The Department of Defense today announced plans that will lead to the systematic vaccination of all U.S. military personnel against the biological warfare agent anthrax. The vaccinations are expected to start next summer.
After a three year study, Secretary of Defense William S. Cohen concluded that the vaccination is the safest way to protect highly mobile U.S. military forces against a potential threat that is 99 percent lethal to unprotected individuals. The anthrax vaccine will initially be administered to approximately 100,000 military personnel assigned or deployed to the high threat areas of Southwest Asia and Northeast Asia. Within the next several years it will be given to all active duty and reserve personnel.
"This is a force protection issue," Cohen said. "To be effective, medical force protection must be comprehensive, well documented and consistent. I have instructed the military to put such a program in place."
Vaccinations would start only after several conditions are met:
- Supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine.
- Implementation of a system for fully tracking personnel who receive the anthrax vaccinations.
- Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program.
- Review of health and medical issues of the program by an independent expert.
"Our goal is to vaccinate everybody in the force so they will be ready to deploy anywhere, anytime," explained Deputy Secretary of Defense John Hamre, who will monitor implementation of the program. "This is an important new dimension to overall force protection. The anthrax vaccination will join other immunizations we already give everyone in the military."
The anthrax vaccine is FDA-licensed and exhibits fewer side effects than flu or typhoid vaccines. It has been widely used in the United States since the early 1970s by livestock workers and veterinarians. The military currently immunizes people working in at-risk jobs and some 3,000 personnel assigned to special operations units, the Army Technical Escort Unit and the Marine Chemical-Biological Initial Response Force.
The Department of Defense will immediately begin consultations with Congress and other federal government agencies and brief military personnel. Vaccinations for the first group of personnel who serve in or who would deploy early to the high threat areas are planned to begin in Summer 1998. Details of the schedule for the total force vaccinations will be determined as the program moves forward.
Defense Department officials have been reviewing an implementation program with the Joint Chiefs of Staff during the past year. The immunization program follows the recommendation of Gen. Henry H. Shelton, chairman of the Joint Chiefs of Staff.
The immunization program will consist of a series of six inoculations per service member over an 18-month period, followed by an annual booster. Although protection levels increase as shots in the series are given, the entire six-shot series is required for full protection.
Consistent with the Force Health Protection Program announced by President Clinton on Nov. 8, 1997, the anthrax vaccination plan will serve as a prototype for long term force protection. The Secretary of the Army is the executive agent for the effort, including procurement of the vaccine, tracking and oversight of the vaccination program, and coordinating with other service secretaries on the execution of the program.
Because of the mobility of military personnel, Cohen said he must be satisfied there is a medical management system in place to track individuals through the series before the immunizations begin. The Secretary of the Army, as executive agent, will serve as the focal point for the submission of information from the services.
Anthrax is a disease that normally afflicts animals, especially cattle and sheep. Anthrax spores can be produced in a dry form that can be incorporated into weapons. When inhaled by humans, these particles cause severe pneumonia and death within a week. At least ten countries have or are suspected of developing a biological warfare capability.
The Defense Department addressed the threat of anthrax and other biological and chemical weapons when it released the report "Proliferation: Threat and Response" in late November 1997.
Even though the plan has been reviewed extensively in the Pentagon, Cohen directed that it be independently assessed before implementation by Dr. Gerald N. Burrow of Yale University, who serves as Special Advisor to the Yale President for Health Affairs.
"We owe it to our people to move ahead with this immunization plan," Cohen said. "But we also want to make sure that our overall immunization program is safe and effective."
Anthrax Vaccination Program
Since the Gulf War, the Department of Defense has increased the level of attention given to biological warfare defense and other force protection measures. The current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense as part of our force protection planning.
Anthrax is one such threat. It is an infectious disease that normally afflicts animals. If placed into weapons, it would be 99% lethal to unprotected individuals who have been exposed. A safe and effective vaccine is available that will protect our forces.
Manufactured under contract by the Michigan Biologic Products Institute (MBPI), the anthrax vaccine has been licensed and in use since 1970. It is a formalen inactivated vaccine that uses dead bacteria rather than live bacteria. In this respect it is similar to diphtheria vaccinations (DPT) that American children receive before entering school. There is no evidence from records at the MBPI that anthrax vaccine is associated with any chronic or permanent local or systemic effects.
Immunization consists of three subcutaneous injections, 0.5ml each, given 2 weeks apart followed by three additional subcutaneous injections, 0.5ml each, given at 6, 12, and 18 months. If immunity is to be maintained, subsequent booster injections of the vaccine at one year intervals following the initial series are necessary.
Inoculations of personnel in high-threat areas will begin as soon as possible with general vaccination of the force to follow. The Michigan Biologic Products Institute, under contract to the Department of the Army, has produced and stockpiled the vaccine to support inoculation of the force.
This decision has not been taken lightly. Applying any program, procedures or process to the entire U.S. military force is a complicated and expensive process that must be thoroughly planned and carefully executed to achieve the desired results. The anthrax vaccine is already used to protect some of our military and civilian employees, but the decision to vaccinate the total force is much more difficult. Protection against anthrax is particularly challenging because the protocol requires multiple vaccinations to achieve immunity, and thus involves significant administrative and logistical issues.
When all associated costs (transportation, storage, administration, etc.) are included, the cost to immunize an estimated 2.4 million personnel (over a six year period) is approximately $130 million.