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COVID-19: DOD Has Focused on Strategy and Oversight to Protect Military Servicemember Health (GAO-21-321)

Summary

GAO-21-321, a June 2021 report from the United States Government Accountability Office to congressional addressees, titled COVID-19: DOD Has Focused on Strategy and Oversight to Protect Military Servicemember Health. It examines the Department of Defense strategy for protecting servicemember health, its oversight of that strategy, and its research and development projects for vaccines, therapeutics, and testing. GAO states that Congress appropriated about $10.5 billion to DOD through the CARES Act. It reports that DOD officials oversee the strategy through sustained leadership attention, data monitoring, and lessons learned reviews.

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“COVID-19: DOD Has Focused on Strategy and Oversight to Protect Military Servicemember Health (GAO-21-321).” Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/21-321-covid-19-dod-has-focused-on-strategy-7b883a575e/, SHA-256 5a29aed308b204c51c02e3f6010e024e9ebdda05118cfca61b4209a4eeb58af6.

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             United States Government Accountability Office
             Report to Congressional Addressees




             COVID-19
June 2021




             DOD Has Focused on
             Strategy and
             Oversight to Protect
             Military
             Servicemember
             Health




GAO-21-321
                                                 June 2021

                                                 COVID-19
                                                 DOD Has Focused on Strategy and Oversight to
                                                 Protect Military Servicemember Health
Highlights of GAO-21-321, a report to
congressional addressees




Why GAO Did This Study                           What GAO Found
The COVID-19 pandemic poses risks                Since January 2020, the Department of Defense (DOD) has developed a
to the health of U.S. servicemembers.            strategy to protect the health of military servicemembers from COVID-19, with a
Protecting forces from COVID-19 is               goal of minimizing risks while continuing operations. The strategy tailors
therefore essential to DOD’s ability to          protection measures to local conditions and risks to health and force readiness.
defend the United States, maintain               GAO found that DOD’s strategy applies several key considerations.
warfighting readiness, and support the
whole-of-government response to the              DOD Application of Key Considerations to Protect Servicemembers from COVID-19
pandemic.
To help facilitate the COVID-19
pandemic response, Congress
appropriated about $10.5 billion to
DOD through the CARES Act. The
CARES Act includes a provision for
GAO to report on its ongoing
monitoring and oversight related to the
pandemic. GAO was also asked to
examine the military health system
response to COVID-19. This report
examines, in regard to COVID-19,
DOD’s (1) strategy for protecting
military servicemember health, (2)
oversight of its strategy, and (3)
research and development projects for
vaccines, therapeutics, and testing.
GAO reviewed guidance and plans for
health protection and pandemic                   DOD officials oversee the implementation of the department’s COVID-19 health
response that comprise DOD’s                     protection strategy for servicemembers through:
strategy, and evaluated alignment of             •   Sustained leadership attention. In January 2020, the Secretary of Defense
the strategy with key considerations                 initiated COVID-19 planning and established a senior task force to oversee
from prior GAO work on pandemic                      the response. Combatant command and installation officials continuously
preparedness. To identify oversight                  evaluate regional and local implementation and perform compliance checks.
efforts, GAO reviewed DOD briefings                  Notwithstanding these efforts, DOD officials stated that they expect some
on the progress of health protection                 limited incidents of personnel not following protocols.
measures, and analyzed 2020 DOD
data on COVID-19 cases,                          •   Data monitoring. Senior leaders and local commanders assess data on
hospitalizations, and testing.                       cases, community spread, and testing, among other metrics, to inform
GAO also interviewed DOD leaders,                    strategy implementation and assess its effectiveness.
officials from the military department
medical organizations, combatant                 •   Lessons learned analyses. While these analyses are ongoing as the
commands, and four military medical                  pandemic continues, DOD has implemented mitigations to address some
treatment facilities selected on the                 challenges identified, such as a new system to collect more timely and
basis of military department and                     specific COVID-19 case data.
location.                                        DOD has research and development projects underway to advance COVID-19
                                                 vaccines and therapeutics and improve detection methods. DOD’s investments
                                                 include many projects that have specific applications for servicemembers, such
View GAO-21-321. For more information,
contact Brenda S. Farrell at (202) 512-3604 or   as pre- and postexposure prophylactic treatments to prevent the onset of the
farrellb@gao.gov.                                disease.


                                                                                            United States Government Accountability Office
Contents


Letter                                                                                             1
                       Background                                                                 6
                       DOD’s Strategy for COVID-19 Health Protection is Risk- and
                         Conditions-Based and Applies Key Considerations for the
                         Reentry of Employees to the Workforce                                   13
                       DOD Oversight Mechanisms for COVID-19 Health Protection
                         Measures Include Leadership Attention, Data Tracking, and
                         Lessons Learned Analyses                                                33
                       DOD’s COVID-19 Research and Development Efforts Aim to
                         Advance Prevention and Treatment Methods and Improve
                         Detection among Servicemember Populations                               44
                       Agency Comments                                                           53

Appendix I             Objectives, Scope, and Methodology                                        56



Appendix II            GAO Contact and Staff Acknowledgments                                     61



Related GAO Products                                                                             62


Tables
                       Table 1. Selected Responsibilities According to the Department of
                               Defense (DOD) Public Health Emergency Management
                               and Force Health Protection Issuances                              9
                       Table 2. Department of Defense’s Tiered Framework for
                               Prioritizing COVID-19 Testing                                     21
                       Table 3. Examples of the Department of Defense’s (DOD) Key
                               Protection Measures and Mitigation Steps After COVID-19
                               Infection                                                         24
                       Table 4. Characteristics of the U.S. and DOD Servicemember
                               Populations Aged 17 to 62                                         39

Figures
                       Figure 1. Timeline of COVID-19 Pandemic and DOD Milestones,
                                January 2020 to February 2021                                     7
                       Figure 2. Examples of DOD Application of Key Considerations to
                                Protect Servicemembers during the COVID-19 Pandemic              15


                       Page i                                     GAO-21-321 COVID-19 Military Health
Figure 3. Examples of Department of Defense Posters on COVID-
         19 Precautions                                                                   17
Figure 4. Considerations for Changing Health Protection Condition
         (HPCON) Levels at Military Installations and Sample
         Protection Measures                                                              19
Figure 5. Department of Defense Weekly COVID-19 Tests in
         2020, by Type, for Active-Duty Servicemembers                                    29
Figure 6. COVID-19 Cases and Hospitalization Rates among
         Active-Duty Servicemembers, March 2020 through
         December 2020                                                                    38
Figure 7. Percentage of Confirmed or Probable COVID-19 Cases
         among Active-Duty Servicemembers Tested, Weeks of
         March 29, 2020 through December 27, 2020                                         41
Figure 8: Examples of Department of Defense Medical Research
         and Development Capabilities for COVID-19
         Countermeasures                                                                  46




