Military Health: DOD's Vaccine Healthcare Centers Network	 
(29-JUN-07, GAO-07-787R).					 
                                                                 
Members of the military have long been required to receive	 
immunizations. The Department of Defense (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. 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. 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. Two recent laws--the National Defense Authorization	 
Act for Fiscal Year 2006 and the National Defense Authorization  
Act for Fiscal Year 2007--contained provisions that required us  
to examine several issues related to the VHC Network. In	 
response, and after consultation with the committees of 	 
jurisdiction, this report describes (1) the efforts the VHC	 
Network is undertaking to address the needs of servicemembers	 
arising from mandatory military immunizations and (2) how DOD has
supported the mission of the VHC Network.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-787R					        
    ACCNO:   A71688						        
  TITLE:     Military Health: DOD's Vaccine Healthcare Centers Network
     DATE:   06/29/2007 
  SUBJECT:   Agency missions					 
	     Anthrax						 
	     Health care facilities				 
	     Health care services				 
	     Health centers					 
	     Immunization programs				 
	     Immunization services				 
	     Military appropriations				 
	     Military personnel 				 
	     Mission budgeting					 
	     Defense budgets					 

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GAO-07-787R

   

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June 29, 2007

The Honorable Carl Levin
Chairman
The Honorable John McCain
Ranking Member
Committee on Armed Services
United States Senate

The Honorable Ike Skelton
Chairman
The Honorable Duncan L. Hunter
Ranking Member
Committee on Armed Services
House of Representatives

Subject: Military Health: DOD's Vaccine Healthcare Centers Network

Members of the military have long been required to receive
immunizations.^1 The Department of Defense (DOD) estimates that over 2.2
million servicemembers^2 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.^3 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.

^1The military first mandated immunizations in 1777, when General George
Washington required troops to receive the smallpox vaccine. Since then,
the smallpox vaccine has been given to members of the military during
major conflicts including the Civil War, World War I, World War II, the
Korean War, and the Vietnam War. The smallpox immunization requirement was
suspended in 1990 and was subsequently reinstated for certain personnel in
2002.

^2For the purposes of this report, we use the term "servicemembers" to
include all members of the military, including active duty, reserve, and
National Guard servicemembers. In addition to servicemembers, DOD may
require others to receive immunizations, such as DOD contractors and
family members who accompany service members to military locations.

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).^4 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.

^3The military suspended the use of the anthrax vaccine in October 2004,
in response to a court order that expressed concern regarding the
administrative process by which the Food and Drug Administration (FDA)
approved the vaccine for its use. The court subsequently modified this
order, which allowed the military to begin to offer the anthrax vaccine on
a voluntary basis in April 2005. In December of 2005, FDA determined that
the vaccine protected against all routes of exposure to anthrax spores,
including inhalation. In October 2006, after the court order had expired,
DOD announced that it was resuming mandatory vaccination for certain
personnel and issued a memorandum that designated which personnel would be
required to receive the immunization and which servicemembers would be
eligible to receive it on a voluntary basis.

^4The first directive was contained in the conference report accompanying
the Consolidated Appropriations Act for Fiscal Year 2000. Congress
directed the National Institutes of Health, CDC, and DOD to conduct a
collaborative study on the safety and efficacy of vaccines used against
biological agents. See H.R. Conf. Rep. 106-479, at 727 (1999). The second
directive was contained in section 751 of the National Defense
Authorization Act for Fiscal Year 2001. This provision required DOD to
establish a system for monitoring adverse reactions to the anthrax vaccine
and to establish guidelines under which servicemembers could obtain access
to a treatment facility for expedited treatment and follow up of adverse
events. See Pub. L. No. 106-398 App., S 751, 114 Stat. 1654, 1654A-193
(2000) (codified at 10 U.S.C. S 1110). The third directive called for the
continued study of the anthrax vaccine by CDC and was provided in the
Consolidated Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-554
App., 114 Stat. 2763, 2763A-25 (2000). Congress indicated in a report
accompanying the 2001 appropriation law that the establishment of the VHC
Network would, among other things, facilitate data collection and
training. See H.R. Conf. Rep. No. 106-1033, at 166 (2000).

