Mandatory Vaccination: The Legality of the Order to Immunize the U.S. Military Against Anthrax Disease

The purpose of this paper is to examine the legality of former Secretary of Defense William Cohen’s order to United States military personnel to be vaccinated against anthrax disease by mandatory inoculation under the Anthrax Vaccine Immunization Program (AVIP). The paper will discuss known facts about anthrax disease, the threat that anthrax disease poses to United States military forces, the vaccine used to prevent the disease, AVIP, and opposition to the safety and necessity of the vaccine. The paper will then present the arguments for and against the legality of the vaccination order. Finally, the paper will conclude with an assessment regarding the vaccination order and the steps taken by the Department of Defense to promote acceptance of the anthrax vaccine and mandatory inoculation.

INTRODUCTION

On December 15, 1997, Secretary of Defense William Cohen announced the mandatory vaccination of all United States military personnel against the threat of anthrax, beginning with troops stationed in or deploying to specific high threat areas, such as the Middle East and Korea. The decision sparked great controversy and created a tremendous amount of debate, including a series of Congressional hearings pertaining to the safety of the anthrax vaccine and the legality of the order for mandatory inoculation. When the vaccinations began in early 1998, some service members raised their own concerns about the safety of the vaccine while others refused to be inoculated and several individuals resigned from the military rather than receive the immunization.

This leads to the issue currently at hand. Are the orders currently being given to members of the United States Armed Forces to submit to anthrax vaccinations legal and consistent with Presidential Executive Order 13139, federal law and the Uniform Code of Military Justice? To answer this question several issues must be addressed, beginning with the known facts surrounding the anthrax bacteria and anthrax disease.

ANTHRAX

Anthrax is a dangerous disease that can affect both animals and humans. It is caused by the bacterium Bacillus anthracis, which grows naturally throughout the world, including in the United States. The availability of Bacillus anthracis makes it appealing as a biological weapon with the potential to cause substantial destruction and loss of life. What makes anthrax particularly dangerous is that infection can occur without anyone knowing it until it is too late. In its early stages, the disease manifests symptoms that are almost identical to the common cold or flu. Doctors may diagnose infected patients incorrectly and not realize what is happening until it is too late. Anthrax spores, which are tasteless, odorless, and invisible, can infect an individual with a minute quantity, between 10,000 and 20,000 spores (Alibek, 1999, p. 77).

There are three known types of anthrax infection: cutaneous, gastrointestinal, and inhalational. Cutaneous, or “skin” anthrax, is the most naturally occurring type of the disease, a result of bacteria entering through a break in the skin. While death is generally rare if given antibiotic therapy, up to 20 percent of untreated cases can be fatal (www.anthrax.osd.mil). Gastrointestinal anthrax is very rare in the United States. It occurs when an individual eats raw or undercooked meat that is contaminated with the anthrax bacteria. Death results in anywhere from 25 percent to 60 percent of cases (www.anthrax.osd.mil). Inhalational anthrax occurs when anthrax spores are breathed in and enter the lungs. The disease progresses very rapidly and, if left untreated, results in death in 99 percent of cases (DoD AVIP Information Pamphlet, 2002, p. 2). Inhalational anthrax is highly lethal, easily manufactured, and can be spread through a variety of delivery systems. Because of its deadliness, it is the type of anthrax most likely to be used by enemies of the United States and therefore poses the greatest biological warfare threat to American military personnel.

THE ANTHRAX THREAT

Senator Bill Frist, the United States Senate’s only physician, has defined bioterrorism as “âÂ?¦the intentional release of potentially deadly bacteria, viruses, or toxins into the air, food, or water supply” (Frist, 2002, p. 22). The intentional release of anthrax would most likely be in the form of aerosolized anthrax spores because the spore form of the bacteria is highly stable and easily produced (Just the FactsâÂ?¦Anthrax, 2001, p. 1). Rapid advances in the technology needed to deliver biological agents have made it easy for countries and terrorist groups to use anthrax as a biological weapon. All of the technology needed to produce anthrax is what is known as “dual-use,” meaning that it can be used for legitimate purposes, as well as for the production of biological weapons. In other words, any country with basic healthcare or pharmaceutical industries has the capability to produce weaponized anthrax.

