination titers of 1:40 or more on hemagglutination-inhibition assay were observed in 96.7% (95% CI, 91.7 to 98.7) of recipients of the 15-µg dose and in 93.3% (95% CI, 87.4 to 96.6) of the recipients of the 30-µg dose (Table 2 and Figure 2). Seroconversion or a significant increase in titer on hemagglutination-inhibition assay occurred in 74.2% of subjects, and the effect was similar between the two study groups (Table 2).

After vaccination, there was a substantial rise in GMTs, with no significant differences in factor increases between the two groups (Table 3). However, we observed age-related differences. Subjects who were 50 years of age or older had a numerically lower factor increase in the GMT than those under the age of 50 years. This age-related effect was reflected in all measures of immunogenicity.

In general, the pattern of antibody responses, as measured by the microneutralization assay, was similar to those observed with the hemagglutination-inhibition assay (Table 3 and Figure 2E through 2H). Baseline microneutralization GMTs in the younger age group were significantly higher than those in the older age group (P<0.001). Postvaccination microneutralization GMTs were also significantly higher in the younger age group than in the older age group, regardless of dose (P<0.001).

We performed an additional analysis examining the effect of baseline serostatus on the immune response to H1N1 vaccination. Subjects who were seronegative at baseline (with a hemagglutination-inhibition or microneutralization titer of <1:10) had lower postvaccination GMTs than those with baseline titers of 1:10 or more. However, subjects who were seronegative at baseline had significantly higher factor increases in the GMT (P<0.001 for both hemagglutination-inhibition and microneutralization assays) (Table 3 in the Supplementary Appendix). The proportion of subjects who were seronegative at baseline and who achieved seroconversion exceeded 86% on the hemagglutination-inhibition assay and 70% on the microneutralization assay. Among subjects with a baseline titer of 1:10 or more, the proportion of those achieving seroconversion exceeded 60% on the hemagglutination-inhibition assay and 70% on the microneutralization assay.

Adverse Events

No deaths, serious adverse events, or adverse events of special interest were reported. Stopping rules were not triggered, and no subjects withdrew from the study. Since the study is ongoing and individual study-group assignments remain blinded, data regarding solicited adverse events are presented as aggregate totals of both study-dose groups.

Data regarding unsolicited adverse events are being collected but are unavailable for this preliminary report.

Solicited local adverse events were reported by 46.3% (95% CI, 40.1 to 52.6) of subjects (Table 4). The most commonly reported events were injection-site tenderness (36.7% of subjects) and pain (21.7% of subjects). Solicited local adverse events were graded as mild by 105 of 111 subjects who reported having such an event (94.6%), with no severe local adverse events reported.

Table 4. Proportion of 240 Subjects Who Reported Having a Solicited Local or Systemic Adverse Event within 7 Days after Receiving One Dose of the H1N1 Vaccine.
Solicited systemic adverse events were reported by 45.0% (95% CI, 38.8 to 51.3) of subjects (Table 4).

The most commonly reported events were headache, malaise, and myalgia. Solicited systemic adverse events that were considered to be related to the H1N1 vaccine were reported by 30.4% of subjects. Of the subjects who had a solicited systemic adverse event, the majority reported events that were mild to moderate in intensity. Two subjects reported adverse events that were graded as severe: vaccine-related myalgia, malaise, and nausea that resolved within 5 days with standard treatment in one subject and non-vaccine-related nausea from day 6 through day 10 after vaccination in the other.

Three subjects had an influenza-like illness, one of whom tested positive for 2009 H1N1 on day 8 after vaccination. The remaining two subjects tested negative for 2009 H1N1.

Discussion

A single 15-µg dose of unadjuvanted 2009 H1N1 vaccine resulted in titers of 1:40 or more on hemagglutination-inhibition assay in 96.7% of adult subjects, despite the prevailing assumption that two doses of vaccine would be required. These results will help to inform pandemic planning, especially in light of widespread concern about vaccine availability because of low manufacturing yields.16 The high level of immune protection afforded by a single 15-µg dose should improve the coverage and logistics of mass H1N1 vaccination programs.

The robust immune response to the H1N1 vaccine after a single dose was unanticipated. Much of the current global pandemic planning is predicated on previous experience that two doses of vaccine are required to elicit a protective immune response in populations that are immunologically naive to a new influenza strain.^{17,18,19,20,21}

The initiation of the study coincided with the peak of the first pandemic wave in Australia. The weekly age-standardized H1N1 notification rate in South Australia, the state in which the study site is located, was higher than the national average at that time (113.6 per 100,000 population in South Australia, and 81.8 per 100,000 population in Australia).²² However, we do not believe that intercurrent infection significantly contributed to the postvaccination response, since we monitored all subjects for influenza-like illness, and only one subject tested positive for 2009 H1N1 during the 21 days after vaccination.

The proportion of subjects with titers of 1:40 or more on hemagglutination-inhibition assay at baseline was higher than expected. Among subjects who were 50 years of age or older, this finding could be attributed to the presence of preexisting antibodies from exposure to H1N1 viruses circulating before 1957.23

It was surprising, however, to see similar baseline antibody titers in the younger age group. A number of factors could have contributed to the observed titers in both age groups at baseline. It is probable that there was some degree of previous 2009 H1N1 infection in the study population, despite stringent exclusion criteria.

Cross-reactive antibodies to 2009 H1N1 may also have played a role. In this issue of the Journal, a study by Hancock et al. that analyzed stored-serum samples from trials of seasonal trivalent inactivated vaccine predating the current pandemic showed the presence of cross-reactive antibodies to 2009 H1N1 in adults.²⁴ The same study showed that vaccination with the seasonal vaccine resulted in a doubling in titers of these cross-reactive antibodies. The latter finding is particularly relevant, given that 45% of the subjects in our study had received the 2009 seasonal vaccine.

Even in subjects with no measurable antibodies at baseline, a single dose of vaccine elicited a robust immune response. The question remains: Why did these subjects have such a brisk response? The 2009 H1N1 pandemic differs from previous pandemics in that although the virus is antigenically very distant from recently circulating H1N1 viruses, it is still of the same H1N1 subtype.²⁵ Cross-protection that was afforded by exposure to antigenically drifted strains of the same influenza subtype has been described.¹⁹ In addition, the 2009 H1N1 virus shares three gene sequences with the recently circulating seasonal H1N1 virus and three sequences with the current seasonal H3N2 virus.²³ Perhaps there is more immunotypic similarity between the 2009 H1N1 virus and recent seasonal strains than has been recognized previously.

The side-effect profile of the H1N1 vaccine, particularly the frequency and severity of solicited adverse events, is consistent with our previous experience with seasonal influenza vaccines in adults.¹⁰ The full safety profile of H1N1 vaccine has not yet been elucidated. Population-based postlicensure surveillance will be required for all H1N1 vaccines, especially to assess rare outcomes, such as the Guillain–Barré syndrome.

Several important questions remain unanswered in this trial.

First, since we studied healthy adults, trials need to be conducted in other populations that may have different responses to the vaccine, such as the elderly, children, and those with impaired immunity.

Second, given the robust immune response to a 15-µg dose, lower antigen doses should be explored.

Third, although our study is being carried out in one locality in Australia during winter in the Southern Hemisphere, our findings need to be borne out by studies in locations where the epidemiology of the pandemic may be different.

Finally, estimates of the true effect of the vaccine when used in mass immunization programs will come from vaccine-effectiveness studies.

-------------------------------------------------------------------------------------------------------------------------
Supported by CSL with funding from the Department of Health and Aging of the Australian government.
All authors report being employees of CSL, and Dr. Greenberg, Dr. Lai, Dr. Hartel, Dr. Gittleson, Ms. Bennet, Ms. Dawson, Dr. Washington, and Dr. Basser report having an equity interest in the company. No other potential conflict of interest relevant to this article was reported.

We thank the subjects for their critical role in this study, the staff of CSL, and other staff participants, including the following: Dr. Sepehr Shakib and the staff at CMAX, a division of IDT Australia; the Clinical Trials Department at Focus Diagnostics in Cypress, CA; Quintiles of Australia; and Medidata of New York.

Source Information

From Clinical Research and Development, CSL, Parkville, VIC, Australia.

This article (10.1056/NEJMoa0907413) was published on September 10, 2009, at NEJM.org.
Address reprint requests to Dr. Greenberg at Vaccines Clinical Research and Development, CSL, 45 Poplar Rd., Parkville, VIC 3052, Australia, or at michael.greenberg@csl.com.au.

References

1. DG statement following the meeting of the Emergency Committee. Geneva: World Health Organization, 2009. (Accessed September 9, 2009, at http://www.who.int/csr/disease/swineflu/4th_meeting_ihr/en/index.html.)

2 .Pandemic (H1N1) 2009 — update 63. Geneva: World Health Organization, 2009. (Accessed September 9, 2009, at http://www.who.int/csr/don/2009_08_28/en/index.html.)

3.  Fiore AE, Shay DK, Broder K, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep 2009;58:1-52. [Erratum, MMWR Recomm Rep 2009;58:896-7.] [Medline]

4. President's Council of Advisors on Science and Technology. Report to the president on U.S. preparations for 2009-H1N1 influenza. Washington, DC: White House, August 7, 2009. (Accessed September 8, 2009, at http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf.)

5. Kuehn BM. H1N1 vaccine. JAMA 2009;302:375-375. [Free Full Text]

6. Mathematical modelling of the pandemic H1N1 2009. Wkly Epidemiol Rec 2009;84:341-348. [Medline]

7. Henderson DA, Courtney B, Inglesby TV, Toner E, Neuzzo JB. Public health and medical responses to the 1957-58 influenza pandemic. Biosecur Bioterror 2009 August 5 (Epub ahead of print).

8. World Health Organization. Availability of a candidate reassortant vaccine virus for the novel influenza A (H1N1) vaccine development. June 2009. (Accessed September 9, 2009 at http://www.who.int/csr/resources/publications/swineflu/ivr153_20090608_en.pdf.)

9. Idem. Summary of available candidate vaccine viruses for development of pandemic (H1N1) 2009 virus vaccines. July 2009. (Accessed September 9, 2009 at http://www.who.int/csr/resources/publications/swineflu/summary_candidate_vaccine.pdf.)

10. Talbot HK, Keitel W, Cate TR, et al. Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine. Vaccine 2008;26:4057-4061. [CrossRef][Web of Science][Medline]

11. Kendal AP, Pereira MS, Skehel JJ, eds. Concepts and procedures for laboratory-based influenza surveillance. Atlanta: Centers for Disease Control, 1982.

12. Rowe T, Abernathy RA, Hu-Primmer J, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999;37:937-943. [Free Full Text]

13. CDC protocol of realtime RTPCR for influenza A (H1N1). (CDC reference no. I-007-05.) Geneva: World Health Organization, 2009. (Accessed September 9, 2009, at http://www.who.int/csr/resources/publications/swineflu/CDCRealtimeRTPCR_SwineH1Assay-2009_20090430.pdf.)

14. Committee for Proprietary Medicinal Products. Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. London: European Medicines Agency, 1996. (Publication no. CPMP/BWP/214/96.) (Accessed September 9, 2009, at http://www.emea.europa.eu/pdfs/human/bwp/021496en.pdf.)

15. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: clinical data needed to support the licensure of pandemic influenza vaccines. May 2007. (Accessed September 9, 2009, at http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091985.pdf.)

16. Neergaard L. Factory logjam could delay some swine flu shots. New York: Associated Press, August 18, 2009. (Accessed September 9, 2009, at http://news.aol.com/article/factory-logjam-could-delay-some-swine/448143.)

17. Englund JA, Walter EB, Gbadebo A, Monto AS, Zhu Y, Neuzil KM. Immunization with trivalent inactivated influenza vaccine in partially immunized toddlers. Pediatrics 2006;118:e579-e585. [Free Full Text]

18. Neuzil KM, Jackson LA, Nelson J, et al. Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. J Infect Dis 2006;194:1032-1039. [CrossRef][Web of Science][Medline]

19. Parkman PD, Hopps HE, Rastogi SC, Meyer HM Jr. Summary of clinical trials of influenza virus vaccines in adults. J Infect Dis 1977;136:Suppl:S722-S730. [Web of Science][Medline]

20. Sencer DJ, Millar JD. Reflections on the 1976 swine flu vaccination program. Emerg Infect Dis 2006;12:29-33. [Web of Science][Medline]

21. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006;354:1343-1351. [Free Full Text]

22. Australian Department of Health and Ageing. Australian influenza report 2009 — current report — 8 to 14 August 2009. (Accessed September 9, 2009, at http://www.health.gov.au/internet/main/publishing.nsf/content/cda-surveil-ozflu-flucurr.htm.)