Two recent laws--the National Defense Authorization Act for Fiscal Year
2006 and the National Defense Authorization Act for Fiscal Year
2007--contained provisions that required us to examine several issues
related to the VHC Network.^5 In response, and after consultation with the
committees of jurisdiction, this report describes (1) the efforts the VHC
Network is undertaking to address the needs of servicemembers arising from
mandatory military immunizations and (2) how DOD has supported the mission
of the VHC Network.

To describe the efforts the VHC Network is undertaking to address the
needs of servicemembers,^6 we interviewed officials from the National VHC,
and from each of the four regional VHCs, on the VHC Network activities. We
also interviewed DOD officials at the Office of the Assistant Secretary of
Defense for Health Affairs, the Defense Health Board, the DOD Center for
Deployment Health Research, the Army Medical Research and Materiel
Command, the Preventive Medicine Residency Training Program of the
Uniformed Services University of the Health Sciences, and the Offices of
the Surgeon General for the Army, Air Force, and Navy to obtain their
perspectives on the mission and activities of the VHC Network. In
addition, we interviewed officials from MILVAX to obtain information on
immunization policies and related requirements and to understand its
relationship with the VHC Network. We also interviewed two providers--one
in the Army and another in the Air Force--who have treated servicemembers
experiencing adverse events, and a Navy nurse familiar with immunizations.
During our interviews, we also obtained information regarding the
education and assistance the VHC Network offers military and civilian
health care providers and the services that it provides to family members
and others, such as DOD contractors, receiving immunizations. Finally, we
spoke to CDC officials to understand how the role CDC plays in monitoring
adverse events among the civilian population compares to the VHC Network's
role in the military. We obtained and analyzed relevant documentation and
data on the VHC Network's activities from the entities we contacted.

To determine how DOD has supported the mission of the VHC Network, we
interviewed officials at the Assistant Secretary of Defense for Health
Affairs, MILVAX, the Offices of the Surgeon General for the Army, Air
Force, and Navy, and the VHC Network. We also obtained budgetary
information concerning the VHC Network, including funding sources, from
fiscal year 2001 through fiscal year 2006. In addition, we reviewed VHC
Network staffing levels during April 2007. We supplemented this work with
interviews with CDC officials to obtain information on the funding CDC
provided to help launch the VHC Network in 2001. To assess the reliability
of the VHC Network's information on regional staffing, clinical support
mechanisms, and educational resources, we talked with agency officials
about their data collection and quality control procedures and reviewed
relevant documentation. We determined that the data were sufficiently
reliable for the purposes of this report. We performed our work from June
2006 through May 2007, in accordance with generally accepted government
auditing standards.

^5See Pub. L. No. 109-163, S 736, 119 Stat. 3136, 3356 and Pub. L. No.
109-364, S 737(a), 120 Stat. 2083, 2302 (2006).

^6We consider the efforts of the VHC Network to address the needs of those
receiving the anthrax immunization under both mandatory and voluntary
circumstances to be within the scope of this report.

Results 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 Web site. 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.

We provided a draft of this report to DOD and HHS. We received written
comments from DOD stating that it concurred with our findings. HHS
provided technical comments, which we incorporated as appropriate.

Background

The human body generally tolerates immunizations without significant side
effects and most immunized individuals require no treatment. Reactions at
or near the injection site, such as redness, itching, and swelling, are
not unusual among those experiencing adverse events. Less common reactions
are systemic events that affect the entire body, such as fever, chills, or
nausea. Instances of severe adverse events are rare. Officials from the
VHC Network and CDC estimate that between 1 and 2 percent of immunized
individuals may experience severe adverse events, which could result in
disability or death. Some of these events may occur coincidentally
following immunization, while others may truly be caused by immunization.
The fact that an adverse event occurred following immunization is not
conclusive evidence that the event was caused by a vaccine. A
comprehensive evaluation of the patient's condition may be necessary to
make this determination, and may be followed by treatment or exemption^7
from further doses of a vaccine.^8

The VHC Network is currently overseen by the Army's North Atlantic
Regional Medical Command (NARMC), which operates under the Army Surgeon
General. As of April 2007, the VHC Network had 40 staff. Fourteen of them
work for the National VHC in medical, educational, and administrative
capacities. The remaining 26 staff members worked for the regional VHCs
(see table 1).

