May 4, 2005 (CIDRAP News ) – With a federal judge's permission, the US Department of Defense (DoD) has announced it will resume giving anthrax shots to military personnel, but on a strictly voluntary basis.
The DoD's mandatory anthrax immunization program had been suspended since October 2004, when US District Judge Emmet G. Sullivan ruled that the Food and Drug Administration (FDA) did not follow proper procedures in approving the vaccine for inhalational anthrax.
In January the FDA issued an "emergency use authorization" (EUA) permitting DoD to resume the vaccinations, but only on a voluntary basis. On Apr 6, Sullivan granted a DoD request to resume giving the shots under the terms of the emergency authorization.
Yesterday the Pentagon announced it was ready to resume giving anthrax shots. Officials said the vaccinations would mostly be limited to military units assigned to the Central Command area, which includes the Middle East, and to troops serving in Korea and in homeland bioterrorism defense.
"The implementing program requires commanders to follow EUA conditions very carefully, providing members of the armed services both education on the program and an option to refuse the vaccination without penalty," the DoD announcement said.
Dr. William Winkenwerder, assistant secretary of defense for health affairs, called the immunization program a "vital protection measure for military personnel, who are at increased risk of exposure to an anthrax attack."
A DoD policy memo about the program says the EUA is scheduled to expire on July 27, less than 3 months away. "At that time, other initiatives may result in resumption of the normal AVIP [Anthrax Vaccine Immunization Program], including mandatory vaccinations for selected personnel," the memo says. "Alternatively, the EUA may be extended or other direction may be provided."
Perry Bishop, a Pentagon spokesman, said DoD will continue to press for mandatory vaccination, according to an Associated Press report published yesterday.
The DoD memo says all personnel eligible for anthrax vaccination must be told they may refuse the shots and will not be punished. Troops must be told they will not be discharged for refusing and they can still be deployed. However, personnel must also be told, "Your military and civilian leaders strongly recommend anthrax vaccination," the memo states.
Personnel will be given a brochure that explains the known and potential benefits and risks of vaccination as well as the alternatives to vaccination.
Before Sullivan's ruling, anthrax shots were mandatory for personnel serving in areas where the risk of anthrax attack was considered high. More than 1.3 million troops had been vaccinated in the program, which began in 1998. But hundreds of troops refused the shots because of concern about side effects, and some were disciplined or discharged from the service.
Sullivan's ruling came in a lawsuit filed by six DoD personnel and civilian contractor employees who objected to the shots. In an initial ruling in December 2003, the judge ordered DoD to stop requiring the shots on the ground that the FDA had never specifically approved the vaccine for inhalational anthrax. The vaccine was originally licensed in 1970.
The FDA responded immediately by declaring that the vaccine was safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004. But in his subsequent ruling in October 2004, Sullivan said the FDA had failed to follow its own rules in declaring the vaccine safe for all forms of the disease.
Last December, military officials asked the Department of Health and Human Services (HHS) for emergency authority to resume the vaccination program. Under the Project Bioshield Act of 2004, the FDA, in a declared emergency, can authorize the use of a medical product that has not gained ordinary FDA approval. The FDA then issued the emergency authorization on Jan 27, but said the shots had to be voluntary.
The anthrax vaccine used by DoD requires six shots over a period of 18 months, followed by annual boosters. Last November HHS awarded an $877 million contract for a new anthrax vaccine that officials hope will require fewer doses and have fewer side effects, but that vaccine is intended to go in a stockpile for civilian use.
May 3 DoD news release
DoD policy memo