23. Zimmer SM, Burke DS. Historical perspective -- emergence of influenza A (H1N1) viruses. N Engl J Med 2009;361:279-285. [Free Full Text]

24. Hancock K, Veguilla V, Lu X, et al. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med 2009;361. DOI: 10.1056/NEJMoa0906453.

25. Garten RJ, Davis CT, Russell CA, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009;325:197-201. [Free Full Text]

[Satyagraha]

Published at www.nejm.org September 10, 2009 (10.1056/NEJMoa0907650)
http://content.nejm.org/cgi/content/full/NEJMoa0907650?query=TOC
Trial of Influenza A (H1N1) 2009 Monovalent MF59-Adjuvanted Vaccine — Preliminary Report

Tristan W. Clark, M.R.C.P., Manish Pareek, M.R.C.P., Katja Hoschler, Ph.D., Helen Dillon, M.R.C.P., Karl G. Nicholson, M.D., F.R.C.P., Nicola Groth, M.D., and Iain Stephenson, M.D., F.R.C.P.

ABSTRACT

Background

The 2009 pandemic influenza A (H1N1) virus has emerged to cause the first pandemic of the 21st century. Development of effective vaccines is a public health priority.

Methods

We conducted a single-center study, involving 175 adults, 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, in both MF59-adjuvanted and nonadjuvanted forms. Subjects were randomly assigned to receive two intramuscular injections of vaccine containing 7.5 µg of hemagglutinin on day 0 in each arm or one injection on day 0 and the other on day 7, 14, or 21; or two 3.75-µg doses of MF59-adjuvanted vaccine, or 7.5 or 15 µg of nonadjuvanted vaccine, administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay and a microneutralization assay on days 0, 14, 21, and 42 after injection of the first dose.

Results

Results of an interim analysis of the responses to the 7.5-µg dose of MF59-adjuvanted vaccine by days 14 and 21 are presented (data from four of the seven groups studied, for a total of 100 subjects). The most frequent local and systemic reactions were pain at the injection site and muscle aches, noted in 70% and 42% of subjects, respectively. Two subjects reported fever, with a temperature of 38°C or higher, after the first dosing. Antibody titers, expressed as geometric means, were generally higher at day 14 among subjects who had received two 7.5-µg doses of the MF59-adjuvanted vaccine than among those who had received only one by this time point (P=0.04 by the hemagglutination-inhibition assay and P<0.001 by the microneutralization assay).

By 21 days after vaccination with the first dose of 7.5 µg of MF59-adjuvanted vaccine, the rates of seroconversion, as measured with the use of a hemagglutination-inhibition assay and a microneutralization assay, were 76% and 92% of subjects, respectively, who had received only one dose to date (with the second dose scheduled for day 21) and 88 to 92% and 92 to 96% of subjects, respectively, who had already received both doses (P=0.11 and P=0.64, respectively).

Conclusions

In preliminary analyses, the monovalent influenza A (H1N1) 2009 MF59-adjuvanted vaccine generates antibody responses likely to be associated with protection within 14 days after a single dose is administered. (ClinicalTrials.gov number, NCT00943358 [ClinicalTrials.gov]).
________________________________________

The emergence of the 2009 pandemic influenza A (H1N1) virus demonstrates the unpredictable nature of influenza.¹ The 2009 H1N1 virus has the potential to cause disease, death, and socioeconomic disruption,^2,3 and mathematical modeling suggests that the effect of the virus can be reduced by immunization.4 The development of effective vaccines is a public health priority.

Traditional seasonal influenza vaccines are produced from reassortant vaccine strains grown in hens' eggs. However, demand for vaccine against the 2009 H1N1 virus will exceed the supply if this method of manufacturing is used. Cell culture provides an alternative platform for the manufacture of influenza vaccines that may be more easily scaled up during a period of heightened demand.^5,6,7

Serologic analysis suggests that after seasonal vaccination in children and adults under 50 years of age, there is little evidence of cross-reactive antibodies against the 2009 H1N1 virus,8 with no evidence of protection from the seasonal vaccine.9 The efficacy of conventional vaccines prepared from avian influenza strains is disappointingly low in subjects who have little evidence of cross-reactive antibodies, even if two doses are given.^{10,11,12,13,14}

The addition of oil-in-water–emulsion adjuvant enhances immunogenicity and induces cross-reactive antibodies against antigenically drifted variants.^{12,13,14,15,16} The use of such adjuvants in influenza A (H1N1) 2009 vaccines has been suggested by the World Health Organization.¹⁷

Preparations for influenza A (H1N1) 2009 vaccination programs are under way, but the optimal formulation is unknown. The need for high-yield vaccine strains, limitations of the supply and production capacity of egg-based vaccines, and an expected requirement for a two-dose vaccine schedule may delay an effective immunization program.

In this preliminary report, we present the clinical-event and immunogenicity profiles of the 7.5-µg dose of the monovalent influenza A/California/2009 (H1N1) MF59-adjuvanted surface-antigen vaccine, derived from cell culture, administered to adults 18 to 50 years of age. Two doses of the vaccine were either given concurrently, one in each arm, on day 0 or one dose was given on day 0 and the other on day 7 or 14. We will update this report with findings from subjects given two doses of 3.75 µg or 7.5 µg of MF59-adjuvanted vaccine, or 7.5 µg or 15 µg of nonadjuvanted vaccine, given 21 days apart, once these data are available.

Methods

The study was designed by one academic author and one industry author; the academic author was responsible for data management and drafting the manuscript. The data were fully accessible and interpreted by all the authors, who vouch for the accuracy and completeness of the data and analyses. The U.K. Medicines and Healthcare Products Regulatory Agency and the Leicestershire, Rutland, and Northamptonshire Ethics Committee approved the study. University Hospitals Leicester was the main sponsor; the vaccine was manufactured by Novartis, who provided funding but had no role in the conduct of the study or in preparation of the manuscript.

Vaccine

The 2009 H1N1 vaccine virus (New York Medical College [NYMC] X-179A) was generated from the influenza A/California/7/2009 strain with the use of classical reassortant methods. The gene segments encoding the hemagglutinin, neuraminidase, and the polymerase PB1 were derived from the influenza A/California/7/2009 strain, with the remaining genes taken from the influenza A/PR8/8/34 virus used as a backbone for influenza vaccines. The strain was supplied by the Centers for Disease Control and Prevention and is a pandemic vaccine strain recommended for use in vaccine development.

The seed virus was grown in Madin–Darby Canine Kidney (MDCK) cell culture by means of standard processes similar to those used for the development of Optaflu vaccines against interpandemic influenza.

The vaccine was formulated and produced by Novartis (Marburg, Germany) as an inactivated surface-antigen H1N1 vaccine, with or without MF59 adjuvant, and supplied in 0.5-ml prefilled single-dose syringes. Each MF59-adjuvanted vaccine contained 7.5 µg of H1 hemagglutinin, 9.75 mg of the squalene MF59, 1.175 mg of polysorbate 80, and 1.175 mg of sorbitan trioleate in buffer. Each nonadjuvanted vaccine contained 15 µg of H1 hemagglutinin in buffer. Hemagglutinin content in the final vaccine was determined by means of reverse-phase high-performance liquid chromatography, because single-radial diffusion reagents were unavailable. Vaccine was stored at 4°C until use.

Study Design

We conducted a single-center, phase 1, randomized study from July through September 2009 at Leicester Royal Infirmary (Leicester, United Kingdom). Subjects were screened for eligibility and provided written informed consent. (For eligibility criteria, see the Supplementary Appendix, available with the full text of this article at NEJM.org.)

The first 100 subjects enrolled were randomly assigned, in a 1:1:1:1 ratio (in five blocks of 20 subjects), to receive two doses of 7.5 µg of MF59-adjuvanted vaccine, either concurrently administered on day 0 (i.e., one injection of the vaccine containing twice the antigen and adjuvant content of a single vaccine) or administered in two doses, one at day 0 and the other at day 7, 14, or 21. Serum samples for antibody measurements were collected on days 0, 14, 21, and 28. We present here the data from interim analyses performed at day 21 for these first 100 subjects.

The remaining 75 subjects enrolled were randomly assigned, in a 1:1:1 ratio (in five blocks of 15 subjects), to receive two doses of 3.75 µg of MF59-adjuvanted vaccine (by administering half the contents of the adjuvanted-vaccine syringe for each), two 15-µg doses of nonadjuvanted vaccine, or two 7.5-µg doses of nonadjuvanted vaccine (by administering half the contents of the nonadjuvanted-vaccine syringe for each) — with one injection at day 0 and the other at day 21. Serum samples were collected on days 0, 14, 21, and 42. The results for these subjects will be reported when analyses are completed.

The vaccine was administered by intramuscular injection into the deltoid muscle of the nondominant arm, or in both arms if both doses were given on day 0. Subjects were observed for 30 minutes after each injection, and for the next 7 days they recorded, in self-completed diaries, the severity of unsolicited and solicited local symptoms (pain, bruising, erythema, and swelling) and systemic symptoms (chills, malaise, muscle aches, nausea, and headache), oral temperature, and use of analgesics. Symptoms were graded as follows: none; mild, if they did not interfere with normal activities; moderate, if they resulted in interference with normal activities; and severe, if they prevented engagement in daily activities and necessitated medical attention. Serious adverse reactions were defined as any reaction that persisted beyond 7 days after vaccination or that necessitated medical attention or hospitalization during the study period.

Laboratory Assays

Antibody responses were detected by means of microneutralization and hemagglutination-inhibition assays, according to standard methods,18,19 at the Centre for Infections, Health Protection Agency (London), and with the use of cell-culture X-179A H1N1 vaccine (see the Vaccine section above), egg-grown NIBRG-121 virus, and a reverse-genetic virus containing hemagglutinin and neuraminidase from the influenza A/California/7/2009 strain (see the Supplementary Appendix for details). Serum samples obtained from subjects were tested with the use of 1:2 serial dilutions. For hemagglutination-inhibition assays, serum samples were tested at an initial dilution of 1:8, and those that were negative for the hemagglutinin antibody were assigned a titer of 1:4. Serum specimens were analyzed to determine absolute end-point titers, and the final dilution was 1:32,768.

For microneutralization assays, serum samples were tested at an initial dilution of 1:10,20 and those that were negative were assigned a titer of 1:5. The final dilution was 1:320, and samples for which the end-point titers were greater were assigned a value of 1:640. Specimens were tested in duplicate, and the geometric mean values were used in analyses.

Statistical Analysis

The group sizes in our study are usual for phase 1 studies and were not based on power calculations. This preliminary report details the results of analyses of data from subjects who received 7.5 µg of MF59-adjuvanted vaccine. Data analysis was undertaken with the use of Stata software (version 9.2, StataCorp).

For solicited and unsolicited adverse reactions, the percentages of subjects (point estimates and 95% confidence intervals) with postvaccination reactions were based on the frequency and severity of the reported responses after vaccination. Exact (Clopper–Pearson) confidence intervals are reported for all proportional end points. We used a two-sided Fisher's exact test to compare proportions between vaccine groups. All reported P values are two-sided, with no adjustment for multiple testing; values of 0.05 or less were considered to indicate statistical significance.
 
For immunogenicity analyses, the geometric mean antibody titers at each time point were used. Geometric mean titers and 95% confidence intervals were computed by taking the exponent (log10) of the mean and of the lower and upper limits of the 95% confidence intervals of the log10-transformed titers. Geometric mean titers were compared between each pair of vaccine groups by means of one-way analysis of variance on the log10-transformed titers with Bonferroni correction for multiple pairwise comparisons, if appropriate. The proportions of subjects in whom seroconversion (a prevaccination hemagglutination-inhibition antibody titer 1:10 and a postvaccination titer  1:40 or a prevaccination titer  1:10 and an increase in the titer by a factor of four or more) or seroprotection (a hemagglutinin-inhibition antibody titer  1:40) was achieved were compared between each group with the use of a two-sided Fisher's exact test. Separate analyses were performed for the hemagglutination-inhibition and microneutralization assays. Because there are no established immune correlates for microneutralization, in that analysis we assessed the proportion of subjects who had seroconversion (an increase in the antibody titer by a factor of four or more) and a microneutralization titer of 1:40 or more.

Results

This preliminary report details interim analyses through day 21 after the first vaccination of 100 subjects (four of the seven groups studied) who received two doses of 7.5 µg of MF59-adjuvanted vaccine, administered either concurrently at day 0 or as in one injection at day 0 and the other at day 7, 15, or 21 (Figure 1). We will report the complete findings of this study when the analyses of data from all seven vaccine groups are complete, through the day 42 immunogenicity assessment.
 