Table 1: Regional VHC Staff Distribution, as of April 2007

                     Walter Reed Fort Bragg                Wilford Hall       
                             VHC        VHC Portsmouth VHC          VHC Total 
Medical personnel           4          3              3            4    14 
Support staff               5          3              2            2    12 
Total                       9          6              5            6    26 

Source: The VHC Network.

Note: Medical personnel include the medical director, nurse practitioners,
and health educators. Support staff include the patient service
coordinator and other administrative support.

The Office of the Secretary of Defense designated the Army as the
executive agent^9 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.^10
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.

^7Under current DOD-wide policy, servicemembers may receive a temporary
(lasting up to 365 days) or permanent medical exemption from immunizations
from appropriate medical personnel, based on factors such as preexisting
immunity, severe reactions to prior vaccination, or pregnancy, and still
be considered medically ready for deployment.

^8For some vaccines, such as the anthrax immunization, immunity is
achieved after the administration of multiple doses of vaccine.

^9An executive agent in DOD provides defined levels of support for
operational missions or other activities that provide support to two or
more DOD services. According to DOD Directive 5101.1, an executive agent
is the head of a DOD component to whom the Secretary or Deputy Secretary
of Defense has assigned specific responsibilities, functions, and
authorities. There are 10 medical programs operating under executive
agents in DOD; the Army is the executive agent for 9 of those programs.

^10Programs, such as MILVAX, that operate under an executive agent have
separate and identifiable lines in DOD's internal budget process.

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.^11 Most immunizations involve injections, and some
require multiple doses. Table 2 shows vaccines generally required for
servicemembers.

Table 2: Vaccines Generally Required for Servicemembers (2006)

Population segment             Vaccine                                     
Trainees                       Diphtheria, hepatitis A, hepatitis B,       
                                  influenza, measles, meningococcal disease,  
                                  mumps, pertussis, poliovirus, rubella,      
                                  tetanus, varicella, yellow fever            
Routine during career (both    Diphtheria, hepatitis A, influenza,         
active duty and reserves)      pertussis, tetanus                          
Individualized based on        Anthrax, hepatitis B, Japanese              
deployment or travel to        encephalitis, meningococcal disease,        
high-risk areas                smallpox, typhoid, yellow fever             
Individualized based on        Haemophilus influenzae type b, hepatitis B, 
occupational or personal needs meningococcal disease, pneumococcal         
                                  disease, rabies, varicella                  

Source: DOD.

Note: Immunization policy varies among military services, based on
individual needs.

The VHC Network Provides Clinical Support, Performs Research, and Offers
Education to Address Servicemembers' Needs

The VHC Network undertakes a variety of activities to support the needs of
servicemembers who receive immunizations. We have grouped these activities
into three categories--clinical support, research, and education. By
focusing on these activities, the VHC Network attempts to prevent,
identify, and treat adverse events.

The VHC Network Offers 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 Web site, 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.^12 Through these
venues, the VHC Network provides the following clinical support.

^11Medical readiness requires that service members are fit and ready to
deploy. For example, active service members are required to have an annual
dental examination, pass an annual health assessment, and be tested for
human immunodeficiency virus within the previous 24 months, in addition to
receiving their mandatory immunizations.

Providing clinical care: The VHC Network treats servicemembers
experiencing potential adverse events, particularly in instances where
symptoms have been persistent, nonresponsive to previous treatment, and
debilitating. VHC Network physicians may serve as primary care providers,
providing in-person care, for patients at the regional VHCs. For patients
at other locations, the VHC Network may serve as the long-distance case
manager. In such cases, VHC Network physicians use telemedicine to
remotely coordinate a patient's care with their primary care providers, by
telephone or through the Internet. Regardless of whether patient care is
provided directly or remotely, it may include diagnostic assessments, such
as performing physical examinations, evaluating the results of laboratory
tests, consulting with current and past healthcare providers, conducting
comprehensive interviews regarding past health history with patients and
family members, and providing necessary treatment. Depending on the
patient's needs, the VHC Network may also make referrals to other health
care providers for subspecialty care, and engage in long-term follow-up of
the patient's progress. According to VHC Network officials, from September
2001, when the VHC Network was created, through mid-April 2007, the VHC
Network has provided clinical treatment to about 2,400 servicemembers.