Because it is so deadly and can be produced so easily, aerosolized anthrax poses the greatest threat of all known biological warfare agents. Anthrax spores remain stable for very long periods, as was demonstrated by British experiments during World War II that left Gruinard Island uninhabitable for forty years (www.anthrax.osd.mil). The fact that aerosolized anthrax has the potential to cause massive casualties to American military forces is demonstrated in several studies conducted to estimate the casualties that would result from an anthrax attack. According to the Journal of the American Medical Association, the World Health Organization in 1970 estimated that 50 kilograms of Bacillus anthracis released over an urban population of five million would cause 250,000 people to become sick and 100,000 people to die (Anthrax as a Biological Weapon, 2002, p. 2238). Ken Alibek, a former biological warfare expert in the former Soviet Union, estimated that 100 kilograms of anthrax spores would, in optimal atmospheric conditions, cause up to three million fatalities in any of the densely populated metropolitan areas of the United States (Alibek, 1999, p. 8). Finally, a 1993 report by the United States Congressional Office of Technology Assessment estimated that 130,000 to 3 million deaths could result from the aerosolized release of 100 kilograms of anthrax spores upwind of Washington, D.C. (AVIP: Information about�, 2002, p. 3).

While casualty estimates may differ slightly, one fact remains clear: the threat is real and failure to take adequate precautions could result in grave consequences. American military forces are deployed throughout the world, and as such are vulnerable to biological weapons that are well within the reach of some terrorist groups and several nations.

Increasingly, experts fear that chemical and biological weapons may become the preferred weapons of international terrorist groups (Taylor & Taylor, 1992, p. 91). Senator Bill Frist offers several reasons for terrorist groups to choose biological agents over other methods of attack. First, it is very difficult to trace a biological agent back to its source. Second, neither sophisticated knowledge nor significant resources are required to launch a bioterrorist attack, and the materials are relatively easy to acquire. Third, a substantial biological arsenal could be developed in a fifteen-foot-square room with only $10,000 worth of equipment (Frist, 2002, p. 25). Additionally, bioterrorism may be embraced by terrorist groups because of what these types of weapons can accomplish. The main goal of terrorism is to intimidate and sow fear, which is exactly what happens with biological weapons. Terrorists are driven by deep-rooted beliefs and there is no limit to the level of violence that they are willing to commit in the pursuit of their goals. Biological weapons are merely one more method for terrorists to use to inflict massive casualties and cause fear and intimidation.

According to Randall Katz, at least ten nations, including the People’s Republic of China, Iran, Iraq, Israel, Libya, North Korea, South Korea, Syria, Taiwan, and Russia, are developing an offensive capability for anthrax use as a biological weapon (Katz, 2001). These countries realize that chemical and biological weapons are cheap, easy to produce and hide, hard to trace, and capable of causing massive destruction and significant loss of life. Therefore, chemical and biological weapons serve as a credible substitute for nuclear weapons and these countries are developing significant stockpiles, delivery systems, and production facilities. Two of these countries pose the most immediate threat to Americans and the international community: Russia and Iraq.

In 1992, Russian President Boris Yeltsin acknowledged that the former Soviet Union had an extensive biological weapons program (www.anthrax.osd.mil). Aerosol technologies had been developed and tested and anthrax and smallpox weaponization were far along in the development process. With the collapse of the Soviet Union in the early 1990s, an unknown number of Soviet scientists with vast biological warfare expertise and knowledge were suddenly unemployed and available to whoever would be willing to pay for their services. The anthrax threat is underscored by the fact that
Soviet defectors revealed that anthrax had been loaded into missiles, bombs, and artillery shells and would have been used in the event of war in Europe (www.anthrax.osd.mil). The lethality of weaponized anthrax was illustrated in 1979 in Sverdlovsk in the former Soviet Union. The accidental aerosolized release of anthrax spores from a military microbiology facility caused an unknown number of anthrax infections and fatalities. Ken Alibek called the accident at Sverdlovsk “âÂ?¦the worst single outbreak of inhalational anthrax on record this century” (Alibek, 1999, p. 75).