Figure 1. Dose Administration and Data Analysis in the Study.

The results of the preliminary study — involving analyses of the 100 subjects receiving two doses of 7.5 µg of MF59-adjuvanted vaccine through day 21, 75 of whom had received both doses by that time and 25 who had yet to receive the second dose (scheduled for day 21) — are presented in this article.
 
By day 21, a total of 75 subjects had received two doses of 7.5 µg of MF59-adjuvanted vaccine (all of whom had their first dose at day 0 and 25 with the second dose on day 0, 25 with the second dose on day 7, and 25 with the second dose on day 14). The remaining 25 subjects had received one dose, with the second dose scheduled for day 21. All subjects received their assigned vaccines, returned all diary cards, and had serum samples obtained at day 21, according to the protocol. Additional serum specimens were obtained on day 14 from 24 of the 25 subjects (96%) who had received one dose only and from 72 of the 75 (96%) who had received both doses. All 100 subjects were included in safety and immunogenicity analyses (Figure 1).

The median age was 33 years (range, 18 to 50), 65% were female, 82% were white, and 37% had previously received seasonal influenza vaccine (Table 1). The baseline characteristics in each group were similar.




Table 1. Baseline Characteristics of the Study Subjects, According to Hemagglutinin Dose and Timing of Doses.
 
Safety Analysis

We studied the reactogenicity after administration of the 7.5 µg of MF59-adjuvanted vaccine. Solicited local and systemic reactions during the first 7 days after the first dose of 7.5 µg of MF59-adjuvanted vaccine are shown in Table 2. Overall, 86% of subjects reported adverse reactions after either vaccine dose (85% after the first and 56% after the second). The frequency or severity of reactions did not increase after the second vaccine as compared with after the first (see the Supplementary Appendix). All self-reported reactions were graded as mild or moderate and were generally self-limited, resolving within a 72-hour period.


Table 2. Solicited Local and Systemic Adverse Effects within 7 Days after Receipt of Either Dose of 7.5 µg of MF59-Adjuvanted Vaccine, According to Vaccine Group.

 
The most frequent local reaction after any dose of 7.5 µg of MF59-adjuvanted vaccine was pain at the injection site, in 70% of subjects. In general, such pain was not accompanied by redness or swelling, although one subject recorded bruising, in an area 20 mm in diameter, after the first dose, with resolution within 72 hours. No severe local reactions were reported.

The most frequent systemic reaction was muscle ache, in 42% of subjects. A total of 11% of subjects reported using an analgesic for systemic symptoms. Two subjects reported fever, defined as temperature of 38°C or more, after receipt of the first dose, but neither used antipyretic medication. In general, the frequency and severity of solicited reactions after injection of the 7.5 µg of MF59-adjuvanted vaccine did not differ among the groups, although subjects who received both doses on day 0 reported a greater frequency of systemic reactions (muscle aches) as compared with the other three groups (P=0.02). No severe systemic reactions were reported.

Seven unsolicited adverse events were reported. Three subjects reported self-limiting diarrhea that resolved within the 48-hour period after the first dose; one subject took over-the-counter loperamide as treatment. Two subjects reported coryza that resolved within 48 hours. One subject reported a toothache that resolved after 5 days. One subject reported a transient itchy rash on the right forearm that resolved within 48 hours (Table 3 in the Supplementary Appendix).

A probable vaccine-related adverse reaction, reported after receipt of the 7.5 µg of MF59-adjuvanted vaccine, is described in the Supplementary Appendix. Briefly, this subject (who received two doses of the MF59-adjuvanted vaccine on day 0) reported a purpuric rash on the lower limbs on day 17, with resolution within 72 hours. Further questioning revealed that she had consulted with her family practitioner in May 2009 for an intermittent leg rash within the 12-month period before the study. Investigations including complete blood count and biochemical profile showed normal values, but an autoimmune profile was positive for antinuclear and extractable nuclear-antigen antibodies. She had not received medication, and this previous medical history was not known at enrollment. Follow-up for the rash included a normal complete blood count and biochemical profile. Results of autoimmune testing were unchanged from those in May 2009.

Immunogenicity against the 2009 H1N1 Virus

Interim analysis was conducted at day 21 after the first dose of 7.5 µg of MF59-adjuvanted vaccine. Antibody responses against the vaccine were measured for each of the four groups.
Antibodies were detected, as measured by hemagglutination-inhibition assay (titer >1:8) and microneutralization assay (titer >1:10) before vaccination in 14% and 39% of subjects, respectively, with this frequency unrelated to age (P=0.91 by hemagglutination-inhibition assay and P=0.48 by microneutralization assay) or previous receipt of seasonal vaccine (P=0.15 and P=0.39, respectively).

On day 14, geometric mean titers, as measured with the use of hemagglutination-inhibition assay (Table 3) and microneutralization assay (Table 4), were higher in subjects who received two doses of 7.5 µg of MF59-adjuvanted vaccine by this time, as compared with those who had received one dose only (P=0.04 by hemagglutination-inhibition assay and P<0.001 by microneutralization assay), but there was no significant difference in titer among the groups (P=0.34 by hemagglutination-inhibition assay and P=0.10 by microneutralization assay). On day 21, there was no significant difference in titer among subjects who had received one dose of 7.5 µg of MF59-adjuvanted vaccine and those who had received two (P=0.18 by hemagglutination-inhibition assay and P=0.051 by microneutralization assay).


Table 3. Antibody Responses to 7.5 µg of MF59-Adjuvanted Vaccine, as Measured with the Hemagglutination-Inhibition Assay, According to Vaccine Group.



Table 4. Antibody Responses to 7.5 µg of MF59-Adjuvanted Vaccine, as Measured with the Microneutralization Assay, According to Vaccine Group.

 
Table 3 shows the ratio of antibody titer after first vaccination and before first vaccination and the percentages of subjects with seroconversion and seroprotection, as measured by means of the hemagglutination-inhibition assay. On day 14, the rates of seroconversion and seroprotection were higher (P=0.01 and P=0.004, respectively) among subjects who had two doses than among those who had only one. On day 21, there was no significant difference in the rate of seroconversion (P=0.11) or seroprotection (P=0.12) among those who had received one and those who had received two doses.

There was also no significant difference in the rate of seroconversion between subjects who had antibody detected at baseline and those who did not (P=0.68 by the hemagglutination-inhibition assay and P=0.66 by the microneutralization assay). Because various dosing intervals were evaluated, postvaccination responses at specific time points may not reflect overall antibody kinetics.

Table 4 shows the percentages of subjects with seroconversion and antibody titers exceeding 1:40, as measured by means of the microneutralization assay. On days 14 and 21, there was no significant difference among the vaccine groups in the rate of seroconversion (day 14, P=0.20; day 21, P=0.64) or those with titers exceeding 1:40 (day 14, P=0.50; day 21, P=1.00). Figure 2 shows the distribution of antibody titers at day 21 after the first dose, according to vaccine group. Titers of the hemagglutination-inhibition antibody exceeded 1:32 in 88% of subjects who had received one vaccine dose by this time and in 92 to 100% of subjects who had received both doses (Figure 2A). All subjects had microneutralization antibody at a titer exceeding 1:40 by day 21 (Figure 2B).
 


Figure 2. Reverse Cumulative-Distribution Curves of Antibody Titers in Serum Samples Obtained on Day 21 after First Dosing of 7.5 µg of MF59-Adjuvanted Vaccine, According to Number and Timing of Doses.
The percentages of subjects are based on the total number of subjects tested in the four vaccine groups. All four groups received the first of two doses on day 0. Three of the groups had received the second dose (on day 0, day 7, or day 14); one group had yet to receive the second dose (scheduled for day ²¹). Panel A shows the results of hemagglutination-inhibition assays, and Panel B shows the results of microneutralization assays. Titers are expressed as the reciprocal of the dilution.
 
Responses, as measured with the use of hemagglutination-inhibition assay, against the NIBRG-121 virus were similar to those against the 2009 H1N1 virus (see the Supplementary Appendix).

Discussion

This report details the interim findings for subjects receiving the 7.5-µg dose of the MF59-adjuvanted vaccine. We found that the immune responses were consistent with seroprotection against the 2009 pandemic influenza A (H1N1) virus within 2 weeks after administration of a single dose of the adjuvanted cell-culture vaccine. Data for the recipients of nonadjuvanted vaccine will be reported when analysis is completed.

Effective vaccination should reduce morbidity, mortality, and virus transmission,⁴ although this is challenging to achieve. The global demand for vaccine will likely exceed manufacturing capacity and will only be met by implementing a range of approaches to vaccine development. Large-scale vaccine production with the use of newly characterized viruses can be challenging if low egg growth limits the supply of antigen. Our vaccine was produced from a classical egg-derived seed virus propagated in a MDCK cell line.^7,21 Cell-culture systems may provide a faster response and potentially greater scale-up than egg production. Cell-culture seasonal influenza seed viruses also show better antigenic matching to clinical isolates than egg-passaged vaccine strains.^5,6,7,8,21

Clinical experience with avian and human influenza A/H1N1–subunit vaccines in immunologically naive subjects who had little evidence of cross-reactive antibodies suggests that two doses are required to induce seroprotection.^{10,11,12,13,14,15,22,23} Traditionally, dosing intervals of 21 to 28 days are used, often delaying effective immunization. In our interim analysis, we report data on several immunization schedules involving two 7.5-µg doses of MF59-adjuvanted vaccine. Flexible dosing would be useful for authorities organizing immunization regimens, although a single vaccination against the 2009 pandemic influenza A (H1N1) virus would be logistically most desirable.

Our findings add to observations that oil-in-water–emulsion adjuvants have short-term reactogenicity equivalent to that of inactivated seasonal vaccines.²⁴ Although adjuvants generally enhance immunogenicity, their effect on the 2009 H1N1 virus is unknown. Our head-to-head evaluation with nonadjuvanted formulations will assess the effect of adding MF59 adjuvant on the speed and magnitude of antibody responses. For avian-influenza subvirion vaccines, oil-in-water–emulsion adjuvants are essential to inducing long-lasting cross-reactive immunity.^{10,12,13,14,15} Although influenza A (H1N1) virus isolates are antigenically homogeneous, the induction of antibody that is cross-reactive to drift variants would be a desirable characteristic of the first vaccines against the 2009 H1N1 virus.

Interpretation of immunogenicity data for the vaccine against the 2009 pandemic influenza A (H1N1) virus is complicated by a lack of recognized immune correlates.

The insensitivity of hemagglutination-inhibition assays to some avian hemagglutinin has required that microneutralization assays, hemagglutination-inhibition assays involving horse erythrocytes, or single radial hemolysis be used.^10,18,25 Because there is significant laboratory variation in testing,²⁰ efforts to develop biologic standards for serologic assays of influenza A (H1N1) viruses are under way. Fifteen percent of subjects had detectable prevaccination levels of hemagglutination-inhibition antibody, consistent with results of seroepidemiologic studies.11 Although we excluded subjects with previous respiratory illnesses, asymptomatic infection with influenza A (H1N1) viruses cannot be ruled out, as local activity was present during the study.

The safety and immunogenicity of these and alternative candidate vaccines against the 2009 H1N1 virus, including egg-derived, whole-virion, recombinant, and live-attenuated vaccines must be assessed in high-risk populations, including children, the elderly, and other persons whose immunologic profiles may differ from those of young adults.8 In addition, the duration of antibody responses and their ability to be boosted after revaccination should be established to predict protection against future pandemic waves.

Finally, although seasonal influenza vaccines have an established safety profile, there are occasional case reports of unusual reactions, including vasculitis.^24,26 MF59, a proprietary oil-in-water–emulsion adjuvant, was first licensed for use in seasonal influenza vaccines in 1997. Over 40 million doses have been delivered in Europe, and over 16,000 doses administered in clinical trials, with no excess reports of autoimmune conditions.²⁷ It is important to ensure post-marketing surveillance during any mass use of a pandemic-virus vaccine, with or without adjuvant.


----------------------------------------------

Cutting to the chase... here's the important part:

This preliminary report of vaccines against the 2009 pandemic influenza A (H1N1) virus with or without MF59 will be updated as analyses are completed but may be useful for the planning of immunization schedules and future trials and comparisons with other vaccine options as they become available.
Supported by grants from University Hospitals Leicester and Novartis.

Dr. Hoschler reports holding equity and stock options in Illumina;
Dr. Nicholson, receiving consulting fees from Novartis Vaccines and GlaxoSmithKline and lecture fees from Baxter Vaccines;
Dr. Groth, holding equity and stock options in Novartis;
and Dr. Stephenson, receiving consulting fees from Novartis Vaccines and Sanofi Pasteur,
lecture fees from Baxter Vaccines and Novartis Vaccines,
and grant support from Hoffmann–La Roche, Novartis Vaccines, and GlaxoSmithKline.