Responding to immunization-related questions: The VHC Network staff answer
questions from servicemembers and their families, providers, and others.
The questions may be general or unique to a patient's individual
situation, and involve topics such as the following:

           o Safe administration of vaccines to prevent adverse events: For
           example, should servicemembers be immunized if they have a history
           of certain allergies or when they are taking a specific
           prescription medication?

           o Identification of potential adverse events: For example, could
           symptoms of vertigo, or short-term memory loss be related to a
           recent immunization?

           o Safe practices after immunization: For example, are there
           precautions a servicemember should take after receiving certain
           vaccines, such as the smallpox vaccine, where there is a risk that
           the virus from the vaccination site may be transferred and infect
           family members or others with whom the servicemember has close
           contact?

           Providing clinical input to administrative decisions: Because of
           its clinical expertise in adverse events following immunization,
           the VHC Network provides input in certain administrative decisions
           involving the longer-term health care needs of those who have
           experienced adverse events as a result of mandatory immunizations.
           For example, it assists servicemembers in obtaining medical
           exemptions from further immunizations, to avoid future severe
           reactions. In other situations, it supports patients who are no
           longer on active duty in obtaining military health care benefits
           so they may be treated for symptoms associated with adverse
           events. For example, it helps members of the reserves with
           establishing their eligibility for military health care benefits
           by providing documentation on the link between their symptoms and
           the mandatory immunizations they received while on active duty.^13

12In addition, according to VHC Network officials, the VHC Network has
also responded to e-mails outside of the secure link.

Many of the DOD officials, military health care staff, and CDC officials
we interviewed considered the VHC Network's clinical support efforts both
important and unique. For example, several indicated that the VHC Network
is uniquely positioned in the military to care for those experiencing
adverse events, because of the staff's expertise in immunology and their
continuous exposure to and familiarity with such cases.^14 In addition,
MILVAX officials told us that the VHC Network's regional sites provide a
single point of access to coordinated medical care for servicemembers
experiencing adverse events. As a result, these officials told us that
servicemembers benefit greatly because they do not have to go through a
lengthy process of seeing several providers before being diagnosed and
treated.

The VHC Network Conducts 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 the
following:

Safely administering vaccines: As a result of its research on possible
causes of adverse events, the VHC Network created a screening form to
capture servicemembers' health histories, prior to immunization. Health
care staff administering vaccines may use these forms to identify any
potential vaccine-related risks. As a result of the information provided,
they may give the servicemember a different vaccine dosage than others
receive or a medical exemption from the vaccine.

Identifying and treating potential adverse events: According to VHC
Network officials, the VHC Network, through its clinical experience and
related evaluation and research work, facilitates the discovery of new
vaccine-related adverse events, particularly rare ones, which may not be
as readily identified by database research and analysis. For example, VHC
Network officials told us that they determined that inflammation of the
heart may be caused by the smallpox vaccine and that they disseminated
that information throughout the military medical community through
presentations, the VHC Network's Web site, and other means. Without this
information, the chest pains some servicemembers experience may not be
associated by providers with the immunization and instead may be
misdiagnosed as a different heart ailment. In addition, the VHC Network
provides tools on its and MILVAX's Web sites to further assist military
providers in properly diagnosing and treating adverse events. For example,
the VHC Network has created clinical definitions for six additional
adverse events not previously characterized, such as new onset of
headaches, muscle pain, chronic fatigue, and autoimmune disorders, in
order to help providers identify such symptoms as possible adverse events.
In addition, the VHC Network provides clinical guidelines to further
assist providers in their diagnosis and care of adverse events.

