Anthrax vaccine risks

In December 1997, Secretary of Defense William Cohen announced a departmentwide anthrax immunization program for high-risk military personnel. Implementation began in March 1998. On May 18, 1998, the Secretary authorized the vaccination of all military forces (Cohen, 1998). Almost 2.5 million troop-equivalent doses of vaccine were required to implement the Secretary s decision, much more than had ever been produced by the licensed manufacturer in its entire history. Prior to Desert Storm, the primary vaccine users had been veterinary, laboratory, and industrial workers at risk of infection, for whom an estimated 60,000 doses of Anthrax Vaccine Absorbed (AVA) were distributed between 1974 and 1989, an average of 4,533 doses per year (foellenbeck et al., 2002). During Desert Storm, approximately 150,000 troops received 300,000 doses of AVA, without accurate recording of recipients or adverse reactions. 

Currently, there is no anthrax vaccine for children. The anthrax vaccine used for adults has never been studied in children, and it is not recommended for people younger than 18 years old. It is currently available only for people in the military service, although public health officials are now considering its use for people in other high-risk professions. 

Because inhalational anthrax in humans is so rare, w e cannot be certain about the risk of reinfection therefore, CDC recommends that another course of antibiotic treatment be given promptly if a person is reexpused to Bacillus anthracis. In animal studies of inhalational anthrax, animals given anthrax vaccine and antibiotics after exposure did not develop anthrax when reexposed 4 months after the original exposures, while animals treated with antibiotics alone became ill when reexpo.sed. 

During the Gulf War, a moral dilemma faced US and Coalition military commanders With a limited supply of both botulinum toxoid and anthrax vaccines, who should receive them Some commanders clearly regretted that only partial vaccinations were performed, and would preferred to have the risk equally parceled out, rather than only treating an arbitrarily chosen group. It was finally decided that some was better than none, and those troops and personnel stationed in areas more likely to be under a BW threat were given priority for inoculation. 

Observational studies Anthrax vaccine adsorbed (AVA) is the only US licensed AVA vaccine approved by the Food and Drug Administration. In recent years, the safety of anthrax vaccine has been controversial, stimulating reviews of its safety and efficacy. During 1 March 1998 to 14 January 2007, about 6 milhon doses of AVA vaccine were administered. As of 16 January 2007, 4753 reports of adverse events after the use of AVA had been submitted to the Vaccine Adverse Event Reporting System (VAERS) [ll ]. The most commonly reported were myalgia, arthralgia, pain, headache, depression, asthenia , rash, anxiety and insomnia, and back pain. Reports to VAERS did not definitively link any serious unexpected risks to this vaccine, and a review of deaths... 

Vaccines may also be utilised for both pre- and post-exposure prophylaxis. The smallpox vaccine may be used to limit disease severity post-exposure. The anthrax vaccine is currently only provided to those at risk of exposure (veterinary staff, laboratory workers and military personnel) and to reduce the risk of disease after exposure to anthrax in some cases. 

Anthrax, a disease caused by infection by Bacillus anthracis via spores, can be transmitted to humans or animals ruminants such as sheep, goats, cattle, and deer are most susceptible. The handling of infected animals or animal products may also lead to human infection. Recently, anthrax has been considered to be a potential candidate for bioterrorism activity. The spores are extremely hardy and may come into contact with humans through a cut or abrasion, through consumption of infected meat, or by inhalation. The Center for Disease Control (CDC) lists anthrax as a category A disease, and the only vaccine that currently exists has a number of drawbacks and health risks. 

While not recommended for routine administration, vaccines additional to those represented in the juvenile programme are available for individuals in special risk categories. These categories relate to occupational risks or risks associated with travel abroad. Such immunization protocols include those directed against cholera, typhoid, meningitis (type A), anthrax, hepatitis A and B, influenza, Japanese encephalitis, rabies, tick-borne encephalitis and yellow fever. 

With the exception of smallpox, next-generation candidates to replace the two current vaccines (smallpox and anthrax), and vaccines for botulism, tularemia, and Venezuelan equine encephalomyelitis will not be approved and available until the end of the decade at the earliest, hampered in part by the normal process for new drug approval and by the risk-averse nature of lead agencies within the Department of Defense. 

Anthrax spores, commonly found in the soil throughout the world (5), can cause infection when ingested by herbivore animals. Naturally occurring human infections follow exposnre to the infected animals or infected animal products. Occupational exposnre has been the most common cause of anthrax, with industrial mill wool sorters at greatest risk. From 1900 to 1978, there were 18 reported human cases in the United States, all in occupations associated with specific exposure, such as goat hair mill workers, tannery workers, and laboratory workers. Widespread animal vaccination programs have reduced animal mortality from anthrax and naturally occurring human anthrax is now a very rare disease (5). 

There is a vaccine available for the prevention of anthrax, but it is only available to those who are at significant risk for anthrax exposure, such as military personnel and veterinarians. Postexposure treatment of individuals is with a course of antibiotics before symptoms appear if exposure is suspected, or as soon as symptoms are noted. Prompt treatment is usually effective however, success is dependent upon exposure dosage, route of exposure, and individual susceptibility factors. 

Vaccines. Anthrax and smallpox vaccines can be used before exposure and also for postexposuie prophylaxis. A pentavalent (ABODE) botulinum toxoid is currently used for laboratory workers at high risk of exposure. It is not effective for postexposure prophylaxis. Vaccines are not currently available for plague, tularemia, or viral hemorrhagic fevers. 

If the risk of such an attack seems inflated beyond reason, the alternative is to do nothing. But then, if the vaccinations were not carried out, and an anthrax weapon were used against US military personnel, the results would of course be catastrophic. The DOD faced a similarly pressing dilemma during the GulfWar where, as A1 Mauroni describes, If DOD held back on developmental vaccines and pretreatments to troops in the Gulf, and Saddam initiated CB warfare, the outcry would have been deafening. ... 

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