Anthrax vaccine adsorbed (AVA) is the only FDA-licensed human anthrax vaccine in the United States. It is produced under the trade name BioThrax by the Emergent BioDefense Corporation (formerly known as BioPort Corporation) in Lansing, Michigan. The parent company of Emergent BioDefense is Emergent BioSolutions of Rockville, Maryland. It is sometimes called MDPH-PA or MDPH-AVA after the former Michigan Department of Public Health (MDPH; succeeded by the Michigan Department of Health and Human Services), which formerly was involved in its production. AVA originated in studies done in the 1950s and was first licensed for use in humans in 1970. In the US, the principal purchasers of the vaccine are the Department of Defense and Department of Health and Human Services. Ten million courses (60 million doses) of the vaccine have been purchased for the US Strategic National Stockpile in anticipation of the need for mass vaccinations owing to a future bio-terrorist anthrax attack. The product has attracted some controversy owing to alleged adverse events and questions as to whether it is effective against the inhalational form of anthrax. Description
Antigen
AVA is classified as a subunit vaccine that is cell-free and containing no whole or live anthrax bacteria. The antigen (immunologically active) portions are produced from culture filtrates of a toxigenic, but avirulent, nonencapsulated mutant — known as V770-NP1-R — of the B. anthracis Vollum strain. (The Vollum strain was the same one weaponized by the old U.S. biological warfare program.)
The academy considered more than a dozen studies using various scientific designs, and heard personally from many concerned US military service members. Development of a replacement vaccine
While effective in protecting against anthrax, the licensed vaccine schedule is not very efficient, involving a cumbersome five (previously six) dose injection series. Typically, five injections are given over a period of 18 months in order to induce a protective immune system response. In addition, in 2004 the US Department of Health and Human Services contracted with Vaxgen Inc. to supply up to 75 million doses of a recombinant anthrax vaccine, for $877 million. To be acceptable to HHS, this vaccine was to be protective against anthrax in three doses or less. On December 19, 2006, HHS voided the contract, because of stability problems with the vaccine, and a failure to start a Phase 2 clinical trial on time. In May 2008, Emergent Biosolutions, the Maryland-based successor to BioPort, both controlled by former Lebanese banker Faud el Hibri, acquired rights to Vaxgens patents and processes.On 30 October 2012, the US National Institute of Allergy and Infectious Diseases agreed to provide $6.5 million to the United Kingdoms Health Protection Agency for initial work on a potential future anthrax vaccine that could be delivered through the nasal passage instead of via a needle. The HPA has long produced the UKs AVP anthrax vaccine. Research is being continuously done to develop and test new improved candidate anthrax vaccines.