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As this issue of Medical Ethics Advisor went to press, the Centers for Disease Control and Prevention (CDC) in Atlanta confirmed 22 cases of anthrax infection — four of them fatal — in the United States.1 Considering that all of the cases have been civilians working in the private sector — and that most of the cases have been linked to contaminated letters sent through the mail — many are questioning why all available vaccine is reserved for the Department of Defense and use of the anthrax vaccine is still solely restricted to members of the military.
"When the risk is high, we must re-evaluate our position about making vaccines available to the public," Mohammad N. Akhter, MD, MPH, executive director of the American Public Health Asso-ciation told members of the Senate Committee on Health, Education, Labor and Pensions during testimony on Oct. 9. Akhter asked that a national committee of experts from the medical, scientific, and intelligence communities be formed to evaluate the risks and benefits of providing both anthrax and smallpox vaccine available to the population at large. Because antibiotic treatment for pulmonary anthrax infection is less effective once symptoms have appeared, it is essential that a vaccine be part of public health preparedness for a large-scale bioterrorist attack, Akhter contends.
But he is not suggesting that current stockpiles of the vaccine, now reserved for military personnel, be made available to vaccinate civilians, he clarifies. In fact, until a newer vaccine is developed, debate about vaccinating civilians is a moot point. "First, the vaccine takes about a month to become effective, and it takes about a year to complete the course of treatment," Akhter explains. The vaccine must be given in six separate shots over the course of 18 months, which is not practical for vaccinating large numbers of the public.
Plus, significant questions remain about the safety of the existing anthrax vaccine, says David C. Straus, MD, a professor of microbiology and immunology at Texas Tech University Health Sciences Center in Lubbock.
There is only one manufacturer in the United States — BioPort Inc. of Lansing, MI — authorized to make the vaccine. But citing deficiencies in the company’s manufacturing and quality control processes, the Food and Drug Administration (FDA) has refused to allow BioPort to produce new vaccine for the past 3½ years. The Department of Defense, currently BioPort’s only customer, wants to buy enough vaccine to inoculate all 2.4 million active and reserve military personnel. However, it still cannot obtain enough vaccine to do so.
The vaccine also has never been approved by the FDA as a measure for preventing inhalation anthrax — the most deadly form of the disease. It has only been demonstrated to be effective at preventing cutaneous anthrax. "You would never use this vaccine to vaccinate everyone in the country," Straus says. "First of all, not everyone in the country is going to come into contact with this stuff. The vaccine still doesn’t have FDA approval, and there is not enough of it." Following allegations (never clinically proven) that the anthrax vaccination was linked to the development of Gulf War Syndrome, several active-duty military personnel have faced discipline and court-martial rather than agree to take the vaccine, he adds. "I have not seen clear discussion one way or the other about how safe and effective this vaccine is," Straus says. "The best thing to do is what they are doing now, treat people with antibiotics who they know have been exposed, or think there is a strong likelihood they have been exposed."
Secretary of Health and Human Services Tommy Thompson indicated that two-thirds of his department’s requested $1.5 billion to combat bioterrorism will be designated to fund development of new antibiotics and vaccines. Once a suitable vaccine is developed, it should be targeted to civilians who are at risk, as well as military personnel, adds Akhter.
"We know of many situations now in which people are more likely to be exposed, postal workers and mail sorters, obviously," he says. "Also, people who work in labs and people who do investigations of these cases, certainly, they should be candidates to be vaccinated — not just the military."
1. Centers for Disease Control and Prevention. Update: Investigation of Bioterrorism-Related Anthrax and Adverse Events from Antimicrobial Prophylaxis. MMWR 2001; 50:973-976.