The Pentagon announced Tuesday it would stop giving anthrax vaccinations to service men and women until a federal judge’s order to end the program is clarified.
“We fully intend to comply with all of our legal obligations in this instance,” Dr. William Winkenwerder, assistant secretary of defense for health affairs, told PBS’ “NewsHour with Jim Lehrer.”
The announcement countered earlier statements from top military officers who criticized Monday’s ruling from U.S. District Judge Emmet G. Sullivan that the vaccinations were being used inappropriately.
Sullivan said Monday he was convinced by six unidentified plaintiffs in a class action suit that the vaccine is being “used for an unapproved purpose” — that is, to protect against exposure to airborne anthrax as well as exposure through the skin.
Top Joint Chief disagrees
Air Force Gen. Richard Myers, chairman of the Joint Chiefs of Staff, told a news briefing that he disagreed with Sullivan’s order that the Pentagon could not require military personnel to take the vaccinations unless they consent.
“We’re using a vaccine that has been around for 40 years,” Myers said. “It is not experimental. It has been approved by the FDA [Food and Drug Administration]. I think it’s very important that we have this capability to protect our troops.”
Winkenwerder told “NewsHour” the Defense Department was still evaluating the ramifications of Sullivan’s ruling.
Earlier, Defense Secretary Donald Rumsfeld disputed Sullivan’s comment that “absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.”
“The comment, if in fact the judge said it, is inaccurate,” Rumsfeld said.
More than 900,000 servicemen and women have received the shots, among the millions of doses of various vaccines administered annually to protect troops against disease and bioterror threats.
500 have refused
Overall, some 500 active-duty service members have refused the vaccine, close to 200 have been court-martialed and more than 500 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine, said Mark S. Zaid, a lawyer for the plaintiffs.
However, most of the punishments and discharges occurred several years ago, the military said.
Winkenwerder said about 10 people have refused the vaccine since the Sept. 11 attacks and subsequent anthrax mailings.
The government has maintained that the licensed vaccine is safe, is not experimental and can protect against anthrax inhaled or absorbed through the skin.
Anthrax is a naturally occurring bacterium that typically affects sheep and cattle. When inhaled, dry anthrax spores can be deadly to humans.
Three decades of use
The government approved the vaccine three decades ago, and it is used to protect veterinarians and scientists who work with anthrax. Plaintiffs in the case before Sullivan — unidentified active duty, National Guard and civilian defense employees — say the license covered only exposure through the skin. Other uses might not be safe, they contend.
Sullivan’s ruling said the label on the vaccine did not specify which method of anthrax exposure it protected against.
He cited a 1998 law that prohibits the use of new drugs or those unapproved for their intended use unless people being given the drug have consented to its use or the president has waived the consent requirement. Congress passed the law amid suspicions that the use of such drugs might have led to unexplained illnesses among veterans of the 1991 Persian Gulf War that came to be known as Gulf War Syndrome.
Believing Iraq and other nations had produced anthrax weapons, then-Defense Secretary William Cohen ordered the armed forces immunized in 1997.
The government does not recommend vaccinating the general public but says the vaccine overall is very safe, with rare severe side effects. Some military personnel have worried that the vaccine could be connected to complaints of chronic fatigue, memory loss and other problems.
The program was started to vaccinate all 2.4 million members of the active and reserve military, but it was radically reduced because of production shortfalls.