While the possibility of Russian scientists selling their skills to the highest bidder or of terrorist groups or rogue nations developing and deploying biological weapons is of great concern, arguably the gravest and most immediate threat to American military personnel is the Iraqi attempt to develop weapons of mass destruction, including chemical, biological, and nuclear.

On July 1, 1995, Iraq acknowledged that it had produced thousands of gallons of anthrax and botulinum (Miller, Engelberg & Broad, 2001, p. 184). It further acknowledged that its weapons specialists had tested and produced artillery shells, bombs, and missile warheads that could deliver their biological weapons (Miller, Engelberg & Broad, p. 186). By the time United Nations weapons inspectors identified and destroyed Iraq’s main biological warfare facility in 1996, the regime of Saddam Hussein had amassed hundreds of thousands of gallons of liquid anthrax and several other biological agents (Alibek, 1999, p. 278). Iraq has also admitted that before the Persian Gulf War it manufactured 100 botulinum bombs, 50 anthrax bombs, and 7 aflatoxin bombs (Smith, 2002). It is now known that when U.S. forces faced the Iraqi Army in Southwest Asia in 1990 and 1991, Iraq had deployed 200 bombs and 25 ballistic missiles laden with biological agents (Zilinskas, 1997). Of those 25 missiles, 16 were filled with botulinum, 5 with anthrax, and 4 with aflatoxin (Smith, 2002).

Iraq’s biological manufacturing infrastructure consists of more than 80 research, development, and production facilities (Zilinskas, 1997). The British intelligence service, MI6, has told British government officials that Iraq may still possess chemical warfare agents, the materials necessary to produce biological agents and as many as 10 Scud missiles with which to deliver them (Smith, 2002). There is much speculation that Saddam Hussein did not use his chemical and biological weapons in the Gulf War because he knew that he could lose the war and remain in power. A major concern for U.S. military forces, given the current situation with respect to Iraq, is that if an attack has the objective of removing Saddam from power, there will be no incentive for him to refrain from using his weapons of mass destruction.

Given the threat that anthrax poses to United States military personnel, it is no surprise that the former Director of the Central Intelligence Agency, James Woolsey, called anthrax “âÂ?¦the most dangerous threat to our national security in the foreseeable future” (www.anthrax.osd.mil). To counter this threat, the BioPort Corporation of Lansing, Michigan manufactures and distributes an anthrax vaccine, known as Anthrax Vaccine Adsorbed, or AVA.

THE VACCINE

Vaccines are among the most important accomplishments in the history of medicine. They work by stimulating the immune system to produce antibodies, buying valuable time for the body to prepare defenses against germs. They offer a layer of protection that antibiotics alone cannot provide. At the beginning of the twentieth century, smallpox, diphtheria, and measles were among the leading causes of death in the United States. Thanks to the development of vaccines to battle these diseases, they are no longer a serious threat to the health of American citizens.

The United States military needs healthy troops to complete their assigned missions. Vaccines help to keep U.S. forces healthy by protecting them against dangerous germs that could harm individuals and affect unit missions. American forces suffered 5,500 smallpox casualties out of 10,000 troops at the battle of Quebec in 1776 (www.anthrax.osd.mil). As a result, General George Washington began using a technique called variolation, a predecessor of vaccination, in 1777. From 1777 to the present, vaccines have had a tremendous effect on the health of U.S. troops. Typhoid casualties in the Spanish-American War of 1898 numbered 20,000. During all of World War I, there were only 1,500 typhoid casualties, thanks to the vaccination of American military forces (www.anthrax.osd.mil).

The anthrax vaccine produced for the United States military is known as Anthrax Vaccine Adsorbed, or AVA. The anthrax vaccine works the same way as other vaccines do, by causing the body to make protective antibodies against the bacterium Bacillus anthracis. AVA was first licensed as an anthrax vaccine by the U.S. Food and Drug Administration in November 1970. The vaccine consists of six doses. The first three doses are given at two-week intervals, and three additional doses are given six months after each previous dose, with annual booster shots for continuing protection.

