The United States will soon have enough smallpox vaccine for its population.
A supposedly forgotten stockpile of 70 to 90 million doses of frozen vaccine was recently discovered by Aventis Pasteur of Lyon, France. ``It's a great insurance policy,'' stated D.A. Henderson, Director of the newly created federal Office of Health Preparedness. Negotiations are underway regarding cost and liability.
A randomized trial using vaccines made before 1982 shows that the existing supply could be stretched by dilution. Sixty healthy, previously unvaccinated adults received undiluted vaccine, a 1:10 dilution, or a 1:100 dilution, with 20 in each group. Vaccinia vesicles occurred in 19 of the full-strength vaccine recipients, 14 of the second group, and three in the 1:100 dilution group. One month after vaccination, 34 of the 36 patients who developed vesicles showed antibody responses to smallpox, compared to just one of the 24 patients who did not show evidence of a ``take.'' Cytotoxic T-cell and interferon-gamma response were found in 94% of vesicle patients and only one non-vesicle patient (N Engl J Med 2002;346:1275, and www.immunizationinfo.org).
Two new vaccines, Acam1000 and Acam2000, produced by United Kingdom-based Cambia, are currently in Phase 2 clinical trials.
The FDA has approved none of the vaccines for marketing, and all will require individual informed consent until 2003.
Controversy rages over what should be done with the vaccine. Researchers at the University of Michigan stated that in a mass immunization campaign, up to 25% of Americans would have to be excluded because of conditions such as an organ transplant or cancer treatment. In the remaining 75% of the population, up to 4,600 people would be expected to suffer ``serious but survivable'' reactions and up to 285 would die from the vaccine side effects. Millions more would suffer relatively minor side effects (Atlanta Journal-Constitution 4/19/02). Persons with suppressed immune systems would be at risk simply from coming in contact with vaccinated persons, who shed live virus from the vaccination site. Individuals with skin disorders like eczema, atopic dermatitis, or acne could be at risk for potentially fatal complications, even if the condition occurred in childhood. Additionally, widespread immunizations could cause a blood shortage because donors are rejected for a year after vaccination (LK Altman, NY Times 5/10/02).
Because of the vaccine risk, CDC officials favor a ``ring containment'' strategy in the event of an attack. This is modeled on the World Health Organization's successful strategy for eradicating natural smallpox. However, this method might be ineffective in a terrorist attack with multiple sources of infection. Therefore, some recommend making smallpox vaccine available to the public as soon as possible and allowing Americans to decide for themselves what is best for them. A woman who wants to become pregnant, for example, might choose to be vaccinated beforehand so that she would avoid exposing her unborn baby to vaccine risk during an attack.
``Widespread, voluntary vaccination before exposure will greatly reduce the number of victims if an attack occurs,'' stated William Bickness, M.D., former director of the Massachusetts Department of Public Health. Spread would be slowed as even a small fraction of vaccinated persons would create ``community immunity.'' Fewer persons would need to be vaccinated during an attack. And lowering the chance of a successful attack would have a deterrent effect (V de Rugy, CV Peña, ``Responding to the Threat of Smallpox Bioterrorism: an Ounce of Prevention Is the Best Approach,'' Cato Institute Policy Analysis 434, 4/18/02, www.cato.org).
Is all this concern misplaced because ``the variola virus is not long for this world,'' having received a ``stay of execution'' only to permit researchers a little more time to study it? ``Retentionists'' are clashing with ``destructionists.'' Virologist Peter Jahrling of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Ft. Detrick, Maryland, argues that the variola virus is needed to develop new drugs and vaccines. For example, an animal model could be used to test antivirals such as cidofovir (Vistide), which is now used to treat cytomegalovirus infections in persons with AIDS and has protected macaque monkeys from lethal exposure to monkeypox with a single dose (Wall St J 3/19/02). But Alfred Sommer, dean of the Johns Hopkins School of Public Health, went ``berserk'' about the animal model, labeling the research ``abhorrent'' and the scientists ``idiots of the worst sort.'' He thinks that destroying the virus would ``send a strong signal to any country with illicit stocks that holding smallpox in reserve as a possible weapon is morally repugnant'' (Science 2002;295:2001-2005).
While VECTOR, a maximum-security research facility in Russia, may be only one of two places on Earth where it is permitted to keep variola stocks, the virus may have many other fortresses. Ken Alibek, former head of the Soviet bioweapons program, stated that Iraq in the 1980s ran an infamous program to turn the smallpox virus into a biological weapon for the Soviets. An Iraqi defector claims that Saddam Hussein has built a fleet of mobile biological weapons trucks, virtually undistinguishable from vehicles used to carry frozen food (Vanity Fair, 5/02).
One of Iraq's partners in terror may be Cuba. John Bolton, Undersecretary of State for Arms Control, has also accused Cuba of supplying dual-use technology to Syria and Libya. Cuba is one of the few developing countries that engages in major biotechnology and drug activities, with advanced capabilities in genetic engineering. Alibek believes that Cuba may have the ability to create genetically modified germ weapons immune to American antibiotics and vaccines (J Miller, NY Times 5/7/02; D Eberhart, NewsMax 5/20/02). ``Circumstantial evidence'' pointing to ``motive, means, and opportunity'' for the development of biological (and chemical) weapons in our own backyard demands serious investigation, states Ernesto Betancourt, who worked with Fidel Castro in 1959. A particularly suspicious feature is that an ``animal feed plant'' is well protected by rapid-action defense units, according to a ``confidential report smuggled from Cuba'' cited by Agustín Blázquez. La Fabriquita could be producing a new variant of anthrax toxin totally resistant to treatment. If the report is true, ``the blackmail potential that this represents renders the U.S. and its people in grave danger and in an almost impotent situation.'' (See Spring 2002 issue of The Medical Sentinel, the journal of the Association of American Physicians and Surgeons: at www.aapsonline.org, click on ``Cuban Bioterror Link.'')
Register now for the 19th annual meeting, to be held at the Sheraton Hotel in Colorado Springs, CO, the last weekend in July. The deadline for our hotel room block, with the special room rate of $99, is June 23. The reservation number: (800) 325-3535. This year, The American Civil Defense Association (TACDA) is coordinating its meeting with ours, so you may want to come in time for their program on Friday, July 26 (see enclosed flyer for speaker list). Our NORAD tour has been approved for Monday morning, July 29, but only for 35 participants, so be sure to call immediately if you wish to be included.
Late program addendum: Nobel Prize nominee Jan Rosinski, one of the few members of the Polish Resistance to survive, plans to attend. His pathbreaking work on the role of space debris in atmospheric phenomena, including the ``ozone hole,'' will be presented by his mathematical theoretician Tom Kerrigan.
DDP, 1601 N. Tucson Blvd. Suite 9, Tucson, AZ 85716, (520)325-2680, www.oism.org/ddp.