Reinstatement of the AVIP (2006-2016)
On October 16, 2006, the DoD announced the reinstatement of mandatory anthrax vaccinations for more than 200,000 troops and defense contractors. (Another lawsuit was filed by the same attorneys as before, challenging the basis of the vaccines license on scientific grounds.) The reinstated policy required vaccinations for most military units and civilian contractors assigned to homeland bioterrorism defense or deployed in Iraq, Afghanistan or South Korea. A modification of previous policy allowed military personnel no longer deployed to higher threat areas to receive follow up doses and booster shots on a voluntary basis. As of June 2008, over 8 million doses of AVA had been administered to over 2 million US military personnel as part of the AVIP. In December 2008, the FDA approved the new BioThrax IM formulation for intramuscular injections thus reducing the immunization schedule from a total of 6 shots to 5 shots (see below). On February 12, 2009, Emergent BioSolutions announced that the Drugs Controller General of India (DGCI) had approved licensing of BioThrax for distribution by Biological E. of Hyderabad.In 2011, BioThrax was approved for sale in Singapore by the Singapore Health Sciences Authority. Building 55 approval (2016)
The FDA approved the companys license (officially called a supplemental Biologics License Application, or sBLA) to manufacture BioThrax in a large building in Lansing, Michigan known as "Building 55." According to Homeland Preparedness News, "The use of Building 55 to manufacture BioThrax could expand manufacturing capacity to an estimated 20 to 25 million doses annually.
Hundreds of service members were compelled to leave the military (some of them court-martialed) for resisting the inoculations during the first six years of the program. Adverse events following AVA administration were assessed in several studies conducted by the DoD in the context of the routine anthrax vaccination program. Between 1998 and 2000, at U.S. Forces, Korea, data were collected at the time of anthrax vaccination from 4,348 service personnel regarding adverse events experienced from a previous dose of anthrax vaccine. Most reported events were localized, minor, and self-limited. After the first or second dose, 1.9% reported limitations in work performance or had been placed on limited duty. Only 0.3% reported >1 day lost from work; 0.5% consulted a clinic for evaluation; and one person (0.02%) required hospitalization for an injection-site reaction. Adverse events were reported more commonly among women than among men. A second study, also between 1998 and 2000, at Tripler Army Medical Center, Hawaii, assessed adverse events among 603 military health-care workers. Rates of events that resulted in seeking medical advice or taking time off work were 7.9% after the first dose; 5.1% after the second dose; 3.0% after the third dose; and 3.1% after the fourth dose. Events most commonly reported included muscle or joint aches, headache, and fatigue.