Vaccine Safety

Pre-Licensure Testing Lacks Adequate Numbers To Predict Adverse Events

Published in Vaccine Weekly, May 23rd, 2001

by N.R. Saltmarsh, staff medical writer - Because serious adverse events attributed to vaccinations are so rare, huge numbers of people must be vaccinated before those risks become apparent.

That is why pre-licensure testing, which involves only thousands of subjects, instead of the necessary hundreds of thousands, is inadequate to determine such risk - and why post-licensure surveillance is critical.

"The recent setback in the development of a safe and effective rotavirus vaccine illustrates an important problem regarding pre-licensure testing and its ability to identify rare vaccine-related adverse effects," said R.M. Jacobson and colleagues at...

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Source: Vaccine Weekly (2001-05-23)

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