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).