Court stops Defense Department anthrax vaccinations

The Defense Department suspended anthrax vaccinations for the second time in a year after the U.S. District Court for the District of Columbia ruled that more public input was required on the dangers of the controversial inoculation.

"This court has an obligation to ensure that [the Food and Drug Administration] follow the law in order to carry out its vital role in protecting the public's health and safety," according to the court's ruling, which was issued Wednesday. "By refusing to give the American public an opportunity to submit meaningful comments on the anthrax vaccine's classification, the agency violated the Administrative Procedure Act."

A Pentagon spokesman said the suspension of anthrax vaccinations would not have any effect on the deployment of personnel to conflicts overseas. A memo from Defense Secretary Donald Rumsfeld also defended the existing policy, saying that Pentagon officials "remain convinced" that the "anthrax vaccine is safe and effective."

Last December, U.S. District Judge Emmet Sullivan ordered the Pentagon to stop administering the vaccine because the FDA did not specifically declare the immunizations to be effective against inhaled anthrax. The ruling was prompted by a lawsuit brought by six anonymous service members who challenged the legality of the Anthrax Vaccination Immunization Program. As part of the AVIP, military personnel are required to receive a series of anthrax immunizations over the course of 18 months, followed by annual booster shots.

Ten months ago, Sullivan said the vaccine should have been classified as an investigational drug. On Dec. 30, 2003, the FDA released a final rule that officially classified the anthrax vaccine as effective for dealing with inhaled anthrax. Sullivan lifted the injunction shortly after. In Wednesday's ruling, Sullivan vacated the final rule and ordered the FDA to "properly" classify the vaccine.

"This court will not permit the government to circumvent this requirement," the ruling stated. "The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all-public scrutiny."

Pentagon spokesman James Turner said it was unclear how long the current injunction would remain in place. According to Turner, officials are reviewing the injunction but it is "too soon to tell" when the immunizations will resume. He expects to know more by the middle of next week.

Anthrax vaccines have caused controversy in the military, with hundreds of service members refusing the immunizations because of concerns over side effects. Some personnel have faced disciplinary actions or have been forced out of the military for their refusal.