DOD Switches Policy on Voluntary Vaccinations
By David Ruppe
Global Security Newswire
WASHINGTON — In announcing the resumption of anthrax vaccinations for military personnel this week, the U.S. Defense Department abandoned a fiercely defended policy against voluntary vaccinations (see GSN, April 1).
The reversal of that policy, however, coincides with relaxed requirements for informing and obtaining the consent of potential recipients before administering such investigational drugs, which are in effect because senior Bush administration officials have declared a potential emergency.
The new plan was announced Tuesday in a press release. The vaccinations were ordered to resume under a “emergency use authority,” which was based on a Pentagon determination last December that a “significant potential [exists] for a military emergency involving a heightened risk to United States military forces of attack with anthrax.”
The Defense Department had halted mandatory anthrax vaccinations in October, after a U.S. District Judge Emmet Sullivan ruled the drug was not yet fully licensed by the Food and Drug Administration as effective against inhaled anthrax and so could not be made mandatory.
The military previously opposed administering the vaccine voluntarily, arguing it could weaken U.S. forces were soldiers to opt out. “We fight as a team. All team members must be healthy. That’s why voluntary vaccination is not an option,” states a Defense Department Web site published to inform service people about the vaccine.
The drug has been licensed for skin-contracted anthrax since 1970, and used by textile workers, but not for inhalation anthrax, the type that would be expected in an attack on U.S. forces.
Some soldiers in past years have been court-martialed for refusing to take the vaccine.
A Pentagon Web site says the vaccine causes serious adverse side effects in “about 1 in 100,000 vaccinations.”
More than 1 million military personnel have been required to take the vaccine in recent years. Hundreds have been assessed and treated for severe reactions by a special network of centers (see related GSN story, today).
Relaxed Information and Consent Requirements
The “emergency use authorization” invoked by senior Bush administration officials enables the military to give voluntarily vaccinations without more stringent legal requirements for informing soldiers about the side effects of the vaccine or obtaining their written consent.
Federal law normally would require that personnel be told that the vaccine is investigational and not approved for its intended purpose. Furthermore, all possible side effects must be disclosed and the person must sign a form consenting to the vaccination.
Under a law signed last year allowing for emergency use authorizations, military authorities only are required to “establish such conditions … as the [defense] secretary finds necessary or appropriate” so that personnel are informed of “significant known and potential benefits and risks of such use.”
An informational brochure the Defense Department said it will give service members before they are offered the shots lists only more common, minor side effects expected from the vaccine, such as itching, swelling and nausea.
A number of service members have reported symptoms such as chronic headaches and debilitating muscle and joint pains and weakness, and more serious illnesses, that have taken them out of service.
The brochure also does not mention the vaccine is investigational for inhalation anthrax.
“The emergency use authorization is much more generic with regard to the information that’s got to be provided to people [normally under U.S. law],” said Lou Michels, an attorney in Chicago representing six anonymous military and civilian personnel who sued government officials over the prior mandatory program.
Pressure, No Punishment
The brochure, released last month, says the vaccine has been used for more than 30 years and that death or serious illness has rarely been reported following treatment. It gives information on who to contact in the event of side effects and lists categories of people who should not receive the vaccine, including pregnant women.
The brochure also includes text — demanded last month by Judge Sullivan — that indicates soldiers cannot be punished for refusing the vaccine and will still be deployable.
Immediately following that text, though, it urges soldiers to take the vaccine.
“The consequences of refusing anthrax vaccine include that you will be more vulnerable to lethal anthrax infection. Your loss could threaten the lives of others in your unit who depend on you, and could jeopardize the success of the mission,” it says.
Such language in the brochure and verbal pressure, the Michels said, will likely be used to pressure soldiers into taking the vaccine.
“I believe that at the end of the day, this program for a lot of these soldiers is not going to be purely voluntary. There is going to be a lot of pressure brought to bear on people to take the shot,” he said.
The DOD press release Wednesday said commanders would inform personnel of “an option to refuse the vaccination without penalty.”
‘Potential for a Heightened Risk’
Deputy Defense Secretary Paul Wolfowitz in December requested the emergency authorization from the head of the Food and Drug Administration, citing a November intelligence report that he said indicated “a significant potential for a military emergency involving a heightened risk” of an anthrax attack on U.S. forces.
The vaccination brochure is less circumspect in its description of a threat.
“U.S. military forces are at high risk of attack with anthrax spores. A significant potential for a military emergency exists. … Your military and civilian leaders strongly recommend anthrax vaccination,” it says.
The vaccinations “for the most part,” will be limited to personnel assigned to homeland biological terrorism defense missions and to the U.S. Central Command and Korea, according to a DOD statement released Tuesday. Adult family members and U.S. government contractors also may be asked to take the vaccine, according to a separate military notice.
The Food and Drug Administration’s determination on whether to license the vaccine for prevention of inhalation anthrax is still pending. A public comment period on the proposed license ended in March and Food and Drug Administration officials are presumably reviewing those comments before making its determination.
“The issue of mandatory vaccination will be reconsidered after the FDA completes its administrative review, which DOD expects to occur later in 2005,” the brochure says.
