Published in Vaccine Weekly, May 23rd, 2001
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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