Some highlights of the history of this vaccine:
- The FDA’s 2002 label on the anthrax vaccine admits to a systemic averse reaction rate of between 5% and 35% – whereas previously, the DoD claimed it was a mere .02%. Since then, the GAO (Government Accounting Office, a watch-dog agency) has come out with a new report estimating the systemic adverse reaction rate is probably as high as 85%. The 2012 package insert for the vaccine indicates a reaction rate for some reactions at 5% and 10%. In addition, it is known that women have twice the adverse reaction rate as men. The GAO issued a 2001 report that of the Guard and Reserve units forced to take the vaccine, fully 25% of the pilots resigned or obtained transfers out of their units rather than take the vaccine and jeopardize their civilian flying careers.
- The anthrax vaccine was never originally licensed for use against aerosolized anthrax, and thus was used on our troops illegally up until December, 2003. Just eight days after the Dec. 22, 2003 decision by federal Judge Emmett Sullivan’s that orders to take the vaccine were illegal, the FDA issued a ruling that it was both legal and safe – based on animal data. There is no correlation between animal data and human data, despite the fact that subsequent research has also used the FDA’s “Animal Rule” to say there is a bridge between the two.
- The anthrax vaccine was originally licensed based on data from a different vaccine. The only safety/efficacy study ever done on human beings was done on that different vaccine. In its package inset this statement refers to that study, without explaining that it was done on the original, cutaneous vaccine used by veterinarians, farmers, and other exposed to an animal or animal carcass with anthrax: “In an open-label safety study of 15,907 doses of BioThrax administered by the subcutaneous route to approximately 7,000 textile employees, laboratory workers and other at risk individuals, local and systemic reactions were monitored” (http://1.usa.gov/1sDvbDI). That was the only field trial ever given, from 1955-59. In 1965 a patent was issued on a vaccine materially different from the one used in the field trial; and twenty years later the Army sent out a Request for Proposal in May of 1985 for a new vaccine to be used against aerosolized anthrax. Throughout the late 1980s there was concern from several quarters that the vaccine was highly reactogenic and did not protect against anthrax.
- The FDA and DOD have also previously admitted that efficacy based on animal studies against inhalation is problematic because no proven correlate of immunity between animals and humans exists for anthrax infection. The current package insert clearly states: “Vaccination with BioThrax may not protect all individuals.” Nobody knows the real answer, because of course no human population has been given the anthrax vaccine and then sprayed with aerosolized anthrax to test it out.
- The anthrax vaccine protocol originally called for 3 shots only; the change to a series of 6 shots with annual boosters was done with no foundation in research or fact. The label was actually changed to reflect the protocol then in practice; the protocol was not dictated by instructions on the label. the 2012 package insert, instructions for the vaccine – now formulated for intramuscular as well as subcutaneous injection – call for a total of five injections, with annual boosters for individuals at high risk of exposure. However, “…the Centers for Disease Control and Prevention in Atlanta says a three-dose series over six months may provide adequate protection for up to three years — a finding that could lead to changes in the FDA-approved schedule.” There is no small irony in the fact that in May of 2012, Emergent (the vaccine’s manufacturer) was given approval to go back to a 3-dose protocol with two boosters at six and 12 months. Still, five shots total are better than the previous six.
- BioPort, the original manufacturer of the vaccine, changed its filtering and fermenting equipment in 1991 without notifying the FDA. The result was a 100-fold increase in the potency of the vaccine. It was used anyway. BioPort also produced non-sterile and contaminated vaccine and changed expiration dates on labels of some of the vaccine lots to portray false expiration dates. BioPort’ was issued a new contract with the government to produce more anthrax vaccine in the week between Judge Sullivan’s ruling and the FDA declaration that the vaccine is legal. Strangely enough, although the government has awarded contracts to several other companies to produce a new and better anthrax vaccine (see “Vaccines in Development” on this web site), as of Oct. 16, 2006, the same BioPort vaccine was going to be mandated for the troops. As this article in the Detroit Free Press notes, the current anthrax vaccine is still being manufactured in the same facilities in Lansing, Michigan, and has no real competitors.
- A Kansas State University Study has definitely pointed to the anthrax vaccine as one of the major components of Gulf War Syndrome.
- An adjuvant, or vaccine booster, called squalene is present in an unknown number of lots of the anthrax vaccine. Though its presence was long denied by the DOD, FDA testing eventually proved its presence in at least five lots, possibly more. The use. of squalene as an adjuvant for human beings is illegal in both the U.S. and Great Britain. It is known to be a primary cause of severe arthritis and other debilitating conditions when injected. It is not known if squalene is present in the current formulation of the vaccine.
- Micoplasma was originally suspected as a problem component in the anthrax vaccine. The NIH says that is not the case in this article.