ARLINGTON, Va. — First it was required, then it was optional, and now it’s required again — for some.

The Defense Department has made anthrax vaccinations mandatory for U.S. troops and emergency-essential DOD civilians and contractors serving in the U.S. Central Command Area of Responsibility and on the Korean peninsula for 15 days or more, a top Defense health official said Monday.

Currently, the Defense Department is not considering expanding the mandatory vaccination program to troops outside those areas, said Dr. William Winkenwerder, assistant secretary of defense of health affairs.

Several hundred thousand U.S. troops are expected to receive the vaccine under the mandatory program, which is expected to resume within the next 30 to 60 days, Winkenwerder told reporters on Monday.

The six-dose vaccine will be given to troops already in theater and troops waiting to deploy, Winkenwerder said.

Winkenwerder declined to say what legal ramifications troops who refuse the vaccine might face.

“I’m not a lawyer and I’m not here to talk about that particular issue today,” he said.

The anthrax vaccination has been optional for U.S. troops since April 2005.

Since then, only about 50 percent of servicemembers in high threat areas contacted about vaccination actually opted to do so, putting those who opted out and their units at risk, Winkenwerder said.

“Military members expect that if something is truly important to the mission, if there truly is a threat, that it would be mandatory, so obviously we’ve been sending a signal that it’s not as important as in fact we believe it is,” he said.

Winkenwerder stressed Monday that the anthrax vaccine is safe, but one attorney has vowed to try to block mandatory anthrax vaccinations.

Mark S. Zaid, an attorney in Washington, D.C., said he plans to represent any servicemember who refuses to be vaccinated for anthrax in a class action lawsuit.

In a Monday e-mail to Stars and Stripes, Zaid called the vaccine “unnecessary, unproven and potentially unsafe.”

“The AVIP (Anthrax Vaccine and Immunization Program) is nothing more than a poorly conceived public relations campaign. The perception is that it is currently being implemented to satisfy personal egos and as a result of a lobbying campaign,” Zaid said.

Winkenwerder called Zaid’s comments “irresponsible.”

“This is a safe and effective vaccine, it has been reviewed — as I had indicated — by independent, outside reviewers who had no relationship to the Department of Defense and who had no objective other than review of the safety and effectiveness of a vaccine,” Winkenwerder said.

The Defense Department has vaccinated more than 1.4 million people against anthrax since 1998, according to the Military Vaccine Agency.

For the future, the Defense Department is looking at cutting at least one of the doses from the six-dose regiment, Winkenwerder said.

Anthrax vaccine timeline

1998 — Defense Department starts a program of inoculating troops with the anthrax vaccine.

June 2001 — Inoculating troops temporarily suspended because of a lack of anthrax vaccine when the manufacturer, BioPort, changed its manufacturing process without approval by the Food and Drug Administration.

June 2002 — Defense Department resumes inoculating troops after FDA approves vaccine and manufacturing process, lifting the temporary suspension from a year earlier.

December 2003 — A federal judge bars the DOD from administering the vaccine after six anonymous former servicemembers file a lawsuit claiming the 1970s-made vaccine was approved by the FDA to protect against the skin form of anthrax, and not against inhaled anthrax.

January 2004 — The judge reverses his injunction after the Justice Department produces documentation showing the FDA issued a finding that the vaccine was, in fact, intended to guard against both the skin and inhaled forms of anthrax.

October 2004 — The courts bar the Defense Department from making the vaccine mandatory, citing mistakes in how the FDA determined the safety of the vaccine.

April 2005 — The judge amends his order, allowing the department to administer the vaccine on an "emergency-use" basis, but solely on a voluntary basis. Troops could refuse shots without reprisal. The ruling also requires anyone receiving the vaccine first to be warned of possible side effects, and made aware of questions surrounding the effectiveness.

December 2005 — FDA deems the anthrax vaccine is both safe and effective.

Source: Stars and Stripes

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