No other potential conflict of interest relevant to this article was reported.

(They ran out of conflict's of interest.. they were all listed above...)

We thank the subjects who volunteered for the study and staff at University Hospitals of Leicester Infectious Diseases Research Unit, Department for Research and Development, and Leicestershire Comprehensive Research Network Office; the clinical investigator team at Novartis Vaccines and Diagnostics for their regulatory support of the study; and the technical staff at the Health Protection Agency influenza laboratory for providing assistance with serologic assessments.

Source Information

From the Infectious Diseases Unit, University Hospitals Leicester and Department of Inflammation, Infection and Immunity, University of Leicester, Leicester, United Kingdom (T.W.C., M.P., H.D., K.G.N., I.S.); the Respiratory Virus Laboratory, Health Protection Agency, London (K.H.); and Novartis Vaccines and Diagnostics, Siena, Italy (N.G.).

Drs. Clark and Pareek contributed equally to this article.

This article (10.1056/NEJMoa0907650) was published on September 10, 2009, at NEJM.org.
Address reprint requests to Dr. Stephenson at the Infectious Diseases Unit, Level 6, Windsor Bldg., Leicester Royal Infirmary, Leicester, United Kingdom, or at iain.stephenson@uhl-tr.nhs.uk .

References
1.   Global alert and response: Pandemic (H1N1) 2009. Geneva: World Health Organization, 2009. (Accessed September 10, 2009, at http://www.who.int/csr/disease/swineflu/en.)  
2.   Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009;360:2605-a-2615. [Free Full Text]
3.   Perez-Padilla R, de la Rosa-Zamboni D, Ponce de Leon S, et al. Pneumonia and respiratory failure from swine-origin influenza A (H1N1) in Mexico. N Engl J Med 2009;361:680-689. [Free Full Text]
4.   Ferguson NM, Cummings DA, Fraser C, Cajka JC, Cooley PC, Burke DS. Strategies for mitigating an influenza pandemic. Nature 2006;442:448-452. [CrossRef][Medline]
5.   Oxford JS, Manuguerra C, Kistner O, et al. A new European perspective of influenza pandemic planning with a particular focus on the role of mammalian cell culture vaccines. Vaccine 2005;23:5440-5449. [CrossRef][Web of Science][Medline]
6.   Audsley JM, Tannock GA. Cell-based influenza vaccines: progress to date. Drugs 2008;68:1483-1491. [CrossRef][Web of Science][Medline]
7.   Szymczakiewicz-Multanowska A, Groth N, Bugarini R, et al. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis 2009;200:841-848. [CrossRef][Web of Science][Medline]
8.   Serum cross-reactive antibody response to a novel influenza A (H1N1) virus after vaccination with seasonal influenza vaccine. MMWR Morb Mortal Wkly Rep 2009;58:521-524. [Medline]
9.   Kelly H, Grant K. Interim analysis of pandemic influenza (H1N1) 2009 in Australia: surveillance trends, age of infection and effectiveness of seasonal vaccination. (Accessed September 10, 2009, at http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19288.)
10.   Nicholson KG, Colegate AC, Podda A, et al. 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. Lancet 2001;357:1937-1943. [CrossRef][Web of Science][Medline]
11.   Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006;354:1343-1351. [Free Full Text]
12.   Atmar RL, Keitel WA, Patel SM, et al. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis 2006;43:1135-1142. [CrossRef][Web of Science][Medline]
13.   Stephenson I, Nicholson KG, Glück R, et al. Safety and antigenicity of whole virus and subunit influenza A/Hong Kong/1073/99 (H9N2) vaccine in healthy adults: phase I randomised trial. Lancet 2003;1959-66.
14.   Stephenson I, Bugarini R, Nicholson KG, et al. Cross-reactivity to highly pathogenic avian influenza H5N1 viruses after vaccination with nonadjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a potential priming strategy. J Infect Dis 2005;191:1210-1215. [CrossRef][Web of Science][Medline]
15.   Leroux-Roels I, Borkowski A, Vanwolleghem T, et al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: a randomised controlled trial. Lancet 2007;370:580-589. [CrossRef][Web of Science][Medline]
16.   Galli G, Hancock K, Hoschler K, et al. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A 2009;106:7962-7967. [Free Full Text]
17.   Global alert and response: WHO recommendations on pandemic (H1N1) 2009 vaccines. Geneva: World Health Organization, 2009. (Accessed September 10, 2009, at http://www.who.int/csr/disease/swineflu/notes/h1n1_vaccine_20090713/en/index.html.)
18.   Rowe T, Abernathy RA, Hu-Primmer J, et al. Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays. J Clin Microbiol 1999;37:937-943. [Free Full Text]
19.   Ellis JS, Zambon MC. Molecular investigation of an outbreak of influenza in the United Kingdom. Eur J Epidemiol 1997;13:369-372. [CrossRef][Web of Science][Medline]
20.   Stephenson I, Heath A, Major D, et al. Reproducibility of serologic assays for influenza virus A (H5N1). Emerg Infect Dis 2009 August (Epub ahead of print).
21.   Doroshenko A, Halperin SA. Trivalent MDCK cell culture-derived influenza vaccine Optaflu (Novartis Vaccines). Expert Rev Vaccines 2009;8:679-688. [CrossRef][Web of Science][Medline]
22.   Nicholson KG, Tyrrell DA, Harrison P, et al. Clinical studies of monovalent inactivated whole virus and subunit A/USSR/77 (H1N1) vaccine: serological responses and clinical reactions. J Biol Stand 1979;7:123-136. [CrossRef][Web of Science][Medline]
23.   Parkman PD, Hopps HE, Rastogi SC, Meyer HM Jr. Summary of clinical trials of influenza virus vaccine in adults. J Infect Dis 1977;136:S422-S430.  
24.   Wiselka MJ. Vaccine Safety. In: Nicholson KG, Hay AJ, Webster RG, eds. Textbook of influenza. Oxford: Blackwell Publications, 1998:346.
25.   Stephenson I, Wood JM, Nicholson KG, Zambon MC. Sialic acid receptor specificity on erythrocytes affects detection of antibody to avian influenza haemagglutinin. J Med Virol 2003;70:391-398. [CrossRef][Web of Science][Medline]
26.   Mader R, Narendran A, Lewtas J, et al. Systemic vasculitis following influenza vaccination -- report of 3 cases and literature review. J Rheumatol 1993;20:1429-1431. [Web of Science][Medline]
27.   Schultze V, D'Agosto V, Wack A, Novicki D, Zorn J, Hennig R. Safety of MF59 adjuvant. Vaccine 2008;26:3209-3222. [CrossRef][Web of Science][Medline]

[sociostudent]

This needs to go MEGA-VIRAL...

[sociostudent]

someone please tell me that they didn't just put aluminum on the CDC site when talking about adjuvants not being in the shot but left out any mention of squalene...
http://www.cdc.gov/vaccines/vac-gen/additives.htm
http://www.bloomberg.com/apps/news?pid=20601087&sid=asYlPo7IOFqw

I sense some tomfoolery with that one. I think they still put it (squalene) in there, maybe that's just my opinion but I think they did, or that they will if the public doesn't ask enough questions about it.

[Please Wake Up!]

According to that Bloomberg article:

The vaccines in both studies didn’t use ingredients called adjuvants included by some countries in formulations to boost effectiveness. No serious side effects were reported, though the trials are too small to detect rare conditions.

So, the "safety" studies did not involve vaccinations containing squalene (supposedly).  That DOES NOT mean that they won't contain squalene when they get to the main production of the vaccines.  Because after all, because of the horrible destructive 'pandemic' situation that we are in  , pretty much anything goes.  Plus, it mentions the other mfg's who are making the H1N1 vaccines, perhaps the ones from these studies don't contain it but the other mfg's will use it.  So many things that they can do here. 

[Satyagraha]

Yes, I think the Bloomberg article was crafted to be 'accurate' (they can point to the study with one control group that received non-adjuvant vaccines), but was deceptive in not mentioning the fact that the other group got adjuvant. I was puzzled by this because it's so easy to shoot down. Thinking about it, they may have decided to go with the minimalist approach to reporting on these studies, in the guise of just reporting about what the US would be getting in their injections.

But they don't mention the fact that squalene can be used in case of emergency (the feds will have this authority).
And they don't mention that we're already considered to be in an emergency 'pandemic'...
So the recipe for the vaccines we'll be taking can/will contain squalene (and thimerosol I suspect).
I'm writing to Bloomberg for clarification and will post any info I receive here.

[sociostudent]

Yes, I think the Bloomberg article was crafted to be 'accurate' (they can point to the study with one control group that received non-adjuvant vaccines), but was deceptive in not mentioning the fact that the other group got adjuvant. I was puzzled by this because it's so easy to shoot down. Thinking about it, they may have decided to go with the minimalist approach to reporting on these studies, in the guise of just reporting about what the US would be getting in their injections.

But they don't mention the fact that squalene can be used in case of emergency (the feds will have this authority).
And they don't mention that we're already considered to be in an emergency 'pandemic'...
So the recipe for the vaccines we'll be taking can/will contain squalene (and thimerosol I suspect).
I'm writing to Bloomberg for clarification and will post any info I receive here.

Awesome, dude. Thanks. This is all starting to feel like a combination of the OPV vaccines in Africa  ("refusal no option")combined with the psy-ops of Jonestown, with the potential for disaster of the "cutter incident" (Sounds like what happened at baxter, huh?)or the thalidomide or  SV-40 debacles.

[sociostudent]

Should we take the H1N1 influenza vaccine?



The Flu by J.P. McEvoy

When your back is broke and your eyes are blurred, 
And your shin-bones knock and your tongue is furred,
 And your tonsils squeak and your hair gets dry, 
And you âre doggone sure that you’re going to die,
 But you âre skeered you won’t and afraid you will,
 Just drag to bed and have your chill;
 And pray the Lord to see you through
. For you’ve got the Flu, boy,
You’ve got the Flu.

When your toes curl up and your belt goes flat,
 And you’re twice as mean as a Thomas cat,
 And life is a long and dismal curse,
 And your food all tastes like a hard-boiled hearse,
 When your lattice aches and your head’s abuzz
 And nothing is as it ever was,
Here are my sad regrets to you,
You’ve got the Flu, boy,
You’ve got the Flu.

What is it like, this Spanish Flu?
 Ask me, brother, for I’ve been through,
 It is by Misery out of Despair,
 It pulls your teeth and curls your hair,
 It thins your blood and brays your bones
 And fills your craw with moans and groans, 
And sometimes, maybe, you get well —
Some call it Flu — I call it hell!
*********************************************************************************************************

Many national and international medical organizations have confirmed that the so-called “swine-flu,” has evolved into a pandemic. Influenza pandemics occur when a new strain of the influenza virus is transmitted to humans from another animal species. These strains are less affected by immunity people may have to older strains of human influenza and can therefore spread extremely rapidly and infect very large numbers of people. That doesn’t mean it’s necessarily worse than the usual seasonal flu, just that it’s more widespread. The main reason the new H1N1 is likely to be more virulent than seasonal flu is that most people have never encountered it before, so they have no pre-existing immunity. The exception may be those over age 65.

So far, the number of serious illnesses and deaths worldwide have not been significant compared to the number of cases. The illness is officially named “novel H1N1” to distinguish it from the H1N1 influenza of 1918, which was also labeled as the “Spanish Flu,” although evidence strongly suggests it originated in Fort Riley, Kansas and was carried overseas by infected American troops during World War One. Some feel the source was a British staging area in Étaples, France. The Spanish Flu was responsible for from twenty to fifty million deaths.

As I said in a previous blog, every decision we make is based on a risk to reward ratio. So, there’s a risk of developing influenza, especially during a pandemic, but the question that must be considered is how serious will this disease be compared to the risk of the vaccine? Inasmuch as influenza vaccine takes time for protective antibodies to develop, waiting until we know the full effect of the flu might be too late to prevent serious complications, including deaths.

I know the internet is filled with “Don’t take the flu vaccine” web sites. Those of you always thinking in terms of conspiracies instead of facts might keep in mind that physicians as well as drug companies and hospitals would greatly increase their profits from a contagious disease pandemic compared to making and giving an effective preventive vaccine. I would like to remind people that the new influenza vaccine is similar in many ways to the seasonal vaccine which has been given to many millions of people with minimum side effects and positive benefits.