The frequency of side effects associated with the anthrax vaccine AVA is similar to the occurrence of adverse reactions in other vaccines. Many people have reported headaches, muscle aches, and various injection site reactions, including redness, swelling, pain, burning, and itching. Redness up to an inch wide occurs in 30 percent of men and 60 percent of women, while only 1 percent of vaccinated individuals report redness more than five inches across (www.anthrax.osd.mil). These reactions are generally temporary and usually work out on their own in a matter of days. Serious side effects are not common, and many medical experts agree that no deaths and only rare side effects have been caused by AVA. The Department of Defense, the Food and Drug Administration, the Centers for Disease Control and an independent panel of civilian physicians review reports of death or serious illness possibly associated with AVA. These groups all agree that AVA is not associated with any unexpected adverse reactions (www.anthrax.osd.mil).

Use of AVA expanded in 1991, when the U.S. military, concerned that Iraq possessed biological weapons containing anthrax spores, administered the vaccine to approximately 150,000 American troops deployed to Saudi Arabia for Operations Desert Shield and Desert Storm (www.bioport.com). After United Nations weapons inspectors confirmed that Iraq had an extensive biological weapons program, the Department of Defense announced the mandatory vaccination of all U.S. military forces.

AVIP

On December 15, 1997, Secretary of Defense William Cohen announced a plan to immunize the entire United States military against anthrax. The Anthrax Vaccine Immunization Program (AVIP) was implemented because countries hostile to the United States had developed anthrax as a biological weapon and because terrorist groups had the potential to acquire and use anthrax weapons against American military forces. The basis for the implementation of the AVIP was Presidential Executive Order 13139, which directed the use of safe and effective vaccines to protect U.S. military forces against biological weapons (EO 13139, 1999).

Secretary of Defense Cohen outlined four conditions that had to be satisfied before the immunizations could begin. First, there had to be supplemental testing of vaccine lots already produced to ensure potency, purity, sterility, and safety, in accordance with Food and Drug Administration guidelines. Second, the Secretary of Defense had to approve the service branch’s implementation plans. Third, a system had to be in place to track all anthrax vaccinations. Finally, there had to be a review of the health and medical aspects of the entire program by an independent medical expert (AVIP: Information aboutâÂ?¦, 2002, p. 4). Once the first three conditions were fulfilled, the former dean of the Yale Medical School, Dr. Gerald Burrow, conducted an independent review and concluded that the entire anthrax vaccination program, including the health and medical aspects, was completely effective and safe (Katz, 2001).

To set the example for all U.S. military personnel, senior defense leaders, including Secretary of Defense Cohen, were among the first individuals to be immunized with the anthrax vaccine. Vaccinations began in Southwest Asia in March 1998 and in South Korea in August 1998. Once the immunizations had begun, some service members began to raise concerns about the safety and effectiveness of the vaccine. Other military personnel refused the vaccine and were subjected to punishment under the Uniform Code of Military Justice or by Court-Martial. Still others resigned from military service rather than be injected with the anthrax vaccine. The debate surrounding the anthrax vaccine helped to spur Congressional hearings as to the safety of AVA and the legality of the order for mandatory inoculation.

THE CONTROVERSY

The majority of resistance to the anthrax vaccine has come from National Guard and Reserve service members, although there have been some active duty forces who have refused the vaccine as well (Gillert, 1999). The Department of Defense maintains the position that U.S. military forces fight wars as teams, and that all members of those teams must be healthy. This is the reason why the anthrax vaccination must be mandatory for everyone. Opponents of mandatory anthrax immunization take many different stances with regard to the vaccine. Generally, there are five arguments that have questioned the necessity and safety of the vaccine.

