Military Vaccines
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PUTTING ORGANIZATION AND FUNDING INTO THE DOD’S VACCINE HEALTH CARE CENTERS NETWORK.
Members of the military have long been required to receive immunizations. DoD estimates that over 2.2 million servicemembers receive at least one mandatory immunization annually. Immunizations are provided through the administration of vaccines, which contain "antigens” or parts of a specific virus or bacterium that are used to trigger an immune response to protect the body from disease. DoD’s immunization requirements vary depending on several factors, such as a servicemember’s branch of military service, location, age and type of personnel, such as newly enlisted recruits, those conducting high-risk travel, and reserve forces.
No immunization is completely safe. Like all individuals, servicemembers may experience side effects as a result of their immunizations, known as adverse events. Most adverse events consist of relatively mild reactions, such as swelling near the site of the immunization. However, a small number of individuals may experience more severe reactions, such as some servicemembers who received the anthrax and smallpox vaccines. DoD made these vaccines mandatory starting in 1998 and 2002, respectively, out of concern that these pathogens could be used as biological weapons. Some servicemembers who received these vaccines experienced severe reactions such as migraines, heart problems, and the onset of diseases including diabetes and multiple sclerosis. Since then, the adverse events associated with these vaccines have caused concern among members of Congress about the safety of some mandatory immunizations.
In response to three congressional directives, DoD established the Vaccine Healthcare Centers (VHC) Network in September 2001 with initial funding provided by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). The purpose of the VHC Network is to meet the health care needs of servicemembers receiving mandatory immunizations. This includes educating servicemembers about how to prevent adverse events and diagnosing and treating those with severe reactions.
In September 2001, the National VHC—or headquarters— opened at Walter Reed Army Medical Center in Washington, D.C., along with a regional VHC site in the same location. By 2003, three more regional VHCs had opened at the Womack Army Medical Center at Fort Bragg in North Carolina, the Wilford Hall Medical Center at Lackland Air Force Base in Texas, and the Portsmouth Naval Medical Center in Virginia.
DoD placed the VHC Network under the command of the Army surgeon general. However, neither DoD nor the Army provided the VHC Network with a mission statement. As a result, VHC Network officials defined their own mission. In addition, since 2001, the VHC Network—which is not included in DoD’s long-term budget planning—has relied upon funding provided on an annual basis from a variety of sources. Its lack of both a recognized mission and a specified funding source caused uncertainty among VHC Network officials about its future existence and organizational structure.
However, in December 2006, DoD made several decisions regarding the VHC Network. These decisions, which become effective in fiscal year 2008, address the VHC Network’s funding and mission and transfer it to the command of the Military Vaccine Office (MILVAX), which oversees military immunization policies across DoD.
IN BRIEF
The VHC Network supports the health care needs of servicemembers that may arise from military immunizations in three ways. First, it offers clinical support. For example, it provides clinical care to servicemembers experiencing potential adverse events, and, in cases where the patient is not located near a regional VHC site, it may remotely coordinate the patient’s care with the other providers directly involved in the patient’s treatment.
Second, the VHC Network conducts research to improve the safe administration of vaccines and the prevention, identification, and treatment of adverse events. Third, it educates servicemembers and military health care staff on adverse events. For example, the VHC Network makes information available by conducting briefings and posting training materials on a Website.
In general, DoD and CDC officials said that they consider the VHC Network’s contributions important, particularly in the area of clinical care. However, several DoD officials, including DoD medical staff members, added that its educational efforts may not be reaching enough military health care providers who remain unaware, for example, of some adverse events and the role of the VHC Network.
DoD’s December 2006 decisions, including the plan to place the VHC Network under the command of MILVAX, will give the VHC Network recognition as a formal entity within DoD’s command structure and an established mission within DoD, and have the potential to provide access to a more stable source of funding, when they are implemented in fiscal year 2008. According to VHC Network officials, the absence of such a mission and a place in DoD’s long-range budget has made it difficult to plan strategically, develop and maintain regional VHC sites, and attract and retain staff. Under DoD’s new plan, the Army, Air Force and Navy will each provide funding for the VHC Network. In addition, there will be opportunities for all the services to provide input into decisions regarding the activities of the VHC Network. VHC Network officials stated that they hope that DoD’s decisions will provide opportunities for the VHC Network to plan for and accomplish its mission with greater predictability.
The Office of the Secretary of Defense designated the Army as the executive agent for the DoD-wide military immunization program. The Army, through the Office of the Army Surgeon General, established MILVAX to coordinate efforts in immunization services for all DoD components. Specifically, MILVAX is charged with delivering education, enhancing scientific understanding, promoting quality and helping to develop and coordinate military immunization programs for all DoD services worldwide. For example, MILVAX provides information related to military immunization requirements through such vehicles as Immunization University, an online source of guidelines and training materials for those administering military immunizations.
In addition, MILVAX monitors databases maintained by each of the military services that track the administration of vaccines and health of servicemembers before and after immunization to identify patterns in symptoms that might indicate adverse events. MILVAX is also responsible for ensuring adherence to standards applicable to the proper shipping and handling of some temperature-sensitive immunization products.
In January 2006, DoD required that, at a minimum, more than 75 percent of servicemembers must be rated as “fully medically ready.” To meet this requirement, among other things, servicemembers must receive all immunizations that, depending on their particular circumstances, are required of them. Most immunizations involve injections, and some require multiple doses.
