Air Force Times
3 May 1999
COVER STORY Page: 12
Anthrax / Everything You Want To Know About The Vaccine Before You Get Your Shot
By Deborah Funk
More than a quarter million soldiers, sailors, airmen and Marines have been inoculated against anthrax since Defense Secretary William Cohen ordered the shots for all service members more than a year ago.
Yet although none of them reported suffering anything worse than short-lived reactions, rumors, fears and concern about the vaccine continue to ripple through the active-duty and reserve ranks. Roughly 200 troops have actually refused the shots, in some cases facing discipline and even discharge from service as a result.
The naysayers question the vaccine's safety and efficacy. They ask: Will the vaccine cause them long-term health problems? Will it protect them against all strains and all forms of anthrax? Is the vaccine manufacturer reliable and safe? Why is the vaccine made with outdated technology?
They hear complaints: One Michigan Air National Guard unit reports some of its members experienced allergic reactions -- blistering, sweating and rashes -- following the vaccinations.
What is anthrax?
Anthrax is a naturally occurring bacterial disease.
It can appear in three forms -- cutaneous, which infects the skin and ulcerates and is the least fatal; gastrointestinal, which attacks the digestive system; and inhalation, the deadliest form and the one most likely to be used by an enemy in a biological weapon.
Military officials say inhalation anthrax is at least 95 percent fatal if untreated, which is one reason it's so high on the list of biological warfare agents. The other is that it's easy to replicate.
Is vaccination necessary?
Vaccination makes plain, good sense, says Arthur M. Friedlander, an Army colonel and doctor who is the science adviser to the U.S. Army Research Institute of Infectious Diseases at Fort Detrick, Md.
Anthrax weapons pose a "significant threat," he says.
"It would be malpractice not to vaccinate someone who is put in harm's way with the possibility of exposure to anthrax," Friedlander says.
Is the vaccine's manufacturer safe and reliable?
The Defense Department buys the anthrax vaccine from BioPort Corp., a Lansing, Mich., company formerly known as the Michigan Biologic Products Institute. BioPort is the only producer of the vaccine, and the company has been cited for quality control and manufacturing practices. The Food and Drug Administration, which licenses vaccines, threatened to revoke the company's manufacturing license two years ago, based on inspection of two vaccines unrelated to anthrax.
Robert Myers, chief operating officer of BioPort Corp., said the warning was not particularly unusual. The FDA increasingly is sending such letters to manufacturers.
The plant has submitted to the FDA samples for every lot it has manufactured, he said.
The plant stopped making anthrax vaccine more than a year ago to undergo defense-funded renovations to the manufacturing line, and is now about to start producing the vaccine again. But it could be nine months before newly manufactured vaccine is released.
Did the anthrax vaccine help cause Gulf War illness?
One reason critics fear extensive vaccinations is because the Defense Department did such a poor job of recording who got which vaccines prior to the Persian Gulf War. Indeed, thousands received the inoculations, but the Defense Department can't tell entirely who did and who did not. So critics charge officials can't prove that the anthrax vaccine is unrelated to the mysterious illnesses that still plague some Gulf War veterans.
Pentagon health officials say that the vaccine didn't make troops sick, and that two independent panels support their contention.
The Presidential Advisory Committee on Gulf War Veterans' Illnesses said it is unlikely that the anthrax vaccine, alone or in combination with another vaccine, caused health effects reported by Gulf War veterans.
The Institute of Medicine said there was no evidence that vaccines in general caused the ailments. This time around, though, the Defense Department has a state-of-the-art tracking system in place for the anthrax vaccination program, defense officials say.
One of the most vocal critics of the anthrax vaccination program is Dr. Meryl Nass, a civilian physician in Maine and a member of Physicians for Social Responsibility, an arms control advocacy organization. But she's one of only a very few health professionals to question the vaccine's safety and efficacy.
Nass spent three years studying the 1979-80 anthrax outbreak in Zimbabwe, the world's largest, and more than a year reviewing literature about the American anthrax vaccine.
