FDA Rules Anthrax Vaccine Safe and Effective to Prevent Anthrax Regardless of Route of Exposure

GAITHERSBURG, Md. -- Emergent BioSolutions Inc. announced today that the Food and Drug Administration (FDA) has issued a Final Order confirming that the company's anthrax vaccine, BioThrax, is safe and effective for immunization against anthrax infection, regardless of the route of exposure.

In the 73-page order, 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 extensive materials submitted to the FDA docket, including 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.

"We are extremely pleased that FDA has confirmed that BioThrax is safe and effective for the prevention of anthrax infection regardless of the route of exposure," said Robert Kramer, CEO of BioPort Corporation, the Emergent subsidiary that manufactures BioThrax.  "This decisive ruling marks an important decision for members of the United States military and appropriate at-risk populations outside the federal government.  We will continue to work closely with the Department of Defense, the Department of Health and Human Services, and other customers to ensure the availability of BioThrax to protect military personnel and civilians who would benefit from the vaccine."

An additional comment in the order reads, "Military personnel involved in the vaccine's administration under the DoD vaccination program also filed comments in support of classifying AVA into Category I, reasoning that the vaccine is important for soldiers entering potentially dangerous areas."

In conducting its exhaustive review, the FDA also examined the adverse event profile of the vaccine and concluded, "Based on our review, we cannot conclude that there is a causal relationship between serious adverse events (other than some injection site reactions and some reports of allergic reactions) or deaths and AVA."

The agency further stated that a number of respondents who submitted comments during the 90-day public comment period claimed that the vaccine was not properly licensed.  In the final rule, FDA wrote, "We disagree. AVA has been legally licensed since November 1970."

BioThrax is the only FDA-licensed vaccine for protection against anthrax, a deadly disease caused by exposure to the anthrax bacteria or anthrax spores. BioPort has provided more than 5 million doses of the vaccine to the Department of Defense for the protection of military personnel and is delivering 5 million doses to the Department of Health and Human Services for the Strategic National Stockpile, which is available to protect the civilian population in the event of a bioterrorist attack. To date, the vaccine has been used to immunize more than 1.3 million soldiers, and in the wake of the October 2001 anthrax letter attacks, public health officials offered BioThrax in combination with antibiotics to protect postal workers, members of Congress, congressional staffers, and others who potentially had been exposed to anthrax.

Source: Emergent BioSolutions Inc.

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