FDA Expands Anthrax Vaccine Approval

TUESDAY, Nov. 24, 2015 (HealthDay News) — U.S. Food and Drug Administration approval for the BioThrax anthrax vaccine has been expanded to include adults aged 18 to 65 with known or suspected exposure, the agency said in a media release. The vaccine was first approved in 1970 for people at high risk of anthrax contact.

Expanded approval for the injected vaccine was granted under the agency’s “animal rule,” which states animals may be used to test a drug or product for purposes that aren’t ethical or feasible among people, the FDA said.

The BioThrax vaccine was tested on exposed rabbits and deemed to provide a “reasonable level of protection,” by providing a survival rate of 70 to 100 percent, the agency said. Adverse reactions among people who have been given the vaccine for pre-disease prevention have included tenderness, pain, swelling, and redness at the injection site; muscle aches; headache; and fatigue.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

BioThrax is produced by Michigan-based Emergent BioDefense Operations Lansing LLC.

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