^13Most members of the reserves are not enrolled in a military health care
insurance program when they are not on active duty. However, they may be
eligible for military health care benefits or health care provided by the
Department of Veterans Affairs, for service-related injuries or illness
incurred or aggravated while on active duty.

^14Providers at the regional VHCs are civilians and do not rotate among
facilities.

Many officials at MILVAX, other DOD entities with an interest in military
health care research, and CDC told us that they believe that the VHC
Network has made important contributions to research. For example, MILVAX
officials cited the VHC Network's role in the investigation of the causes
of death of three servicemembers after receiving multiple immunizations,
including the smallpox vaccine, the VHC Network's study of the possible
genetic predisposition to adverse events, and its work on the association
between inflammation of the heart and the smallpox vaccine.

The VHC Network Educates Servicemembers, Providers, and Others about
Adverse Events and VHC Resources

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 the following:

Presentations: The VHC Network staff make various presentations about
vaccine-related adverse events and the role of the VHC Network. The VHC
Network estimates that in 2006 it conducted 810 presentations. For
example, VHC Network staff conducted briefings at the Soldier Readiness
Processing program, which prepares servicemembers for deployment, at the
four VHC locations. These briefings accounted for almost 30 percent of all
presentations and reached about 20,000 servicemembers. Other presentations
involved briefings at mass immunization sites, family support group
meetings, and various orientation sessions, for example, for new hospital
staff at military medical centers including the four VHC sites. VHC
Network staff also participated in health fairs and conferences.

Printed material: The VHC Network publishes the Immunization Tool Kit, a
booklet that contains vaccine-related information on matters such as the
safe administration of immunizations, possible adverse events, and sources
of additional information targeted to military and civilian health care
providers. Almost 78,800 copies of the Immunization Tool Kit have been
distributed since it was first published in 2001, through March 2007.

Web resources: The VHC Network offers educational resources on its Web
site such as Project Immune Readiness, a distance learning tool that
targets military health care staff administering immunizations, but is
also available to anyone interested in learning more about vaccines. Among
other things, the tool uses educational modules to teach health care staff
how to prevent and recognize adverse events. For example, in 2005, 2,060
people completed 7,779 of these modules.

Collaborative efforts: The VHC Network and MILVAX regularly collaborate in
education efforts. For example, MILVAX reviews new material to be included
in the VHC Network's Project Immune Readiness, such as guidance on the
proper handling and storage of vaccines. In addition, a representative of
the Uniformed Services University of the Health Sciences, which provides
training on public health in the military, told us that VHC Network staff
have assisted in developing its preventive medicine training.

While many DOD officials and medical staff we contacted acknowledged the
contributions of the VHC Network in education, several said that they do
not believe that enough military healthcare providers are being reached.
Specifically, we were told that many providers are still unaware of the
VHC Network, its role, and the potential links between certain symptoms
and adverse events, which, in turn, affects their ability to not only
provide proper diagnosis and treatment, but also to educate those being
immunized.^15 According to DOD officials with whom we spoke, the nature of
DOD's organization, with its continuous rotation and restructuring of
personnel, creates a challenge for the VHC Network to effectively reach
out to every targeted audience.

Recent Decisions by DOD Have the Potential to Provide Greater Stability to
the VHC Network

In December 2006, DOD made decisions addressing matters regarding the VHC
Network, including its organizational status, mission, and funding. VHC
Network officials stated that the unpredictability of the VHC Network's
budget from one year to the next had affected facility development and
staff retention, and compromised the VHC Network's ability to provide
services and to accomplish its mission. DOD's recent decision to place the
VHC Network under the command of MILVAX, beginning in fiscal year 2008,
provides recognition of the VHC Network's status and mission, in addition
to offering the potential for more funding security through access to
DOD's long-term budget planning process.

Uncertainties in DOD's Commitment to the VHC Network Had Affected Its
Status, Mission, and 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.

