FDA: Anthrax vaccine is safe
From staff and wire reports
The Food and Drug Administration on Thursday confirmed its previous finding that the anthrax vaccine being given to members of the U.S. military is safe and effective for all forms of the disease, including the inhalation variety that is most likely to be encountered on the battlefield.
That is a key step in the government’s efforts to overturn a federal court ruling in late 2004 that shut down the military’s mandatory anthrax vaccine program and allowed the shots to continue only on a voluntary basis only.
The court ruling came in a multiyear lawsuit that began when six members of the military challenged the Pentagon’s use of a mandatory vaccination against anthrax in some military troops.
Published in the Federal Register, the FDA review on the Anthrax Vaccine Absorbed, or AVA, “determines AVA to be safe and effective and not misbranded.”
FDA spokeswoman Julie Zawisza said the agency found no evidence to alter its previous finding that the vaccine is safe.
“We believe the vaccine is safe and effective for intended use, which would include [prevention of] inhalation anthrax,” she said.
The agency also received public comments about the vaccine, but Zawisza was unable to characterize them Thursday.
However, after the public comment period closed in May, a random review by Army Times of about 20 percent of the roughly 300 comments received — many of them from current a former service members and their families — showed strong opposition to the vaccine.
Since 1998, 1.2 million troops have been vaccinated against anthrax in six-shot regimens. But there have been numerous reports of service members who believe the vaccine made them ill.
Hundreds of others had been punished or discharged for refusing the shots until U.S. District Judge Emmet Sullivan in suspended the military’s mandatory program in December 2004 after finding fault with the FDA’s process for approving the drug as safe and effective against inhalation anthrax.
In large part, Sullivan based his ruling on the fact that the FDA did not follow its own regulatory procedures, which included a failure to solicit public comment on the vaccine.
Several months after ordering the shutdown of the military’s mandatory vaccine program, Sullivan said the Pentagon could resume giving vaccinations, but only to troops who volunteer for them. Several months into the voluntary program, only about half the service members offered the vaccine were accepting it.
Following Sullivan’s ruling, the government quickly appealed to reinstate mandatory inoculations. That lawsuit is ongoing in federal court.
Dr. William Winkenwerder, assistant secretary of defense for health affairs, said in a statement that the military will continue to provide anthrax vaccines on a voluntary basis, and service members will still be able to refuse the vaccine.
However, he added, “The threat of anthrax as a weapon remains real. It is very important to provide our service members with maximum protection against this threat, particularly when operating in certain areas of the world.
He said that for “people at increased risk of exposure, the benefits of the vaccine far outweigh the risks when all factors are considered.”
“Vaccination against anthrax is the best round-the-clock protection available to protect our forces at risk.”
Read the FDA’s final rule on the anthrax vaccine published in the Federal Register.
