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The Department Of Defense Anthrax Vaccine Immnuization Program: Unproven Force Protection [PDF]

In February, members of the House of Representatives Government Reform National Security subcommittee released a report reviewing the Department of Defense (DoD) anthrax vaccination program. The House report calls that program ``a well-intentioned but overwrought response'' that might not effectively protect U.S. troops if they were to be exposed to the potentially deadly spores that cause this disease. The report also recommends changing the two-year-old program from mandatory to voluntary for military personnel until a vaccine that can better shield them from biological weapons is developed. The report is based on material presented during seven hearings held by the subcommittee. It was issued by the panel's majority members, who are led by Rep. Chris Shays (R-Conn.).

A member of the Indiana Air National Guard gets her first anthrax inoculation from registered nurse David Cox Saturday, 8 January 2000, at the Indiana Air National Guard Base in Fort Wayne, Ind. At least 12 of the 34 pilots in the Indiana Air National Guard in Fort Wayne refused to take an anthrax vaccination required for an upcoming overseas mission. (AP Photo/The Journal Gazette, Matt Sullivan.)

Pentagon officials immediately challenged the House report, issuing a detailed rebuttal that disputes its central claim that the inoculation program is an exaggerated response to a low-probability threat. ``Anthrax kills and kills quickly,'' the Pentagon response says. ``The enemy has it, and it is easy to employ. If you breathe it, and are not vaccinated, you will die.'' Marine Corps Major General Randy West, the Pentagon's special advisor on germ weapons, insists ``there are a lot of countries that have weaponized anthrax, or are trying to get it.'' According to officials in the Pentagon, at least 10 countries have ``weaponized'' anthrax or are developing germ weapon programs, including China, Iran, Iraq, Israel, Libya, North Korea, South Korea, Syria, Taiwan, and Russia.

In their report, members of the House panel point out that this anthrax vaccine was designed to protect agricultural workers against subcutaneous infec-tion--not to provide mass protection against weaponized, aerosolized anthrax. In effect, its place in the DoD program amounts to an ``off-label'' use, according to the report, which views the safety and effectiveness of the vaccine as ``uncertain.'' The report also says that until a biological attack with anthrax occurs, the effectiveness of the vaccine in protecting against airborne anthrax spores remains ``unproven At best, the vaccine provides some measure of protection to most who receive it [However,] how much protection is acquired, by whom, for how long, are questions the Defense Department answers with an excess of faith, but a paucity of science.''

Pentagon officials say that they, too, would prefer to use a newer version of the anthrax vaccine. However, they insist that the product is safe and effective, and note that it has Food and Drug Administration (FDA) approval. Although there is little research on the inhalation of anthrax spores by humans, DoD officials say, the vaccine should not be regarded as merely investigational. Further, they deny that they have underreported the number and severity of adverse reactions among those who have received the vaccine. Moreover, the officials say, it would be irresponsible to do nothing in light of the increasing threat of biological warfare.

``When a disease is fatal, the use of drug or vaccine animal data is the only way to demonstrate protection in humans,'' Pentagon officials say. ``Obviously, it would be unethical to conduct tests on humans. In circumstances of this kind, reliance on animal data is necessary and appropriate.''

The subcommittee report charges that the Pentagon's reporting system is not designed to identify all adverse events that may have occurred as a result of the vaccinations. The program ``is predisposed to ignore or understate potential safety problems,'' it says, calling the Pentagon's figures ``preposterously low.'' In addition, the report says the vaccine is not needed for 2.4 million troops. ``Born of a post-Gulf War panic over apparent weaknesses in chemical and biological warfare defenses,'' the program is ``an unmanageably broad military undertaking built on a dangerously narrow scientific and medication foundation,'' it says. Thus, despite its size, the narrowly focused anthrax vaccine program is a ``Maginot line'' for germ warfare that would help against only one type of pathogen, when adversaries are likely working on several, if not many, different kinds of such agents.

The DoD vaccination program, begun in 1998, requires six shots over 18 months to protect against anthrax, a bacterial disease of livestock that can also be deadly to humans. To date, 1.4 million injections have been given to about 400,000 troops; the program will ultimately inoculate 2.4 million active-duty troops and reservists. So far, 351 individuals within the U.S. Armed Services have refused to take the vaccine, according to the Pentagon. Officials say that, to date, they have received 620 reports of adverse reactions following injections. These include 106 cases where troops have missed a day of work, and 26 cases where individuals were hospitalized. But of these 26 cases, only 6 could be unambiguously attributed to the vaccine, according to officials.

Marlene Cimons
Marlene Cimons covers health policy for the Los Angeles Times from Washington, D.C.