^15For example, according to CDC's Morbidity and Mortality Weekly Report
of May 18, 2007, a child of a servicemember who received the smallpox
vaccine experienced a life-threatening reaction to his father's
immunization. ( [3]http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5619a4.htm ,
downloaded on May 18, 2007.) Such a reaction can occur from close physical
contact with people who have recently received this vaccine. Greater
awareness of adverse events and their prevention among servicemembers and
military health care staff could help prevent such incidents.

The VHC Network had not been included in the military's long-term 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
5-year budgets,^16 prepared in fiscal years 2004 and 2006, the VHC
Network's costs were not included in the 5-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 (GWOT) funds.^17 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.^18 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. Table 3 shows the VHC Network's sources of funding for fiscal
years 2002-2006.

^16The Five-Year Defense Program budget is prepared on a biannual basis, 2
years in advance of the 5-year period and is meant for long-range DOD
planning.

^17GWOT funds support military operations to combat terrorism worldwide.
Congress has been appropriating GWOT funds since 2001, through both annual
appropriations and supplemental appropriations. Each service allocates its
share of GWOT funds among its various functions. Only the Army has used
GWOT funds to support the VHC Network.

^18The conference reports accompanying DOD's Appropriations Acts for
Fiscal Years 2003 and 2006 contained funding tables indicating that a
total of about $5.5 million was to be spent on the VHC Network for those
years. See H.R. Conf. Rep. No. 107-732, at 323 (2002) (accompanying Pub.
L. No. 107-248) and H.R. Conf. Rep. No. 109-359, at 454 (2005)
(accompanying Pub. L. No. 109-148).

Table 3: Funding Sources for VHC Network Activities, Fiscal Years
2002-2006

                                          Fiscal Fiscal Fiscal Fiscal         
Financial support (dollars      Fiscal   year   year   year   year         
in millions)                 year 2002   2003   2004   2005   2006   Total 
GWOT--Army Surgeon General      $5.200 $1.920 $5.640 $5.551 $2.874 $21.185 
NARMC                                                 0.117  0.060   0.177 
Defense Health Program                                                     
Appropriations^a                        2.543                2.970   5.513 
MILVAX                                  0.444  0.623  0.610  0.366   2.043 
Total                           $5.200 $4.907 $6.263 $6.278 $6.270 $28.918 

Source: DOD.

Notes: Since February 2006, the VHC Network also received over $2.3
million in grants and awards from DOD and the National Institutes of
Health for various projects. The Army, Air Force, and Navy have also
provided facility space and utilities for the VHC regional sites located
at their bases.

aThe conference reports accompanying DOD's Appropriations Acts for Fiscal
Years 2003 and 2006 contained funding tables indicating that a total of
about $5.5 million was to be spent on the VHC Network for those years. See
H.R. Conf. Rep. No. 107-732, at 323 (2002) (accompanying Pub. L. No.
107-248) and H.R. Conf. Rep. No. 109-359, at 454 (2005) (accompanying Pub.
L. No. 109-148).

Although the total annual funding for the VHC Network has been fairly
consistent from year to year,^19 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.^20 The
facility, costing approximately $500,000, was completed in 2004. However,
it was never occupied as a VHC regional site because the Army's 5-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.

In addition, VHC Network officials stated that the lack of reliable
funding made it difficult to plan for staffing. For example, although Air
Force and Navy personnel were utilizing services provided by the Wilford
Hall and Portsmouth regional VHC sites, the Army considered closing these
two regional VHCs in 2006, because of the absence of budgetary support
from the Air Force and Navy. In particular, VHC Network officials noted
that the uncertainty surrounding the future of the Portsmouth regional VHC
made it difficult to recruit and retain staff there. The position of
medical director at the Portsmouth site had been vacant since April 2004,
when the site's last medical director resigned, citing funding uncertainty
as part of her reason for resigning.^21 By December 2006, when DOD made
decisions addressing the mission and funding of the VHC Network, the
Portsmouth VHC had been unable to recruit replacements for vacant staff
positions, in part, because it could not ensure that the positions would
exist in the upcoming year.

^19The VHC Network's fiscal year 2007 budget of $6.105 million is funded
through contributions from each of the services: the Air Force and Navy
provided approximately $1.6 million each, the Army provided approximately
$2.5 million, and the balance--approximately $0.3 million--will be
available through NARMC's GWOT allocations.

