Who should get the anthrax vaccine?

A federal panel debates making the controversial drug, now restricted to the military, available more widely.

Published November 3, 2001 12:06AM (EST)

The lonesome death of Kathy Nguyen, the Bronx hospital worker who succumbed to anthrax on Wednesday, has raised the pressure another notch on public health officials, who must decide soon whether mail handlers, cops, nurses and even the public at large should receive a controversial vaccine against anthrax.

Until this week, all confirmed anthrax cases had been traced to mailrooms or a handful of letters directed to celebrities or news media. The approach to managing the disease was to blanket potentially exposed individuals with antibiotics, while disinfecting their workplaces.

Authorities haven't ruled out a post office link to Nguyen, a 61-year-old Vietnamese immigrant who lived in the Bronx and worked in a Manhattan hospital. But her case, as well the mysterious, cutaneous-anthrax infection of a New Jersey woman, have raised fears that lethal doses of free-floating anthrax spores could threaten more Americans than previously thought possible, though the threat of mass infection still remains small.

"If, in fact, the postal paradigm is changing, it's a whole new ballgame," said Dr. Anthony S. Fauci, the NIH's top infectious disease specialist. "Not only will it change where we look for anthrax, but also the kind of recommendations we'll be making for the public health."

Fauci, in a speech before hundreds of doctors at the National Institutes of Health on Wednesday, wouldn't speculate about whether the recommendations would likely include vaccination for a large swath of the public.

"You examine carefully what's going on, you collect the data and make a rational decision about the next step," he said. For the moment, it isn't a good idea for the public to get treatment of any kind.

"Twenty-one billion pieces of mail have been delivered since Oct. 2, and there is maybe one case of anthrax outside the context of the Postal Service," he said. "Most infectious disease specialists would agree at this point that the risk of hurting yourself with antibiotics is greater than the risk of getting anthrax from a letter delivered to your house."

But several hundred scientists studying the anthrax attack in CDC laboratories have reportedly started receiving the vaccine. Tens of thousands of postal workers and others potentially exposed to anthrax spores have received antibiotics, but no vaccine.

Currently, a bioterrorism subcommittee of the Advisory Committee for Immunization Practices, at the Centers for Disease Control, is discussing which populations should get the vaccine. The advisory committee should be making its recommendations soon, said panel member Lucy Thompkins, a Stanford microbiologist.

Dr. Charles Helms, an Iowa infectious disease specialist who chairs the subcommittee, says the committee began deliberations last week and is meeting by conference call. "Our decision and when we'll finish are still a bit up in the air," Helms said.

Certainly if anthrax attacks continue -- or the individuals behind the tainted letters decide to conduct an experiment, say, in the subway -- there would be a rising clamor for mass vaccination. But there are several enormous problems with vaccinating the public: Very little of the vaccine exists, and those who've taken the complex, six-injection vaccination course that was designed in the 1950s have complained of side effects, some of them severe.

The most obvious problem right now is the scarcity of the vaccine. The Pentagon is believed to have 24,000 doses, in reserve for use by threatened troops, and as many as 5 million doses more are said to have been stored by BioPort, the Lansing, Mich., manufacturer. But the Food and Drug Administration shut down BioPort's plant three years ago and put an embargo on the 5 million vaccines it has produced, because of worries about possible contamination.

BioPort has been repeatedly cited for FDA violations, including complaints about sterility, equipment maintenance as well as scientific procedure. BioPort's troubles have become a mini-scandal in the halls of Congress, where Reps. Walter Jones, R-N.C., and Christopher Shays, R-Conn., have repeatedly questioned the company's capacity to produce the crucial vaccine, and some have argued that the contract should have been taken from the politically well-connected firm. One of BioPort's owners is Adm. William Crowe, who served as chairman of the Joints Chiefs of Staff during the Reagan administration, but later was one of the few military leaders to back Bill Clinton.

"The most fundamental problem has to do with the quality of the process of vaccine manufacture," a congressional aide who asked not to be named told Salon last month. "They cannot show they can produce the same vaccine of the same potency and consistency twice in a row."

But Health and Human Services Secretary Tommy Thompson said Tuesday that BioPort could release its 5 million stored doses, and start producing 80,000 more a week, as early as Nov. 22. By then, Thompson said, the FDA will have had time to review the company's latest application to reopen the factory. The FDA hasn't committed itself to reopening the plant, said spokeswoman Leonore Gelb. In any case the Pentagon, which owns the doses that have been manufactured to date, would have to release it for wider use.

Currently, anyone known to be in danger of anthrax exposure is getting 60 days of Cipro or doxycycline. That makes them safe through early December at least.

But no one is exactly clear on what to do if the bioterror widens. Neither postal workers nor anyone else can take antibiotics forever. They cause side effects, create drug-resistant bacteria, and only protect you from anthrax as long as you're on them.

