/How did FDA derive its risk estimates and decide the risk of vCJD from vaccines was remote and theoretical?

Scientists, regulatory authorities in Europe and the pharmaceutical industry of the U.S. have considered the risk of BSE in pharmaceutical products.

In estimating these risks it is necessary to consider the:

  • Country of origin of any bovine material
  • Type of bovine tissue used
  • Steps used to process the bovine tissue
  • Amount of bovine derived material used
  • Stage of vaccine manufacture at which the bovine material is used

Using previously published methods for calculating theoretical risk of cased of vCJD from pharmaceutical products, FDA has calculated a conservative estimation of the risk of a vaccine causing a case of vCJD. These estimates were presented in public session at the joint advisory committee meeting on July 27, 2000.

FDA believes these estimations are a realistic worst case scenario and that the real risk any US licensed vaccine could cause vCJD is even lower than the estimates presented (link to risk assessments and transcripts).

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