Anthrax is a deadly infectious disease caused by the spore-forming bacterium Bacillus anthracis. Early symptoms may resemble a common cold, but after several days the symptoms can progress to severe breathing problems and shock. Inhalation anthrax is usually fatal; a cutaneous form that affects the skin is less lethal.
A month after the Sept. 11, 2001, terrorist attacks, letters tainted with anthrax bacteria infected people in New York, Connecticut, New Jersey, Florida and Washington. The still unsolved attacks killed five people, sickened 17 and put about 10,000 on antibiotics.
Angelita Kisena of Compton, Calif., administers an anthrax vaccine to a crew member aboard the USS Mount Whitney. For now, the Defense Department says the vaccine will be voluntary.
(Sean Gallup -- Getty Images)
Michels said he was pleased by the department's change of position making the program voluntary, because that had been a central goal of the lawsuit. "But we're concerned that this may be a half-step that will later lead to a resumption of mandatory vaccinations," he said.
Asked whether the Pentagon would like to return to a mandatory program, the spokesman left the possibility open. He said a major consideration in accepting a voluntary program was that the emergency authorization is good for only six months unless the FDA extends it.
"Depending on the outcome of FDA's administrative review, DOD will then revisit this issue," he said.
The controversy over the anthrax vaccine is grounded in a dispute over whether it was ever properly tested for human use. The Defense Department and the FDA concluded, based on studies including clinical trials done in the 1950s testing the vaccine against cutaneous anthrax, that the vaccine is safe and effective for inhaled exposure, as well. But Sullivan ruled that the FDA had not properly examined the scientific issues and ordered the government to use its normal procedures in determining whether the vaccine should be used.
The BioShield Act explicitly allows the FDA to approve drugs and vaccines that have not been fully tested during times of declared emergency.
The lawsuit that blocked the program focused largely on the vaccine's effectiveness of the product and whether the FDA broke its own rules in approving it in December 2003. But the most active concern has been over safety, especially side effects that include immune disorders, muscle pain and birth defects.
Almost 500 active-duty service members have refused to take the vaccine, and more than 100 have been court-martialed as a result. According to the Defense Department, 18 service members were discharged in 2003 for refusing, and a total of 436,515 were vaccinated.
In its package insert, BioThrax, the maker of the vaccine, reports that more than 2 million people were inoculated between 1990 and late 2001, and it received 1,850 reports of adverse reactions. About 6 percent of those calls involved serious and life-threatening reactions. Researchers generally estimate that the number of adverse reactions is 10 times as great as the number reported.
In his October ruling, Sullivan said the FDA had not followed proper procedures in approving the vaccine. The application was made in the mid-1980s, but it lay fallow for years. When the Defense Department learned in 2003 that the vaccine had never been formally approved, the FDA quickly re-reviewed the old application and approved it.