FDA Rules On Military's Anthrax Vaccine

By THOMAS D. WILLIAMS
Courant Staff Writer

February 1 2005

The Food and Drug Administration Monday issued an emergency order allowing the military to use a controversial anthrax vaccine.

The order, published in the Federal Register, came three months after a federal court stopped the Pentagon from forcing servicemen to be vaccinated or face punishment. The new order permits voluntary use.

The FDA says the Pentagon will make its own determination whether to resume the mandatory use of the vaccine after FDA finishes reconsidering the vaccine's license March 28.

The FDA opened a 90-day period for public comment on the vaccine in December after the court stopped the military's mandatory vaccination of soldiers. That allows vaccine opponents and the Pentagon to argue the pros and cons. Ultimately, the FDA, which believes the present license is legal, is expected to validate it.

On Oct. 27, U.S. District Court Judge Emmet G. Sullivan in Washington, D.C., ordered a halt to the military's mandatory use of the vaccine. He said the vaccine was being used improperly, as supposed protection against inhaled anthrax spores. The vaccine was originally developed to fight anthrax infection absorbed through the skin. Sullivan's ruling forced the Pentagon to obtain informed consent of each service member inoculated, or a presidential waiver to allow its continued use.

Sullivan said if the military wanted to use the vaccine, the FDA would need to examine whether it is effective against inhaled spores.

Pentagon spokesman Jim Turner said Monday defense department health officials had no immediate comment on the development.

John J. "Lou" Michels, a lawyer representing the service members who challenged the vaccine in federal court, said the new FDA order "is just another example of the FDA effectively rolling over for the Department of Defense with regard to this program."

Michels said he would watch developments closely because he believes the Pentagon will find a way to illegally force service members to use the vaccine through the legal powers of the U.S. Health and Human Services Department.

Nearly 500 active-duty service members have refused the vaccine and more than 100 have been court-martialed. More than 500 pilots and flight crew have retired or transferred from the Air National Guard or Reserve to avoid the vaccine.

The adverse reaction rate of the vaccine is 100 times that initially stated by the vaccine's manufacturer. Adverse reactions include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least a half dozen deaths and a number of birth defects have been attributed to its use.
Copyright 2005, Hartford Courant