Workshop Announced on Next-Generation Smallpox Vaccines

The public workshop will take place Sept. 16 in Gaithersburg, Md., and seek to identify key issues in the development and evaluations of these vaccines.

The U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and the National Institute of Allergy and Infectious Diseases will host a public workshop Sept. 16 about the development and evaluation of next-generation smallpox vaccines. It will take place at the Hilton Washington DC North/Gaithersburg in Gaithersburg, Md., and will include presentations on the humans' response to smallpox vaccines and development of animal models for demonstrating vaccines' effectiveness.

The World Health Organization declared smallpox eradicated in 1980, but FDA says the threat of smallpox as a biological weapon remains. First-generation smallpox vaccines were prepared on the skin of calves or other animals or in chicken eggs. "Although these vaccines were not evaluated for efficacy in well-controlled trials, they were highly effective as evidenced by the successful global eradication of smallpox. Manufacturing of these vaccines has ceased and they are no longer licensed in the United States," the agency's notice says. FDA licensed the first second-generation vaccine, ACAM2000, in 2007; it is aseptically propagated using cell culture technology under modern manufacturing practices and standards.

"Because ACAM2000 may cause serious adverse reactions," the notice states, "there is a desire to develop safer vaccines should there be a need to vaccinate the general population due to a threat of an attack with the smallpox virus. Currently, the next-generation smallpox vaccines under development do not produce the characteristic 'vaccine take.' In addition, it is not ethical or feasible to evaluate the effectiveness of these vaccines in humans as the natural disease has been eradicated. Therefore, the effectiveness of these next-generation smallpox vaccines may be based on animal efficacy data, if scientifically appropriate, and to comparative human immune response data. As for any biologic product, licensure of new smallpox vaccines requires demonstration of safety, purity, and potency."

The workshop will discuss regulatory challenges and the strengths and weaknesses of various animal models that can be used to predict effectiveness. About 15 days after the workshop takes place, a transcript of it will be available at

For more information, contact Bernadette Williamson-Taylor at FDA's Center for Biologics Evaluation and Research, 301-827-2000 or e-mail (in the subject line, type "Smallpox Workshop").

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