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THE VACCINE APPROACH TO BIOLOGICAL WEAPONS
DEFENSE: SOME POINTS TO PONDER.

Prof. Garth L. Nicolson
(email: gnicimm@ix.netcom.com )

Chief Scientific Officer and Professor
The Institute for Molecular Medicine
15162 Triton Lane
Huntington Beach, Ca 92649

The Deputy Secretary of the Department of Defense, John Hamre, and the Surgeon General of the Army, LtGeneral Ronald Blank, have strongly supported the U.S. vaccine strategy for Biological Weapons (BW) defense, such as against weapons-grade anthrax (Bacillus anthracis), a commonly used spore-forming bacteria that causes death within 1-6 days of lethal exposure. Although this is probably the most commonly manufactured and used BW weapon, it is only one of over a dozen BW agents that have been produced in large quantities suitable for deployment and tactical use in recent years. It is also one of the few BW agents where commonly used commercial vaccines actually exist that are capable of preventing most (but not all) lethal infections. Unfortunately, there are a number of considerations that must be taken into account before such vaccines should be considered extremely effective against the types of BW weapons likely to be encountered in future conflicts.

1. The vaccine against Bacillus anthracis to be administered by the U.S. Armed Forces to over one million men and woman is claimed to be highly effective as an anti-BW strategy. I have not been able to find any published scientific evidence for this claim (effectiveness against weapons-grade anthrax strains of Bacillus anthracis modified to be more pathogenic and evasive than the usual strains found in the environment). The published data do not include an examination of the effectiveness of various vaccines against infections via inhalation of aerosolized anthrax spores, nor do they include data for highly pathogenic strains of anthrax that are likely ones to be encountered in an actual BW attack.

2. In general, the medical and scientific reports on the effectiveness of vaccines against Bacillus anthracis are limited to examination of the protection of animals against injected sublethal or lethal doses of the microorganism. In a real BW attack, many times the lethal (human) dose could be encountered in an aerosolized BW and chemical mixture that is designed to inhibit and overwhelm the body's defensive abilities. "Russian Doll Cocktails" containing microorganisms plus macrophage and other inhibitors are likely to be used in BW attacks to impede the immune system's ability to contain the infection by blocking pulmonary macrophages. The pulmonary macrophage is the first level of defense against inhaled foreign microorganisms. In addition to destroying many of the inhaled microorganisms or preventing their entry into the body, macrophages help mobilize another arm of the immune system that contains the "memory T cells" (a type of immune "helper" cell preprogrammed by prior immunizations that tell other immune cells to attack the infection directly or produce antibodies against the infectious agent) that are essential in immune responses of the types that vaccines are designed to stimulate.

3. What assurances do we have that future vaccines will be free of bacterial contamination that could cause disease? Obviously, the purity and safety of vaccines depend on their abilities to remain free of contamination by the same or other microorganisms. When I dared to present this as a possibility to a group of Defense Department physicians and scientists, I was roundly attacked. Vaccine preparation methods are considered adequate to prevent this as a possibility, but unless each "batch" or lot of vaccine is routinely tested for possible contamination, including animal testing, this remains a possibility that must be carefully examined, not uncritically dismissed as a remote hypothetical possibility.

4. BW use on the battlefield of the future will likely involve MULTIPLE agents, not just one or even a few. Countries like Iraq operate under "Soviet War Doctrine," a battle strategy that stresses combinations of conventional and unconventional weapons. This means that combinations of multiple BW, CW (Chemical Warfare) or even NW (Nuclear Warfare) agents may be used together to confuse the diagnosis and treatment of casualties. The rationale is to overwhelm a medical corps ability to effectively manage large numbers of casualties with unknown or incomplete diagnoses. Iraqi Field Manuals found during the Gulf War described this strategy in detail. Unfortunately, the vaccines against other likely BW agents are even less proven and more problematic than the anthrax vaccine. I know of no scientific information on the effects of and prevention of disease due to combinations of different BW agents.

5. The vaccine against Bacillus anthracis to be administered to the U.S. Armed Forces is considered safe. As evidence for this, the Dept of Defense has stated that there have been few adverse reactions to the vaccine to be used. If our most recent conflict, the Persian Gulf War, is any example of our ability to monitor adverse reactions, the provisions for recording and monitoring of adverse reactions to vaccines were extremely poor. I have personally interviewed veterans (and I have also interviewed several nurses involved in the vaccinations) who described classical vaccine reactions in the Gulf, possibly due to the injection of multiple vaccines all at once or within a short period of time. The multiple use of vaccines administered at the same time could have resulted in immune suppression in many solders. This, in turn, could have inadvertently increased the chance of opportunistic infections taking hold that under ordinary circumstances might have been preventable.

6. Our strategy of defense against BW agents is prior immunization using multiple vaccines. Unfortunately, this can only be successful if the exact BW agents likely to be encountered are known in great detail and for some time in advance of exposure. For example, most effective commercial vaccines against Bacillus anthracis require a rather lengthy immunization protocol, administering multiple vaccine and booster doses over a period of a year or more. If multiple vaccines are to be administered, then they would have to be administered at different times to prevent immune suppression. Obviously, this strategy requires advance knowledge of the threat and careful long term preparation against the threat. Any new threat that arises will require some time to prepare for, possibly years.

7. What information exists that supports the rationale that multiple immunizations will protect against a BW attack using multiple BW agents? I know of no published scientific information that tests the hypothesis that vaccines can protect against simultaneous exposure to multiple aerosolized agents. In addition, I know of no evidence that there is a vaccine that protects against all strains of a single agent. Recently in the press reports it appears that the Russians have developed Bacillus anthracis strains for which they claim protective vaccines do not exist. Irrespective of the accuracy of such reports, what is the evidence that our "multivalent" Bacillus anthracis vaccine will protect against all known anthrax strains?

8. Are there other strategies besides the vaccine approach to BW defense? During the Gulf War the French forces elected not to use vaccines as a primary defense against Iraqi BW and not to use anti-nerve agents as a defense against Iraqi CW. Instead, they used prophylactic antibiotics to counter Iraqi BW, and they depended on protective suits to counter Iraqi CW. Interestingly, the French Armed Forces were the ONLY nation in the Coalition Forces that did not report any cases of Gulf War Illness, nor were there any illnesses reported in the immediate families of French Gulf War veterans. In contrast, in U.S. forces there are now well over 100,000 veterans with Gulf War Illnesses, and according to U.S. Senate report, in many cases these illnesses have spread to immediate family members.

9. Are there ways to counter prophylactic antibiotic use for BW defense? Yes, BW agents can be modified or "constructed" that have integrated into their genetics antibiotic-resistance genes. Just like the "engineering" of more lethal BW agents to circumvent known vaccines, such microorganisms can be "engineered" to resist specific antibiotics. Oddly enough, certain U.S. units were issued antibiotics like ciproflaxin and doxycycline just before the ground offensive in the Gulf War. These antibiotics would be expected to be effective in preventing infections of at least two of the agents identified in veterans with Gulf War Illness (Mycoplasma fermentans and Brucella spp.). Examination of the numbers, deployments and types of casualties and their diagnoses in the units administered antibiotics before and during the Gulf War could tell us if the French approach to BW defense was more or less effective than our approach of administering multiple vaccines to prevent BW casualties.

Although our Armed Forces must be mission oriented for their success in any future conflict, we owe it to the men and women who serve to be just as forceful, thoughtful and careful about their protection when we place them in harms way.

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