The anthrax vaccine given to military personnel and civilians after Sept. 11, 2001, had never received final FDA approval for effectiveness in preventing anthrax inhalation infections, which is theoretically how the organism would be turned into a bioterrorism weapon. Thus, Biothrax vaccine continued to be classified as experimental.
In 2002, Congress’s General Accountability Office (GAO) published a survey that revealed that 85 percent of the Air National Guard and Air Force Reserves personnel experienced adverse reactions following anthrax vaccination. This was significantly higher than the reported 30 percent claimed by the vaccine’s manufacturer. This survey also noted that between September 1998 and September 2000, about 16 percent of the pilots and aircrew members of the guard and reserve had (1) transferred to another unit (primarily to nonflying positions to avoid or delay receiving the anthrax shots), (2) moved to inactive status, or (3) left the military.
This report also stated that Additionally, an estimated one in five (18 percent) of those still participating in or assigned to a unit in 2000 – that is those who had not already changed their status – indicated their willingness to leave in the near future. Both groups, those who had already left and those indicating their intention to leave, ranked AVIP [Anthrax Vaccine Immunization Program as a key factor in their decision to leave or change their participation.
On October 27th, 2004, U.S. District Court Judge Emmet G. Sullivan ordered the Department of Defense (DOD) to immediately halt anthrax vaccinations after ruling that the mandatory vaccination program was illegal. Sullivan initially ruled in 2003 that the FDA had never approved the vaccine and ordered the vaccination programs to be stopped; however, eight days later, the FDA approved the vaccine based on an application made 18 years earlier, and the vaccination program was resumed. The Oct. 27, 2004 decision concluded that the FDA did not follow its own rules in declaring the vaccine safe and effective. Specifically, the individuals who filed suit regarding the mandatory anthrax vaccination argued that the FDA did not adequately review the vaccine’s effectiveness against inhalation anthrax.
In January 2005, the FDA issued an “emergency use authorization” (EUA) that permitted the DOD to resume anthrax vaccination on a voluntary basis. In April 2005, Sullivan granted the DOD permission to continue vaccination programs based on the EUA guidelines. Military personnel would be provided with informed consent and permitted to decline vaccination without repercussions. However, in October 2006, the DOD once again mandated anthrax vaccination for service members deploying to Korea, Iraq, and Afghanistan. This mandate followed the December 2005 FDA ruling that reported the vaccine as effective against all forms of anthrax.
Since 1998, BioPort, now Emergent BioSolutions, has delivered millions of anthrax vaccine doses, primarily to the U.S. Department of Defense as the sole source supplier of anthrax vaccine for the U.S. military. The U.S. government has also given the company millions of dollars in bailouts despite concerns that this money was not used appropriately and could not be accounted for.
In 2009, the FDA granted Emergent Biosolutions a shelf life extension for its Biothrax anthrax vaccine, from three to four years. In 2011, the U.S. government awarded Emergent Biosolutions a 5-year sole-source contract for the purchase of nearly 45 million doses of Biothrax.
