U.S. Armed Services Outline Implementation of Voluntary Anthrax Vaccinations Programs
By David Francis
Global Security Newswire
WASHINGTON — The attorney representing six anonymous Defense Department employees in a suit that stopped a U.S. Defense Department’s mandatory anthrax vaccination program is praising implementation plans outlined by the Armed Services last month for a voluntary inoculation program (see GSN, May 23).
However, John Michels, counsel for the Pentagon employees who requested and received an injunction against the mandatory program last October, questioned why the guidance does not require soldiers to give consent to receive the actual vaccination. Instead, under the new practice, vaccine candidates are asked to acknowledge that they have received a brochure outlining the risks associated with the vaccine.
“They don’t actually have the guys signing for consent,” Michels said. “They have to sign, ‘Yes, I’ve gotten the brochure,’ but they don’t give consent to be vaccinated. I don’t understand why.”
“Why not say I certified that I received the brochure and I consent to be vaccinated?” Michels asked.
Calls to the Pentagon for clarification on consent were referred to the individual branches of the Armed Services. Calls to the branches were not returned at press time.
Despite his confusion over consent, Michels is pleased with the implementation plans. He said many of the requirements for vaccinations, allowed under emergency use authority granted to the Pentagon by the Food and Drug Administration, mirror what he has been asking the Pentagon for since the original suit was filed.
“This looks an awful lot like what we asked for,” Michels said. “We’re surprised they’re going through all this trouble.” Michels believes the Pentagon is taking special care to ensure no legal challenges to the emergency use authority.
The EUA, which allows for voluntary inoculations, took effect at the beginning of May and expires at the end of June. It can be extended by the Food and Drug Administration. Throughout May, military branches gave instructions to commanders on how to implement the voluntary program.
The Pentagon has appealed the original ruling that stopped the program in hopes of resuming mandatory vaccinations.
Program Implementation
The requirements outlined in actions plans for the Army, Navy, Air Force and Marines are generally similar. Vaccinations are limited to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in Korea. Soldiers must be informed that a federal court stopped the mandatory program and that all vaccinations are voluntary, and superior officers cannot pressure anyone to take the vaccine.
All wishing to receive the vaccine must be briefed on the risks and benefits of the vaccines by their commanders, and must acknowledge receipt of the brochure explaining these risks. The Air Force requires a soldier sign the brochure, while the Army, Marines and Navy only require a roster be kept of who received the information.
All data on immunization will be entered into the soldier’s medical file and tracked electronically using the system of each respective branch. Refusals will also be tracked. Reports of adverse events associated with the vaccine will be tracked in the Vaccine Adverse Events Reporting System.
If a soldier is transferred outside of Central Command or Korea, the regimen of vaccination shots does not have to continue.
The Coast Guard’s plan is much more limited, only allowing vaccinations of personnel in specific areas determined by the Pentagon.
Vaccinations cannot begin until the Military Vaccine Agency certifies that the brochures explaining risks are received by the individual branches.
Michels said these requirements ensure soldiers are well-informed before taking the vaccine, and know they have the option to refuse.
“This is starting to look more and more like the practice of medicine,” he said.
Global Security Newswire
WASHINGTON — The attorney representing six anonymous Defense Department employees in a suit that stopped a U.S. Defense Department’s mandatory anthrax vaccination program is praising implementation plans outlined by the Armed Services last month for a voluntary inoculation program (see GSN, May 23).
However, John Michels, counsel for the Pentagon employees who requested and received an injunction against the mandatory program last October, questioned why the guidance does not require soldiers to give consent to receive the actual vaccination. Instead, under the new practice, vaccine candidates are asked to acknowledge that they have received a brochure outlining the risks associated with the vaccine.
“They don’t actually have the guys signing for consent,” Michels said. “They have to sign, ‘Yes, I’ve gotten the brochure,’ but they don’t give consent to be vaccinated. I don’t understand why.”
“Why not say I certified that I received the brochure and I consent to be vaccinated?” Michels asked.
Calls to the Pentagon for clarification on consent were referred to the individual branches of the Armed Services. Calls to the branches were not returned at press time.
Despite his confusion over consent, Michels is pleased with the implementation plans. He said many of the requirements for vaccinations, allowed under emergency use authority granted to the Pentagon by the Food and Drug Administration, mirror what he has been asking the Pentagon for since the original suit was filed.
“This looks an awful lot like what we asked for,” Michels said. “We’re surprised they’re going through all this trouble.” Michels believes the Pentagon is taking special care to ensure no legal challenges to the emergency use authority.
The EUA, which allows for voluntary inoculations, took effect at the beginning of May and expires at the end of June. It can be extended by the Food and Drug Administration. Throughout May, military branches gave instructions to commanders on how to implement the voluntary program.
The Pentagon has appealed the original ruling that stopped the program in hopes of resuming mandatory vaccinations.
Program Implementation
The requirements outlined in actions plans for the Army, Navy, Air Force and Marines are generally similar. Vaccinations are limited to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in Korea. Soldiers must be informed that a federal court stopped the mandatory program and that all vaccinations are voluntary, and superior officers cannot pressure anyone to take the vaccine.
All wishing to receive the vaccine must be briefed on the risks and benefits of the vaccines by their commanders, and must acknowledge receipt of the brochure explaining these risks. The Air Force requires a soldier sign the brochure, while the Army, Marines and Navy only require a roster be kept of who received the information.
All data on immunization will be entered into the soldier’s medical file and tracked electronically using the system of each respective branch. Refusals will also be tracked. Reports of adverse events associated with the vaccine will be tracked in the Vaccine Adverse Events Reporting System.
If a soldier is transferred outside of Central Command or Korea, the regimen of vaccination shots does not have to continue.
The Coast Guard’s plan is much more limited, only allowing vaccinations of personnel in specific areas determined by the Pentagon.
Vaccinations cannot begin until the Military Vaccine Agency certifies that the brochures explaining risks are received by the individual branches.
Michels said these requirements ensure soldiers are well-informed before taking the vaccine, and know they have the option to refuse.
“This is starting to look more and more like the practice of medicine,” he said.