The first viewpoint opposing the anthrax vaccine argues that anthrax has never been used in war and, even if it is used, is unlikely to be an effective weapon. Supporters of the anthrax vaccine argue that anthrax is widely available, highly stable, easily produced, and readily weaponized. Of all biological agents, anthrax, it is argued, poses the gravest and most immediate threat to American military personnel. Anthrax casualties would destroy the combat effectiveness of units and place a tremendous burden on the military health care system. Department of Defense leaders argue that the risk from not immunizing troops against anthrax is one that they are not willing to take, claiming that large numbers of American service members will die if unvaccinated troops are exposed to the anthrax bacterium. Based on the known weapons of mass destruction development programs of several nations hostile to the United States, inhalational anthrax is a legitimate threat.
The second argument made by opponents of the anthrax vaccine is that other protective measures, such as protective masks and antibiotics, will provide sufficient protection against an anthrax attack. The Department of Defense counters that it protects American troops with biological detection devices, protective gear, and antibiotics, but these protective measures have limitations that make it a necessity for an additional layer of protection against the most serious biological threat, anthrax.
The Biological Integrated Detection System (BIDS) can determine the presence of anthrax in about 30 minutes (Alibek, 1999, p. 284). While 30 minutes is a shorter period of time than would be necessary for initial symptoms to manifest themselves, it is not fast enough to prevent exposure to anthrax spores.

Similarly, while protective clothing and gas masks provide some defense against the anthrax agent, they are inadequate for total defense. Protective masks and clothing are only effective if they are being worn at the time of the attack. Since any biological attack will likely be a surprise, troops would have to be in suits and masks at all times, which is not only unlikely, but also detrimental to mission accomplishment. American military personnel cannot stay in protective gear for unlimited periods and be expected to perform their missions well.

The main problem with relying on antibiotics is that there is no sure-fire way to determine exposure. Additionally, antibiotics alone cannot prevent a lethal infection once anthrax spores have produced signs of illness. After it has been determined that an anthrax attack has occurred, it is desirable to start antibiotic therapy to increase the likelihood of survival. Antibiotics, when used in conjunction with vaccination, provide the best possible odds of survival.

The Department of Defense maintains that anthrax vaccination provides the best overall protection available. In addition, unlike physical protective devices or antibiotics, AVA protects military personnel without the requirement for advance warning or detection of a biological attack.

Third on the list of arguments against the anthrax vaccine is the contention that AVA is not effective against all strains of anthrax, especially bioengineered strains. Opponents of the vaccine have argued that anthrax strains could be developed that would cause the disease despite vaccination. The Department of Defense counters by arguing that every disease-causing strain of the bacterium Bacillus anthracis produces the same protein, and that AVA stimulates the immune system to produce antibodies that neutralize that protein (Desk Ref�, 1999, p. 18).

The Department of Defense and the Food and Drug Administration cite several studies to support the claim that the anthrax vaccine is effective. Researchers from the Centers for Disease Control conducted field studies of the anthrax vaccine in the late 1950s that demonstrated over 90 percent effectiveness in mill workers (DoD AVIP Information Pamphlet, 2002, p. 4). During this study, which was designed to measure the effectiveness of the vaccine against cutaneous anthrax, 25 out of 754 unvaccinated workers became infected with cutaneous anthrax while only 1 out of 379 vaccinated workers did (www.anthrax.osd.mil). While researchers were conducting the study, there was an unexpected outbreak of inhalational anthrax in which 5 unvaccinated workers became infected, but no vaccinated workers did. Of the five unvaccinated workers, four died because of the anthrax infection. The 92.5 percent effectiveness rate of the anthrax vaccine was jointly against cutaneous anthrax and inhalational anthrax.

In a series of animal studies conducted by the U.S. Army Medical Research Institute of Infections between 1990 and 2001, AVA consistently demonstrated protection against anthrax infection. In a study of Rhesus monkeys, 62 of 65 (95%) vaccinated animals survived lethal doses of inhalational anthrax, while zero of 18 unvaccinated monkeys survived (www.anthrax.osd.mil). In a study of rabbits, 114 of 117 (97%) vaccinated animals survived lethal doses of inhalational anthrax, while zero of 28 unvaccinated rabbits survived (www.anthrax.osd.mil). Rhesus monkeys and rabbits were chosen for the studies because their respiratory systems closely resemble those of humans.

While no vaccine is ever 100 percent effective, the studies conducted on mill workers and animals provided the scientific data for FDA licensing of the anthrax vaccine and for Department of Defense acceptance of AVA as protection for American military personnel. As for the vaccine’s effectiveness against bioengineered strains of anthrax, the National Academy of Sciences’ Institute of Medicine concluded in March of 2002 that “âÂ?¦it is unlikely that either naturally occurring or anthrax strains with bioengineered protective antigen could both evade AVA and cause the toxicity associated with anthrax” (DoD AVIP Information Pamphlet, 2002, p. 5).

