October 21, 2002

Anthrax: FDA Halts Use of Older Vaccine Doses

The U.S. Food and Drug Administration has halted use of older lots of Defense Department anthrax vaccine after complaints it was not properly tested for safety and effectiveness, the Hartford Courant reported Saturday (see GSN, Oct. 17).

Connecticut Air Force Reserve pilots Maj. Russell Dingle and Maj. Thomas Rempfer jointly filed a citizen petition with the FDA and a federal lawsuit against the manufacturer of the vaccine, claiming it had never been properly tested.

In the 1970s and 1980s, the Pentagon began producing the anthrax vaccine through the Michigan Health Department, according to the Courant. The Pentagon used old testing data gathered by the pharmaceutical company Merck, which had originally obtained a license to produce the vaccine, to justify the safety of the Michigan-produced vaccine.

Since the FDA never properly oversaw this testing and the vaccine production process was changed during the 1990s, the vaccine is not properly licensed, said Dingle and Rempfer, who were ordered to take the vaccine while serving in the Air National Guard in 1998.

In 1998, the U.S. company BioPort purchased the Michigan anthrax vaccine production operation and all of its stocks of vaccine doses, which were used to vaccinate about 500,000 soldiers, the Courant reported. The FDA has now ordered that only new batches of BioPort vaccine can be used to vaccinate military personnel (see GSN, Feb. 1). The Pentagon had previously approved the use of both old and new BioPort doses for soldiers to be stationed in high-threat areas only.
Since the FDA has acknowledged that the older stocks of BioPort vaccine — doses produced by the Michigan Health Department — were not properly tested for safety, the Pentagon should pardon those soldiers who refused to be vaccinated with those doses, Dingle and Rempfer said. The Pentagon should also take care of the hundreds of soldiers who became ill after being vaccinated, they said (Thomas Williams, Hartford Courant, Oct. 19).