By Sgt. 1st Class Kathleen T. Rhem, USA
American Forces Press Service

WASHINGTON, Feb. 26, 2002 – Defense officials expect to
announce within a month what shape the new Anthrax Vaccine
Immunization Program will take.

In 1998, the department began an aggressive program to
vaccinate all service members against the disease – a
potential biological warfare agent. The vaccination program
came under public criticism because of some service
members' fears about the vaccine's safety.

Critics became more vocal when Defense officials scaled
back the program several times due to vaccine shortages.
Bioport, the sole manufacturer of the vaccine, worked with
the FDA for over three years to gain approval of its
renovated facilities as supplies of FDA-released anthrax
vaccine dwindled.

Bioport received final FDA approval in January to resume
production and distribute more vaccine. Defense Department
officials are now looking at how or even whether to
continue the previous program of full vaccination of all
service members.

"We've undergone a very thorough process over the last
several weeks looking at options and have discussed those
with people both on the military medical side as well as
the non-medical side (and) civilian leadership, and we will
soon be making some announcements," Dr. Bill Winkenwerder
said.

Winkenwerder is the assistant secretary of defense for
health affairs. He said he understands the concerns service
members have and wants to allay any fears among the troops
and the American public.

Military medical officials have asked the Armed Forces
Epidemiological Board and the Institute of Medicine to
conduct a scientific review of the safety of the vaccine
and report back to the department. Winkenwerder said he
expects those reports to be "available in the near future."

DoD is working with the Centers for Disease Control and
Prevention in Atlanta on clinical studies into how the
vaccine is administered. Currently, the FDA-approved
regimen is six shots over 18 months.

DoD officials would like to find out if that could be
reduced to five or even four shots over a shorter period of
time, said Army Col. Randy Randolph, director of the
Anthrax Vaccine Immunization Program Agency. Randolph said
the CDC is ready to begin enrolling volunteers for clinical
studies designed to determine if the number of doses can be
reduced while maintaining the same level of immunity. Any
change will require FDA approval.

The study will also look at the method of administering the
vaccine to see if it's possible to reduce the injection-
site reactions currently reported. The most common side
effect associated with the anthrax vaccine is a localized,
minor reaction at the site of injection. Randolph said
roughly 30 percent of men and 60 percent of women report
minor reactions less than an inch in size.

More serious reactions are rare, he said. Less than one
percent of men and women receiving the vaccine report a
local reaction of larger than five inches.

Today the only FDA-approved method of injecting the vaccine
is to do so subcutaneously, meaning it is injected just
below the skin. A pilot study indicated injecting the
vaccine into muscle tissue, called intramuscularly, might
reduce such reactions tenfold, Randolph said.

Local reactions are not dangerous, but Randolph said they
are still worth trying to reduce. "No one likes swelling,
and no one likes pain and redness," he said.

Winkenwerder said DoD began vaccinating troops "in response
to a perceived threat of anthrax being used as a biological
terror agent." Anthrax-laced mail delivered to various
government and media offices in October 2001 show those
concerns to have been well-founded.

Whatever form the military vaccination program takes now,
Winkenwerder said he is confident this vaccine works and is
safe. "Our primary concern is the safety and the health of
… the service men and women and their families," he said.
"On the basis of the FDA's review and the basis of very
extensive work we've done and others outside of DoD have
done to look at the safety and effectiveness (of the
anthrax vaccine), we believe -- and I personally believe --
that this is a safe and effective vaccine."

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