Judge to Allow Voluntary Anthrax Vaccinations
By David Ruppe
Global Security Newswire
WASHINGTON — The U.S. Defense Department can resume vaccinations for anthrax, but should make additional efforts to inform potential recipients that the shots are not mandatory, a federal judge said in a ruling read today but held until Monday (see GSN, March 30).
U.S. District Court Judge Emmet Sullivan said the vaccinations could occur under an “emergency use authorization” issued by senior government officials in January, which allows for voluntary vaccinations using drugs not licensed by the Food and Drug administration — without soliciting the informed consent of the potential recipients.
Lawyers representing six unidentified soldiers and civilian contractors who sued the government to stop the mandatory vaccinations have argued that soldiers could more readily be pressured to take the vaccine under the emergency use authorization.
U.S. law allows the government to conduct vaccinations with unlicensed drugs after obtaining either the recipient’s informed consent or a presidential waiver of the consent requirement. There has been no such waiver. Citing that law, Sullivan in October issued an injunction to stop a Defense Department program of mandatory mass anthrax vaccinations without informed consent.
However, a law passed last year after that ruling allows unlicensed drugs to be administered voluntarily, without informed consent, in the event of an emergency. Senior government officials declared a state of emergency in January.
Soliciting informed consent includes providing extensive information on the drug’s possible side effects to the potential recipient prior to the vaccination. The emergency use authorization law, lawyers for the plaintiffs said, allows officials to provide less information about potential side effects and is not specific about when such information should be provided.
A U.S. government lawyer, Andrew Tannenbaum, told Sullivan today that he anticipated that the Defense Department would give potential recipients a brochure describing some of the possible side effects prior to vaccination.
Under questioning, though, Tannenbaum conceded that the brochure did not inform potential recipients about Sullivan’s October ruling that the vaccinations could not be compulsory.
Sullivan delayed activation of the ruling until Monday to give the Bush administration time to say first what additional measures it would take to inform potential recipients of the judge’s injunction last year forbidding mandatory vaccinations.
Sullivan suggested posting the ruling prominently at each of the hundreds of military vaccination sites around the world.
“Service-people may not know they have a choice to make,” he said.
The Defense Department has posted the October ruling on a Web page. Sullivan rebuked the department for previously compelling vaccinations for some military personnel after his ruling went into effect.
Global Security Newswire
WASHINGTON — The U.S. Defense Department can resume vaccinations for anthrax, but should make additional efforts to inform potential recipients that the shots are not mandatory, a federal judge said in a ruling read today but held until Monday (see GSN, March 30).
U.S. District Court Judge Emmet Sullivan said the vaccinations could occur under an “emergency use authorization” issued by senior government officials in January, which allows for voluntary vaccinations using drugs not licensed by the Food and Drug administration — without soliciting the informed consent of the potential recipients.
Lawyers representing six unidentified soldiers and civilian contractors who sued the government to stop the mandatory vaccinations have argued that soldiers could more readily be pressured to take the vaccine under the emergency use authorization.
U.S. law allows the government to conduct vaccinations with unlicensed drugs after obtaining either the recipient’s informed consent or a presidential waiver of the consent requirement. There has been no such waiver. Citing that law, Sullivan in October issued an injunction to stop a Defense Department program of mandatory mass anthrax vaccinations without informed consent.
However, a law passed last year after that ruling allows unlicensed drugs to be administered voluntarily, without informed consent, in the event of an emergency. Senior government officials declared a state of emergency in January.
Soliciting informed consent includes providing extensive information on the drug’s possible side effects to the potential recipient prior to the vaccination. The emergency use authorization law, lawyers for the plaintiffs said, allows officials to provide less information about potential side effects and is not specific about when such information should be provided.
A U.S. government lawyer, Andrew Tannenbaum, told Sullivan today that he anticipated that the Defense Department would give potential recipients a brochure describing some of the possible side effects prior to vaccination.
Under questioning, though, Tannenbaum conceded that the brochure did not inform potential recipients about Sullivan’s October ruling that the vaccinations could not be compulsory.
Sullivan delayed activation of the ruling until Monday to give the Bush administration time to say first what additional measures it would take to inform potential recipients of the judge’s injunction last year forbidding mandatory vaccinations.
Sullivan suggested posting the ruling prominently at each of the hundreds of military vaccination sites around the world.
“Service-people may not know they have a choice to make,” he said.
The Defense Department has posted the October ruling on a Web page. Sullivan rebuked the department for previously compelling vaccinations for some military personnel after his ruling went into effect.
