FDA: Vaccine safe, effective to prevent anthrax regardless of route of exposure

GAITHERSBURG, Md. — Emergent BioSolutions Inc. announced Dec. 16, 2005, that the Food and Drug Administration has issued a final order confirming that the company’s anthrax vaccine, BioThrax, is safe and effective for immunization against infection, regardless of the route of exposure.

In the 73-page order, the FDA writes, “After review of the comments and finding no additional scientific evidence to alter the proposed categorization, FDA accepts the panel’s recommendation and adopts Category I as the final category for AVA and determines AVA to be safe and effective and not misbranded.”

The order goes on to state, “FDA agrees with the report’s finding that certain studies in humans and animal models support the conclusion that AVA is effective against B. anthracis strains that are dependent upon the anthrax toxin as a mechanism of virulence, regardless of the route of exposure.”

The decision follows the agency’s comprehensive review of the clinical, scientific and epidemiological data establishing the safety and efficacy of the vaccine.

The ruling is supported by more than 20 scientific studies in 27 peer-reviewed journals, as well as by numerous expert panels, including the Institute of Medicine’s Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, the Anthrax Vaccine Expert Committee established by the Department of Health and Human Services, the CDC’s Advisory Committee on Immunization Practices and the Panel on Review of Bacterial Vaccines and Toxoids convened by FDA.

BioThrax is the only FDA-licensed vaccine for protection against anthrax. It is a liquid suspension made from an avirulent strain of Bacillus anthracis.