It’s well known that especially in the USA, there’s a significant group who are adamantly opposed to all vaccines. Now, I’m not going to sling barbs at them, but most of the so-called evidence they present has not been confirmed by careful medical studies. The most recent example, perhaps, is the claim that various childhood immunizations result in autism. Repeated studies in many countries have shown this not to be factual, but there are many who continue to write all sorts of books and articles claiming the relationship has been proven. There are clinics which attempt to relate vaccines to intestinal inflammation, which in turn somehow causes autism.

With regard to the usual anti-vaccine groups, that long claim vaccinations in children are dangerous and worthless despite strong scientific evidence to the contrary, when I think back on the horrendous cases we used to see from what people today think of as simple childhood diseases, I realize how out of touch this type of thinking is. Spending time working in a large contagious disease hospital during my training, we saw children and adults die from chicken-pox encephalitis, pneumonia from measles and innumerable other similar diseases. Vaccines have changed the entire field of viral infections. Every community hospital had wards filled with iron lungs for paralyzed polio victims when I was a young doc, yet many were opposed to polio vaccines back then and many still are.

The current attacks specifically aimed at the influenza vaccine claim the vaccine contains a highly toxic chemical, squalene, which they state was responsible for the Gulf War syndrome.

As to the veracity of the current anti-flu vaccine charges, again we need more light and less heat. At this time, the evidence I've seen would indicate the benefit of H1N1 vaccine greatly outweigh the risk. There is no medication I know of, including aspirin, that doesn't have the potential for some serious side effects. That doesn’t mean we don’t have many, many highly effective medications.

As for squalene, there's quite a bit of controversy floating around the internet about its health effects. Numerous claims, both positive and negative, are being made. Remarkable health qualities have been ascribed to it. Others are critical of the presence of squalene as an adjuvant (a compound added to "turbocharge" the raw vaccine, allowing less virus-related material to be needed, thus creating more doses). However, there is little clinical evidence to prove that squalene does anything to increase or decrease an individual's quality of life. Squalene is added to improve the efficacy of several vaccines including pandemic flu and malaria vaccines. It’s added to help stimulate the human body's immune response.

It’s true that following the swine flu immunization in 1976, there was an increase in a serious neurological disease called Guillain-Barre Syndrome. Also, that epidemic did not turn out to be nearly as serious as had been anticipated. The vaccines developed since are much better and even then the increase in G-B syndrome was one to two additional cases per million vaccines. Most patients recovered completely with proper treatment. The CDC says there is no reason to think this year's swine flu vaccine will cause Guillain-Barre. You can read more about those tests and the vaccines at www.cdc.gov/h1n1flu.

Remember, the current H1N1, is similar to the 1918 Spanish Flu pandemic [also H1N1] that killed many millions of people worldwide. It resulted in more deaths in one year than the Black Death due to bubonic plague did in several years. That influenza virus also primarily attacked the young. Of course, we have much better diagnostic and therapeutic technology available now. The last real pandemic was Hong Kong flu, which only killed one million over two years.

Fear is indeed a powerful force. Caution is necessary, but it's easier to be flat out against something than to give it the proper scientific evaluation. The last thing on my mind is to be an alarmist, but it often pays to be a realist.

Bottom line as of today: Take the H1N1 vaccine, if you qualify and have it administered to your children. Follow the other widely distributed advice. Do not stockpile the antivirals [Relenza and Tamiflu] and take or give them indiscriminately, as this will greatly increase the risk of the virus developing immunity to these valuable drugs and keep them out of the hands of those truly infected and quite ill.


(What is this SOB trying to say? Is squalene in the shot??!)

[sociostudent]

Experimental Swine Flu Vaccines Contain a Smorgasbord of Potentially Deadly Additives

September 18, 2009
Trials are beginning on Novartis' H1N1 vaccine and Novartis is recommending that children participating in the trial receive two doses of the experimental vaccine that reportedly contains ingredients found in spermicides, cleaners, and cosmetics as well as thimerosal and squalene (MF-59) -- raising concerns because the only safety checks for the children participating in the tests are a few blood draws and follow-up phone calls but no neurological testing, and adverse reactions to the Swine Flu vaccines being tested are being purposely omitted by researchers.

Despite the fact that the Government is giving the Pharmaceutical companies total impunity from any and all damages the populations receive as a result of their experimental cocktail, the Center for Disease Control (CDC) continues insisting that the new vaccine will be safe and effective. Experts -- there's that oft-deceptive word again -- are saying we can trust the experimental vaccine because the technology used to create it is time tested. As you'll see below, these so-called 'experts' are intentionally deceiving the public once again. The answer to the question I asked a couple of months ago -- Swine Flu outbreak or bioterrorism and intent to commit mass murder? -- is becoming increasingly clear.

As the information below reveals, these 'experts' from various government agencies are once again purposely cherry picking and ignoring information with the intention of deceiving, knowing full well that many people could die while trying to push their treachery off as the truth. The government has had a major aversion to the truth for years.

Participants of the study being conducted on children were not allowed to know the exact ingredients of the experimental vaccine on the grounds that it was a study and that the information is privileged. However, there are some clues that can be obtained from the parental consent form.

Squalene Linked to Gulf War Syndrome and ALS

Page two of the form informs you that MF-59 is an adjuvant that is used in influenza vaccines licensed for adults and/or the elderly in many countries, but not in the United States. So, if children are being used as guinea pigs in the study, why is vaccine that is licensed for adults and/or the elderly going to be used on newborns, children and pregnant women?

MF-59 (Squalene) is listed by the U.S. National Library of Medicine as being too dangerous for human use. Squalene is not licensed for use in the U.S. The anthrax vaccine used on Gulf War veterans in the early 1990's was laced with Squalene. It is known to have had disastrous consequences, which include Gulf War Syndrome and ALS. Information on the toxicity and adverse effects of Squalene are available from the National Library of Medicine.

In 2006, Dr. Sherri Tenpenny wrote an article noting the dangers of Squalene. Squalene is manufactured naturally in the liver as a precursor for cholesterol. Ingested Squalene is different from injected Squalene. When Squalene is injected, it can lead to self-destructive immune responses such as autoimmune arthritis and lupus. Squalene in MF-59 can cross react with the body's Squalene on the surface of human cells. Destruction of the body's own Squalene can lead to the diseases mentioned above and other central nervous system diseases.

Novartis has not performed testing for the carcinogenicity of MF-59 adjuvant or any of their other preventive vaccines and has no plans to.

Further down the parental consent form -- while not explicitly mentioned as ingredients -- it is noted that if your child had an allergic reaction in the past to neomycin or polymyxin, sodium ethylmercurothiosalicylate or thimerosal (mercury containing compounds often used as preservatives in vaccines), beta propriolactone or nonoxynol 9 (commonly used in cleaners, cosmetics and spermicides) you must tell the medical staff. People with egg allergies should avoid the Swine Flu vaccine.

Thimerosal is Known to Cause Harm in Children

What exactly are the vaccines comprised of? It's not revealed by those conducting the study, but the list of products producing allergic reactions is very revealing. Cleaners, cosmetics, spermicides, Squalene and Thimerosal reveals that these vaccines aren't safe at all.

Thimerosal is a neurological toxin -- that the Government and the Pharmaceutical companies are aware of but have intentionally kept covered up -- that is known to cause harm in children. It has been linked to autism because of its mercury content. The effects of nonoxynol are not yet known.

People with weakened or no immue system are susceptible to getting the flu from the vaccine. A lengthy list of some of the possible risks and side effects, more information about neurological testing and the neurological damage caused by many vaccines can be found in this article from VacTRUTH.

There are no measures in place to understand what the child's immune response would be. No neurological measurements are taken. But, there's a reason for that: as long as no neurological measurements are taken, according to Dr. Andrew Moulden, the Pharmaceutical industry can say the vaccine is safe. Some researchers are denying that a study participant's adverse reactions were caused by the Swine Flu vaccine.

Vaccine Recipients Could be Vulnerable to all Kinds of Health Issues

Children -- the guinea pigs -- participating in the trials receive a brief physical exam, vital signs and body temperature are measured, blood samples are taken to check for immune response, diaries are reviewed with the staff and there are some follow up phone calls. Since these children are being reviewed for 13 months, how can they claim the vaccines are safe for public use in less than 2 months? There are eight investigational vaccine formulas being tested. Participants have no idea which ones they are receiving.


People receiving this vaccine could -- and most likely will -- be vulnerable to all kinds of health issues and, eventually, premature deaths. Intentional deception of the part of the Government and the Pharmaceutical companies is more proof that there is more intent here to harm than to do good.

Various Swine Flu vaccines appear to be smorgasbords of dangerous and/or deadly chemicals. The fact that the Food and Drug Administration (FDA) complicitly fasttracked approval of untested, potentiall deadly vaccines for public use is cause for concern, and more proof that the U.S. government is purposely deceiving the American public.

The Novartis vaccine does contain trace amounts of Thimerosal and each multidose vial contains 25 mcg mercury. Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (=1 mcg ovalbumin), polymyxin (=3.75 mcg), neomycin (=2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v). More information (PDF) about the Novartis vaccine and vaccines from other manufacturers is available from the U.S. FDA.

Gov't and Pharma Covering up the Truth About Vaccines

Making matters even worse is the fact that both the Government and the media are well aware that vaccines containing mercury are dangerous to kids, but both have purposely stayed quiet. Analysis of a document that blows the lid off the cover-up being engineered by the Pharmaceutical companies and powerful governmental agencies can be found in this article by Dr. Russell Blaylock. This intentional cover-up has gone on for years.

Studies performed by the CDC found significant correlation between vaccines containing thimerosal and neurodevelopmental injury but CDC decided to keep it covered up. Exposure to vaccines containing thimerosal was tied to neurodevelopmental disorders including tics, speech and language delays and possibly ADD (Attention Deficit Disorder). The possible association between mercury and autism is being re-examined.

According to Dr. Blaylock's analysis, exposure to thimerosal-containing vaccines at one month was associated significantly with the misery and unhappiness disorder that was dose related -- the higher the child's exposure to thimerosal the higher the incidence of the disorder. A significant increased risk of ADD with 12.5 ug exposure at one month was found.

Exposure at 3 months found an increased risk of neurodevelopmental disorders with increasing exposure to thimerosal. Despite the findings, there was no mention of the associations found between thimerosal-containing vaccine exposure and neurodevelopmental disorders when the findings of the study were published...it was intentionally omitted from the report. The Pediatrician who published the report worked for the CDC -- he also worked for GlaxoSmithKline but there was no mention of that either. GlaxoSmithKline produces vaccines and has been involved in some scandals. Novartis and Baxter have also had their share of dubious scandals.

Dangers of Vaccines Being Covered Up

There is an obviously massive cover-up of the dangers of these vaccines in progress -- as has been the case with flouride, food-based excitotoxins, pesticides and aluminum. The article by Dr. Blaylock is lengthy but well worth the time it takes to read it.

There are some places that are forcing their employees to get the vaccine, but a lot of healthcare professionals will be refusing it. A preliminary Injunction to stop mandatory vaccinations has reportedly been issued in the United States District Court of New Jersey. As with the regular seasonal flu death estimates, the death estimates regarding the Swine Flu will most likely be overinflated -- the usual fear-mongering that has resulted in billions of dollars in profits for the Pharmaceutical companies that are rushing to make the vaccines is ongoing.

Information -- another of the 'white papers' that was sponsored by a Pharmaceutical giant -- published in March of 2009 by the RAND corporation reportedly identifies parental consent laws, medical homes, and lack of access to medical records as the main barriers "for immunizing low-income adolescents." The paper suggests turning schools in low income areas into a vaccine wonderland. This little adventure apparently began in 2007, suggesting that a situation such as the alleged Swine Flu 'pandemic' has been planned for awhile now.

As I said above, the answer to the question I asked a couple of months ago -- Swine Flu outbreak or bioterrorism and intent to commit mass murder? -- is becoming increasingly clear. More information and News on the 'pandemic' can be found from Pandemic Flu Online and from Above Top Secret. More information on the questionable ingredients being used in some of the Swine Flu vaccines can be found from VacTRUTH. An explanation of why millions of Americans don't need to be vaccinated against the Swine Flu can be found from Natural News.

[sociostudent]

Risks of the Swine Flu Vaccine
Written by Alex Newman    
Thursday, 03 September 2009 13:00
The coming swine flu vaccination campaign is expected to begin in October. But with vaccine safety tests being fast-tracked under “public health emergency” rules and the use of some questionable ingredients, many health experts are warning about a myriad of risks associated with the vaccine and the importance of being educated.

“Right now, you need to become educated about vaccination, influenza, vaccine risks and the public health laws in your state,” warned Barbara Loe Fisher, the president of the National Vaccine Information Center. “You need to find out what your rights and options are under new public health laws that may require you — and your children — to be vaccinated or quarantined.”

So what are the risks of the swine flu vaccines? It depends on who you ask.

