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Anthrax Vaccine Announcement Expected Within the Month

American Forces Press Service

WASHINGTON, Feb. 28, 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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