WASHINGTON, December 19, 2000 (GulfLINK) - The Office of the Special Assistant for Gulf War Illnesses released today an information paper detailing vaccine use during the Gulf War. Since the return of approximately 697,000 Gulf War veterans nearly 10 years ago, a number of veterans have expressed concern that vaccines may have adversely affected their health.

The paper complements a recently released report from the Institute of Medicine that evaluates the published scientific research on the health effects of specific vaccines used during the Gulf War. Citing inadequate and insufficient scientific evidence to determine whether biological warfare agent vaccines are associated with long-term adverse health effects, the IOM recommended long-term studies of the recipients of the anthrax and botulinum toxoid vaccine.

Vaccines are commonly used health interventions that serve as critical countermeasures against infectious diseases and biological warfare agents. The military's dynamic nature and the unique and diverse missions also require constant review and updating of vaccine policy to incorporate advances in preventive medicine, as well as responding to changing health threats, analysts said.

"The purpose of this information paper is to provide information to veterans and other interested individuals about vaccines, their use by the military, and issues arising from the administration of biological warfare vaccines in the Gulf War," says Army Col. Frank O'Donnell, M.D., director, medical outreach and issues. "For veterans, we hope this paper provides some context in which vaccines were used and a reasonable explanation for the difficulties surrounding their use."

The information paper was co-authored by Thomas Cardella, M.D., an infectious diseases specialist, and Tom Rupp, a senior health policy analyst. Both are assigned to the special assistant's medical issues team.

The authors reviewed policy guidance, operational and historical documents, and clinical reports as source documents for the information paper. No individual health records were reviewed, says Cardella. He adds the paper cannot provide detailed information on the specific vaccines that individual servicemembers may have received. However, the general information about the individual vaccines used in 1990 and 1991, why they were used and who would have received them may shed light on a subject of significant interest to Gulf War veterans.

During the Gulf War, vaccines - including two non-traditional vaccines, anthrax and botulinum toxoid - were identified for administration in response to the infectious disease and biological warfare agent threat. The decisions to select and use these specific vaccines were based on assessments of the infectious diseases and biological warfare agents that service members were likely to encounter during the deployment.

Military immunization policies then - and today - are developed in consultation with the Armed Forces Epidemiological Board and the Armed Forces Medical Intelligence Center. Particular emphasis is given to conditions that affect operational readiness, pose a risk in the community or occupational environment or are unique to a particular geographic or cultural setting, explains Rupp. The Defense Department also complies with communicable disease and adverse reaction reporting requirements established by civilian public health authorities.

The report notes that administration of the biological vaccines was characterized by several difficult issues, including a shortage of available quantities of vaccines to protect all servicemembers at risk, prioritizing military units for vaccination based the available vaccines and anticipated threat, and ensuring servicemembers had the information needed about the vaccines.

"Because supplies of the two biological warfare vaccines were limited, the DoD allocated the vaccines only to those personnel believed to be at greatest risk of exposure," Cardella says. "It was anticipated that the relatively long period between exposure and the onset of illness would make anthrax an agent more likely to be used against fixed and rearward units. The guidance called for two doses of vaccine approximately 14 days apart."

U.S. Central Command directed that personnel in units in the vicinity of Riyadh, Dhahran-Damman, King Khalid Military City -"KKMC" - Logistics Bases A, B C, D, and E, Headquarters VII Corps, the XVIII Airborne Corps, the 1^st Cavalry Division and Bahrain receive the anthrax vaccine.

The botulinum toxoid vaccination guidelines specified that only personnel in units prioritized by Central Command, VII Corps and the 1^st Marine Expeditionary Force, were to be vaccinated at that time and that limited available quantities of the vaccine would be available in February and March 1991 to vaccinate additional personnel. The guidance called for two doses of vaccine approximately two weeks apart, followed by a third dose 10 weeks after the second dose.

Because of the supply shortage, in some units vaccines were administered as voluntary. Rupp says that a message published after the Gulf War indicates that anthrax vaccinations were not portrayed as mandatory, but as highly recommended. Other reports indicated that the botulinum toxoid vaccine was likely declined by several thousand servicemembers. Informed consent wasn't required for either vaccine

There is no accurate count of how many servicemembers received these vaccines. Estimates are that 150,000 received at least one dose of anthrax vaccine and 8,000 received at least one dose of botulinum toxoid vaccine. Rupp says that a recent survey of Gulf War veterans suggests that numbers of servicemembers who received these vaccines may be higher.

"It is unfortunate that we don't have more accurate records of vaccinations form the Gulf War," says Cardella. "Today, this lack of documentation complicates research on possible connections between vaccines and the unexplained illnesses of some Gulf War veterans."

In addition to problems with lack of accurate recordkeeping, operational security concerns may have prevented many servicemembers from receiving important information about the vaccines they needed.

"During the Gulf War, the policy for informing servicemembers about the biological warfare vaccines was contained in the Central Command guidelines and was classified in order to preserve operational security. Prepared statements were to be read to servicemembers at the time of vaccination, but were not to be distributed," Cardella says. "Vaccine recipients were cautioned not to discuss the vaccinations with anyone."

Based on veterans' accounts, the policy to provide information to all servicemembers appears to have been implemented with varying consistency and success. A medical detachment commander reported that poor communication about the vaccines led to many fears among those potentially receiving the vaccines. There was a great deal of misinformation about the anthrax vaccine, he said. Many thought the vaccine was not FDA approved. Many feared drastic side effects. Other servicemembers reported they were provided no information on why the anthrax and botulinum toxoid vaccines were being given.

"Communicating information about health hazards of war and information about the benefits and risks of medical countermeasures like vaccines is essential. We tell Gulf War veterans they are their own best health advocate. They can't be an advocate unless they have the information needed," says O'Donnell. "This is one lesson of the Gulf War that is crystal clear."

Today, military personnel increasingly face routine deployments overseas and confront exposures to environmentally hazardous battlefields and risks associated with biological warfare agents. Vaccines are an integral part of DoD's new strategy of force health protection. The Gulf War experience has brought to light some shortfalls in vaccine administration.

"We have forwarded the observations in this information paper to the Lessons Learned Implementation Directorate for coordination with applicable offices within the military departments," O'Donnell says. "We intend to help ensure that identified issues are appropriately addressed."

Information papers are reports of what the Defense Department knows today about military, procedures and equipment used during the Gulf War. This release, the tenth information paper published by the special assistant's office, is intended to provide a basic understanding of vaccine administration. Although not an investigative report, the report will be updated if additional information becomes available. Gulf War veterans who have records, photographs, recollections or find errors in the details of the report are asked to contact the office at (800) 497-6261.