Anthrax Vaccines - American Anthrax Vaccines

American Anthrax Vaccines

The US undertook basic research directed at producing a new anthrax vaccine during the 1950s and '60s. The product known as Anthrax Vaccine Adsorbed (AVA) — trade name BioThrax — was licensed in 1970 by the U.S. National Institutes of Health (NIH) and in 1972 the U.S. Food and Drug Administration (FDA) took over responsibility for vaccine licensure and oversight. AVA is produced from culture filtrates of an avirulent, nonencapsulated mutant of the B. anthracis Vollum strain known as V770-NP1-R. No living organisms are present in the vaccine which results in protective immunity after 3 to 6 doses. AVA remains the only FDA-licensed human anthrax vaccine in the United States and is currently produced by Emergent BioDefense Corporation, formerly known as BioPort Corporation in Lansing, Michigan. In the U.S., the principal purchasers of the vaccine are the Department of Defense and Department of Health and Human Services. Ten million doses of AVA have been purchased for the U.S. Strategic National Stockpile for use in the event of a mass bioterrorist anthrax attack.

In 1997, the Clinton administration initiated the Anthrax Vaccine Immunization Program (AVIP), under which active U.S. service personnel were to be immunized with the vaccine. Controversy ensued since vaccination was mandatory and a perception developed that AVA was unsafe, causing sometimes serious side effects. Mandatory vaccinations were halted in 2004 by a formal legal injunction which made numerous substantive challenges regarding the vaccine and its safety. After reviewing extensive scientific evidence, the FDA again determined in 2005 that AVA is safe and effective as licensed for the prevention of anthrax, regardless of the route of exposure. In 2006, the Defense Department announced the reinstatement of mandatory anthrax vaccinations for more than 200,000 troops and defense contractors. Despite another lawsuit filed by the same attorneys, the vaccinations are required for most US military units and civilian contractors assigned to homeland bioterrorism defense or deployed in Iraq, Afghanistan or South Korea.