CLINICAL SUPPORT
The VHC Network offers clinical support to servicemembers, health care providers, and others, such as family members. Such support is available in person to servicemembers and others who visit the VHC Network’s regional locations. Clinical support is also provided by telephone—servicemembers, and others with clinical questions, may call the DoD Vaccine Clinical Call Center, which is operated by the VHC Network. This center is available 24 hours a day, 7 days a week. According to its officials, the VHC Network has responded to at least 1,700 calls made to its call center, from June 2004—when the call center first became operational—through March 2007. The VHC Network also provides clinical support through its Website, which contains a link that allows for confidential e-mail communication. Through this link, according to VHC Network officials, 146 inquiries have been addressed from August 2005, when the link became operational, through March 2007. Through these venues, the VHC Network provides the following clinical support.
RESEARCH TO IMPROVE VACCINE SAFETY
The VHC Network conducts research to improve DoD’s ability to identify, treat and prevent adverse events related to immunizations. The VHC Network uses information it gathers through its clinical support activities and supplements that information with medical literature reviews and joint efforts with other entities with an interest in military immunizations.
For example, the VHC Network regularly coordinates with MILVAX in researching possible adverse events and related trends. Through its routine review of military immunization databases, MILVAX may identify a trend in certain symptoms and ask the VHC Network to investigate the cause. The two entities may also collaborate in their research activities, such as a recent study of the flu vaccine that compared the safety of the injectable vaccine to that of the nasal spray vaccine. The VHC Network also engages in research projects with other entities such as CDC and universities, covering topics such as immunologic responses to anthrax immunization and postimmunization chronic fatigue syndrome. Through these research efforts, the VHC Network aims to improve vaccine safety by safely administering vaccines and identifying and treating potential adverse events.
EDUCATING SERVICEMEMBERS
The VHC Network has a number of activities to educate servicemembers, providers and other military health care staff about adverse events, the role of the VHC Network, and the resources it provides. The VHC Network uses a variety of approaches, including presentations and printed material.
FUNDING
Since its establishment in 2001, the VHC Network had been operating under the command of the Army. Although the VHC Network officials defined their own mission, they did not undertake the steps necessary to establish a recognized mission within DoD. The VHC Network also sought, but never obtained, the oversight of a DoD executive agent, which would have provided it with a defined mission within the agency.
In addition, the structural and financial support for the VHC Network was not formalized. Although the VHC Network was initially designed to serve the Army, Air Force and Navy, officials from the Air Force and Navy told us that they did not contribute to formulating the mission and activities of the VHC Network regional sites located at their bases and, consequently, they had little incentive to financially support the VHC Network’s activities and mission.
The VHC Network had not been included in the military’s longterm budget planning, which, VHC Network officials stated, limited their ability to strategically plan to accomplish their mission. VHC Network budget requests were submitted to the Army annually beginning in fiscal year 2002; however, the VHC Network was never incorporated into the Army’s budget. Similarly, although requests were submitted for inclusion in DoD’s five-year budgets, prepared in fiscal years 2004 and 2006, the VHC Network’s costs were not included in the five-year budgets.
The VHC Network obtained funding from a variety of sources, relying primarily on funds provided by the Army surgeon general on a year-by-year basis from fiscal year 2002 through fiscal year 2006. During this period, the Army surgeon general provided the VHC Network approximately $21.1 million from its allocated global war on terrorism funds. In addition, for fiscal years 2005 and 2006, NARMC provided approximately $177,000 to support VHC Network activities not covered by GWOT funds. About $5.5 million from the Defense Health Program appropriation was directed to be spent on the VHC Network, as outlined in conference agreements for fiscal years 2003 and 2006. For fiscal years 2003 through 2006, MILVAX provided funding for activities such as VHC Network educational efforts and the operation of the DoD Vaccine Clinical Call Center.
Although the total annual funding for the VHC Network has been fairly consistent from year to year, according to VHC Network officials, its exclusion from the Army’s and DoD’s budget projections complicated their ability to plan to provide services.
For example, using fiscal year 2003 funds, the VHC Network built a regional site in Landstuhl, Germany. The facility, costing approximately $500,000, was completed in 2004. However, it was never occupied as a VHC regional site because the Army’s five-year budget projections for fiscal years 2006 to 2011 did not include funds to operate it. In addition, the Army wanted to clarify the mission of the VHC Network before it agreed to the VHC Network’s expansion. The Army used the facility for other purposes.
PATH FORWARD
The Department of Defense also took several actions to address the VHC Network funding concerns. While DoD’s decision to place the VHC Network under MILVAX does not guarantee funding for the VHC Network, MILVAX’s position as a program operating under an executive agent ensures that the VHC Network will be included in budget planning.
With MILVAX’s new responsibility for the VHC Network’s mission and activities, the VHC Network’s budget will be included within MILVAX’s request for inclusion in DoD’s five-year internal budget projections, beginning with fiscal year 2008. In addition, DoD decided that the Army, Air Force and Navy will share responsibility for funding the VHC Network.
VHC Network officials have expressed hope that the changes in funding will provide the network with additional security and facilitate VHC Network officials’ ability to plan activities. ♦