Friday, June 10, 2005

U.S. Armed Services Outline Implementation of Voluntary Anthrax

By David Francis
Global Security Newswire



WASHINGTON - The attorney representing six anonymous Defense Department
employees in a suit that stopped a U.S. Defense Department's mandatory
anthrax vaccination program is praising implementation plans outlined
by the
Armed Services last month for a voluntary inoculation program (see GSN,
May
23).

However, John Michels, counsel for the Pentagon employees who requested
and
received an injunction against the mandatory program last October,
questioned why the guidance does not require soldiers to give consent
to
receive the actual vaccination. Instead, under the new practice,
vaccine
candidates are asked to acknowledge that they have received a brochure
outlining the risks associated with the vaccine.

"They don't actually have the guys signing for consent," Michels said.
"They
have to sign, 'Yes, I've gotten the brochure,' but they don't give
consent
to be vaccinated. I don't understand why."

"Why not say I certified that I received the brochure and I consent to
be
vaccinated?" Michels asked.

Calls to the Pentagon for clarification on consent were referred to the
individual branches of the Armed Services. Calls to the branches were
not
returned at press time.

Despite his confusion over consent, Michels is pleased with the
implementation plans. He said many of the requirements for
vaccinations,
allowed under emergency use authority granted to the Pentagon by the
Food
and Drug Administration, mirror what he has been asking the Pentagon
for
since the original suit was filed.

"This looks an awful lot like what we asked for," Michels said. "We're
surprised they're going through all this trouble." Michels believes
the
Pentagon is taking special care to ensure no legal challenges to the
emergency use authority.

The EUA, which allows for voluntary inoculations, took effect at the
beginning of May and expires at the end of June. It can be extended by
the
Food and Drug Administration. Throughout May, military branches gave
instructions to commanders on how to implement the voluntary program.

The Pentagon has appealed the original ruling that stopped the program
in
hopes of resuming mandatory vaccinations.

Program Implementation

The requirements outlined in actions plans for the Army, Navy, Air
Force and
Marines are generally similar. Vaccinations are limited to troops
deployed
in Central Command theaters, such as Iraq and Afghanistan, and in
Korea.
Soldiers must be informed that a federal court stopped the mandatory
program
and that all vaccinations are voluntary, and superior officers cannot
pressure anyone to take the vaccine.

All wishing to receive the vaccine must be briefed on the risks and
benefits
of the vaccines by their commanders, and must acknowledge receipt of
the
brochure explaining these risks. The Air Force requires a soldier sign
the
brochure, while the Army, Marines and Navy only require a roster be
kept of
who received the information.

All data on immunization will be entered into the soldier's medical
file and
tracked electronically using the system of each respective branch.
Refusals
will also be tracked. Reports of adverse events associated with the
vaccine will be tracked in the Vaccine Adverse Events Reporting System.

If a soldier is transferred outside of Central Command or Korea, the
regimen
of vaccination shots does not have to continue.

The Coast Guard's plan is much more limited, only allowing vaccinations
of
personnel in specific areas determined by the Pentagon.

Vaccinations cannot begin until the Military Vaccine Agency certifies
that
the brochures explaining risks are received by the individual branches.

Michels said these requirements ensure soldiers are well-informed
before
taking the vaccine, and know they have the option to refuse.

"This is starting to look more and more like the practice of medicine,"
he
said.

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