Some doctors have suggested that people who worked in exposed areas get vaccinated before they go off antibiotics. Data from U.S. Army experiments on monkeys and from Sverdlosk, where the Russians accidentally released trillions of anthrax spores into the air in 1979, indicate that spores could remain unhatched in the body for longer than two months.

The CDC is pondering who else might need to be vaccinated. Fauci said the immunized group could include "first responders -- people who do the laboratory testing, people who do the decontamination. But there has been no final decision. Same with the mail handlers."

Of course, any decision would be moot for now because there's very little vaccine and the Pentagon hasn't yet agreed to release any of it.

"The discussions are constrained," Fauci said, "by the amount of vaccine available. It's a balancing act between considering something in principle and knowing what amount of vaccine you have available."

Other researchers insist it's premature to talk about vaccinating civilians at all. "My sense is we shouldn't be providing the vaccine to any civilians at this point," said Dr. Gregory Poland, a vaccine expert reached at his office at the Mayo Clinic in Rochester, Minn.

"If you included everyone from the list of first responders you'd have more people than are in the military. Which first providers should get the vaccine -- people in New York? Well then you'll have cops and nurses in L.A. and Chicago complaining. And if you vaccinate them, what about the firemen in Sacramento?"

The protocol for the anthrax vaccine calls for a total of six shots to be administered over 18 months, with yearly boosters -- an impractical proposition for civilians. "A first responder today isn't necessarily a first responder next month," says Poland.

"If we had plenty of vaccine and it took one dose, it'd be a no-brainer. But there's not enough vaccine and you can see the logistical problems."

The anthrax vaccine has been nothing but trouble for the military from the moment it began ordering 2 million troops to be vaccinated in 1998. Only about 500,000 got any vaccine before dwindling supplies forced the military to drastically cut back the program. Fewer than 100,000 troops got all six doses.

The vaccine had been licensed by the FDA in 1970 without large safety and efficacy studies. Hundreds of biowarfare researchers got the vaccine over a two-decade period, but there was little systematic study of its effects prior to the Gulf War, when 150,000 service members got the shots.

After the war, anthrax vaccine was one of the factors blamed for Gulf War syndrome, the vague collection of neurological disorders that thousands of vets complained of. While that link has never been proven, the Institute of Medicine, part of the National Academy of Sciences, reported in September 2000 that "evidence is sufficient to demonstrate an association" between the vaccine and short-term local and systemic effects including redness and swelling at the site of injection. The panel came to no conclusions about the long-term safety profile of the vaccine.

"The vaccine is safe and effective but it is also highly reactogenic," says Poland. Doubts about the vaccine's safety led at least 120 troops to risk courts martial over the past three years, and 500 others quit the military rather than be vaccinated.

The General Accounting Office, the investigative arm of Congress, has released several corrosive reports including one last Tuesday. "In a survey we conducted in calendar year 2000," GAO official Nancy Kingsbury told a congressional panel, "85 percent of National Guard and reserve forces given the anthrax vaccine reported some reactions." A quarter of the guardsmen reported systemic reactions including chills and fevers.

The GAO's latest study suggested that the FDA didn't keep abreast of what BioPort, which conducted its manufacturing in a semi-military environment, was doing with the vaccine. After military complaints about the vaccine, the FDA intensified its oversight and began reporting a series of problems, including contaminated vaccine vials and inconsistent product, at BioPort.

A Pentagon study in 1990 found up to a hundredfold increase in levels of protective antigen, the active vaccine ingredient, after production equipment was changed, Kingsbury reported. The FDA was unaware of the change until this past July, she said.

A number of high-ranking officers have quit the military in the dispute over the vaccine. Maj. Russ Dingle was one of eight Connecticut National Guard pilots who put their careers on the line to avoid the vaccine. Dingle, who also flies for American Airlines, ended up being demoted to a non-flying Air Force Reserve job.

At the time, in 1999, Dingle was copilot in the cockpit of John Ogonowski, whose Flight 11 from Boston to Los Angeles would be hijacked and crash into the World Trade Center on Sept. 11.

"My advice to the postal workers would be to avoid the vaccine, but it's their choice. It had better not be a condition of employment like it was for me," says Dingle.

Other scientists have suggested that what is needed is an entirely new vaccine -- one that might be easier to administer than the six-injection course, or perhaps something that would protect against a variety of biological warfare agents, including smallpox or botulism, not just anthrax. That might sound like a good idea -- but Poland figures it would take at least seven years for such a vaccine to get produced and pushed through the bureaucracy.

"Right now we don't have vaccine," concludes Fauci. "By the time we have vaccine the situation will or will not have evolved to give specific recommendations." The New York case, he adds, "requires an extraordinarily intensive investigation. It may be there's an explanation that fits right into the existing paradigm. Or not."

By Arthur Allen

Arthur Allen writes on health, science and other issues for Salon and Kaiser Health News. He lives in Washington.

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