WASHINGTON, April 1 (UPI) -- The Department of Defense effectively was cleared Friday to resume vaccinating military service members with the controversial anthrax vaccine, but it also was placed under court order to submit weekly reports to assure the vaccinations would remain voluntary.
The inoculation program was suspended last Oct. 27 after U.S. District Court Judge Emmet Sullivan ruled the compound -- called Anthrax Vaccine Absorbed or AVA -- had not been properly approved for use against inhalation anthrax. It was illegal, the judge said, to administer it to service personnel until the Food and Drug Administration properly approved the drug. As a result he issued an injunction against the program.
When the injunction took effect, the only way AVA could be used prior to FDA approval was either with a presidential waiver or with the informed consent of those who agreed to the vaccination. The original program was mandatory and those who refused vaccination often were disciplined -- even court-martialed.
At the Friday hearing, however, Sullivan agreed to a Pentagon request to modify his injunction to allow vaccinations under a special emergency waiver called an Emergency Use Authorization.
The EUA was issued in January 2005 by the Department of Health and Human Services and the FDA under new authority granted by the Bioshield Act. Bioshield, the same bill that allocated over $5.5 billion for the purchase of new vaccines, was signed into law last year.
The modification will allow the military to proceed with its inoculations as long as it gives each serviceman or woman a brochure about the vaccine and makes sure they are aware they can forego vaccination without fear of penalty. That last point was very important to Sullivan, who said the change he was making to the injunction would not take effect until Monday, so it would give the Pentagon time to lay out a plan for making clear to military personnel they could refuse vaccination for anthrax.
"This is a weighty decision people have to make," Sullivan said. "I want them to know they have choices."
Effectively ignored in the debate, however, was the amount of information that would be provided to those facing inoculation. Under the original informed-consent approach, each person would have received a full statement of the vaccine's risks.
The brochure submitted to the court falls far short of that, critics said. While limiting the information slashes the amount of paper work -- a practical consideration in the face of vaccinating potentially thousands of enlisted, reserve and contract personnel -- it also means the Pentagon will not have to describe problems with the vaccine in detail.
The greatest concern has been the voluntary nature of the shots, not the question of informed consent, said Mark Zaid, an attorney representing opponents to the vaccine.
"Congress allowed the (Defense Department) to exempt informed consent in this statute," Zaid told United Press International. "I am not sure there is anything we can do about that."
Congress will review the issue again, said Lawrence Halloran, staff director and counsel for the House Government Reform Subcommittee on National Security.
"I suspect," Halloran told UPI, "we are talking about a hearing before anything else where we get HHS and FDA and DOD in here and say 'What were you thinking?'"
Sullivan made it clear whatever use was made of the EUA, the injunction remained in place. He ordered the Pentagon to submit weekly reports on any vaccinations given outside the permission granted by the EUA.
The reports will show zero violations, assured attorney Andrew Tannebaum, who spoke on behalf of the Pentagon.
"If the answer is anything other than zero, the court will consider high monetary fines," Sullivan said. "I'm talking high five figures or six figures."