“There can be no argument that unnecessary mass injection of millions of children with a vaccine containing an adjuvant known to cause a host of debilitating autoimmune diseases is a reckless, dangerous plan,” explained Dr. Joseph Mercola, a health activist, author and strong critic of the swine flu immunization program. He proceeds to provide evidence justifying his concerns.

The adjuvant Mercola is referring to is based on an oil known as squalene. It is used to reduce the amount of viral antigen required in vaccines, which allows companies to produce more vaccines for less money at a faster rate.

But according to countless medical professionals and experts, using it in immunizations is a bad idea. It is also going to be somewhat experimental. There isn’t a single vaccine containing squalene that is approved for use in America, according to Meryl Nass, M.D., who notes that Novartis and GlaxoSmithKline will make use of it as a “novel feature of the H1N1 vaccines.”

Squalene is a naturally occurring oil, found in the human brain, joints, and other places. The problem, according to some experts, comes when it is administered in a vaccine. They claim that in this circumstance, the body creates antibodies to attack the oil. And it is believed by many to be responsible for the wide variety of symptoms that were called collectively "Gulf War Syndrome," a sometimes debilitating set of phenomena present in a large number of U.S. military personnel who served during the first war in Iraq.

“The substantial majority (95%) of overtly ill deployed GWS patients had antibodies to squalene. All (100%) GWS patients immunized for service in Desert Shield/Desert Storm who did not deploy, but had the same signs and symptoms as those who did deploy, had antibodies to squalene,” noted a Tulane Medical School study published in Experimental Molecular Pathology. “In contrast, none (0%) of the deployed Persian Gulf veterans not showing signs and symptoms of GWS have antibodies to squalene.” The study has been challenged, but it is still widely cited.

Another study published in the American Journal of Pathology highlighted problems with the use of the substance as well. One injection of squalene into rats led them to develop what humans know as rheumatoid arthritis, or “chronic, immune-mediated joint-specific inflammation.”

Another potential risk from the vaccine was highlighted by Dr. Wolfgang Wodarg, the chairman of the health committee in the German parliament and the European Council. As reported in an article entitled "German health expert’s flu warning — Does virus vaccine increase risk of cancer?" in the German newspaper Bild, “the nutrient solution for the vaccine consists of cancerous cells from animals,” and according to Wodarg, "we do not know if there could be an allergic reaction.”

Johannes Löwer, the president of the German government’s Paul Ehrlich Institute, also warned that the side effects of the shot could be worse than the actual swine flu, according to the article.

Thimerosal, a mercury-based preservative that will also be used in the swine flu vaccine, has come under fire from a broad array of medical experts. Despite a number of studies that concluded the substance does not cause autism, there are critics of the various studies. Also critics point to widespread concern about other mercury-related complications.

The Food and Drug Administration actually told pharmaceutical companies to stop using the substance in early childhood vaccines. But many still contain it. And the swine flu vaccine will be no exception, though Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said that because of concerns over the preservative, there will be some vaccines available without it.
(It still has traces of mercury, I wish they wouldn't lie and say it was all out of there)

Critics, however, are still not satisfied. "We don't have adequate safety studies on this vaccine before we are moving forward to market," noted Lyn Redwood, the president of a non-profit organization called SafeMinds (Sensible Action For Ending Mercury-Induced Neurological Disorders) dedicated to investigating and raising awareness about the risks associated with mercury in medicinal products. "I'm really not convinced that we know for sure that the risk of the disease outweighs the risk of the vaccine, especially since this is a brand new additive that we have never used before in combination with thimerosal."

But thimerosal, squalene, and cancerous animal cells are far from the only concerns.  Among other potentially dangerous chemicals and substances often found in influenza vaccines are formaldehyde, antibiotics, and even ethylene glycol, known as anti-freeze. Various health experts have varying opinions about the effects of all of these additives, but many doctors still warn against them.  

Another cause for concern surfaced in the United Kingdom when the government’s Health Protection Agency sent a letter to senior neurologists warning that the new swine flu vaccine is linked to the deadly nerve disease known as Guillain-Barre Syndrome (GBS), the Daily Mail reported in an article entitled "Swine flu jab link to killer nerve disease: Leaked letter reveals concern of neurologists over 25 deaths in America." The risk of contracting the paralysis-inducing illness was reportedly eight times greater in those who received the infamous government swine flu vaccine of 1976, which killed more people than the actual virus. The leaked letter warned recipients to keep an eye open for GBS and report it immediately.

Many vaccine opponents go much further than highlighting the potential risks, with some making unsubstantiated claims that it will be used as a tool for mass depopulation or eugenics. Some point to anecdotal evidence like comments by Obama’s science czar, who called for drastic population reduction methods in a book called Ecoscience. But what is certain is that the vaccine carries risks — a lot of them according to experts.
(Well, at least we're making some progress.)

The people who seem totally convinced about the inoculations’ safety and efficacy — or who are at least downplaying the potential risks and side effects — appear to be mostly government bureaucrats or people with vested interests. Virtually every medicinal product carries some risk, and these vaccines are no different. To say otherwise is disingenuous.

What is important is that the population be educated about the potential complications and then decide with their families and healthcare providers what approach they would like to take, taking into consideration the risks of the vaccine and of the swine flu. It should be an individual decision without bureaucratic interference or propaganda.

[sociostudent]

Gardasil and Swine Flu Vaccines may be risky business
Gardisil and Swine Flu Vaccines May Be Risky Business
Written by Allison Wolff
Published on September 2nd, 2009
10 Comments
Posted in Baby, Business, Education, Health, Parenting

I’m dying to write a light-hearted post, but I keep coming across new news on the potential risks involved with Gardisil, the teen vaccine intended to stave off cervical cancer, and the swine flu vaccine and I feel that I must continue to get the word out on vaccines. The more I read and listen, the more suspicious I am becoming that our national vaccination policy is a well-meaning government program that, like so many others, is caught up in nasty politics and big business.

As a side note, it is difficult to write about these matters without sounding alarmist. My goal here is to encourage parents to educate themselves about vaccines. Like any medical issue, citizens need to take responsibility for their own health. It is too easy to just do what the doctor says. See my last post about vaccinating baby for more resources that can help educate you about the potential hazards of vaccinations.

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In studying the National Vaccine Information Center’s (NVIC) website, I found several sources that are worth telling the world about. The NVIC is a well-regarded “not-for-profit organization founded in 1982 to prevent vaccine injuries and deaths through public education and defend the informed consent ethic.” One of the founders, Barbara Loe Fisher, lost a child to the DPT vaccine in 1980, and has since become a well-researched expert on the business and politics surrounding the vaccine industry. On August 24th, she posted a video-based statement about the risks of the Gardisil Vaccine and the potential politics involved in the government’s push for citizens to get the Swine Flu vaccine. I encourage every parent to take a look.

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In the video, Fisher mentions some disturbing facts about Gardisil. 1 in 1855 girls have a “bad health outcome” from the vaccine. Compared to other vaccine vs. disease risk statistics, these are not good odds. Common bad health outcomes include:

    * Passing out within 24 hours of receiving the shot. Several teens have passed out while driving and died. Others have received head injuries. Fisher is calling for a warning from doctors that sudden collapse is possible within 24 hours after the vaccine is administered.
    * Seizures
    * Blod clots which can travel to the lungs or brain
    * Autoimmune disorders such as Lupus and Rheumatoid Arthritis

You should know that cervical cancer can be easily prevented with regular pap smears.

Fisher also discusses the fact that doctors are notoriously bad about submitting “bad health outcome” reports to the CDC, greatly hampering the public’s ability to understand the real risks involved with some of the more controversial vaccines as many incidents go unreported. Further, the medical world often writes off bad health outcomes as coincidences, never reporting vaccine-related incidents at all. Another disturbing point she makes is that there is no public access to the “bad health outcome report” databases which means they cannot be reviewed or publicly scrutinized, a process that is critical to evolving standards.

Fisher, in the video, also discusses the swine flu “epidemic”. In declaring a national health emergency around swine flu, the government has called into effect some new, post 9-11 laws that allow vaccines to be fast-tracked to market with limited testing. The Swine flu vaccine has some worrisome components that are the same or similar to components in the swine flu vaccine of the 70’s which killed and debilitated more people than did the disease itself and in the anthrax vaccine given to Gulf War troops who ended up with debilitating auto immune issues as a result. What’s ridiculous is that the swine flu has proven to be no more deadly than the regular old flu which comes around every year and doesn’t kill anyone who is in good health. Fisher suspects some fishy business and bad politics behind this vaccine push–or mandate, depending on what state you live in. See NVIC’s facts about Swine Flu for more.

You might also be interested to see this report from August 12, 2009 on CBS News where Fisher, along with Dr. Jennifer Ashton, a CBS News Medical Correspondent, discuss the possible dangers of the swine flu versus the H1N1 vaccine.

Dr. Mercola’s website also has some great commentary on the swine flu vaccine and also features the CBS News story mentioned above. I found this information regarding the most controversial component of the swine flu vaccine, squalene, particularly interesting:

    “Your immune system recognizes squalene as an oil molecule native to your body. It is found throughout your nervous system and brain. In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties.

    The difference between “good” and “bad” squalene is the route by which it enters your body. Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant.

    Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system.

    Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene. MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental antrhax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets.”

Having gone to high school with a few Gulf War vets who have Gulf War Syndrome, I can tell you that the effects of squalene are horrible.

Again, I encourage you to take the time to understand the risks and benefits of vaccinations. Like with any other health issue you face, don’t be afraid to arm yourself with the information you need to have an intelligent conversation with your doctor.

[sociostudent]

Well, Well, Well: H1N1 Vaccine

Trust and risk

Connie Howard / health@vueweekly.com

Clinical trials for the H1N1 swine flu vaccine have now begun in Canada, the US and Europe, and Canadian health officials have been clear: it's foolish not to take advantage of the shot once it arrives.

Some of my readers have also been clear: they're tired of me disagreeing with health officials. So I apologize in advance. It's just that when we're only half-informed, my belief in our right to the whole story kicks in.

Information we're being given on the coming vaccine is definitely incomplete, fuzzy and both confusing and soothing. Trust the trial and approval process, they tell us. But the shot could well end up containing squalene to ensure a strong and long-lasting immune response on minimal viral material, so I'm unwilling to trust.

Squalene isn't currently approved for use in vaccines, but approval can quickly be granted in the case of an emergency such as a pandemic. Squalene, a naturally occurring antioxidant found in our bodies and in foods like olive oil and natural health products, is a good thing. The problem is that although it is beneficial and innocuous when ingested, it is anything but innocuous when injected as part of an immune-activating compound.

In launching an immune response to the viral component of the vaccine, we also appear to launch one to squalene in general, attacking its essential role in the health of our nervous systems.

Where we discovered that squalene in vaccines was problematic was with the anthrax vaccine used with Persian Gulf War military personnel. Some lots of the vaccine administered contained squalene (a fact initially denied by the Department of Defense, but later confirmed by the FDA), and the link between the contaminated vaccines and Gulf War Syndrome is as clear as day.

From the February 2000 issue of Experimental Molecular Pathology, we know that of the deployed soldiers suffering with Gulf War Syndrome, over 95 percent had antibodies to squalene, and that of those not deployed but immunized, 100 percent had antibodies to squalene. Veterans not showing symptoms of Gulf War Syndrome had no antibodies to squalene.

The risk of vaccine reaction is low, though, I keep hearing, and surely they won't use squalene, and surely they'll test the vaccine adequately before they roll it out, and anyhow, risking the symptoms of autoimmune disease is preferable to risking mass spread of the swine flu. OK, if you say so, but I'm not convinced.

Accelerated vaccine approvals might be justifiable for a deadly virus, but the swine flu strain has so far been relatively mild, posing no more danger than the regular seasonal flu.

But push the vaccine they will, from the safe perch of legal immunity for vaccine manufacturers.

We're also stocking up with millions of doses of the antiviral drug Tamiflu, children being the most recent on the list of those for whom the drug is approved, even though it had been linked to the deaths of children four or five years ago and the Canadian Medical Association Journal had issued a safety alert at that time saying it should not be given to children less than a year old. Has the drug become safer or more effective since then?

To offer something besides negativity, we do have some very safe immune-boosting measures available to us. Elderberry extract has been shown to inhibit entry of the H1N1 virus into target cells, and vitamin D's impact on immune function has long been known by those inclined toward alternative health—there is a clear and direct link between low levels of vitamin D and problematic cold and flu infection. The Public Health Agency of Canada, currently conducting research on vitamin D's potential with flu viruses, now plans to expand the research to include the H1N1 swine flu virus.

