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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.[Footnote 1] The Department of Defense (DOD) estimates 
that over 2.2 million servicemembers[Footnote 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.[Footnote 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.

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).[Footnote 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.

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.[Footnote 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,[Footnote 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.

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[Footnote 7] from further doses of a 
vaccine.[Footnote 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:

Medical personnel; Walter Reed VHC: 4; Fort Bragg VHC: 3; Portsmouth 
VHC: 3; Wilford Hall VHC: 4; Total: 14.

Support staff; Walter Reed VHC: 5; Fort Bragg VHC: 3; Portsmouth VHC: 
2; Wilford Hall VHC: 2; Total: 12.

Total; Walter Reed VHC: 9; Fort Bragg VHC: 6; Portsmouth VHC: 5; 
Wilford Hall VHC: 6; Total: 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.

[End of table]

The Office of the Secretary of Defense designated the Army as the 
executive agent[Footnote 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.[Footnote 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.

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.[Footnote 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: Trainees; Vaccine: Diphtheria, hepatitis A, 
hepatitis B, influenza, measles, meningococcal disease, mumps, 
pertussis, poliovirus, rubella, tetanus, varicella, yellow fever.

Population segment: Routine during career (both active duty and 
reserves); Vaccine: Diphtheria, hepatitis A, influenza, pertussis, 
tetanus.

Population segment: Individualized based on deployment or travel to 
high-risk areas; Vaccine: Anthrax, hepatitis B, Japanese encephalitis, 
meningococcal disease, smallpox, typhoid, yellow fever.

Population segment: Individualized based on occupational or personal 
needs; Vaccine: Haemophilus influenzae type b, hepatitis B, 
meningococcal disease, pneumococcal disease, rabies, varicella.

Source: DOD.

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

[End of table]

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.[Footnote 12] Through these venues, the VHC Network provides 
the following clinical support.

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:

* 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?

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

* 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.[Footnote 13]

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.[Footnote 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.

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.[Footnote 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.

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,[Footnote 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.[Footnote 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.[Footnote 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.

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

Financial support (dollars in millions): GWOT--Army Surgeon General; 
Fiscal year 2002: $5.200; Fiscal year 2003: $1.920; Fiscal year 2004: 
$5.640; Fiscal year 2005: $5.551; Fiscal year 2006: $2.874; Total: 
$21.185.

Financial support (dollars in millions): NARMC; Fiscal year 2002: 
[Empty]; Fiscal year 2003: [Empty]; Fiscal year 2004: [Empty]; Fiscal 
year 2005: 0.117; Fiscal year 2006: 0.060; Total: 0.177.

Financial support (dollars in millions): Defense Health Program 
Appropriations[A]; Fiscal year 2002: [Empty]; Fiscal year 2003: 2.543; 
Fiscal year 2004: [Empty]; Fiscal year 2005: [Empty]; Fiscal year 2006: 
2.970; Total: 5.513.

Financial support (dollars in millions): MILVAX; Fiscal year 2002: 
[Empty]; Fiscal year 2003: 0.444; Fiscal year 2004: 0.623; Fiscal year 
2005: 0.610; Fiscal year 2006: 0.366; Total: 2.043.

Financial support (dollars in millions): Total; Fiscal year 2002: 
$5.200; Fiscal year 2003: $4.907; Fiscal year 2004: $6.263; Fiscal year 
2005: $6.278; Fiscal year 2006: $6.270; Total: $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.

[A] The 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).

[End of table]

Although the total annual funding for the VHC Network has been fairly 
consistent from year to year,[Footnote 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.[Footnote 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.[Footnote 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.

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.[Footnote 
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.

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 crossem@gao.gov. 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.

Signed by: 

Marcia Crosse: 
Director, Health Care:

Enclosures - 2:

[End of section]

Enclosure 1: 

Comments from the Department of Defense:

[See PDF for image]

[End of figure]

Health Affairs:

The Assistant Secretary Of Defense:

1200 Defense Pentagon: Washington, DC 20301-1200:

JUN 14 2007:

Ms. Marcia Crosse: Director, Health Care: U.S. Government 
Accountability Office: 441 G Street, N.W. Washington, DC 20548: 

Dear Ms. Crosse: 

This is the Department of Defense (DoD) response to the GAO draft 
report, GAO-07-787R, `Military Health: DoD's Vaccine Healthcare Centers 
Network,' dated May 22, 2007 (GAO Code 290549).

Thank you for the opportunity to review the Draft Report and provide 
comments. I concur with the report's findings and results.

My points of contact on this audit are Dr. Michael Kilpatrick 
(Functional) at (703) 578-2675 and Mr. Gunther Zimmerman (Audit 
Liaison) at (703) 681-3492.

Sincerely,

Signed by: 

S. Ward Casscells, MD

[End of section] 

Enclosure II: 

GAO Contact and Staff Acknowledgments:

GAO Contact:

Marcia Crosse at (202) 512-7114 or crossem@gao.gov:

Acknowledgments:

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

(290549):

[End of section]

FOOTNOTES

[1] The 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. 

[2] For 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.

[3] The 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. 

[4] The 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.,  751, 114 Stat. 1654, 1654A-193 (2000) (codified at 10 
U.S.C.  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).

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

[6] We 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.

[7] Under 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. 

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

[9] An 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.

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

[11] Medical 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.

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

[13] Most 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.

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

[15] For 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. (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. 

[16] The 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.

[17] GWOT 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. 

[18] The 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). 

[19] The 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. 

[20] Landstuhl 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.

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

[22] The 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,  737(b), 120 Stat. 2083, 
2302-03 (2006).