Abbreviations

ASD(HA)                    Assistant Secretary of Defense for Health Affairs
CDC                        Centers for Disease Control and Prevention
COVID-19                   Coronavirus Disease 2019
DHA                        Defense Health Agency
DOD                        Department of Defense
EUA                        emergency use authorization
FDA                        Food and Drug Administration
JPEO CBRND                 Joint Program Executive Office for Chemical,
                           Biological, Radiological, and Nuclear Defense
MTF                        medical treatment facility




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Page ii                                               GAO-21-321 COVID-19 Military Health
                       Letter




441 G St. N.W.
Washington, DC 20548




                       June 3, 2021

                       Congressional Addressees

                       More than a year since the World Health Organization declared it a
                       pandemic, the Coronavirus Disease 2019 (COVID-19) continues to pose
                       risks to the health of U.S. servicemembers and the Department of
                       Defense’s (DOD) missions. As of May 20, 2021, over 164 million
                       confirmed COVID-19 cases, including over 3.4 million deaths globally,
                       had been reported to the World Health Organization. By the same date, in
                       the United States, more than 32.8 million COVID-19 cases and 584,975
                       deaths had been reported to the Centers for Disease Control and
                       Prevention (CDC). Yet, the CDC estimates that the total disease burden
                       (including unreported cases) could be at least four times higher than
                       reported. Given that U.S. servicemembers live and work among the
                       general population of the United States and over 160 other countries
                       affected by COVID-19, the scope and severity of the pandemic
                       underscore the imperative of maintaining servicemembers’ health to
                       defend the United States and preserve warfighting readiness for
                       emergent contingencies. Moreover, servicemember health is paramount
                       to DOD’s support of civil authorities in the whole-of-government response
                       to the COVID-19 pandemic.

                       DOD and its military health system have long maintained a spectrum of
                       capabilities necessary to prevent, prepare for, and respond to infectious
                       disease outbreaks, including those of the past 2 decades––Severe Acute
                       Respiratory Syndrome (known as SARS), Middle East Respiratory
                       Syndrome (known as MERS), H1N1 influenza, Ebola, and Zika virus. 1
                       DOD’s capabilities in this area range from global health engagement
                       activities to improve partner nations’ public health capabilities and
                       interoperability; biosurveillance assets across the world to monitor
                       emerging infectious diseases; specialized health care personnel,
                       including epidemiologists and public health officers; stockpiles of
                       pandemic medical supplies and equipment; a public health emergency
                       management response framework and pandemic plans; and a research
                       and development infrastructure—including laboratories and


                       1Like COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East
                       Respiratory Syndrome (MERS) were respiratory illnesses caused by coronaviruses that
                       originated in animals and spread to humans.




                       Page 1                                             GAO-21-321 COVID-19 Military Health
manufacturing facilities—to study diseases and develop medical
countermeasures. 2

Our prior work has reviewed DOD’s and the federal government’s
pandemic preparedness. In 2006, we reported on DOD’s then-evolving
plans for pandemic influenza. 3 We made four recommendations to
improve accountability and oversight of planning, and DOD implemented
all of them. We have also reported on federal response issues related to
the H1N1 pandemic—the most recent pandemic experienced by our
nation prior to COVID-19—and disease outbreaks like the one caused by
the Zika virus in the United States in 2016. 4 In 2011, based on our
findings from the H1N1 pandemic response, we made two
recommendations to help the federal government prepare for a future
influenza pandemic or other public health emergencies, which the
Departments of Health and Human Services and Homeland Security
implemented. In 2017, we made five recommendations to improve
diagnostic tests (such as those for Zika virus) and information on
mosquito control. The Food and Drug Administration (FDA) and the CDC
implemented four of the recommendations; as of January 2021 the FDA
had not yet implemented the other. More recently, in June 2020 we
testified about considerations for federal workers as they reenter
workplaces during the COVID-19 pandemic, which include a range of
factors to carry out their missions while protecting workforces and
members of the public. 5

To help facilitate DOD’s ability to respond to the COVID-19 pandemic, in
March 2020 Congress appropriated approximately $10.5 billion to the



2Medical countermeasures are drugs, vaccines, and devices to diagnose, treat, prevent,
or mitigate potential health effects of exposure to infectious diseases and chemical,
biological, radiological, and nuclear agents.
3GAO, Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but
Accountability, Funding, and Communications Need to be Clearer and Focused
Departmentwide, GAO-06-1042 (Washington, D.C.: Sept. 21, 2006).
4GAO, Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated
into Future Planning, GAO-11-632, (Washington, D.C.: June 27, 2011) and Emerging
Infectious Diseases: Actions Needed to Address the Challenges of Responding to Zika
Virus Disease Outbreaks, GAO-17-445 (Washington, D.C.: May 23, 2017).
5GAO, Federal Workforce: Key Considerations for Agencies Returning Employees to
Workplaces during Pandemics, GAO-20-650T (Washington, D.C.: June 25, 2020).




Page 2                                                 GAO-21-321 COVID-19 Military Health
department in funding through the CARES Act. 6 These supplemental
appropriations included approximately $3.8 billion for the Defense Health
Program to prevent, prepare for, and respond to COVID-19. 7 The
Defense Health Program was also appropriated $82 million by the
Families First Coronavirus Response Act for COVID-19 related health
care items and services. 8

The CARES Act includes a provision for us to report on our ongoing
monitoring and oversight efforts related to the COVID-19 pandemic. 9 This
report is part of our body of work in response to the CARES Act and
focuses on DOD’s efforts related to protecting the health of
servicemembers. 10 It also responds to a request from the Armed Services
Committee of the House of Representatives for us to examine the military
health system response to COVID-19. 11 With regard to COVID-19, this


6Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. No. 116-136, div.
B, title III, 134 Stat. 281, 518 (2020).
7The Defense Health Program provides worldwide medical services to active-duty
servicemembers and other eligible beneficiaries, including costs associated with the
delivery of TRICARE benefits. At the end of fiscal year 2020, DOD had obligated about
$1.9 billion of its Defense Health Program supplemental appropriations for COVID-19
requirements, and returned $1 billion of unobligated funds to the Under Secretary of
Defense, Comptroller. In May 2020, DOD identified $252 million of the $3.8 billion
Defense Health Program appropriation for transfer or reprogramming to fund other
COVID-19 response efforts. We reported in September 2020 that DOD’s transfers or
reprogramming actions were taken because of fewer than expected requirements for
costs such as hospital bed expansion at medical treatment facilities (MTFs) and
expeditionary hospital packages. DOD had budgeted the remaining $3.6 billion of Defense
Health Program funds from the CARES Act for costs associated with increased health
care and laboratory operations, procurement of vaccines and antivirals, and procurement
of medical equipment, diagnostics tests and other medical countermeasures. GAO,
COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions,
GAO-20-701 (Washington, D.C.: Sept. 21, 2020).
8Families First Coronavirus Response Act, Pub. L. No. 116-127, title II, 134 Stat. 178, 181
(2020).
9Pub. L. No. 116-136, § 19010 (2020).