We've done the trust first, clean-up-the-mess-later thing before, and nowhere more tragically than with pregnant women and children. Remember thalidomide for morning sickness and DES (diethylstilbestrol) for miscarriage prevention? With thalidomide we exchanged temporary nausea for permanent birth defects; with DES we traded risk of miscarriage for cancer in both mom and baby. V

(My take on this lady is that she suffers from a serious case of "cognitive dissonance" with a secondary case of "peer pressure" to accept the shots. I'm not saying she's not intelligent--she's extremely intelligent, but being hit hard with the govt. and Big Pharma propaganda about the safety of the vaccines...95% of women in the U.S. are in the SAME BOAT.)

[sociostudent]

Respondents question H1N1 vaccine: apathy, fear or common sense?

Respondents question H1N1 vaccine: apathy, fear or common sense?
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Recent polls conducted in Canada, the United States, England, & Hong Kong are showing an interesting trend. The majority of those polled are not jumping on the vaccination bandwagon to the dismay of the World Health Organization & the Centers for Disease Control.

What is of particular significance is that several studies involving health care professionals show roughly half of those polled express severe reservations for the safety of the vaccination as well as questioning the necessity of national vaccination programs to combat what has been shown to be a mild to moderate flu.

With the safety of the vaccine in question it is prudent to look at the development of it. In an effort to fast track the vaccine are we thoroughly testing and completing sufficient trials in a relatively short period of time? 25 separate companies have been contracted to supply the vaccine using their own formulations.

Are we able to adequately oversee this immense production effort? It is suggested that the H1N1 vaccine will be manufactured using established processes and in the same facilities that are used to make the currently licensed seasonal influenza vaccines. But unlike other seasonal flu vaccines the H1N1 vaccine will include an adjuvant. An adjuvant is a substance, when added to a vaccine, increases the body’s immune system response. In Canada & the United States adjuvant vaccines have never been approved for use. Until now.

In the case of the H1N1 vaccine, the adjuvants used are AS03 & MF59, both containing squalene. Squalene is a naturally occurring substance present in human and animal brain tissue. By it’s self, squalene is a “safe” substance, but in it’s role as an adjuvant it can trigger an autoimmune response, where by the body actually attacks itself. In individuals with weakened immune systems this can have devastating consequences. The use of squalene in an adjuvant vaccine in the 1990’s has been linked to Gulf War syndrome and other diseases.

Further, concerns are raised by the presence of Thiomersal, a preservative used in the vaccine to prolong shelf life. Thiomersal contains 47-58% mercury which many believe maybe linked to autism and a host of other neurological disorders. Although it has been suggested that there is no definitive scientific link to the onset of autism it has become a very controversial issue and has raised significant concern.

Also at issue is the link to Guillain-Barre Syndrome during the 1976 Swine Flu Vaccination Program. 40 people died and over 500 hundred were paralyzed and became ill immediately after receiving the vaccination. It was a stark contrast to the 1 unfortunate individual who died of the actual flu virus. 40 million people were vaccinated in an 8 week period before the program was abruptly cancelled when it became apparent the virus simply was not spreading. The US government subsequently paid out millions of dollars to the vaccine victims.

The U.S. and Canada will spend roughly 2.5 billion dollars on the development of the vaccine. They have been advised by health authorities that 70 % of the population need to submit to the vaccine for it to effectively eliminate a wide spread epidemic.

A substantial amount of money is being invested in a program that, to date, does not have the confidence or support of the majority.

Written by Diane Briggs-Hoyle
dbhoyle@gmail.com
www.dbhoyleart.blogspot.com

[wezthebikie]

CSL here is Australia are a big part of the Swine Flu Vaccine Scam. Rachel David, their spokeswoman, even admitted, that they don't test the safety of the vaccines. I will track down a link to the statement, it left me speechless.

[Heather Rainbow]

http://without-consent.com/

look up scientific papers, it shows side effects


"SQUALENE IS AN AUTOTOXICANT INDUCING POLYARTHRITIS IN RATS AND IMMUNOPATHIES IN MAN (Michael W. Whitehouse, Frances W.J. Beck, Gary Matsumoto, Depts. Medicine, University of Queensland, Princess Alexandra Hospital, Qld; and Wayne-State University, Detroit, Michigan, USA.
http://www.without-consent.com/media/SqualeneAutotoxicant-whitehouse_beck_matsumoto.pdf

[Satyagraha]

http://without-consent.com/

look up scientific papers, it shows side effects


"SQUALENE IS AN AUTOTOXICANT INDUCING POLYARTHRITIS IN RATS AND IMMUNOPATHIES IN MAN (Michael W. Whitehouse, Frances W.J. Beck, Gary Matsumoto, Depts. Medicine, University of Queensland, Princess Alexandra Hospital, Qld; and Wayne-State University, Detroit, Michigan, USA.
http://www.without-consent.com/media/SqualeneAutotoxicant-whitehouse_beck_matsumoto.pdf

Thank you Heather - great site! Welcome to the forum.

[Satyagraha]

This is the first full clinical trial focusing on Children that I've seen.
NOTE: This study is still in the recruitment phase. They anticipate results will be available in APRIL 2010.

Peds Sanofi H1N1 Influenza Vaccine
Administered at Two Dose Levels
This study is ongoing, but not recruiting participants.
First Received: July 21, 2009   
Last Updated: September 24, 2009   

Sponsored by:  National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:  National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:  NCT00944073

http://clinicaltrials.gov/show/NCT00944073

Purpose

The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in up to 650 healthy participants of three age groups:

1. "greater than or equal to 6 months to less than 36 months"

2. "greater than or equal to 36 months to 9 years

3. "and 10 - 17 years, with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination.

Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups.

Group 1 will receive 15 mcg of vaccine;

Group 2 will receive 30 mcg of vaccine.

Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle.
Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection.

Participants will be involved in study related procedures for approximately 7 months.


http://clinicaltrials.gov/archive/NCT00944073/2009_07_30

View of NCT00944073 on 2009_07_30
ClinicalTrials Identifier: NCT00944073
Updated: 2009_07_30
Descriptive Information
Brief title Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

Official title A Phase II Study in Infants (Greater Than or Equal to 6 - Less Than 36 Months), Children (Greater Than or Equal to 36 Months - 9 Years) and Adolescents (10 - 17 Years) to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels
 

Detailed description

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization to declare a pandemic on June 11, 2009.

Data from several cohorts in different age groups that received licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide protection against the new virus.

Adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children.

These data indicate the need to develop vaccines against the new H1N1 strain and suggest that different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate for persons in different age groups. Based on clinical data from other novel influenza A viruses, a higher dose, or multiple doses of an unadjuvanted, inactivated influenza H1N1 vaccine may be necessary to confer protection to a maximal number of vaccine recipients.

This protocol explores the antibody response following vaccination at 2 different dosage levels (15 mcg and 30 mcg) in up to 650 children aged 6 months to 17 years, inclusive. This study assesses the immune response following a single dose of vaccine, to assess whether individuals have any pre-existing 'prime' immunity, such that the initial H1N1 vaccination serves as a boost, thus conferring a more rapid time to protection and the need for fewer doses.

Antibody responses will be assessed after a second dose.

This is a randomized, double-blinded, Phase II study in healthy infants, toddlers, children, and adolescents and is designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine. The primary objectives are safety, to assess the safety of the unadjuvanted, inactivated influenza H1N1 vaccine when administered at the 15 mcg or 30 mcg dose; and immunogenicity, to assess the antibody response following a single dose of unadjuvanted, inactivated influenza H1N1 vaccine, stratified by age of recipient, when administered at the 15 mcg or 30 mcg dose.

The secondary immunogenicity objective is to assess the antibody response following two doses of unadjuvanted, inactivated influenza H1N1 vaccine, stratified by age of recipient, when administered at the 15 mcg or 30 mcg dose. There will be 3 age strata, each containing 200 subjects: greater than or equal to 6 months to less than 36 months , greater than or equal to 36 months to 9 years, and 10 - 17 years .

Subjects will be randomized into 2 groups, with 300 subjects per group (100 per strata), to receive intramuscular inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). '

The vaccine will be administered on Days 0 and 21.

Following immunization, safety will be measured by assessment of adverse events

   (AEs) for 21 days following the last vaccination 
   (Day 42 for those receiving both doses and Day 21 for those who do not receive the second dose); 

    serious adverse events (SAEs) and new-onset chronic medical conditions for 6 months post the final vaccination
   (Day 180 after second vaccination); 

    and reactogenicity to the vaccines for 8 days (Day 0-7) following each vaccination.

Immunogenicity testing will include HAI and neutralizing antibody testing on serum obtained
    on the day of each vaccination (prior to vaccination) and
    21 days following the second vaccination (Day 42).

For subjects aged 10-17 years, serum for antibody assays will also be obtained at
    Day 8-10 following each vaccination.

However, for the greater than or equal to 6 months - less than 36 months and the greater than or equal to 36 months - 9 years age strata,
    the first 30 subjects enrolled in each dose level will have blood collected for antibody assays
    prior to vaccination on Day 0 - Visit 1,
    and then Day 8-10 - Visit 2 and
    Day 8-10 post second vaccination - Visit 4 only.
 
This is a little chart I made to help understand the DURATION of this study... or when we can expect final results of this testing. Any release of test results PRIOR to the end date for the study would be 'preliminary' results, and would not be considered FINAL test results. Therefore, we cannot assume testing is complete until the last set of tests are analysed and reported at the end.



Phase: Phase 2
Study type Interventional
Study design Prevention
Study design Randomized
Study design Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Study design Parallel Assignment
Study design Safety/Efficacy Study

Primary outcome Safety: occurrence of solicited local and systemic adverse events (AEs).
Within 8 days post vaccination (Day 0-7). Yes 

Primary outcome Safety: occurrence of vaccine-associated serious adverse events (SAEs).
Throughout the course of the study. Yes 

Primary outcome Immunogenicity: proportion of subjects, stratified by age, with 4-fold or greater HAI antibody titer increases against the influenza H1N1 2009 virus following a single dose of H1N1 vaccine (15 mcg or 30 mcg).
Days 0, 21, 42. Age 10-17 years, Day 8-10. > or equal to 6 - <36 months and > or equal to 36 months - 9 years, first 30 subjects enrolled in each dose level, Day 0 - Visit 1, Day 8-10 - Visit 2 and post second vaccination - Visit 4 only.
No 

Primary outcome Immunogenicity: proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater, against the influenza H1N1 2009 virus following a single dose of H1N1 vaccine (15 mcg or 30 mcg). Days 0, 21, 42. Age 10-17 years, Day 8-10. > or equal to 6 - <36 months and > or equal to 36 months - 9 years, first 30 subjects enrolled in each dose level, Day 0 - Visit 1, Day 8-10 - Visit 2 and post second vaccination - Visit 4 only.
No 

Secondary outcome Immunogenicity: proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater against the influenza H1N1 2009 virus following 2 doses of H1N1 vaccine (15 mcg or 30 mcg). Days 0, 21, 42. Age 10-17 years, Day 8-10. > or equal to 6 - <36 months and > or equal to 36 months - 9 years, first 30 subjects enrolled in each dose level, Day 0 - Visit 1, Day 8-10 - Visit 2 and post second vaccination - Visit 4 only.
No 

Secondary outcome Immunogenicity: proportion of subjects, stratified by age, with 4-fold or greater HAI antibody titer increases against the influenza H1N1 2009 virus following 2 doses of H1N1 vaccine (15 mcg or 30 mcg). Days 0, 21, 42. Age 10-17 years, Day 8-10. > or equal to 6 - <36 months and > or equal to 36 months - 9 years, first 30 subjects enrolled in each dose level, Day 0 - Visit 1, Day 8-10 - Visit 2 and post second vaccination - Visit 4 only.
No 

Condition Influenza 
Arm/Group Arm Label: Group 2: 30 mcg H1N1 Vaccine         Experimental
300 subjects to receive 30 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21.
 
Arm/Group Arm Label: Group 1: 15 mcg H1N1 Vaccine         Experimental
300 subjects to receive 15 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21.
 
Intervention Biological/Vaccine: Inactivated H1N1 Vaccine         Arm Label: Group 1: 15 mcg H1N1 Vaccine
Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral muscle of the thigh.
 
