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3l.9 Why was a connection between the rotavirus vaccine and intussusception not observed prior to FDA approval of the vaccine?




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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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previous page: 3l.8 What is the relationship between the rotavirus vaccine and intussusception?
  
page up: Childhood Vaccinations FAQ
  
next page: 3l.10 What other reactions have been reported following the rotavirus vaccine?