A fourth argument put forth by opponents of AVA is that the anthrax vaccine’s long-term effects have not been sufficiently investigated. The Department of Defense asserts that anthrax vaccine has had all of the testing that other vaccines get before they are introduced for use (Desk RefâÂ?¦, 1999, p. 18). The argument is that few long-term studies of any non-living vaccine, such as anthrax vaccine, have been conducted, although vaccines have been dispensed for decades.
The fifth argument offered by anthrax vaccine challengers is that the manufacturer’s production facility does not meet with FDA standards, and that the deficiencies result in an unsafe vaccine. Critics of the vaccine cite an FDA inspection that found deviations from approved standards in record keeping and testing procedures (Gillert, 1998).

After purchasing the anthrax vaccine production facility from the state of Michigan, BioPort Corporation voluntarily closed the facility in January 1998 for renovations that were part of an overall $20 million facility improvement strategy that would conclude in January 1999. The Food and Drug Administration conducted an on-site inspection, the inspection cited by opponents of the vaccine, of the renovated facility in November 1999, and found deficiencies in the documentation of manufacturing processes. The shortcomings were not severe enough to revoke BioPort’s license or to warrant a recall of vaccine lots already produced and distributed. BioPort submitted follow-up documents to the FDA in late 2001, and all aspects of BioPort’s facilities and processes were approved on January 31, 2002 (www.fda.gov).

Safety concerns about the vaccine generally fall into three categories: pregnancy and sterility, a possible link to Gulf War illnesses, and the possible release of expired vaccine lots. The Department of Defense contends that vaccinated women are just as likely to get pregnant and give birth as unvaccinated women, and that miscarriages and sterility happen at the same rates in both groups (www.anthrax.osd.mil). Once female service members become pregnant, in accordance with U.S. national vaccine guidelines, they are no longer vaccinated with any vaccine, including AVA. During Operations Desert Shield and Desert Storm, an estimated 150,000 American troops received 250,000 to 300,000 doses of AVA (AVIP: Info aboutâÂ?¦, 2002, pp. 7-8). While some have claimed a link between the anthrax vaccine and the illnesses suffered by troops participating in operations in the Persian Gulf, there is no reasonable evidence that points to AVA as a cause of Gulf War illnesses. Multiple panels, including the Presidential Advisory Committee on Gulf War Veterans’ Illnesses, the Institute of Medicine, the National Institute of Health, and the Defense Science Board, have found no evidence to support the alleged link.

According to the Department of Defense, 18 different safety studies of AVA involving over 500,000 recipients and 7 independent panels of civilian scientists have all affirmed the safety of the anthrax vaccine (www.anthrax.osd.mil). The current manufacture of AVA by BioPort Corporation meets all current FDA standards of production and the license to manufacture the anthrax vaccine has been valid without interruption since 1970 (www.fda.gov). Finally, as to the question of expired lots of AVA, the Department of Defense and BioPort state that the FDA approves each individual lot of vaccine and that no expired lots have ever been released to the military services or immunization clinics.

THE CASE FOR THE ILLEGALITY OF THE ORDER

The argument that the order for mandatory inoculation with the anthrax vaccine is illegal claims that AVA should be classified as an Investigational New Drug (IND) requiring the informed consent of individuals to be vaccinated. Because American military personnel are not giving their informed consent to be vaccinated with an IND, as is required by Presidential Executive Order 13139, the order for mandatory inoculation is illegal.

The Food and Drug Administration considers a drug as “new”, even if it has been used for years, if there is a change in the target use of the product, a change in the formula, dilution of the drug, a change in the route of administration of the drug, or even repackaging of the drug (Michels & Smith, 2001). The argument for IND status is based on three of these factors: a change in the formula for the vaccine, a change in the approved dosage schedule (route of administration), and a change in the licensed target use for the vaccine.

According to Randall Katz, the Government Accounting Office, in a 1999 report, stated that the vaccine given to American military personnel did not have the same chemical formula as the vaccine approved by the FDA in 1970 (Katz, 2001). Critics of mandatory vaccination assert that the alteration in AVA’s formula meets the criteria for IND status. The Department of Defense contends that the current vaccine is basically the same as the original vaccine; only it is more potent and more pure (www.anthrax.osd.mil).

