US judge halts compulsory anthrax vaccination for soldiersBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7474.1062-a (Published 04 November 2004) Cite this as: BMJ 2004;329:1062
A US federal judge has ordered the Department of Defense to halt compulsory anthrax vaccination of soldiers, saying that the Food and Drug Administration violated its own rules by failing to seek public comment before approving the vaccine.
The Pentagon began a programme to inoculate 2.4 million troops in 1998, and so far 1.2 million have received the shot. But more than 500 members of the armed forces have been disciplined or court-martialled for refusing it. One soldier received a seven month prison sentence.
Six unnamed military personnel sued the Pentagon, charging that the vaccine's approval had not met legal requirements and was therefore an investigational drug requiring informed consent.
Judge Emmet Sullivan of the district court in Washington agreed, saying: “Congress has prohibited the administration of investigational drugs to service members without their consent. This court will not permit the government to circumvent this requirement.”
He also questioned the vaccine's efficacy, noting that the FDA's expert advisory panel had found in 1980 that in studies of the vaccine, “inhalation anthrax occurred too infrequently to assess the protective effect of vaccine against this form of the disease.”
The vaccine was found to offer protection only against cutaneous anthrax, a risk for workers in the leather industry. An FDA Proposed Rule for the vaccine issued in 1985 found that “the benefit-to-risk assessment” was “satisfactory” for this “limited high-risk population.”
The approval process was then opened to public consultation. In 1998, when the Pentagon began a compulsory programme against inhalation anthrax, the FDA ruled that the requirement for public comment had already been met.
Judge Sullivan initially ordered the Pentagon to stop mandatory vaccination last December, saying that the FDA had never changed the vaccine's investigative status. The FDA then immediately ruled the vaccine safe for widespread use. Last week, Judge Sullivan noted this decision came “18 years after the Proposed Rule, but only eight days after this court's order.”
As a result of the judge's decision, the Pentagon ordered a “pause” in anthrax vaccinations.
Dr Tom Jefferson, who reviewed evidence on the vaccine for the Cochrane Collaboration and questioned its efficacy in a BMJ editorial this September (BMJ 2004;329: 524-5), said the decision to stop the programme altogether rather than continue with voluntary shots proved that the Pentagon knew there was no serious anthrax threat to its troops. “The claim that this vaccine can prevent inhalation anthrax is nothing short of a flight of fancy,” he added.