The Bush administration asked a federal appeals court yesterday to reinstate mandatory anthrax inoculations for many military personnel, while a lawyer for soldiers who refused the shots said the anti-anthrax vaccine was never intended for the purpose the Pentagon is using it.
The government is appealing a decision by U.S. District Judge Emmet Sullivan, who suspended anthrax vaccinations after he found fault in the Food and Drug Administration’s (FDA) process for approving the drug. A half-dozen unnamed members of the armed forces are challenging the Pentagon’s program.
Labeling for the anti-anthrax vaccine says it is for individuals with high-risk exposure such as veterinarians and certain industrial workers.
Appeals Judge David Tatel asked why the part of the definition regarding high-risk exposure isn’t broad enough to cover members of the military.
John Michels, an attorney for the six members of the military who refused the shots, said the government originally sharply restricted its use.
“Nobody thought that this stuff was licensed for inhalation anthrax,” Mr. Michels said.
At issue is whether federal regulators limited the vaccine’s use to combating anthrax spores transmitted by touch.
“The labeling does not include any limitation,” Justice Department attorney Michael Raab told the judges.
Since 1998, 1.2 million troops have been vaccinated against anthrax in six-shot regimens. Hundreds of service members had been punished or discharged for refusing them.
In April, Judge Sullivan said the Pentagon can resume giving anthrax vaccinations, but only to troops who volunteer for them.
The vaccine is being given primarily to troops who are serving in South Korea, the Middle East and South Asia, the Pentagon says. It also will go to soldiers who work in counterterrorism roles related to defense against biological weapons inside the United States.
About one person in 100,000 has a serious adverse reaction to the vaccine, according to the Pentagon.
Over the past six years, the vaccination program has been plagued by manufacturing problems and troop protests.
Started in 1998 with the goal of vaccinating all 2.4 million members of the active and reserve military, the program was radically reduced after factory violations by the nation’s sole anthrax-vaccine manufacturer left a dwindling supply of the drug.
Saying troops should not be used as “guinea pigs,” Judge Sullivan ruled in December 2003 the FDA had never approved the vaccine and issued an order stopping its use on troops. A week later, the FDA approved the vaccine, and the shots were resumed only to be halted again by Judge Sullivan 13 months ago.