Between July 2000 and June 2001, the Department of Defense ordered a series of temporary slowdowns of the mandatory AVIP due to a shortage of the anthrax vaccine. As part of the slowdown, the Department of Defense announced that military personnel who received only two shots of the six shot sequence would not have to start their vaccinations over again. Instead, those service members would be able to receive additional shots to complete their sequence (Katz, 2001). Critics argue that this is a change in the FDA-approved dosage schedule and therefore meets the criteria to classify the anthrax vaccine as an IND. Supply of AVA was restored in January 2002 when the FDA approved BioPort’s facility renovations.

The final argument for IND-status claims that the license for AVA that was issued by the FDA in 1970 was for cutaneous anthrax, not inhalational anthrax. The Department of Defense’s AVIP, however, has as its main goal the prevention of inhalational anthrax, the most likely biological warfare agent. Critics of mandatory vaccination contend that AVA has never been licensed for use against airborne anthrax spores and that this change in target use satisfies the criteria for IND status (Michels & Smith, 2001).

Kathryn C. Zoon, the Director of the Center for Biologics Evaluation and Research of the FDA, made the following statement to Congress:

We continue to believe that the vaccine is safe and effective
protection for those individuals at high risk for exposure.
Approved labeling for the anthrax vaccine states that immunization
with this product is recommended for individuals who may come
in contact with animal products that may be contaminated with
Bacillus anthracis spores; and for individuals engaged in
diagnostic or investigational activities which may bring them in
contact with Bacillus anthracis spores. It is also recommended for
persons at high risk, such as veterinarians and others handling
potentially infected animals (www.fda.gov).

The anthrax vaccine license that was issued in 1970 was issued based on data from the study of mill workers in the 1950s. The study demonstrated a vaccine effectiveness rate of over 92%, which was a combined rating for cutaneous and inhalational anthrax (AVIP Desk RefâÂ?¦, p. 18). The Department of Defense uses this fact, and the broad language of the license, specifically the reference to “persons at high risk,” as the basis for the mandatory vaccination of military personnel with the anthrax vaccine.

In summary, critics claim that because the anthrax vaccine formula has changed, the dosage schedule has been modified, and the target use of the vaccine has changed from the original licensed use, AVA should be classified by the FDA as an Investigational New Drug. If AVA were listed as an IND, vaccination would require the informed consent of American military personnel pursuant to Presidential Executive Order 13139 and 10 USC, section 1107 (Michels & Smith, 2001). In the absence of informed consent, the order to U.S. troops to be vaccinated with the anthrax vaccine violates the Presidential Executive Order and U.S. law, and is therefore illegal.

THE CASE FOR THE LEGALITY OF THE ORDER

The Department of Defense contends that inhalational anthrax poses a clear and present danger to United States military personnel. The Anthrax Vaccine Immunization Program is designed to counter that threat. Military regulations require that American troops be immunized with many different vaccines, beginning with an initial series of inoculations upon entry into military service. These mandatory vaccines include tetanus, diphtheria, influenza, hepatitis A, measles, mumps, rubella, polio, and yellow fever (Gillert, 1999). Some of these vaccines are given to every service member, while some are only given to troops in certain military specialties or assigned to certain geographic areas of the world. All of these vaccines are mandatory and give the Department of Defense legal precedent for the implementation of the AVIP and the issuance of the order for all service members to be vaccinated.

There is a long history of mandatory inoculation for U.S. service members. As a result of the mandatory vaccination of troops in World War II, the American military suffered zero cases of yellow fever and only 12 cases of tetanus, despite the fact that 2.7 million service members were admitted to the hospital for wounds and injuries (DoD AVIP Information Pamphlet, 2002, p. 3).
Additionally, two court cases serve as legal precedent for the legality of the vaccination order. In U.S. v. Chidwell, the Navy Board of Review upheld the convictions of two U.S. Marines who refused to be vaccinated against smallpox, typhoid, paratyphoid, and influenza because of their religious beliefs. The court held that religious beliefs were not above military orders and that “to permit this would be to make the professed doctrines of religious belief superior to military orders, and in effect to permit every soldier to become a law unto himself” (Katz, 2001). In U.S. v. New, the Army Court of Criminal Appeals made three findings with regard to the legality of orders: that an order is presumed to be lawful and a soldier disobeys an order on his own responsibility and at his own risk; that the accused charged with disobeying lawful orders bears the heavy burden of showing that the orders were illegal; and that unless the order requires an obviously illegal act, or is obviously beyond the issuer’s authority, the service member will obey the order (Katz, 2001).

