The Pentagon said Monday it will once again begin requiring anthrax vaccinations for troops heading into dangerous regions, reinstating a program that has been challenged repeatedly over possible health risks.
Dr. William Winkenwerder Jr., the assistant secretary of defense for health affairs, said the vaccinations will begin in 30 to 60 days, and will involve troops and civilian Defense Department personnel and contractors who are serving in the Middle East, Central Asia and the Korean Peninsula.
“This is a safe and effective vaccine,” Winkenwerder said in a conference call with reporters. He said the move to reinstate the vaccine does not suggest there is any new or elevated threat but the possibility of an anthrax attack is “very real and it has not gone away.”
Opponents of the program promised a fresh challenge. Mark S. Zaid, one of the lawyers who previously sued to stop the mandatory program, said he would file a new lawsuit “as soon as needles start going into arms.” Other groups who have opposed the program also criticized the new requirements.
“This is a vaccine that is unproven, unnecessary and has the potential to jeopardize the health of a service member where little benefit will be derived,” Zaid said. “It’s always been a public relations program and nothing more.”
He questioned why the Pentagon is inoculating troops in the Middle East when the 2001 anthrax attacks that left five people dead and sickened 17 took place in the United States.
U.S. official: Vaccine considered safe
Winkenwerder said the vaccine has been thoroughly reviewed by the federal Food and Drug Administration and several independent groups and deemed safe.
He said anyone who refused the vaccine would be reminded of its importance and safety. Then, if needed, their supervisor would get involved and the matter would be resolved “like any other refusal to follow a lawful order.”
He said that while significant numbers of troops refused the vaccine in 1998-99, very few have objected to taking it since then. About 10 people were discharged for refusing the vaccine in 2004, but he said he did not know how many may have refused and gotten other punishments. He was unsure what would happen if a civilian employee or contractor refused the vaccine.
The drug has been at the center of a multiyear lawsuit that began when six members of the military challenged the mandatory vaccination program.
Since 1998, at least 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 until U.S. District Judge Emmet Sullivan in December 2004 suspended the vaccinations after he found fault in the FDA’s process for approving the drug.
FDA affirms safety finding
Several months later Sullivan said the Pentagon could resume vaccinations on a voluntary basis. Then, last December the FDA affirmed its earlier finding that the vaccine was safe and effective.
According to Winkenwerder, there is enough vaccine to inoculate the several hundred thousand troops that will be deploying to Iraq, Afghanistan and other dangerous locations.
Pentagon officials are also working with the Centers for Disease Control and Prevention to determine if at least one of the six initial shots can be eliminated. The vaccine also requires an annual booster shot.
Other groups questioned the vaccine’s safety.
“The (Defense Department) has a moral duty to fully disclose anthrax vaccine risks, as well as benefits, to soldiers and allow them to make an informed, voluntary vaccination decision,” said Barbara Loe Fisher, president of the nonprofit National Vaccine Information Center.
The center has launched the Military and Biodefense Vaccine Project to inform the public and service members about potential illnesses, disabilities and deaths that may be associated with the vaccine.