WASHINGTON – The Pentagon can resume giving anthrax vaccinations (search), but only to troops who volunteer for them, said a federal judge who had banned the shots amid safety questions.
Citing a law passed last year, U.S. District Court Judge Emmet G. Sullivan (search) partially lifted his October ban on the vaccination program, also plagued over its six years by manufacturing problems and troop protests.
Sullivan in October ordered the Pentagon to halt its anthrax shots, saying the Food and Drug Administration (search) had acted improperly when it allowed the experimental vaccine for use against inhalation anthrax.
But he ordered in a ruling Wednesday that shots can be restarted on a voluntary basis under a new law that allows unapproved drugs in cases of declared emergencies. In enacting the Project BioShield Act of 2004 (search), "Congress appears to have authorized the use of unapproved drugs or the unapproved use of approved drugs" when health and defense officials declare a military emergency or the potential for a military emergency, Sullivan wrote in the ruling.
The Defense Department had sought such emergency authority from the Health and Human Services Department in December, saying troops in South Korea and the Middle East are at risk but giving no further public explanation. Weeks later, health officials granted emergency authority for use of the vaccine.
In allowing partial resumption of the vaccination program, Sullivan said he was making no finding as to whether the emergency declared by defense and health officials was legal.
The Pentagon had given millions of anthrax vaccine shots — in six-shot regimens — to more than 1.1 million troops since 1998, and hundreds of people have been kicked out of the military for refusing them. Sullivan's ruling came in a lawsuit filed by six unnamed military personnel and civilian workers who objected to the shots.
Pentagon officials have insisted the shots are safe and effective. But the troubled program has been off-again, on-again for years.
Saying troops should not be used as "guinea pigs," Sullivan ruled in December 2003 the FDA had never approved the vaccine and issued an order stopping its use on troops. A week later week, the FDA approved the vaccine, and the shots were resumed only to be halted again in October.
The program also was drawn to a near halt in 2001 and 2002 by shortages of the vaccine. The program started in 1998 with the goal of vaccinating all 2.4 million members of the active and reserve military, but it was radically reduced after factory violations by the nation's sole anthrax vaccine manufacturer left a dwindling supply of the drug.