^20Landstuhl Regional Medical Center in Germany is the primary medical
treatment center for casualties of U.S. operations within Europe,
Southwest Asia, and the Middle East.

^21The Wilford Hall medical director currently serves as the Portsmouth
medical director.

DOD's Decisions Could Make the VHC Network's Status, Mission, and Funding
More Predictable

DOD addressed the challenges facing the VHC Network in December 2006.
After deliberations and unanimous agreement from the Army, Air Force, and
Navy, DOD finalized decisions that will take effect in fiscal year 2008
regarding the VHC Network's mission, status, and funding.^22 DOD's
decisions provided recognition of the VHC Network's mission and place
within DOD's command structure, and have the potential to provide access
to more predictable funding. Its decisions included (1) placing the VHC
Network under the command of MILVAX, (2) funding the VHC Network through
contributions from each of the services, (3) formalizing Army, Air Force,
and Navy input into and oversight of the VHC Network's mission and
activities, and (4) providing outcomes oversight through an independent
panel and a program review scheduled for 2010.

DOD provided the VHC Network clear organizational status through the
decision to transfer it from NARMC's command to MILVAX. This will enable
the VHC Network to share in the benefits afforded to MILVAX as a program
operating under an executive agent. In addition, DOD concluded that all
three services will periodically be asked to provide input into decisions
concerning the VHC Network's activities, making each service a stakeholder
in the success of the VHC Network's mission.

DOD also made several decisions that support the VHC Network's mission.
For example, it concluded that the mission developed by the VHC Network
was appropriate and that the VHC Network should continue with its current
activities, including maintaining its network structure of a headquarters
and regional sites. MILVAX and VHC Network officials are currently working
together, with input from the services, to revise MILVAX's mission to
include VHC Network activities. In addition, DOD decided that it would
provide oversight of the VHC Network through an independent expert panel,
which will conduct a program review in 2010. A MILVAX official stated that
being within the MILVAX command may also provide the VHC Network
additional opportunities to accomplish its mission. For example, MILVAX
has a staff of 18 analysts in the United States and abroad who could
assist in publicizing the VHC Network's services to clinicians and other
military personnel. This official suggested that greater visibility may
help ensure that those in need of the VHC Network's services know how to
access them, which may be especially important considering the
reintroduction of the mandatory anthrax immunization and DOD's January
2006 directive to achieve a higher level of medical readiness, partly
through immunizing servicemembers.

DOD 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 5-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 told us that they hope that
the changes in funding will provide the VHC Network with additional
security and facilitate VHC Network officials' ability to plan activities.

^22The National Defense Authorization Act for Fiscal Year 2007 prohibited
DOD from downsizing or restructuring the VHC Network during fiscal year
2007. See Pub. L. No. 109-364, S 737(b), 120 Stat. 2083, 2302-03 (2006).

Agency Comments

We provided a draft of this report to DOD and HHS. In its written
comments, DOD said that it concurred with our findings. DOD's written
comments are reprinted in enclosure I. HHS provided technical comments,
which we incorporated as appropriate.

                                   - - - - -

We are sending copies of this report to the Secretary of Defense and other
interested parties. In addition, this report will be available at no
charge on GAO's Web site at http://www.gao.gov. We will also make copies
available to others upon request. If you or your staff members have any
questions about this report, please contact me at (202) 512-7114 or
[email protected]. Contact points for our Offices of Congressional Relations
and Public Affairs may be found on the last page of this report. GAO staff
who made major contributions to this report are listed in enclosure II.

Marcia Crosse
Director, Health Care

Enclosures - 2

Enclosure 1:  Comments from the Department of Defense

Enclosure II:  GAO Contact and Staff Acknowledgments

GAO Contact

Marcia Crosse at (202) 512-7114 or [email protected]

Acknowledgments

Geraldine Redican-Bigott, Assistant Director; Adrienne Griffin; TaNaisha
Lee; Pauline Seretakis; and Margaret Weber made key contributions to this
report.

(290549)

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