WASHINGTON — In March 1998, the Defense Department made anthrax vaccination mandatory for all military personnel deployed to high-risk areas such as Iraq and Afghanistan because of fears in the U.S. intelligence community that the deadly bacteria could be a top threat based on concerns dating to the first Gulf War that Iraq was developing spores for use as a biological weapon.
But the Defense Department’s vaccination policy doesn’t follow government health agency recommendations regarding how many doses of the vaccine should be administered. And the vaccine, BioThrax, is controversial, with concerns raised about the vaccine’s adverse side effects and whether it effectively protects soldiers because no long-term efficiency study has been performed on humans.
Full protection requires a series of five shots, according to guidelines issued by the Food and Drug Administration. However, reservists receive an average of 3.7 shots, according to statistics provided by the Defense Department’s Military Vaccine Agency. Figures for active duty were not available.
Lt. Col. Patrick M. Garman, deputy director of the Military Vaccine Agency, said the Defense Department’s policy doesn’t adhere to the FDA’s recommendation because inoculation is not a perfect science and individuals have some protection after one dose.
Dr. Beatrice Golomb, an associate professor of medicine at the University of California at San Diego who has researched the immune response to BioThrax since the first Gulf War, said though it is plausible that one or two doses of BioThrax could provide sufficient protection for some individuals, immune responses are different so others would need more shots.
An official from Emergent BioSolutions Inc., the only company licensed to produce BioThrax, acknowledged that no conclusive study is available to pinpoint what level of antibodies a person needs to be considered fully protected against the threat of anthrax.
During service members’ first pre-deployment training, they must begin the vaccination series with the first shot and follow through with the FDA-approved dosing schedule while deployed. Once they return to the U.S., continuing the series is their responsibility. The schedule included six shots until 2008, when a Centers for Disease Control study concluded five shots were sufficient for full protection and the FDA amended its requirement.
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said, a five-shot vaccine is “just not practical” for reservists because they are not full-time military and can’t keep up with the dosing schedule over an 18-month period because they are not authorized to get medical care from the military after they return to civilian life.
Tui Marshall is a member of the Oklahoma National Guard currently on his third deployment, this time to Afghanistan. After 11 years in the service, he has only received three doses of BioThrax, even though he said he wants to finish the series.
“I would have to pay out of pocket,” said Marshall. And the appropriate medical facilities don’t always have the vaccine readily available, he said.
It’s important that guardsmen be fully vaccinated because an anthrax attack would most likely occur in the U.S., and guardsmen serve as first responders, said Barry Kellman, president of the International Security and Biopolicy Institute. “When everyone else is running away, they are running into the center of chaos,” he said.
The anthrax vaccine was developed by the Army more than 50 years ago, and was first licensed in 1970 by the National Institutes of Health. For decades, it was primarily used to immunize agricultural workers who could contract naturally occurring anthrax through contact with infected livestock. The vaccine wasn’t used for mass inoculations until government officials determined at-risk military personnel should be vaccinated in the 1990s.
The Defense Department’s immunization program protocol has changed since the program began. In 1997, the department stated in a news release that the immunization program to begin the next year would consist of all six inoculations.
By March 1999, Undersecretary of Defense Rudy de Leon wrote in a memorandum, “Ideally, personnel should receive at least the first three vaccinations in the series.”
The current implementation policy says, “It is DoD policy to use the anthrax vaccine consistent with the FDA-approved dosing schedule.’’ This schedule requires five doses, plus annual boosters.
The policy also says: “All individuals who begin the anthrax vaccine dosing series shall be informed of the recommended dosing schedule and advised to return to the vaccination clinic at the appropriate times under the schedule.”
Because full inoculation takes 18 months, longer than most deployments, Garman explained, the military’s focus is getting service members to begin the series, giving them some, if not complete protection.
“It’s not a clear, red line or hurdle that you jump over to make you fully protected,” Garman said. “You have some protection after one immunization.”
Early in the program, more than 400 Air National Guardsmen and Air Force Reservists were severely reprimanded or discharged for refusing the vaccine based on safety concerns—with some claiming that an adverse side effect, ranging from redness and fatigue to neurological disorders and death, could affect their flight status and cause a subsequent career setback.
“The word is out on this vaccine,” said Steve Fischer, a National Guardsman for more than 25 years. Fischer became violently ill after receiving his third shot in 1999, and went from an able-bodied master electrician to being unable to perform basic functions. “I lost ability in my hands, I could barely lift my feet to step up on a curb, and I had sores all over my face,” he said.
Within months of getting sick, Fischer was discharged from the guard.
A 2002 Government Accountability Office report concluded that 77 percent of Air National Guardsmen and Air Force Reservists would have declined the vaccine had it been voluntary.
More than 7,260 adverse reactions to BioThrax have been reported according to the National Vaccine Information Center. With more than 10 million shots administered, the reaction rate is less than 1 percent. But Fischer and other experts said possibly thousands of reactions went unreported because troops were pressured not to report symptoms.
In 1997, the Defense Department estimated the anthrax immunization program over a six-year period would cost $130 million. Officials from the Military Vaccine Agency couldn’t provide a total spent on the program during its 13 years.
But Emergent BioSolutions Inc., a Rockville, Md., firm, has received more than $360 million in government contracts, according to USAspending.gov. This doesn’t include costs for transporting, storing and administering the vaccine. Government officials, including Garman, said producing a total is complicated by fluctuations in the vaccine’s price over the years, as well as the difficulty in tracking expenses across several branches of the government.
One dose of BioThrax today costs more than $30, in 1998 it cost under $4—a more than 800 percent increase.
“An increase in price reflects the fact that they’ve got something of value,” Kellman said. “But that logic only works if Emergent had actually developed the vaccine itself. They didn’t; they were given the technology to produce the vaccine from the U.S. government.”
Emergent BioSolutions’ Vice President of Corporate Communications Tracey Schmitt said many factors enter into the pricing, including costs to maintain an FDA-compliant manufacturing facility and standard inflation adjustments.
“Dozens of audits and financial reviews have been conducted by various government agencies,” she said. “Each has concluded that the pricing structure is both fair and reasonable.”
Caplan said a new vaccine requiring fewer doses is needed, and the technology exists to create it.
Dr. Thomas Inglesby, director of the Center for Biosecurity at the University of Pittsburgh, said that though much of the experimental work for a new vaccine is done, it’s still years away from being licensed. “It’s worth asking the government and industry whether everything that could be done is being done to move this technology forward rapidly,” he said.
Although the wars are winding down, the U.S. government is stockpiling millions of doses of BioThrax for civilian use. “Many people think you are going to be able to lean on a vaccination program in the event of a large-scale attack,” Caplan said. “But if you look at the military program, it may not be true that we’d get satisfactory results after all.”