Global Security Newswire
WASHINGTON — In announcing the resumption of anthrax vaccinations for military personnel this week, the U.S. Defense Department abandoned a fiercely defended policy against voluntary vaccinations (see GSN, April 1).
The reversal of that policy, however, coincides with relaxed requirements for informing and obtaining the consent of potential recipients before administering such investigational drugs, which are in effect because senior Bush administration officials have declared a potential emergency.
The new plan was announced Tuesday in a press release. The vaccinations were ordered to resume under a “emergency use authority,” which was based on a Pentagon determination last December that a “significant potential [exists] for a military emergency involving a heightened risk to United States military forces of attack with anthrax.”
The Defense Department had halted mandatory anthrax vaccinations in October, after a U.S. District Judge Emmet Sullivan ruled the drug was not yet fully licensed by the Food and Drug Administration as effective against inhaled anthrax and so could not be made mandatory.
The military previously opposed administering the vaccine voluntarily, arguing it could weaken U.S. forces were soldiers to opt out. “We fight as a team. All team members must be healthy. That’s why voluntary vaccination is not an option,” states a Defense Department Web site published to inform service people about the vaccine.
The drug has been licensed for skin-contracted anthrax since 1970, and used by textile workers, but not for inhalation anthrax, the type that would be expected in an attack on U.S. forces.
Some soldiers in past years have been court-martialed for refusing to take the vaccine.
A Pentagon Web site says the vaccine causes serious adverse side effects in “about 1 in 100,000 vaccinations.”
More than 1 million military personnel have been required to take the vaccine in recent years. Hundreds have been assessed and treated for severe reactions by a special network of centers (see related GSN story, today).
Relaxed Information and Consent Requirements
The “emergency use authorization” invoked by senior Bush administration officials enables the military to give voluntarily vaccinations without more stringent legal requirements for informing soldiers about the side effects of the vaccine or obtaining their written consent.
Federal law normally would require that personnel be told that the vaccine is investigational and not approved for its intended purpose. Furthermore, all possible side effects must be disclosed and the person must sign a form consenting to the vaccination.
Under a law signed last year allowing for emergency use authorizations, military authorities only are required to “establish such conditions … as the [defense] secretary finds necessary or appropriate” so that personnel are informed of “significant known and potential benefits and risks of such use.”
An informational brochure the Defense Department said it will give service members before they are offered the shots lists only more common, minor side effects expected from the vaccine, such as itching, swelling and nausea.
A number of service members have reported symptoms such as chronic headaches and debilitating muscle and joint pains and weakness, and more serious illnesses, that have taken them out of service.
The brochure also does not mention the vaccine is investigational for inhalation anthrax.
“The emergency use authorization is much more generic with regard to the information that’s got to be provided to people [normally under U.S. law],” said Lou Michels, an attorney in Chicago representing six anonymous military and civilian personnel who sued government officials over the prior mandatory program.
Pressure, No Punishment
The brochure, released last month, says the vaccine has been used for more than 30 years and that death or serious illness has rarely been reported following treatment. It gives information on who to contact in the event of side effects and lists categories of people who should not receive the vaccine, including pregnant women.
The brochure also includes text — demanded last month by Judge Sullivan — that indicates soldiers cannot be punished for refusing the vaccine and will still be deployable.
Immediately following that text, though, it urges soldiers to take the vaccine.
“The consequences of refusing anthrax vaccine include that you will be more vulnerable to lethal anthrax infection. Your loss could threaten the lives of others in your unit who depend on you, and could jeopardize the success of the mission,” it says.
Such language in the brochure and verbal pressure, the Michels said, will likely be used to pressure soldiers into taking the vaccine.
“I believe that at the end of the day, this program for a lot of these soldiers is not going to be purely voluntary. There is going to be a lot of pressure brought to bear on people to take the shot,” he said.
The DOD press release Wednesday said commanders would inform personnel of “an option to refuse the vaccination without penalty.”
‘Potential for a Heightened Risk’
Deputy Defense Secretary Paul Wolfowitz in December requested the emergency authorization from the head of the Food and Drug Administration, citing a November intelligence report that he said indicated “a significant potential for a military emergency involving a heightened risk” of an anthrax attack on U.S. forces.
The vaccination brochure is less circumspect in its description of a threat.
“U.S. military forces are at high risk of attack with anthrax spores. A significant potential for a military emergency exists. … Your military and civilian leaders strongly recommend anthrax vaccination,” it says.
The vaccinations “for the most part,” will be limited to personnel assigned to homeland biological terrorism defense missions and to the U.S. Central Command and Korea, according to a DOD statement released Tuesday. Adult family members and U.S. government contractors also may be asked to take the vaccine, according to a separate military notice.
The Food and Drug Administration’s determination on whether to license the vaccine for prevention of inhalation anthrax is still pending. A public comment period on the proposed license ended in March and Food and Drug Administration officials are presumably reviewing those comments before making its determination.
“The issue of mandatory vaccination will be reconsidered after the FDA completes its administrative review, which DOD expects to occur later in 2005,” the brochure says.