10We regularly issue government-wide reports on the federal response to COVID-19. For
the latest report, see GAO, COVID-19: Sustained Federal Action Is Crucial as Pandemic
Enters Its Second Year, GAO-21-387 (Washington, D.C.: Mar. 31, 2021). Our next
government-wide report will be issued in July 2021 and will be available on GAO’s website
at https://www.gao.gov/coronavirus.
11We initiated this review in response to the Chairwoman and Ranking Member of the
Subcommittee on Military Personnel, House Armed Services Committee of the 116th
Congress.




Page 3                                                GAO-21-321 COVID-19 Military Health
report examines DOD’s (1) strategy for protecting the health of military
servicemembers, (2) oversight mechanisms for implementing its health
protection strategy, and (3) research and development projects for
vaccines, therapeutics, and testing.

For each of our objectives, our scope included DOD’s actions to address
COVID-19 since January 2020, focusing on active-duty servicemembers.
For objectives one and two, we interviewed officials from geographic
combatant commands and a nongeneralizable sample of four military
medical treatment facilities (MTF) that we selected to represent each
geographic region of the world in which DOD operates, and each military
department. 12 From the geographic combatant commands, we obtained
force health protection guidance for COVID-19 and examples of health
surveillance update briefings. Our observations from these interviews and
related documents provided insight into DOD’s strategy for protecting
military servicemembers as well as illustrative examples of how
commands and selected MTFs have overseen DOD’s implementation of
its strategy for protecting servicemembers.

In addition, for our first objective we reviewed DOD’s force health
protection policies, guidance, and planning documents issued through
February 2021 specific to COVID-19, and identified actions that comprise
DOD’s strategy to protect servicemembers. 13 We also reviewed DOD’s
global pandemic campaign plan and an example of a regional campaign
plan from U.S. Indo-Pacific Command, which were published prior to the
COVID-19 pandemic. To understand the plans’ relevance to the COVID-
19 health protection strategy, we identified health protection measures
discussed in the plans that were similar to or different from those
identified in DOD’s other force health protection policies, guidance, and
planning documents for COVID-19. We compared DOD’s strategy with
key considerations for agencies during pandemics based on our prior
work to determine how the actions aligned, and whether there were

12The five combatant commands we interviewed included U.S. Northern Command, U.S.
Southern Command, U.S. Indo-Pacific Command, U.S. Central Command, and U.S.
European Command. The four MTFs we interviewed included the 60th Medical Group at
David Grant Medical Center, Travis Air Force Base, California; Naval Health Clinic Corpus
Christi, Naval Air Station Corpus Christi, Texas; Naval Hospital Okinawa, Camp Foster,
Japan; and the Army’s Landstuhl Regional Medical Center, Kaiserslautern, Germany.
13In addition, we reviewed COVID-19 force health protection guidance that DOD issued
and made publicly available on the defense.gov website from March 1, 2021 through May
20, 2021 to determine whether key changes were made to previously issued guidance
during the time that DOD was reviewing a draft of this report for comment.




Page 4                                               GAO-21-321 COVID-19 Military Health
deficiencies or additional steps DOD has taken beyond those key
considerations. 14

To assess consistency between DOD’s guidance and that of the CDC—
the lead federal agency for prevention of and control of diseases—we
selected measures discussed in DOD’s force health protection guidance
representing the range of protection activity categories of the CDC
guidance, including day-to-day protection, mitigating infections, and
COVID-19 testing. We compared those selected measures with guidance
from CDC’s website. To further our understanding of the strategy for
health protection, we interviewed DOD officials, including senior leaders,
combatant command representatives, and personnel from selected
MTFs.

In addition, for our second objective, we reviewed key documentation on
oversight activities, including briefing documents from working groups
within DOD on the progress of health protection measures, along with
commanders’ orders for health emergencies. We reviewed these
documents to identify DOD’s methods for assessing compliance and the
consistency and uniformity of implementation. We also analyzed DOD
data from January 2020 to December 2020 on numbers of COVID-19
tests by type, positive tests, and positivity rates among active-duty
servicemembers, along with confirmed positive cases, hospitalizations,
and deaths, to identify trends and compare them with statements by DOD
leaders regarding their assessment of the effectiveness of health
protection actions. We determined the data were sufficiently reliable for
our purposes to describe trends over time and provide examples of
analyses DOD leaders use to monitor efforts to protect servicemembers

14Specifically, federal agencies should consider doing the following: prioritize leadership
attention and continuous communication across the organization; make decisions about
reentry based on local conditions; identify mission-essential functions and employees, and
classify their exposure risk level; implement social distancing and other appropriate
protection measures for employees; establish COVID-19 testing protocols; and establish
protocols to prioritize and distribute antivirals and vaccines. We refer to these as “key
considerations” because they are not exhaustive. We developed them by reviewing prior
work on pandemic response and planning. Namely, in June 2020, we testified on key
considerations for agencies as their employees reenter workplaces during pandemics.
GAO-20-650T. To ensure these key considerations were comprehensive and relevant as
knowledge of the pandemic increased later in 2020, we identified leadership attention (in
conjunction with communicating to employees) and testing protocols as other critical
factors on the basis of our more recent reports on COVID-19. See GAO, COVID-19:
Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges
Require Focused Federal Attention, GAO-21-265 (Washington, D.C.: Jan. 28, 2021);
COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response,
GAO-21-191 (Washington, D.C.: Nov. 30, 2020); and GAO-20-701.




Page 5                                                  GAO-21-321 COVID-19 Military Health
                       from COVID-19 by (1) reviewing the databases for errors, (2) cross-
                       checking data with other DOD documentation and reporting, and (3)
                       interviewing DOD officials knowledgeable about the data. Finally, we
                       reviewed lessons learned reports and interviewed DOD officials, including
                       personnel from selected MTFs, about oversight mechanisms they employ
                       to assess their health protection efforts.

                       For our third objective, we reviewed DOD briefing documents from
                       periodic progress updates on all COVID-19 medical countermeasures
                       research and development projects initiated since January 2020. We also
                       identified and reviewed documentation on individual projects from DOD’s
                       press releases, updates to ClinicalTrials.gov, and scientific journal
                       articles. Together with interviews of DOD officials, we analyzed and
                       described DOD’s overall strategy to leverage its research and
                       development capabilities and those of academic and industry partners.
                       We also identified DOD-unique aspects of the various project
                       investments, including benefits to the servicemember population that
                       differ from the needs of the general population. We provide further details
                       on our scope and methodology in appendix I.

