Mandatory Anthrax Shots to Return

The Defense Department will resume mandatory anthrax vaccinations for more than 200,000 troops and defense contractors within 60 days, a Pentagon official said yesterday, rejecting the concerns of some veterans and service members who say that the vaccine has not been proved safe or effective.

The vaccinations will be required for most military units and civilian contractors assigned to homeland bioterrorism defense or deployed in Iraq, Afghanistan or South Korea, said William Winkenwerder Jr., a physician and the assistant secretary of defense for health affairs. As troops rotate in and out of those regions, the number receiving vaccinations will grow considerably, he said.

A lawsuit filed by six former or current service members had blocked the mandatory vaccinations since October 2004, when U.S. District Judge Emmet G. Sullivan ruled that the Food and Drug Administration had erred in approving the vaccine in 2003 without seeking public comment and conducting a full review.

But the FDA then held a 90-day comment period to overcome that hurdle and granted the vaccine final approval last December, clearing a legal path for the Pentagon to resume the controversial program.

"The FDA went out again . . . and came to the very unambiguous and clear conclusion that the vaccine was safe and it was effective against all forms of exposure," Winkenwerder said. "In our view, that has definitively settled the question."

But Mark Zaid, an attorney for the six plaintiffs, said yesterday that Sullivan's ruling and the Pentagon's remedy both turned on procedural technicalities. The plaintiffs plan to file a new lawsuit challenging the government's contention that human studies from the 1950s and more recent studies in animals demonstrated the safety and efficacy of the vaccine.

"It is an unnecessary, unproven and potentially unsafe vaccine," Zaid said. "Everyone is concerned as to their health, and the fact is that there is no scientific evidence that the vaccine works in humans. . . . I think this program is nothing more than a glorified public relations campaign to demonstrate that they are doing something."

Anthrax is a deadly infectious disease caused by the spore-forming bacterium Bacillus anthracis . A month after the Sept. 11, 2001, attacks, letters tainted with anthrax infected people in Connecticut, Florida, New Jersey, New York and the District. The unsolved attacks killed five people, sickened 17 and caused about 10,000 to be put on antibiotics.

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