/What steps has the FDA taken to ensure that people are not exposed to the BSE agent in vaccines?

FDA has taken a number of measures to minimize any chance that the BSE could be introduced into biologic products during manufacture.

Most recently, FDA has directed manufactures not to use products from animals born, living, or slaughtered in countries where BSE has occurred, or countries where there is a high or unknown risk of BSE.

In this recent action, the FDA has requested that vaccine manufactures replace bovine-derived materials obtained from countries on the USDA list with materials obtained from countries not on the USDA list.

This recommendation, which is consistent with existing FDA guidance first issued in 1993 on the sourcing of bovine-derived materials, is intended to reduce even the remote risk for vCJD from vaccines.