                       We conducted this performance audit from May 2020 to June 2021 in
                       accordance with generally accepted government auditing standards.
                       Those standards require that we plan and perform the audit to obtain
                       sufficient, appropriate evidence to provide a reasonable basis for our
                       findings and conclusions based on our audit objectives. We believe that
                       the evidence obtained provides a reasonable basis for our findings and
                       conclusions based on our audit objectives.


Background
Timeline of COVID-19   The department has issued force health protection guidance and
Pandemic and DOD       supplements since January 30, 2020 on a range of topics that include risk
                       reduction measures, testing, treatment, and travel. Figure 1 shows these
Milestones
                       issuances, along with COVID-19 trends and U.S. federal actions, through
                       February 2021—the first year of the pandemic.




                       Page 6                                       GAO-21-321 COVID-19 Military Health
Figure 1. Timeline of COVID-19 Pandemic and DOD Milestones, January 2020 to February 2021




                                       Notes: Except for FHP Supplement 11, each of the FHP supplements shown in the figure was
                                       rescinded and replaced by a later supplement. From March 2021 through May 2021, DOD issued five
                                       new FHP supplements and two revisions to existing supplements, which provided updated guidance
                                       to personnel on: laboratory testing services; deployment and redeployment procedures; use of
                                       masks, personal protective equipment, and non-pharmaceutical interventions; protecting personnel in
                                       DOD workplaces; traveling; and movement and medical treatment of COVID-19 patients.




                                       Page 7                                                     GAO-21-321 COVID-19 Military Health
DOD Policy and Planning   According to DOD Directive 6200.04, Force Health Protection (FHP), it is
for Public Health         DOD policy that commanders, supervisors, individual servicemembers,
                          and the military health system shall promote, improve, conserve, and
Emergencies and Force
                          restore the physical and mental well-being of servicemembers across the
Health Protection         full range of military activities and operations. 15 The Assistant Secretary of
                          Defense for Health Affairs (ASD(HA)) is the principal advisor to the
                          Secretary of Defense and the Under Secretary of Defense for Personnel
                          and Readiness for all DOD health and force health protection policies,
                          programs, and activities. 16 The ASD(HA) establishes force health
                          protection guidelines and prioritizes distribution of vaccines and antiviral
                          medications by the military services in consultation with the geographic
                          combatant commands.

                          Force health protection is a broad endeavor that includes several
                          components:

                          •   casualty prevention, which is the application of prevention and
                              protection capabilities, such as control of vaccine-preventable
                              diseases;
                          •   preventive medicine, including public health and epidemiology, to
                              monitor, identify, prevent, and control communicable diseases,
                              illnesses, and injuries;
                          •   comprehensive health surveillance and risk management, which
                              includes identifying populations at risk and identifying and assessing
                              these populations’ potentially hazardous exposures, monitoring and
                              reporting disease and injury rates, and reporting health risks to higher
                              authority while employing countermeasures; and
                          •   biosurveillance of information related to all-hazards, threats, or
                              disease activity affecting human, animal, or plant health. 17
                          Force health protection is part of DOD’s all-hazards emergency
                          management framework to prepare and respond to public health
                          emergencies caused by a pandemic; a chemical, biological, radiological,



                          15Department of Defense Directive 6200.04, Force Health Protection (FHP) (Oct. 9, 2004).

                          16Department of Defense Directive 5136.01, Assistant Secretary of Defense for Health
                          Affairs (ASD(HA)) (Sept. 30, 2013) (incorporating change 1, Aug. 10, 2017).
                          17Joint Chiefs of Staff, Joint Pub. 4-02, Joint Health Services (Dec. 11, 2017)
                          (incorporating change 1, Sept. 28, 2018).




                          Page 8                                                 GAO-21-321 COVID-19 Military Health
                                           nuclear, or high-yield explosive incident; or other hazard. 18 To advance
                                           force health protection in a public health emergency (and protect DOD
                                           facilities, property and individuals working or residing on DOD
                                           installations), DOD Instruction 6200.03, Public Health Emergency
                                           Management (PHEM) within the DOD establishes policy, assigns
                                           responsibilities, and provides direction across the department to ensure
                                           mission assurance and readiness. 19 Table 1 describes selected
                                           responsibilities across the department in accordance with DOD’s policies
                                           for public health emergency management and force health protection.

Table 1. Selected Responsibilities According to the Department of Defense (DOD) Public Health Emergency Management and
Force Health Protection Issuances

Under Secretary of Defense for     Provides criteria, guidance, and instruction to incorporate public health emergency management
Personnel and Readiness            requirements into appropriate DOD policy, program, and budget documents.
Assistant Secretary of Defense for Under the authority, direction, and control of the Under Secretary of Defense for Personnel and
Health Affairs (ASD(HA))           Readiness, oversees the policy; program planning and execution; and allocation and use of public
                                   health, medical, and veterinary resources. Develops appropriate force health protection guidance
                                   to achieve the greatest public health benefit while minimizing disruptions to DOD missions and
                                   deployments.
Director, Defense Health Agency    Supports the Secretaries of the military departments’ public health emergency management
                                   responsibilities and activities. Provides technical support to the surgeons general of the military
                                   departments, geographic combatant commanders, appropriate joint force commanders, DOD
                                   agencies, and other DOD components.
Assistant Secretary of Defense for Coordinates with the ASD(HA) on public health emergency management policy and guidance to
Homeland Defense and Global        ensure integration and consistency with policies and programs related to homeland defense,
Security                           global security, and defense support of civil authorities among others.
Chairman of the Joint Chiefs of    Assesses force health protection as part of the overall planning of any force deployment decision.
Staff                              Periodically reassesses the force health protection posture of deployed forces. Reviews
                                   Combatant Commanders’ joint plans, deployment orders, and other relevant documents for force
                                   health protection considerations.
Secretaries of the military        Ensure execution of public health emergency management program requirements at installations.
departments                        Ensure military commanders establish, at their discretion, a health protection condition level
                                   during an emergency to communicate specific health protection measures on installations. Report
                                   metrics in accordance with ASD(HA) requirements.




                                           18DOD considers a pandemic to be a medical event and not a chemical biological,
                                           radiological, nuclear event. Joint Chiefs of Staff, Joint Pub. 3-41, Chemical, Biological,
                                           Radiological, and Nuclear Response (Sept. 9, 2016).
                                           19A public health emergency within DOD is the occurrence or imminent threat of an illness
                                           or health condition that poses a high probability of a significant number of deaths, serious
                                           or long-term disabilities, widespread exposure to an infectious or toxic agent,
                                           overwhelmed health care resources, or severe degradation of mission capabilities.
                                           Department of Defense Instruction 6200.03, Public Health Emergency Management
                                           (PHEM) within the DOD (Mar. 28, 2019).




