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Pre-Licensure Testing Lacks Adequate Numbers To Predict Adverse Events.(Brief Article)
2001 MAY 23 - (NewsRx.com & NewsRx.net) --
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 the Mayo Clinic and the Mayo Foundation.
They contended that rare but serious adverse events are difficult to predict in pre-licensure testing and that this is true not only of the rotavirus vaccine, which was withdrawn from the market, but of all vaccines.
"A sample size of 10,000 subjects may provide excellent estimates of efficacy, but cannot provide an adequate denominator to rule out rare adverse events," noted Jacobson and coauthors ("Adverse events and vaccination-the lack ...
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Source: HighBeam Research, Pre-Licensure Testing Lacks Adequate Numbers To Predict Adverse...