Pentagon to resume mandatory anthrax shots for some

Oct 19, 2006 (CIDRAP News) – The Pentagon announced this week that it will resume, after a 2-year hiatus, mandatory anthrax vaccination for troops and other personnel stationed in the Middle East and South Korea.

An Oct 16 Department of Defense (DoD) news release said that "military personnel, emergency-essential DoD civilians, and contractors" in those areas will be required to receive the vaccine. The program also will include units involved in "homeland bioterrorism defense," the statement said.

"The anthrax vaccine will protect our troops from another threat—a disease that will kill, caused by a bacteria that already has been used as a weapon in America, and that terrorists openly discuss,” said Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs, in the DoD release.

Winkenwerder said "several hundreds of thousands" of troops will receive the vaccine, according to an Oct 17 United Press International story. The story said that about 140,000 troops are stationed in Iraq, 30,000 in Korea, and tens of thousands in Kuwait, Bahrain, Qatar, and other Middle Eastern countries. An Oct 17 Reuters report put the number of troops in Afghanistan at 21,000.

The mandatory vaccination program has been the subject of a long legal battle. Soldiers concerned about the vaccine's side effects sued to stop the program several years ago, arguing that the Food and Drug Administration (FDA) had never specifically approved the vaccine for preventing inhalational anthrax. In December 2003 a federal judge in Washington, DC, ordered the program stopped.

The FDA quickly responded with an affirmation that the vaccine was safe and effective for all forms of anthrax disease, and the judge then lifted his injunction. But in October 2004 he stopped the program again, ruling that the FDA had not followed proper procedures in issuing the new approval.

In January 2005, the FDA granted a Pentagon request for emergency authority to restart the vaccination program, but said the shots had to be voluntary. DoD has been giving the shots on a voluntary basis since April 2005.

In December 2005, the FDA completed a final investigation of the vaccine and reaffirmed its earlier finding that it was safe and effective.

Under the voluntary policy, about 50% of the affected service members have accepted anthrax vaccination, Winkenwerder reported in the DoD news release. He commented, "This rate of vaccination not only put the service members at risk, but also jeopardized unit effectiveness and degraded medical readiness."

"It is clear nobody likes getting shots if they don't have to," Winkenwerder said, as quoted in an Oct 17 Los Angeles Times story. "We have been sending a signal that it is not as important as we believe it is."

The announcement of the program's resumption is generating renewed resistance.

"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," said Mark S. Zaid, an attorney who first challenged the vaccination program, as quoted by the Associated Press (AP) yesterday. "It's always been a public relations program and nothing more," he added.

Zaid said, according to the AP, that he would file a new lawsuit "as soon as needles start going into arms."

Critics of the program have said the vaccine—Anthrax Vaccine Adsorbed—can cause problems like infertility and autoimmune disorders, such as multiple sclerosis and lupus, according to the Los Angeles Times story. The article also said some soldiers died after being vaccinated, but the Pentagon said that no causal link to the vaccine was established.

"The vaccine has been thoroughly reviewed by several independent outside groups" and the FDA, Winkenwerder said in the Times story. "In all the studies we have performed, looking very, very thoroughly at the vaccine, there is no increase in mortality, there is no increase in morbidity, there is no increase in hospitalizations."

Another vaccine critic is the National Vaccine Information Center, a nonprofit advocacy group. Its president, Barbara Loe Fisher, told the AP, "The [DoD] 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."

The mandatory vaccination program should restart in 30 to 60 days, according to the DoD release.

Dec 19, 2005 CIDRAP News story: "FDA reaffirms worth of DoD anthrax vaccine"