                                           Page 9                                                   GAO-21-321 COVID-19 Military Health
 Geographic combatant                               Ensure unity of effort in the implementation of public health emergency management at DOD
 commanders                                         installations within the combatant command’s area of responsibility. Establish force health
                                                    protection policies and programs for the protection of all forces assigned or attached to the
                                                    command.
 DOD component heads                                Implement public health emergency management guidance of the ASD(HA). Ensure that the
                                                    headquarters and installation identify appropriate public health and medical subject matter experts
                                                    to advise on public health and medical issues.
 Military commanders                                Ensure an appropriate local response to public health emergencies by directing the public health
                                                    emergency officer, medical treatment facility commander or director, and medical emergency
                                                    manager to establish a framework of health protection measures for the installation population
                                                    that are specific to the scope and severity of the current situation.
Sources: Department of Defense Directive 6200.04, Force Health Protection (FHP) (Oct. 9, 2004); Department of Defense Instruction 6200.03, Public Health Emergency Management (PHEM) within the
DOD (Mar. 28, 2019). | GAO-21-321



                                                                DOD guidance states that pandemic disease outbreaks are public health
                                                                emergencies of national significance, which would likely result in surge
                                                                requirements that overwhelm civilian medical facilities and health care
                                                                providers. 20 Accordingly, combatant commands, with support from the
                                                                military services, are directed to develop and execute pandemic plans,
                                                                which include force health protection measures consistent with guidance
                                                                from the ASD(HA). DOD’s Global Pandemic Campaign Plan, issued in
                                                                2013, provides overarching guidance to DOD and the military services on
                                                                how to plan and prepare for a pandemic outbreak. U.S. Northern
                                                                Command is DOD’s lead combatant command for pandemic planning and
                                                                synchronizing efforts across other supporting combatant commands. In
                                                                this role, Northern Command is responsible for providing strategic
                                                                planning guidance for DOD’s efforts to prepare for and respond to
                                                                pandemic diseases.

                                                                DOD’s Global Pandemic Campaign Plan contains general procedures
                                                                commanders should follow to protect forces, allowing for some
                                                                adaptations in the context of a specific outbreak. It explains how U.S.
                                                                Northern Command would respond to a pandemic by identifying
                                                                capabilities—such as personal protective equipment and medical
                                                                countermeasures—to prevent human-to-human transmission. The plan
                                                                also includes key assumptions about how a pandemic could affect DOD’s
                                                                ability to provide homeland defense. According to DOD officials, the plan
                                                                provides execution guidance, while policies and guidance comprise
                                                                strategy for force health protection in a pandemic.




                                                                20DOD Instruction 6200.03.




                                                                Page 10                                                                      GAO-21-321 COVID-19 Military Health
DOD’s Medical Research   Under the authority, direction, and control of the Under Secretary of
and Development and      Defense for Personnel and Readiness, the ASD(HA) develops policies,
                         procedures, and standards that govern the management of programs for
Health Surveillance
                         medical research and development, and clinical investigations within the
Infrastructure           military health system. Specifically, the ASD(HA) oversees medical
                         research and development, and clinical investigations funded by the
                         Defense Health Program appropriation. Funding for DOD’s COVID-19
                         medical research and development is overseen and prioritized by the
                         Under Secretary of Defense for Research and Engineering, and the
                         ASD(HA).

                         DOD maintains a large enterprise of organizations that sponsor and
                         conduct medical research. The Defense Health Agency (DHA), the Joint
                         Program Executive Office for Chemical, Biological, Radiological, and
                         Nuclear Defense (JPEO CBRND), and the Defense Advanced Research
                         Projects Agency sponsor projects that are executed by partners in
                         industry and academia. Other DOD entities perform medical research in
                         their facilities and with partners in industry and academia, including the
                         U.S. Army Medical Research Institute of Infectious Diseases, the Walter
                         Reed Army Institute of Research, the Naval Medical Research Center,
                         the Air Force Research Laboratory, and the Uniformed Services
                         University of the Health Sciences.

                         In addition to medical research performed in laboratory settings, DOD
                         also manages clinical investigation programs with human volunteers to
                         add to medical knowledge. These clinical investigation program activities
                         are generally carried out at MTFs. They include observational studies and
                         clinical trials to advance the understanding of diseases or conditions,
                         including related treatment, diagnosis, and prevention. Clinical trials
                         provide data on the safety and effectiveness of new drugs, biological
                         products (such as vaccines), and medical devices.

                         DHA’s Armed Forces Health Surveillance Division is DOD’s central
                         epidemiologic resource, which enables, among other things, monitoring
                         trends over time of diseases (as well as other illnesses and injuries
                         among servicemembers). For example, the Division’s epidemiology and
                         analysis section provides health surveillance products to DOD
                         policymakers, commanders, health care providers, public health officers,
                         and researchers. Furthermore, the Division’s Global Emerging Infections
                         Surveillance program supports force health protection decision-making
                         with a global laboratory network that analyzes and provides infectious
                         disease surveillance information to geographic combatant commands and
                         partner agencies.


                         Page 11                                      GAO-21-321 COVID-19 Military Health
Prior GAO Reports on   Since June 2020, we have reported on progress of the whole-of-
COVID-19               government efforts to mitigate the COVID-19 pandemic and protect the
                       health of the American people, including challenges that have hampered
                       the federal response. Our reports in this area have addressed:

                       •   Testing and supplies. In June 2020, we found that the Department
                           of Health and Human Services and other agencies faced several
                           challenges that resulted in significant delays in testing nationwide and
                           a dearth of quality information on testing at the federal level. 21
                           Specifically, agencies faced challenges developing accurate tests
                           quickly and coordinating needed testing supplies. We found that, early
                           in the national response, shortages of key testing supplies became
                           problematic due to unprecedented domestic demand and overall
                           global competition, which contributed to the delay in broad-scale
                           testing. There were shortages in test kit supplies such as swabs and
                           testing reagents, and in personal protective equipment needed to
                           administer tests. Subsequently, in January 2021, we found that our
                           concerns about shortages of these and other medical supplies have
                           persisted. 22
                       •   Data on testing, cases, and hospitalizations. In June 2020, we first
                           reported that the CDC reported incomplete and inconsistent data from
                           state and jurisdictional health departments on the amount of viral
                           testing occurring nationwide, making it more difficult to track and know
                           the number of infections, mitigate the effect of infections, and inform
                           decisions on reopening communities. 23 Likewise, in September 2020,
                           we reported that some hospitalizations data from the CDC were
                           limited to approximately 10 percent of the U.S. population. 24 CDC also
                           collects data on hospitalizations from states and jurisdictions that
                           voluntarily report cases; however, according to CDC officials, these
                           data were incomplete.
                       •   Communications. In June 2020, we further reported that inconsistent
                           communications have hampered the federal COVID-19 response. 25


                       21GAO, COVID-19: Opportunities to Improve Federal Response and Recovery Efforts,
                       GAO-20-625 (Washington, D.C.: June 25, 2020).
                       22GAO-21-265.

