For many years, the anthrax vaccine used by veterinarians, researchers, and those handling animal products that could be contaminated with anthrax bacteria, was manufactured by the Michigan Department of Health in a Lansing, Michigan lab. The vaccine manufacturing plant owned by the state had also been used for many years to manufacture and distribute DPT vaccines to Michigan state residents. In 1995, the plant’s name was changed to Michigan Biologic Products Institute (MBPI).
In the early 1990s, U.S. military personnel serving during Operation Desert Storm were administered anthrax vaccines due to concerns that Iraq had manufactured weapons capable of dispersing anthrax spores.
Many military members who served during the Operation Desert Storm era reported significant health issues, including chronic fatigue syndrome, joint and muscle pain, rashes, dizziness, headaches, seizures, and autoimmune issues. These symptoms were eventually labeled Gulf War Syndrome and were found to affect both deployed and non-deployed troops. Additionally, many individuals experiencing these symptoms had anti-squalene antibodies (ASA) that were not present before anthrax vaccination.
Several lots of anthrax vaccines were tested and found to contain squalene, but the source was unknown. While the FDA considered the levels of squalene in the vaccines to be too low to be capable of harm, researchers disagreed with this conclusion and expressed concerns that there were many unanswered questions.
FDA inspections of the anthrax vaccine manufacturing plants in the 1990s revealed multiple deficiencies that were not promptly corrected. These deficiencies were believed to impact both the efficacy and safety of the vaccine lots. As a result, vaccine production was halted until problems were adequately addressed.
Despite issues regarding the manufacturing of the anthrax vaccine, Defense Secretary William Cohen ordered mandatory anthrax vaccination for all military personnel in 1997.
In 1998, BioPort Corporation, headed by U.S. Admiral William J. Crowe, Jr. (now deceased) and international business entrepreneur Fuad El-Hibri, purchased the Michigan vaccine lab. Anthrax vaccine manufacturing was taken over by BioPort Corporation when they bought the Michigan state plant, made modifications, and geared up to meet the Pentagon’s goal of vaccinating all 2.4 million active-duty and reserve troops with anthrax vaccine. However, BioPort failed FDA quality control inspection several times, which resulted in the interruption of anthrax vaccine supplies and the use of the vaccine by the military.
In the late 1990s and early 2000s, Congressional hearings were held in the U.S. House of Representatives Government Reform Committee on anthrax vaccine safety, efficacy, and lack of informed consent protections in the military’s mandatory anthrax vaccination policies. Testimony from vaccine-injured military veterans included several hundred cases where career soldiers chose to face court-martial rather than agree to be vaccinated or revaccinated with anthrax vaccine after experiencing serious reactions.
