FDA Issues Advice on Trials of Smallpox Vaccines

In preparation for a potential smallpox outbreak or bioterrorism attack, the FDA released final guidance with recommendations for testing smallpox vaccines in animals.

The final guidance calls for data from at least two lethal animal studies to show efficacy of the vaccine because “no single animal model is known to be the best predictor of human responses to smallpox.”

The guidance directs sponsors conducting such animal studies to prepare designs for one or more clinical trials in the event of a public emergency involving smallpox.

“The design of these animal studies should be based on the general principles of human clinical trial design,” the agency says.