She says her research suggests that the complaints raised by some who received the vaccine are very similar to the autoimmune disorders associated with Gulf War illnesses. And she notes that some animal studies show that the vaccine produces little protection against some strains of anthrax. So, thanks to advanced biotechnology, more virulent strains of anthrax could be resistant to this vaccine and other medical therapies, she said.
Why aren't there any long-term studies of the anthrax vaccine?
The package insert that comes with the anthrax vaccine states clearly that no long-term studies have been conducted to determine whether the vaccine has carcinogenic or reproductive health repercussions.
Such a warning can be alarming.
But the lack of long-term research is fairly typical for vaccines, according to Barbara Loe Fisher, co-founder of the National Vaccine Information Center, a nonprofit organization that launched the vaccine safety movement more than 15 years ago.
Other commonly used vaccines for which such information is unavailable include chicken pox, polio, measles, mumps and rubella, she said.
Is the vaccine safe?
Yes, according to the Food and Drug Administration. An independent science advisory panel concluded in 1985 that the anthrax vaccine did not pose medical risk.
The anthrax vaccine was licensed in 1970, after studies showed it protected textile mill workers against cutaneous anthrax when they handle contaminated fur or hides.
But those studies didn't look for effectiveness against inhalation of the virus because that wasn't the disease of the day. Still, the label doesn't restrict its use to any particular type of anthrax.
From 1991 through 1997, only four adverse reactions to the vaccine were reported to the FDA. And while 80 more adverse reactions have been reported since 1998, when the Pentagon started administering the vaccine en masse, that's not many considering that, as of March 10, 218,965 U.S. troops had received at least one of the six doses required for vaccination.
Nass of Physicians for Social Responsiblity argues that the number of adverse reactions is underreported, perhaps by 100 cases.
Most of the reactions reported to federal regulators were mild and contained to the site of the injection. But some were serious and affected other parts of the body.
At least nine troops were hospitalized, and there was one case of Guillain-Barre syndrome, a condition associated with a flu vaccine that can lead to paralysis. Military officials say the service member recovered, with no long-term effects.
Nass argues such evidence does not weigh in on the side of safety.
The only way to know if a vaccine is causing harm is if a number of people suffer the same adverse side effects, Nass said. "In the case of this vaccine I believe that occurred."
Nass said 50 to 100 people have informed her that the vaccine is making them sick. All share the same symptoms: They can't sleep well, concentrate or remember, she said. Their vision is worsening and they can't tolerate loud noise or bright light. They suffer headaches, abdominal cramping, increased thirst and tingling in their arms and legs. Some complain of bloody diarrhea, she said.
Is there any evidence to prove the vaccine is safe?
Yes. There is the original study done in the textile mills, as well as anecdotal information.
Dr. Philip Brachman, whose studies in the late 1950s and early '60s led to the vaccine's development, said he sees no evidence that the vaccine would cause the magnitude of reactions claimed by Nass and others.
Brachman, now a professor at the Rollins School of Public Health at Emory University in Atlanta, said he doesn't know of any long-term ill effects the vaccine would create.
Anecdotal evidence gathered by the Army Research Institute of Infectious Diseases, known as USAMRIID, supports that theory.
More than 1,500 institute workers have received the shot -- some as many as 20 times -- as part of their special immunization program.
None have reported cancer, said Army Lt. Col. (Dr.) Phillip R. Pittman, USAMRIID's medical division chief. Some have fathered or given birth to healthy babies. One did show possible signs of multiple sclerosis symptoms six weeks after receiving her first shot last summer, but USAMRIID officials believe that is a coincidence, he said.
A 1996 USAMRIID study that included 35 women found that seven of the 35 vaccinated women gave birth to healthy children. One has delivered a second healthy child, Pittman said.
Is the vaccine effective?
Probably -- but not absolutely.
When the vaccine was licensed in 1970, it wasn't because of the military or concerns about germ warfare. Back then, anthrax was an occupational disease contracted by coming into contact with contaminated animals, or their fur or hides.
The study focused on preventing cutaneous anthrax because that was the most common form. Results were impressive.
Today's vaccine is even more effective -- four times as potent as the original, Friedlander said.
Whether the vaccine works against inhalation anthrax is another question. Although five cases of inhalation anthrax occurred during the 1970 test, none of the victims of the disease had been vaccinated. But there were too few cases to determine whether it was effective against inhaled anthrax.
