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Since anthrax had been virtually eliminated in the United States, only about 68,000 doses of MBPI’s anthrax vaccine were administered over the next two decades – an average of about 1,300 per year. It was a marginal product used primarily by veterinarians and tannery workers. The Iraqi invasion of Kuwait would radically alter its status.

As the U.S.-led coalition deployed to the Persian Gulf in 1990, military commanders were gravely concerned over the possibility that Saddam Hussein would attack with biological weapons. Since he was believed to hold substantial stockpiles of anthrax spores, protecting our troops against this deadly disease was a high priority, and MBPI was the only vaccine manufacturer that had a licensed anthrax vaccine at that time. Even though it had not been approved for protection against inhalation anthrax, a decision was made to vaccinate all U.S. troops, and some 600,000 doses were administered – despite the fact that the vaccine had never been tested for inhalation anthrax.

In the months following the Gulf War’s conclusion, tens of thousands of soldiers who had fought there began complaining of a variety of symptoms – all essentially autoimmune dysfunctions. Their malady would eventually be given a name – Gulf War Syndrome. There was a problem, however, no specific cause could be identified. One prevailing theory was that troops had been exposed to low levels of biological and chemical weapons when Hussein’s stockpiles were destroyed. Eventually, another potential cause was suspected: the anthrax vaccine troops were given to protect them against this very threat. Still, confirmation of the Iraqi stockpiles of biological weapons was seen as a warning bell. Our troops would have to be protected against this threat in the future.

With the newfound concern over biological weapons in general and anthrax in particular, DOD officials renewed their interest in a vaccine to protect the troops. Although the MBPI product had been used in the Gulf War, it was widely viewed as a stopgap within the military command structure – something that was used by default because there were no other options.

There were several reasons why many military leaders held this view. First, as noted, was the fact that existing vaccine had not been specifically designed to combat inhalation anthrax – the primary threat in a wartime environment. A second concern was how effective the existing vaccine would be against a bio-engineered “weaponized” version of the anthrax spore such as troops would likely encounter. A third concern was the fact that the existing vaccine was over twenty years old and used antiquated manufacturing processes. Finally, there were concerns regarding the manufacturer itself.

MBPI had fallen on hard times. A lack of investment had allowed the facility to fall into such a sad state of repair that it failed a number of FDA inspections. By the late 1990s it was estimated that at least $15 million would have to be invested by the State to bring it into compliance. Otherwise, the FDA indicated they would shut it down. As a result, a decision was made to sell the facility to a private company. It was at this point that things got interesting.

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