Author Topic: Importance of background rates of disease in assessment of vaccine safety during  (Read 555 times)

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Offline Carlos Santillan

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"Because of the advent of a new infl uenza A H1N1 strain, many countries have begun mass immunisation programmes.
Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine
safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with
but not caused by vaccination. We identifi ed background rates of selected medical events for several countries. Rates
of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such
as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with
novel infl uenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in
the UK, 21·5 cases of Guillain-Barré syndrome and 5·75 cases of sudden death would be expected to occur within
6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86·3 cases of optic neuritis
per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant
women would be predicted to have a spontaneous abortion within 1 day of vaccination."
complete document , PDF
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