                       23GAO-20-625.

                       24GAO-20-701.

                       25GAO-20-625.




                       Page 12                                           GAO-21-321 COVID-19 Military Health
                          Specifically, in March 2020 the federal government issued
                          inconsistent guidance regarding the safety of group gatherings. The
                          lack of clear, consistent communication from the federal government
                          can lead to a loss of credibility with the public and other stakeholders
                          when responding effectively to a pandemic requires the public’s
                          participation. In November 2020, we reported that frequent changes to
                          general CDC testing guidelines were not always communicated with a
                          scientific rationale, which risks creating confusion and eroding trust in
                          important federal partners. 26 We recommended that the Department
                          of Health and Human Services ensure the CDC clearly discloses the
                          scientific rationale for any change to testing guidelines at the time the
                          change is made. The department concurred with the
                          recommendation. As of May 2021, the CDC had begun steps to
                          implement it by, for example, providing links on its website to studies
                          that explained the scientific rationale for testing guidance issued on
                          February 16, 2021. A list of other related products is included at the
                          end of this report.

                      Since January 2020, DOD has developed a strategy—outlined in force
DOD’s Strategy for    health protection guidance for COVID-19, planning documents, and
COVID-19 Health       orders—for protecting servicemembers from COVID-19. DOD’s strategy
                      seeks to balance the reduction of health risk with the need to continue
Protection is Risk-   operations. In March 2020, the Secretary of Defense described the
and Conditions-       department’s three priorities as protecting troops, DOD civilians, and their
                      families; safeguarding national security capabilities; and supporting the
Based and Applies     whole-of-nation response. 27 According to DOD leaders, the strategy
Key Considerations    balances these three priorities by assuming that complete elimination of
                      new infections is infeasible; rather, the goal is to conduct training and
for the Reentry of    other operations to the extent possible to maintain readiness while
Employees to the      minimizing infections. The strategy relies on coordination and
                      collaboration between operational forces and medical personnel and is
Workforce             informed by scientific updates from leading federal agencies and
                      academic institutions.

                      On the basis of our review of DOD policies and guidance, combatant
                      command campaign plans for pandemic influenza, and interviews with
                      DOD officials, we found that the strategy for COVID-19 health protection
                      is an extension of these documents in terms of the desired end states,
                      objectives, procedures, and responsibilities they outline. For example, the
                      26GAO-21-191.

                      27Secretary of Defense Memorandum, Message to the Force – COVID-19 Response
                      (Mar. 27, 2020).




                      Page 13                                         GAO-21-321 COVID-19 Military Health
plans we reviewed describe timeframes and tasks to achieve desired end
states. They identify the force health protection measures that are
imperatives in all phases of a pandemic—measures that are in turn
described in DOD’s policies and guidance.

Further, as shown in figure 2 and described in detail below, we found that
DOD’s strategy has applied key considerations for the reentry of federal
employees to the workplace.




Page 14                                     GAO-21-321 COVID-19 Military Health
Figure 2. Examples of DOD Application of Key Considerations to Protect
Servicemembers during the COVID-19 Pandemic




Note: These six considerations for protecting servicemembers are adapted from GAO, Federal
Workforce: Key Considerations for Agencies Returning Employees to Workplaces during Pandemics,
GAO-20-650T (Washington D.C.: June 25, 2020).




Page 15                                                 GAO-21-321 COVID-19 Military Health
Prioritize leadership attention and continuous communication
across the organization. The department issued its first force health
protection guidance on January 30, 2020 and has issued another 21
supplements thereafter as of May 2021. The Secretary of Defense and
other leaders have periodically issued additional memorandums outlining
or reinforcing policies. For example, on November 20, 2020, the Acting
Secretary of Defense reminded leaders across the department that as
COVID-19 cases increase in the United States they should ensure their
staff are following protection guidelines. 28

According to a Public Affairs official in the Office of the Secretary of
Defense, the department’s communications approach for COVID-19 has
emphasized providing clear, factual information on a routine basis, and
setting guiding principles for commands and agencies to develop their
local communications plans. A key element of this approach includes
featuring COVID-19 guidance prominently on DOD’s public website. The
site is updated continuously with information for personnel and the public
on DOD’s COVID-19 response efforts, travel restrictions, and infection
statistics. Furthermore, we found that the websites for each geographic
combatant command and selected MTFs also highlight COVID-19
updates, including information about the current health protection
condition level and restrictions at installations, signs and symptoms of the
disease, what personnel should do if they are feeling ill, and news stories
about personnel receiving vaccines.

The communications component of DOD’s force health protection
strategy has also included the use of posters as visual reminders to
remain vigilant and follow guidance (see fig. 3).




28Secretary of Defense Memorandum, Coronavirus Disease 2019 Guidelines (Nov. 20,
2020).




Page 16                                           GAO-21-321 COVID-19 Military Health
Figure 3. Examples of Department of Defense Posters on COVID-19 Precautions




Officials from combatant commands and selected MTFs we interviewed
described various ways that leaders have instructed personnel to follow
DOD’s COVID-19 risk reduction measures to reinforce the imperatives of
preventing infections and preserving warfighting readiness. These
measures have included town halls, public service announcements, social
media posts, and online resource portals.

Make decisions about reentry based on local conditions. On May 22,
2020, the Secretary of Defense announced the end of a nearly 2.5 month-
long travel restriction and its replacement with a conditions-based
approach to personnel movement and travel. 29 Under the new approach,
three criteria drive resumption of unrestricted travel between installations
for DOD personnel: declining case trends in the local area, compliance
with installation-level criteria, and senior-leader approval. On March 15,

29Secretary of Defense Memorandum, Transition to Conditions-based Phased Approach
to Coronavirus Disease 2019 Personnel Movement and Travel Restrictions (May 22,
2020).




Page 17                                           GAO-21-321 COVID-19 Military Health
2021, the Secretary of Defense updated this conditions-based approach,
which lists the following four factors that senior leaders must assess
before determining that movement is permitted to or from a DOD
installation, facility, or location:

•   removal of local travel restrictions;
•   availability of essential services (e.g., schools, childcare, and moving
    services);
•   quality control/assurance capability for household goods packing and
    moving; and
•   favorable health protection conditions (i.e., installations operating
    below health protection condition C). 30
DOD allows unrestricted travel between installations when all these
criteria are met, or when an approval authority grants an exemption or
waiver. As of February 16, 2021, DOD permitted unrestricted travel at 102
of 231 installations worldwide, or 44 percent of all installations. This
marked a change in eight installations from the prior week of February 8,
2021—from one week to the next, eight installations had travel
restrictions lifted (including four installations in South Korea and four
domestic installations), and none had restrictions imposed.

