U.S. Court Orders Detailed Instructions Be Given to Military Personnel Before Anthrax Vaccination
By David Francis
Global Security Newswire
WASHINGTON — A U.S. federal judge who stopped a mandatory Defense Department anthrax vaccination program last year has ordered military medical personnel to give detailed instructions to service members before administering the voluntary vaccination (see GSN, Aug. 2).
The Aug. 30 court order follows reports that on July 22, a soldier in Iraq was vaccinated without being informed that it was optional.
The Pentagon began in May giving anthrax vaccinations to military and civilian personnel on a voluntary basis under emergency-use authority granted by the U.S. Health and Human Services Department. The authority was granted after U.S. District Judge Emmet Sullivan stopped the mandatory vaccination program following a lawsuit by six anonymous Defense Department employees. The Pentagon has appealed Sullivan’s decision to the U.S. Appeals Court.
Sullivan, who in the past has criticized the Pentagon for continuing to give shots after he issued the injunction in October 2004, has now required that specific instructions be given before the inoculation is administered.
The order mandates that no later than Sept. 15, the Pentagon must provide the following instructions to all medical personnel: “If administering anthrax vaccination, ensure the patient has signed in, received training and trifold [a brochure outlining risks and benefits of the vaccine], understands the right to refuse, and states they want to receive the anthrax vaccine. Immediately prior to administration of the anthrax vaccination (once site and vaccine are prepared) ask the patient, ‘Do you want to receive the anthrax vaccination?’ If the patient confirms, administer.”
Sullivan’s ruling comes days after the Pentagon filed a reply brief with the U.S. Appeals Court in response to a brief filed by counsel for the six Defense Department employees. The briefs were filed as part of the Pentagon’s appeal of Sullivan’s injunction.
In the brief, the Pentagon argued that the plaintiffs offer no support for a continued suspension of the mandatory anthrax vaccination program.
“Even if the district court were correct on the merits, there is no basis for its sweeping, military-wide injunction,” the brief states. “The court’s injunction is wholly unnecessary to provide relief to the six plaintiffs, and, without providing any gain in safety, it improperly sets aside the military’s judgment as to the optimal means for protecting American service members against the threat of anthrax.”
“Contrary to plaintiffs’ suggestions, the interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” the brief continues. “The court’s ruling jeopardizes the safety of the countless persons who have never been a part of this action.”
The Pentagon has argued that the vaccine has been considered safe and effective for anthrax regardless of the route of exposure — by skin contact or inhalation — by the Food and Drug Administration. Contrary to the plaintiffs’ arguments, the agency in 1972 accepted the determination of the National Institutes of Health that the vaccine is safe, and has never contradicted this finding, according to the Pentagon.
“Accordingly, given the continued operative effect of the original NIH license for AVA [anthrax vaccine adsorbed], the FDA’s repeated declarations that the original license includes use against inhalation anthrax, and the count scientific bases for that conclusion, the district court’s determination is entirely without support,” the Pentagon says.
Global Security Newswire
WASHINGTON — A U.S. federal judge who stopped a mandatory Defense Department anthrax vaccination program last year has ordered military medical personnel to give detailed instructions to service members before administering the voluntary vaccination (see GSN, Aug. 2).
The Aug. 30 court order follows reports that on July 22, a soldier in Iraq was vaccinated without being informed that it was optional.
The Pentagon began in May giving anthrax vaccinations to military and civilian personnel on a voluntary basis under emergency-use authority granted by the U.S. Health and Human Services Department. The authority was granted after U.S. District Judge Emmet Sullivan stopped the mandatory vaccination program following a lawsuit by six anonymous Defense Department employees. The Pentagon has appealed Sullivan’s decision to the U.S. Appeals Court.
Sullivan, who in the past has criticized the Pentagon for continuing to give shots after he issued the injunction in October 2004, has now required that specific instructions be given before the inoculation is administered.
The order mandates that no later than Sept. 15, the Pentagon must provide the following instructions to all medical personnel: “If administering anthrax vaccination, ensure the patient has signed in, received training and trifold [a brochure outlining risks and benefits of the vaccine], understands the right to refuse, and states they want to receive the anthrax vaccine. Immediately prior to administration of the anthrax vaccination (once site and vaccine are prepared) ask the patient, ‘Do you want to receive the anthrax vaccination?’ If the patient confirms, administer.”
Sullivan’s ruling comes days after the Pentagon filed a reply brief with the U.S. Appeals Court in response to a brief filed by counsel for the six Defense Department employees. The briefs were filed as part of the Pentagon’s appeal of Sullivan’s injunction.
In the brief, the Pentagon argued that the plaintiffs offer no support for a continued suspension of the mandatory anthrax vaccination program.
“Even if the district court were correct on the merits, there is no basis for its sweeping, military-wide injunction,” the brief states. “The court’s injunction is wholly unnecessary to provide relief to the six plaintiffs, and, without providing any gain in safety, it improperly sets aside the military’s judgment as to the optimal means for protecting American service members against the threat of anthrax.”
“Contrary to plaintiffs’ suggestions, the interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” the brief continues. “The court’s ruling jeopardizes the safety of the countless persons who have never been a part of this action.”
The Pentagon has argued that the vaccine has been considered safe and effective for anthrax regardless of the route of exposure — by skin contact or inhalation — by the Food and Drug Administration. Contrary to the plaintiffs’ arguments, the agency in 1972 accepted the determination of the National Institutes of Health that the vaccine is safe, and has never contradicted this finding, according to the Pentagon.
“Accordingly, given the continued operative effect of the original NIH license for AVA [anthrax vaccine adsorbed], the FDA’s repeated declarations that the original license includes use against inhalation anthrax, and the count scientific bases for that conclusion, the district court’s determination is entirely without support,” the Pentagon says.
