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Vaccinations Continue as Army Commissions Anthrax Studies

By Douglas J. Gillert
American Forces Press Service

WASHINGTON, Oct. 7, 1999 – An interagency team of medical experts will coordinate long-term studies on the safety and effectiveness of the anthrax vaccine.

Responding to concerns of some service members and their families, the Army's Anthrax Vaccine Immunization Program office established a committee to look closer at the vaccine. The office falls under the Army surgeon general, executive agent for the DoD anthrax immunization program.

The committee includes representatives from DoD, the Food and Drug Administration, Centers for Disease Control and Prevention and the Armed Forces Epidemiological Board. Defense officials described the committee as a "roll-up-your-sleeves working group" intended to define research needs and set up studies to answer questions raised about the vaccine.

A variety of researchers will be used, possibly including existing federal research scientists, contracted civilian universities and independent researchers, officials said.

But even as the Army looks for problems with the vaccine, DoD will continue requiring service members to receive the shots.

"Anthrax is considered the No. 1 biological threat in the world today," said Lt. Col. John Grabenstein, deputy director of the Anthrax Vaccine Immunization Program. "It is lethal on the battlefield." Because service members may be vulnerable, it's necessary to continue inoculating them against anthrax while the studies are conducted, he said.

The first studies of the anthrax vaccine's safety were reported in the Bulletin of the Johns Hopkins Hospital in 1958, 12 years before the Food and Drug Administration approved and licensed it for use. Additional studies have followed through the years. Grabenstein, who co-chairs the committee, said it's common to continue studying long-term effects after a vaccine is approved for human use. In the case of anthrax, however, earlier and ongoing studies have been more extensive, he said.

"Continuing to collect more data is simply part of our proper responsibilities for assessing the safety of this vaccine," he said.

Some of the more favorable information on the anthrax vaccine comes from Fort Detrick, Md., where laboratory workers at the Medical Research Institute of Infectious Diseases have received the shots for nearly 30 years without discernible problems.

"Of 1,700 laboratory workers followed for 10 to 25 or more years after anthrax vaccination, none developed any unexplained symptoms due to repeated doses of anthrax or any other vaccine they received," Grabenstein said. "Those are the folks that give us the greatest confidence in the safety of this vaccine."

In another study at Tripler Army Medical Center in Hawaii, 600 hospital workers were evaluated after getting the first three of six required doses. "We're planning a follow-on study after they receive their fourth, fifth and sixth doses, and we'll continue monitoring them for a period of time," Grabenstein said.

Another study uses databases to, for example, compare individual shot records against hospital visits to see if any unusual patterns appear.

What hasn't been decided is what new research the committee will commission, if any. "That's why we are bringing in scientists from the FDA, CDC and Armed Forces Epidemiological Board -- to give us the nation's best advice," Grabenstein said.

The studies look for signs that the vaccines may cause more than initial side effects, such as increased long-term cancer or reproductive health risks. But Grabenstein said there's no reason to expect they'll find anything that so taints the anthrax vaccine it will cease to be licensed for use.

"There have been no long-term or delayed effects from other vaccines, and we don't have any reason to expect it to happen with the anthrax vaccine," he said. "But we're going to make sure." The latest studies will last from a few to 10 or more years.

"We're going above and beyond standard requirements to provide additional information to satisfy questions from service members," he said. "It's important for us to have not just a good vaccine but have public confidence in the vaccine."

Grabenstein said he and others associated with vaccine studies don't expect to find any major problems with the anthrax vaccine.

"People who have gotten 10 or 30 years worth of flu shots don't have long-term effects from those shots," he said. "That's a good analogy of what we expect with multiple doses of anthrax vaccine over time, and that's what has already become apparent at Fort Detrick."

The human immune system is designed to confront multiple challenges with multiple defenses, Grabenstein said. "Your body is able to carry around in it simultaneously a billion different antibodies. We have a wonderful defense capability with our immune system."

Vaccines serve as so-called "dress rehearsals" for attacking real microbes, Grabenstein said. "The vaccine prepares you so that if you're confronted with the real microbe -- in this case, the anthrax weapon -- you literally have a layer of armor to protect you, but the armor's inside you.

"Anthrax vaccine is just another vaccine," he said. "There's nothing special about it -- no quality waivers were granted by the FDA, and there were no shortcuts in its production process. It is a quality vaccine. I got in line to get mine with no hesitation. I see no reason to avoid it, and I recommend it to everybody for personal protection."

For more information about the anthrax vaccine and the DoD anthrax vaccination program, visit the Anthrax Immunization Program Web site at http://www.anthrax.osd.mil.

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