Recruitment Information
Status Recruiting

Last follow-up date 2010-04 (Anticipated) 
Primary completion date 2010-04 (Anticipated) 

Criteria
Inclusion Criteria:

-Are males or non-pregnant females aged 6 months to 17 years, inclusive.
-Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
-The subject must be in good health as determined by axillary (<10 years of age) or oral temperature (axillary temperature <100 degrees Fahrenheit or oral temperature <101 degrees Fahrenheit), medical history, and targeted physical examination based on medical history.
-Subject and/or parent(s)/legal guardian(s) must be willing and able to comply with planned study procedures and be available for all study visits.
-Subject and/or parent(s) legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

Exclusion Criteria:

-Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein).
-Have a positive urine or serum pregnancy test within 24 hours prior to vaccination or are breastfeeding.
-Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
-Have an active neoplastic disease or a history of any hematologic malignancy.
-Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (> 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
-Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis including major depression.
-Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others.
-Are receiving any psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate) or any drugs for treatment of depression.
-Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
-Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).
-Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination. This is inclusive of routine childhood immunizations provided outside the scope of this study, and seasonal influenza vaccines. The initiation of this protocol does not take precedence over routine immunizations.
-Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses. (This includes, but is not limited to, known cardiac disease, chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, autoimmune disorders and transplant recipients.)
-Have a history of severe reactions following previous immunization with influenza virus vaccines.
-Have an acute illness, including an axillary temperature greater than 100 degrees Fahrenheit or an oral temperature greater than or equal to 101 degrees Fahrenheit, within 1 week of vaccination.
-Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
-Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have history of novel influenza H1N1 2009 infection or treatment.
-Have a known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
-Have a history of alcohol or drug abuse.
-Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination.
-Have a history of Guillain-Barré Syndrome.
-Have any condition that the investigator believes may interfere with successful completion of the study.
 
Gender Both 
Minimum age 6 Months
Maximum age 17 Years
Healthy volunteers Yes

[Chips]

The Novartis study for which the parental permission form is available at - http://www.scribd.com/doc/19638768/Vaccine-Trial-Paperwork - is targeted specifically for Healthy Pediatric Subjects, Ages 3 to <9. Why is this "study" apparently discounted?

[Satyagraha]

The Novartis study for which the parental permission form is available at - http://www.scribd.com/doc/19638768/Vaccine-Trial-Paperwork - is targeted specifically for Healthy Pediatric Subjects, Ages 3 to <9. Why is this "study" apparently discounted?

Thanks for posting that reference to a study by Novartis. I have not seen the acutual study until you posted this... do you have the link to the study itself? I'd like to post it.  Believe me, it was not 'discounted' - I simply have not found it in my searches. I appreciate any further contributions you may have to add ... we all need to scour the available research information to make this thread complete. The more information we can add here, the more accurate our picture of the testing will be.   Post everything you can find - thanks!

[Jackson Holly]

The Novartis study is ongoing, right?

[Satyagraha]

Checked out the Novartis site for information on the clinical trial 'Chips' referenced above:
http://www.novartis.com/newsroom/swine-flu/
Looks promising:

Novartis continues to make good progress in our efforts to rapidly produce and commercialize a vaccine against the A(H1N1) virus. We started clinical trials with our A(H1N1) vaccines in July and on September 3, 2009, we announced the results of a pilot trial that demonstrated Novartis candidate MF59® adjuvanted cell culture-based vaccine, elicited a strong immune response to Influenza A(H1N1).

An adjuvant can help produce an enhanced immune response. Data from the study showed a strong, potentially protective, immune response in 80% of subjects after one dose of the adjuvanted A(H1N1) vaccine and in more than 90% after two doses. MF59® adjuvanted cell culture-based A(H1N1) vaccine was well tolerated, with pain at the injection site the most frequent adverse event.

Larger pivotal trials with both cell culture and traditional egg-based vaccines are also under way and include more than 6,000 adults and children at different clinical trial centers around the world.

Pending approval from Regulatory authorities and evolution of the yields, we expect deliveries to begin to government customers in the fourth quarter of 2009 and continue into 2010.

So I did a search for H1N1 Clinical Trials, and found this:
http://www.novartis.com/newsroom/media-releases/en/2009/ 1339223.shtml  | 49.4KB

Novartis MF59® adjuvanted cell culture-based vaccine shows strong immune response in A(H1N1 ...
Basel, September 3 2009[/b] - A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine[1] indicates that the swine flu vaccine elicited a strong immune response and was well tolerated. The trial was run by the UK's University of Leicest...

Well.. that's a press release, not the study info we need...
So I found (Eureka!) their "Clinical Trials" page...
http://www.novartisclinicaltrials.com/webapp/etrials/home.do

Thinking ok... now I've found the info on the childrens' study they're doing...
Using the handy "Find a Clinical Trial" search field, I did a search for H1N1, and got this:


No Studies Found
There were no studies found that matched your keyword "H1N1". You may try another search or continue on to our Clinical Trials Search page to see trials listed by disease area

So I did a search for 'Influenza', and what came back was this:


No Studies Found
There were no studies found that matched your keyword "Influenza". You may try another search or continue on to our Clinical Trials Search page to see trials listed by disease area


Ok, clearly a webmaster issue; their search engine is broken. So... I see they have this:

Novartis clinical trial results database
http://www.novartisclinicaltrials.com/webapp/clinicaltrialrepository/public/login.jsp

I click to enter that database... and got this...

http://www.novartisclinicaltrials.com/webapp/etrials/error_404.do

Our apologies  
The NovartisClinicalTrials.com page you requested cannot be found. If you were looking for a clinical trial listing, the clinical trial may have completed enrollment and is no longer seeking clinical trial participants.

View our complete list of clinical trials(to the homepage) to find information on another clinical trial that you may qualify for.


So... Chips - please try to find us the actual study and post it here. We need this info, and the parental consent form shows us that they're doing some testing, but we need the details and timelines that will be outlined in the study.  Besides, I'll think of you as a TROLL unless you pitch in and help by contributing.

I'll continue searching (obviously looking for this info at Novartis' website is not yielding results, so I'll check elsewhere).

[Chips]

Thank you for the search for studies. I'll be able to resume the quest in a few hours. I was about to post what follows below when I was notified by the forum that you had posted an additional reply.

I was thinking that perhpas you were aware of the study and you knew of a valid reason to discount it. I'm glad that's not the case. I'm a novice, not the least adept (yet) at accessing the actual studies. The original lead came from an infowars post in which the poster's wife had signed up for the study, in essence in an effort to infiltrate and glean what she could; she came away with the parental permission form and silence in response to her questions about potential harm of squalene adjuvant.

Any and all help to linking to that specific study would be greatly appreciated!

My efforts thus far have been geared toward establishing as best as possible a valid ball park percentage for risk of autoimmune disease in recipients of squalene adjuvanted vaccine. As lay consumers I feel we (the general public) assume that vaccine risks are minimal - miniscule, actually, or we wouldn't be asked to accept them - and if it can be shown that the risks instead are maximal it would underscore warnings we pass on to others. Those risks are indeed maximal. To include them in vaccine trials, let alone an actual campaign, is unconscionable.

Many to whom I've passed on squalene warnings are now coming back quoting debunkings of said warnings - assurances that adjuvants are not included in vaccines in the United States. I'm seeking solid evidence that squalene adjuvanted vaccine is indeed being used in ongoing trials. The verbiage in that Novartis parental permission form is pretty solid, but test results such as those quoted on this thread would be better.

[Satyagraha]

Many to whom I've passed on squalene warnings are now coming back quoting debunkings of said warnings - assurances that adjuvants are not included in vaccines in the United States. I'm seeking solid evidence that squalene adjuvanted vaccine is indeed being used in ongoing trials. The verbiage in that Novartis parental permission form is pretty solid, but test results such as those quoted on this thread would be better.

Thanks for the reply, and I'm glad to see you are not trollish. What a waste of time when people troll - it serves nobody's interests. I'll continue to search for Novartis' studies; and will post when I find any. In the meantime, there is a tremendous amount of information about Squalene posted to this forum. You can start here... this thread is specifically about Novartis' vaccines:

http://forum.prisonplanet.com/index.php?topic=118137.0

One thing I'd like to say is this: nobody here wants these vaccines to be harmful. We would all love them to work well, to be harmless in the long run, and I think we would all applaud the pharmaceutical companies for bringing miraculous cures to us. But so far the evidence does not bear this out. We have to be careful - watchful - and try to inform people of the risks. We have zero dollars, no advertising, no big expense budgets to get our message out (vs. the billions Pharma spends on promoting their vaccines)... we have this forum, and our own initiative in getting people informed. That's the mission here - not to obfuscate, but to speak the truth. So you can bet that I'll post all the studies I can find, when I find them.

 

[sociostudent]

Thank you for the search for studies. I'll be able to resume the quest in a few hours. I was about to post what follows below when I was notified by the forum that you had posted an additional reply.

I was thinking that perhpas you were aware of the study and you knew of a valid reason to discount it. I'm glad that's not the case. I'm a novice, not the least adept (yet) at accessing the actual studies. The original lead came from an infowars post in which the poster's wife had signed up for the study, in essence in an effort to infiltrate and glean what she could; she came away with the parental permission form and silence in response to her questions about potential harm of squalene adjuvant.

Any and all help to linking to that specific study would be greatly appreciated!

My efforts thus far have been geared toward establishing as best as possible a valid ball park percentage for risk of autoimmune disease in recipients of squalene adjuvanted vaccine. As lay consumers I feel we (the general public) assume that vaccine risks are minimal - miniscule, actually, or we wouldn't be asked to accept them - and if it can be shown that the risks instead are maximal it would underscore warnings we pass on to others. Those risks are indeed maximal. To include them in vaccine trials, let alone an actual campaign, is unconscionable.

Many to whom I've passed on squalene warnings are now coming back quoting debunkings of said warnings - assurances that adjuvants are not included in vaccines in the United States. I'm seeking solid evidence that squalene adjuvanted vaccine is indeed being used in ongoing trials. The verbiage in that Novartis parental permission form is pretty solid, but test results such as those quoted on this thread would be better.

I would start by reading Vaccine A (an excellent expose on the use of squalene-based adjuvants and what the side-effects are, and how the military tried to cover their asses on the devastating consequences of its' use)

[Chips]

I'd prefer it if neither the trial 2009 h1n1 vaccine nor the product that will be used in the upcoming campaign is or will be (squalene) adjuvanted. But my preference doesn't matter. The Novartis parental permission form weighs very heavily in this equation, and I am about to try my hand at spotting some official signs of that trial on the web. I think the trial is real, and I think they really included adjuvanted vaccine.

Pilikia - you are obviously an old hand at this; don't you think it unusual to not be able to locate any details of a study?

socio - I did read Vaccine-A, and no better advice could be given. It was an eye-opener.

Though not surprising it is at once saddening and infuriating to see in these postings official Novartis statement of trial adjuvanted vaccinations in the UK. The vaccine manufacturers are fully aware of the GWI research and the potential catastrophic effect on every recipient of their adjuvanted vaccines.

[Chips]

There is a Search Ongoing Pediatric Trials page on the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) website:

http://clinicaltrials.ifpma.org/no_cache/en/search-trials-ongoing/pediatric/index.htm

I typed in "adjuvanted" in Terms to search for:, and "United States" in Trials conducted in:, and had nine results returned. The Novartis Colorado 2009 h1n1 vaccine trial is not among them (and I do wonder why), but the following two are:

Inactivated Influenza A/H9N2 Vaccine With and Without MF59 Adjuvant in Ambulatory Adults
Location: Houston, Texas
Status: Completed

Booster Trial to 07-0019 With A/Anhui/05 With and Without MF59
Location: Atlanta, Georgia
Status: Not yet recruiting

That's a definitive statement that, despite the fact that squalene adjuvant has not been approved for use in the U.S., they feel free to include it in trials. There may be similar evidence in the reams of trial info already posted in this thread, but I hadn't had time to read them thoroughly and was - still am - more focused on the search for the Colorado trial. I happened to come across the two trials listed above.

There is a 2009 WHO paper basically stating that if there's a flu pandemic, there's far too little antigen available to fill global needs, so adjuvant is, in essence, highly recommended.

All of this makes that much stronger the case that the Colorado trial included adjuvant.

[Satyagraha]

Pilikia - you are obviously an old hand at this; don't you think it unusual to not be able to locate any details of a study?

socio - I did read Vaccine-A, and no better advice could be given. It was an eye-opener.

Though not surprising it is at once saddening and infuriating to see in these postings official Novartis statement of trial adjuvanted vaccinations in the UK. The vaccine manufacturers are fully aware of the GWI research and the potential catastrophic effect on every recipient of their adjuvanted vaccines.

I find it bizarre that the Novartis website will NOT work to show you the studies; they only show you the press releases about the studies. I thought it was a problem with the search engine - and since we're in this level 6 pandemic, and they are a primary vendor - it's ridiculous that the site is not working. Suspicious even. I'll check again tomorrow and email them if it's still broken... see what they say, and post it here if I get a response. Medical journals publish the studies, and that's where we're most likely to get the information.