Installation protocols for COVID-19 leverage DOD’s long-standing public
health emergency management framework. 31 As outlined in the
framework, each installation commander, in consultation with the
installation’s public health emergency officer and MTF commander or
director, is responsible for setting a health protection condition with
permissible and prohibited activities based on factors such as local
COVID-19 transmission and the ability to meet the continued mission of
that command (see fig. 4).




30Secretary of Defense Memorandum, Update to Conditions-based Approach to
Coronavirus Disease 2019 Personnel Movement and Travel Restrictions (Mar. 15, 2021).
31DOD Instruction 6200.03.




Page 18                                            GAO-21-321 COVID-19 Military Health
Figure 4. Considerations for Changing Health Protection Condition (HPCON) Levels at Military Installations and Sample
Protection Measures




                                         Consistent with DOD’s conditions- and risks-based strategy for COVID-
                                         19, local commanders may set health protection condition levels that are
                                         more stringent than surrounding community requirements based on
                                         mission and other risk considerations. Our review found that measures
                                         have varied based on location type. For example, at Joint Base San
                                         Antonio from March 2020 through December 2020, the commander
                                         increased the health protection condition three times and decreased it
                                         once between levels B and C. Measures that the installation commander
                                         directed included

                                         •   at level B, social distancing and temporary cancellations of religious
                                             services with large gatherings; and
                                         •   at level C, identification checks of all passengers age 17 and over at
                                             all entry control points; visitor access restrictions; telework for non-
                                             critical personnel with management approval; and cancellation of
                                             open recreation or sports activities at child care centers.




                                         Page 19                                          GAO-21-321 COVID-19 Military Health
At the Pentagon, where the DOD Chief Management Officer was
responsible for health protection conditions until January 1, 2021, 32 the
measures have included

•   at level B, random entrance screening, including temperature checks,
    and a goal of 20 percent or more of the workforces teleworking; and
•   at level C, gatherings limited to less than 10 people and a goal of 60
    percent or more workforces teleworking.
Identify mission-essential functions and employees, and classify
their exposure risk level. The military health system is responsible for
delivering mission-essential health care services, including services in
support of COVID-19 missions. To these ends, DOD has identified
mission-essential medical personnel and taken steps to reduce their
exposure risk. For example, to conserve vital health care resources and
protect patients, medical personnel, and the community from further
exposure and transmission of COVID-19, in March 2020 the ASD(HA)
directed MTFs to postpone almost all elective surgeries, invasive
procedures, and dental procedures performed on beneficiaries at military
and dental treatment facilities. 33 Although the ASD(HA) has since
permitted the resumption of elective surgeries at the discretion of MTF
commanders, the military health system continues to protect the delivery
of critical health care functions and personnel with measures such as
prioritizing allocation of personal protective equipment to health care
providers and encouraging the use of telemedicine, particularly for follow-
up appointments and ongoing care of isolated patients with COVID-19. 34

DOD has also identified personnel essential to national security functions
to preserve their readiness, manage risks, and prioritize resources
accordingly. For example, according to U.S. Northern Command officials,
its mission-critical personnel are available on a rotating shift schedule to
ensure personnel will be available even if others must quarantine. DOD

32On January 1, 2021, the National Defense Authorization Act for Fiscal Year 2021
abolished the position of DOD Chief Management Officer and required that the Secretary
of Defense transfer each duty or responsibility of the DOD Chief Management Officer to
another DOD officer or employee within 1 year. Pub. L. No. 116-283, § 901 (2021).
33Assistant Secretary of Defense for Health Affairs Memorandum, Elective Surgical,
Invasive, and Dental Procedures in Military Treatment Facilities (Mar. 24, 2020).
34Assistant Secretary of Defense for Health Affairs Memorandum, Resuming Elective
Surgical, Invasive, and Dental Procedures in Military Medical and Dental Treatment
Facilities (May 19, 2020).




Page 20                                               GAO-21-321 COVID-19 Military Health
has also directed the military services and combatant commands to
categorize all of their forces in a tiered structure of priority to national
security and exposure risk for the purposes of allocating limited testing
resources to screen for COVID-19 infections. Specifically, in a May 2020
memorandum to the military departments and other components, DOD
described its tiers of priority for units and personnel, as shown in table
2. 35

Table 2. Department of Defense’s Tiered Framework for Prioritizing COVID-19
Testing

Testing priority tier                            Examples of personnel and units
Tier 1 - Critical national                       •     strategic and nuclear deterrence forces
capabilities                                     •     homeland defense forces
                                                 •     senior Department of Defense leaders
                                                 •     National Mission Forces
                                                 •     accession sources (recruits, training)
Tier 2 - Engaged field forces                    •     U.S. Northern Command COVID-19 response
                                                       forces
                                                 •     forward deployed forces in Afghanistan and Iraq
                                                 •     critical capabilities/assets
Tier 3 - Forward deployed/re-                    •     U.S. Indo-Pacific Command
deploying forces                                 •     U.S. Southern Command
                                                 •     U.S. European Command
Tier 4 - All other forces                        n/a

n/a = not applicable
Source: Department of Defense COVID-19 Task Force Memorandum, Testing and Reporting of DoD COVID-19 Screening, Attachment
1 (May 18, 2020). | GAO-21-321



Similarly, DOD has prioritized initial COVID-19 vaccination doses in
accordance with mission-critical functions and exposure risk. Examples of
personnel in the first tiers of priority for receiving the COVID-19 vaccine
included medical and emergency services personnel, personnel
performing activities associated with critical national capabilities,
personnel preparing to deploy to locations outside the United States, and
high-risk individuals. DOD’s testing and vaccine plans are discussed in
more detail later in this report.

Implement social distancing and other appropriate protection
measures. DOD established health protection guidelines in January

35Department of Defense COVID-19 Task Force Memorandum, Testing and Reporting of
DoD COVID-19 Screening, Attachment 1 (May 18, 2020).




Page 21                                                                 GAO-21-321 COVID-19 Military Health
2020, and since then has updated its guidelines to identify protection
measures and the situations in which they should apply. We found that
DOD’s guidance generally aligns with CDC guidance in our review of
selected areas, including use of face coverings, social distancing, and
returning to work after illness. For example, the Secretary of Defense
requires 6 feet of social distancing to the extent practicable, in
accordance with CDC guidelines. 36 However, many training and
operational settings in DOD are not conducive to social distancing. In
such instances, military services have adopted alternate approaches to
reduce exposure risk. For example, the Navy issued detailed guidance in
April 2020 for protecting ship crews. 37 The services have taken various
steps to protect new recruits in basic training, such as temporarily
reducing training capacity, requiring restriction of movement periods off
base prior to entry, and testing recruits for COVID-19 prior to and at the
end of training.