The Department of Defense uses the Manual for Courts Martial as the basis for establishing the legality of an order. Section 16c (1) (c) states that “âÂ?¦a general order or regulation is lawful unless it is contrary to the Constitution, the laws of the United States, or lawful superior orders or for some other reason that is beyond the authority of the official issuing it” (Manual for Courts Martial, 2000, p. IV-24). Additionally, the Manual for Courts Martial states that “The order must relate to military duty, which includes all activities reasonably necessary to accomplish a military mission, or safeguard or promote the morale, discipline, and usefulness of members of a command and directly connected with the maintenance of good order in the service” (Manual for Courts Martial, 2000, p. IV-19-20).

There is no Department of Defense policy for handling anthrax vaccination refusals, other than allowing local commanders to impose punishment under Articles 90 and 92 of the Uniform Code of Military Justice. Article 90 prohibits willfully disobeying a superior commissioned officer and Article 92 prohibits failing to obey an order or regulation. The DoD deems noncompliance with the AVIP as a violation of a lawful order, and as such, each case is handled individually at the lowest possible level.
As of May 2002, the Department of Defense had administered more than 2.1 million doses of anthrax vaccine to more than 525,000 service members (DoD AVIP Information Pamphlet, 2002, p. 4). As of October 2001, 102 people have been court-martialed for refusing the anthrax vaccine and hundreds more have resigned from the military (Brennan, 2001). The Manual for Courts Martial states that the lawfulness of an order is ordinarily decided upon by a military judge (Manual for Courts Martial, 2000, p. II-111). Military judges have uniformly found vaccination orders to be lawful and to date none of the anthrax refusal cases have made it outside of the military justice system.

CONCLUSION

For critics of the mandatory anthrax vaccination program, the issue boils down to the belief that AVA should be classified as an Investigational New Drug because its formula has changed, the dosage schedule has been altered, and the vaccine is being used for a purpose for which it is not licensed. As an Investigational New Drug the anthrax vaccine would require the informed consent of all American military personnel before the vaccine could be administered. Because the AVIP is mandatory and informed consent is not being given, critics claim that the order is in violation of Presidential Executive Order 13139 and 10 USC section 1107 and is therefore illegal.

The Department of Defense views the order as comparable to any other lawful order, such as the wearing of flak vests, protective masks, or chemical protective clothing. Violations of the mandatory anthrax vaccination order are punishable under the Uniform Code of Military Justice in accordance with the provisions in the Manual for Courts Martial.

In order to better educate American military forces, the Department of Defense has launched several initiatives to promote understanding of the anthrax threat, the vaccine, and the vaccination program. One of these measures is a 23-minute video that discusses the safety of the vaccine, the lethality of anthrax disease, the threat anthrax poses, and rumors about the vaccination program (Garamone, 2000). Other measures include a toll-free information line to respond to questions about the vaccine and the AVIP, a detailed AVIP web site, a customized email question-and-answer service, and a speakers bureau for conducting open-house forums, staff assistance visits, conferences, and training on immunization tracking systems (AVIP: Information about�, 2002, pp. 11-12).

The mandatory vaccination of American military personnel against anthrax disease has proven to be a contentious issue both with the American public and with U.S. troops. While individuals or groups may make their own decisions regarding the legality or illegality of the mandatory vaccination order, the U.S. military’s judicial system is currently upholding the lawfulness of the AVIP. Any challenge to the program will likely have to be made in a U.S. federal court. However, tensions regarding the vaccine may lessen to a degree given the anthrax attacks against the United States in 2001. Whether or not anthrax vaccination will remain an issue is yet to be seen.

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