/Why is FDA leaving vaccine on the market that did not follow its own recommendations regarding sourcing of bovine derived materials?

The FDA has looked at the benefit of vaccines and the risk of vCJD from vaccine use. Vaccines have a proven benefit in reducing the incidence of serious, often life-threatening diseases.

Conversely, the Public Health Service, FDA and the members of FDA’s advisory committees on TSE and Vaccines and Related Products (VRBPAC) believe the risk that anyone will get vCJD from a vaccine is remote and theoretical.

Failure to obtain recommended vaccinations with licensed vaccines puts a person at risk for serious disease. Without routine vaccination, the incidence of disease would increase. This was seen in Sweden, Japan and the UK when the number of children vaccinated against pertussis decreased due to concerns about vaccine adverse events associated with the whole-cell DTP vaccine.

In addition, removal of safe and effective licensed vaccines from the market could cause insufficient supply and potentially increase the number of unvaccinated or under vaccinated individuals at risk from preventable diseases.

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