3l.9 Why was a connection between the rotavirus vaccine and intussusception not observed prior to FDA approval of the vaccine?
Description
This article is from the Childhood Vaccinations FAQ, by Lynn Gazis-Sax lynng@alsirat.com with numerous contributions by others.
3l.9 Why was a connection between the rotavirus vaccine and intussusception not observed prior to FDA approval of the vaccine?
Approval by the FDA only requires trials on about 5,000-10,000
subjects. Rare reactions to a new drug or vaccine will therefore be
unknown at the time of FDA approval.
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