Judge Emmet Sullivan of the U.S. District Court in the District of Columbia issued a ruling Wednesday recognizing an emergency authorization from the Department of Health and Human Services as being able to meet the restrictions of his earlier injunction.
The court issued the injunction against the program Oct. 27, after determining that the medication called Anthrax Vaccine Absorbed -- used to protect service men and women against inhalational anthrax, a possible bioweapon -- was not properly licensed for that use. The injunction could be lifted if the Food and Drug Administration approves the vaccine for that application or the president signs a waiver, Sullivan said.
The Bioshield Act signed into law last year added a third option that Defense Department lawyers then asked the court to include. It allows the department to seek an Emergency Use Authorization from HHS to use an otherwise unapproved drug under emergency circumstances. The Pentagon needs only to certify that an emergency or a potential emergency exists.
Last December, that is exactly what defense officials did and HHS granted the EUA in January.
There is one significant difference, however, between a new EUA inoculation program and its predecessor: Soldiers and others asked to take the vaccine as part of their military service can refuse. The original program was mandatory and people were disciplined, even court martialed, because they refused the series of six shots.
Under an EUA, people must to be allowed to refuse without penalty or the court will impose heavy fines. Sullivan has gone so far as to review personally the wording in a pamphlet to be given to those being asked to take shots, in order to be sure it clearly states they can refuse. He also ordered weekly reports on any vaccinations that fell outside the EUA.
No date has been set for resumption of the shots, though William Winkenwerder, assistant secretary of defense for health affairs, told a House subcommittee Wednesday he was optimistic it would be done soon.
The matter is far from over. The injunction remains in place and there is a possibility the legality of the EUA will be challenged.
Rep. Chris Shays, R-Conn., has said granting an EUA for such a purpose was beyond the scope and intent of the law.
Sullivan appeared to invite a challenge to the EUA when he said his ruling did not address the emergency authorization's merits or legality.
"This court expressly makes no finding as to the lawfulness of any specific EUA that has been or may be approved by the Department of Health and Human Services," Sullivan wrote.
Some 1.3 million Defense personnel have been vaccinated since the program first started in the early 1990s. At that time, roughly 150,000 individuals headed to the Middle East for the first Gulf War were given the shots. The program was stopped and then restarted in earnest in 1997.
Vaccine critics have said it causes serious side effects and the early shots are suspected as a possible cause or contributing factor to Gulf War Syndrome. Resistance to taking the vaccine, manufactured by Bioport of Lansing, Mich., has grown in recent years, though some 20 studies have attested to its safety, the Defense Department said.
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