By Christopher Lee
Washington Post Staff Writer
Tuesday, October 17, 2006
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.
Although the previous anthrax attacks occurred on U.S. soil, Winkenwerder said troops overseas are believed to be a higher risk, and military personnel in the United States do not have to receive the six shots.
"I have not been vaccinated because I'm not in any of the targeted groups," Winkenwerder said. "If I was, I would receive the vaccine without hesitation."
The Clinton administration began the mandatory vaccinations in 1997. Over the next few years, hundreds of active-duty service members refused to take the vaccine, and more than 100 were court-martialed as a result. Winkenwerder said that 27 people refused the vaccine and left the military in 2003, and that 10 did so in 2004. A voluntary vaccination program that Sullivan allowed last year saw participation rates of 50 percent, Winkenwerder said. In all, more than 1.2 million military and civilian personnel have received the vaccine.
Some who received vaccinations for anthrax and smallpox around the time of the 2003 invasion of Iraq have complained of fatigue, migraines, pain and diseases such as multiple sclerosis.
Winkenwerder said that, as with any vaccine, some who receive the shots develop adverse reactions, but that there is no evidence to indicate a particular problem with the anthrax vaccine.
But as recently as this spring, the Government Accountability Office, the investigative arm of Congress, said questions remain about the vaccine. "The long term safety of the licensed vaccine has not been studied," the agency said in a May 9 report. ". . . Also, there is some evidence that the current anthrax vaccine may have diminished efficacy against certain virulent strains of anthrax."
Barbara Loe Fisher, president of the National Vaccine Information Center, said her nonprofit advocacy group is adding more information to its Web site about the research and development of biological defense vaccines.
"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 decision," she said in a statement.