Services told to start voluntary anthrax shots
Air Force Times
By Deborah Funk, Times staff writer
U.S. troops serving in Central Asia, the Middle East and South Korea once again can receive anthrax vaccinations - but only if they choose to get the shots.
The Pentagon has told the services to begin anthrax inoculations under an "emergency use authority" granted by the Food and Drug Administration, which can be employed only if the shots are given voluntarily.
Troops deploying to the Central Command's area of operations or Korea for at least 15 consecutive days are eligible for the shots.
Special-mission units and units with jobs related to bio-warfare or bioterrorism also will be offered the vaccinations, as will any adult family members living in the Central Command area of operations and South Korea.
The significant difference between this program and the Pentagon's original vaccination plan is that this time, service members are not required to take the shots, cannot be coerced into doing so and cannot be punished in any way if they decline. Refusal cannot harm a career nor cause legal troubles under the conditions of the emergency use authority.
"There will be no adverse consequences," confirmed Army Col. John Grabenstein, deputy director of the Military Vaccine Agency.
In a memo to the services, David S.C. Chu, undersecretary of defense for personnel and readiness, said that while the emergency use authority remains in effect, "military leaders at all levels will respect this option to refuse."
"For individuals who express initial doubts about the value of anthrax vaccination, counseling may reinforce education and information messages and answer questions or concerns, but may not coerce," Chu added.
At press time, it was unclear exactly when the vaccinations will start. But before any service members can be vaccinated, they must be told the risks and benefits of the vaccine, the conditions of the emergency use authority and their right to refuse vaccination. That information will be given in briefings and is also available in a brochure, a copy of which can be viewed online at www.vaccines.mil/documents/742AnthraxEUAtrifold5Apr05.pdf. Slides from the briefing are online at www.anthrax.mil/documents/740AnthraxEUAbrief-indiv10Apr05.pdf
The Army was expected to start offering vaccinations in the first 10 days of May. At press time, the other services could not say when they would resume the shots.
Military units will record whether someone received the brochure and accepted or refused vaccination. Notices of refusal will not be entered into personnel records, but rather will be kept in a vaccination tracking system that also records when people are vaccinated and the lot from which their vaccine came.
Although its label says the vaccine is to be given in six doses at specific intervals over 18 months, service members will not continue the series once their duty assignment takes them out of the areas or jobs considered at heightened risk, Chu's April 29 memo said.
The emergency use authority prohibits vaccinating people who leave those heightened-risk assignments, Grabenstein said.
These latest developments come less than a month after a federal judge granted permission to administer the shots on a voluntary basis. Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia issued a ruling Oct. 27 to halt the mandatory vaccinations, at least temporarily.
The Pentagon asked the FDA for permission to use the vaccine on a voluntary basis until at least July 27. Sullivan modified his order April 6 to allow the voluntary shots under the emergency use authority.
FDA officials, meanwhile, are taking administrative steps to satisfy the shortcomings Sullivan cited in his ruling that the vaccine is not licensed to protect against inhalation anthrax. The government also is appealing that ruling to a higher court.
John J. "Lou" Michels Jr., an attorney for six anonymous service members and government civilian workers who sued to stop the mandatory program, said he has "no confidence" in the military's ability to document who receives a brochure, who receives a shot voluntarily, when it was administered and from what lot. He predicted that vaccine recipients will have adverse reactions to the shots and that many people who get vaccinated will say they had no choice.
By Deborah Funk, Times staff writer
U.S. troops serving in Central Asia, the Middle East and South Korea once again can receive anthrax vaccinations - but only if they choose to get the shots.
The Pentagon has told the services to begin anthrax inoculations under an "emergency use authority" granted by the Food and Drug Administration, which can be employed only if the shots are given voluntarily.
Troops deploying to the Central Command's area of operations or Korea for at least 15 consecutive days are eligible for the shots.
Special-mission units and units with jobs related to bio-warfare or bioterrorism also will be offered the vaccinations, as will any adult family members living in the Central Command area of operations and South Korea.
The significant difference between this program and the Pentagon's original vaccination plan is that this time, service members are not required to take the shots, cannot be coerced into doing so and cannot be punished in any way if they decline. Refusal cannot harm a career nor cause legal troubles under the conditions of the emergency use authority.
"There will be no adverse consequences," confirmed Army Col. John Grabenstein, deputy director of the Military Vaccine Agency.
In a memo to the services, David S.C. Chu, undersecretary of defense for personnel and readiness, said that while the emergency use authority remains in effect, "military leaders at all levels will respect this option to refuse."
"For individuals who express initial doubts about the value of anthrax vaccination, counseling may reinforce education and information messages and answer questions or concerns, but may not coerce," Chu added.
At press time, it was unclear exactly when the vaccinations will start. But before any service members can be vaccinated, they must be told the risks and benefits of the vaccine, the conditions of the emergency use authority and their right to refuse vaccination. That information will be given in briefings and is also available in a brochure, a copy of which can be viewed online at www.vaccines.mil/documents/742AnthraxEUAtrifold5Apr05.pdf. Slides from the briefing are online at www.anthrax.mil/documents/740AnthraxEUAbrief-indiv10Apr05.pdf
The Army was expected to start offering vaccinations in the first 10 days of May. At press time, the other services could not say when they would resume the shots.
Military units will record whether someone received the brochure and accepted or refused vaccination. Notices of refusal will not be entered into personnel records, but rather will be kept in a vaccination tracking system that also records when people are vaccinated and the lot from which their vaccine came.
Although its label says the vaccine is to be given in six doses at specific intervals over 18 months, service members will not continue the series once their duty assignment takes them out of the areas or jobs considered at heightened risk, Chu's April 29 memo said.
The emergency use authority prohibits vaccinating people who leave those heightened-risk assignments, Grabenstein said.
These latest developments come less than a month after a federal judge granted permission to administer the shots on a voluntary basis. Judge Emmet G. Sullivan of the U.S. District Court for the District of Columbia issued a ruling Oct. 27 to halt the mandatory vaccinations, at least temporarily.
The Pentagon asked the FDA for permission to use the vaccine on a voluntary basis until at least July 27. Sullivan modified his order April 6 to allow the voluntary shots under the emergency use authority.
FDA officials, meanwhile, are taking administrative steps to satisfy the shortcomings Sullivan cited in his ruling that the vaccine is not licensed to protect against inhalation anthrax. The government also is appealing that ruling to a higher court.
John J. "Lou" Michels Jr., an attorney for six anonymous service members and government civilian workers who sued to stop the mandatory program, said he has "no confidence" in the military's ability to document who receives a brochure, who receives a shot voluntarily, when it was administered and from what lot. He predicted that vaccine recipients will have adverse reactions to the shots and that many people who get vaccinated will say they had no choice.
