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Judge dismisses suit to limit DoD anthrax vaccinations

FYI - the verdict is undergoing appeal.


Feb 29, 2008 (CIDRAP News) – A federal district judge has dismissed a lawsuit aiming to stop the Pentagon's mandatory anthrax vaccination program for troops serving in some areas overseas, the Associated Press (AP) reported today.

Judge Rosemary M. Collyer in Washington, DC, said the Food and Drug Administration (FDA) acted appropriately when it determined the vaccine was safe and approved its use, according to the AP.

In her ruling, the story said, Collyer wrote, "The court will not substitute its own judgment when the FDA made no clear error of judgment." She dismissed a suit by eight military personnel who argued that the vaccine is unapproved and that vaccination should be optional.

A legal battle over the Department of Defense's (DoD's) mandatory vaccination program has dragged on for years. Soldiers concerned about the vaccine's side effects sued to stop the program, arguing that the FDA had never specifically approved the vaccine for preventing inhalational anthrax. In December 2003 a federal judge in Washington, DC, ordered the program stopped.

In response, the FDA affirmed that the vaccine was safe and effective for all forms of anthrax disease, and the judge then lifted his injunction. But in October 2004 he stopped the program again, ruling that the FDA had not followed proper procedures in issuing the new approval.

In January 2005, the FDA granted a Pentagon request for emergency permission to restart the vaccination program, but said the shots had to be voluntary. DoD resumed the program on a voluntary basis in April 2005. In December 2005, the FDA completed a final investigation of the vaccine and reaffirmed its earlier finding that it was safe and effective.

In October 2006 the Pentagon again made the shots mandatory for personnel serving in the Middle East and South Korea. Mandatory vaccinations have continued since then, according to Cynthia O. Smith, a DoD spokeswoman in Washington.

About 1.8 million troops have received anthrax shots since the program was launched in March 1998, according to online information from DoD. The program has been controversial, with some troops objecting to the shots because of reported serious side effects. When the shots were optional, only about 50% of affected personnel accepted them, the Pentagon said in 2006.

Smith said the vaccination requirement covers all uniformed personnel and "emergency-essential" civilian workers in the US Central Command and Korea. The shots are also required for certain forces at sea and uniformed personnel in units with missions related to biological warfare or bioterrorism, she reported.

"We vaccinate our service members to protect them against deadly diseases, both natural and those potentially spread by terrorists or enemy forces," Smith told CIDRAP News in an e-mail message. "We take very seriously the potential use of weapons of mass destruction by terrorists."

The vaccine, called anthrax vaccine adsorbed and developed in the 1950s, requires six doses over a period of 18 months, followed by annual boosters.

The Department of Health and Human Services (HHS) has been trying to develop a second-generation anthrax vaccine for the nation's emergency stockpile of drugs and medical supplies for civilians. The aim is to acquire a vaccine that requires fewer doses and has fewer side effects.

In 2004 HHS awarded an $877 million contract to VaxGen Inc. to make a new vaccine, but in 2006 the agency canceled the contract after problems with the vaccine's stability delayed a clinical trial. No new contract has yet been announced.