How is the vaccine tested?
Today, the rarity of the disease and the practical elimination of a domestic wool mill industry makes further clinical studies impossible.
Instead, researchers test the vaccine with animals, which are then exposed to aerosolized anthrax.
The Institute of Medicine notes in a recent report that "the vaccine has been shown to provide protection in studies using rhesus monkeys."
USAMRIID researchers, who conducted the monkey studies with a highly virulent anthrax strain, say the vaccine gave rabbits similar protection when challenged with equally virulent strains.
Results are less impressive with some other animals. Nass points to Army studies that show only 23 percent to 71 percent of guinea pigs survived when exposed to aerosolized anthrax after vaccination. Mice survived at even lower rates.
"Whether this will carry over to humans has not been established," Nass wrote in the journal Infectious Disease Clinics of North America published by W.B. Saunders Co., Philadelphia.
Test results, says Friedlander, depend on the animal and the particular strain of anthrax used.
Eight of the 32 strains tested on the guinea pigs overcame the vaccine.
But Friedlander says the guinea pig isn't as reliable a predictor of human reaction.
"We believe the rhesus monkey is a better predictor of how humans respond to the anthrax vaccine than the guinea pig," Friedlander said. All but one of the 45 rhesus monkeys exposed to inhalation anthrax survived.
Nass isn't impressed. She says the guinea pig studies can't be ignored because the great bulk of anthrax research has been conducted with guinea pigs.
"They can't throw away the guinea pigs," Nass said.
Does the vaccine guarantee survival of anthrax exposure?
No -- the vaccine is no guarantee.
Some people will develop antibodies to fight the organism, but some may not. Others may be so overwhelmed by the amount of anthrax organisms attacking their body that the vaccine's protection won't be enough, defense and civilian authorities say.
Dr. George Robertson, a microbiologist who is project director for BioReliance Corp., likens the vaccine to any other piece of protective equipment.
"We must understand that this vaccine is like your helmet," says Robertson, who is also an Army Reserve colonel. "We all know that it won't stop every bullet, but going into harm's way, any commander would be derelict if he didn't ensure that the troops wore helmets."
Robertson argues that the vaccine works "most of the time. ... It is very important to recognize that no vaccine is completely protective in all members of a vaccinated population against any dose of a pathogen."
The vaccine, Robertson said, is "the best single measure we can take. However, it is only one part of biological defense."
Can some strains of anthrax overcome the vaccine?
No one knows. The Army Medical Research Institute of Infectious Diseases is trying to obtain a Russian strain of anthrax that is reported to be genetically engineered.
They want to know how stable the product is to determine whether it can be weaponized. And they want to know whether the licensed anthrax vaccine can protect against it.
Can the vaccine be improved?
The Institute of Medicine thinks so.
The U.S. should place greater priority on developing, manufacturing and stockpiling an improved anthrax vaccine, it concludes in its December 1998 report, "Chemical and Biological Terrorism, Research and Development to Improve Civilian Medical Response."
"The current state of knowledge on anthrax pathogenesis and studies of experimental anthrax vaccines indicate that a second-generation vaccine can be developed that could provide protection equal to, or better than, the current vaccine and would require fewer doses," according to the report.
The existing vaccine is made by growing the bacteria in a liquid. The bacteria secrete a protein, called P.A., into the liquid, and then the bacteria are filtered out. Protection comes from the body's ability to develop immunity to the protein.
Notes the textbook, Vaccines: "Clearly a vaccine that is completely defined, that is less reactogenic, and that requires one or two doses to produce long-lasting immunity would be highly desirable".
What is being developed?
Newer vaccines, including one at USAMRIID, have been in development for years.
The Institute of Medicine committee believes a very effective two-dose vaccine is attainable.
Is vaccination prior to exposure the only protection?
No. Gas masks also provide protection.
And antibiotics can protect those exposed if they get them immediately after suspected exposure and for a very prolonged period of time. That treatment could be shortened by combining the antibiotics with vaccination, Friedlander said.
"The best thing is to get the vaccine before you go into harm's way," he said.
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