Monday, April 04, 2005

Pentagon clear to give anthrax shots again

By Dee Ann Divis
Senior Science & Technology Editor

WASHINGTON, DC, Apr. 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

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

"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

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