From April 5, 2020 through May 2021, DOD required personnel to wear
face coverings. On May 13, 2021, in keeping with updated CDC
guidelines, DOD stopped requiring personnel who are fully vaccinated
(i.e., at least 2 weeks beyond their final dose) to wear a mask indoors or
outdoors at DOD facilities. According to department guidance, personnel
who are not fully vaccinated should continue to wear masks indoors. 38
However, DOD’s guidance states that commanders and supervisors
should not ask about an employee’s vaccination status. Other protection
measures are discussed further below.

MTF and combatant command officials stated that they have adopted
split shifts to reduce the density of personnel in confined workspaces,
reconfigured workspaces to facilitate social distancing, and created
single-direction entry and exit doors for their buildings. Officials at
selected MTFs stated that they have taken additional measures to
facilitate social distancing and reduce the density of staff and patients
inside their buildings, such as establishing drive-through and delivery
36Centers for Disease Control and Prevention, Social Distancing, accessed February 16,
2021, https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/social-
distancing.html.
37Navy and Marine Corps Public Health Center, Guidance for Underway Evaluation and
Management of Suspected Persons Under Investigation (PUI) for Coronavirus Disease
2019 (COVID-19) (updated June 24, 2020).
38Deputy Secretary of Defense Memorandum, Updated Mask Guidelines for Vaccinated
Persons (May 13, 2021).




Page 22                                              GAO-21-321 COVID-19 Military Health
pharmacy services. Moreover, MTF officials stated they have physically
separated COVID-related testing and care of COVID-19 patients from
other parts of their facility.

On the basis of combatant command and military department guidance
and interviews with DOD officials, we also found that DOD has
encouraged maximizing telework to the extent practicable to facilitate
social distancing and reduce exposure risk. 39 According to DOD officials,
they do not maintain department-wide data on the number of
servicemembers who are teleworking at a given time. DOD officials told
us that individual offices and commands are responsible for monitoring
telework among servicemembers, and some do so as part of their
personnel accountability mechanisms to determine whether absence from
the workplace is due to telework, illness, or time off. Given DOD’s mission
and diversity of occupations, telework may be infeasible for the
substantial number of military personnel who do not work in an office
setting. In such instances, DOD and the military services have mandated
other risk reduction practices, including those previously discussed.
Examples of these and DOD’s other day-to-day protection measures and
mitigation steps after infection are outlined below in table 3.




39Civilian DOD employees, who often work alongside servicemembers, are encouraged to
telework. DOD guidance issued in March 2020 and extended in November 2020 provided
that DOD components may allow civilian employees to telework during an emergency with
a child or other persons requiring care or supervision present at home. Office of the Under
Secretary of Defense for Personnel and Readiness Memorandum, Civilian Personnel
Guidance for DOD Components in Responding to Coronavirus Disease 2019 (Mar. 8,
2020); Under Secretary of Defense for Personnel and Readiness Memorandum,
Extension of Maximum Telework Flexibilities (Nov. 20, 2020). During the fourth quarter of
fiscal year 2020, according to data provided by DOD civilian personnel policy officials,
about half of DOD’s approximately 786,000 civilian employees had teleworked to some
extent. We also have an ongoing review of the use of telework across federal agencies
during the COVID-19 pandemic, including DOD. We expect to report on this later in 2021.




Page 23                                               GAO-21-321 COVID-19 Military Health
Table 3. Examples of the Department of Defense’s (DOD) Key Protection Measures
and Mitigation Steps After COVID-19 Infection

Protection measures                                  Mitigation steps after infection
•      social distancing when practicable            •   isolation and testing
•      telework when feasible                        •   quarantine of close contacts
•      face coverings                                •   contact tracing
•      hand hygiene and workspace disinfection       •   sanitation and disinfection of work
       procedures for high-touch areas                   spaces
•      restriction of movement, including travel     •   return to work when criteria to end
       and social activities                             isolation is met
•      sick individuals directed not to come to          • at least 10 days since symptoms
       work                                                 first appeared, and
•      limited building entry points with one-way        • at least 24 hours with no fever
       directional signs, screening, and                    without fever-reducing
       temperature checks                                   medication, and
•      accountability procedures to document             • other symptoms of COVID-19
       and monitor employee health conditions               are improving
       and work absences
•      divided shifts to reduce the density of
       workers in a space
Source: GAO analysis of DOD guidance. | GAO-21-321




Page 24                                                   GAO-21-321 COVID-19 Military Health
A Navy Approach to Prevent and Mitigate                          A key aspect of DOD’s strategy to reduce COVID-19 exposure risk is
COVID-19 Outbreaks on Ships: The COVID-19                        referred to as “restriction of movement.” Where reasonably necessary for
Free “Bubble”
The Navy has experienced high-profile COVID-19
                                                                 a valid military purpose, such as mitigating the impacts of COVID-19,
outbreaks on ships, such as the USS Theodore                     commanders may lawfully issue orders restricting the movement of
Roosevelt in March 2020. To address the unique                   servicemembers under their authority (to include military personnel who
challenges of protecting sailors in close quarters,
since April 2020 the Navy has issued detailed,                   may or may not yet have been exposed to COVID-19). 40 Until April 2021,
platform-specific guidance to commanders and                     DOD guidance during the COVID-19 pandemic generally required
ship medical departments with procedures to
prevent infections and mitigate outbreaks. Key to                servicemembers to restrict movement to their home for 14 days prior to or
its approach for ships is ensuring a COVID-free                  after traveling, limit close contact with others, and self-monitor for COVID-
crew before departure within a “bubble.” To
accomplish this before a long period at sea (e.g.,
                                                                 19 symptoms. 41 Updated guidance that DOD issued on April 12, 2021
deployment), all crew members undergo a 14-day                   permits reduced movement restriction periods, such as 10 days or 7
restriction of movement, or isolation, before                    days, depending on circumstances such as travel destination (e.g., within
embarking the ship, or a 14- to 21-day restriction of
movement on the ship with medical screening and                  or outside the United States) and whether the traveler has been fully
temperature checks before embarkation.
During the first 30 days, commanders consider
closing areas such as gyms where close contact is
inevitable. Personnel transit the ship up and
forward on the starboard side and down and aft on
the port side. Face coverings must be worn at all
times.
If COVID-19 appears on the ship, commanders are
to take every reasonable action to trace and
contain its spread, and “aggressively fix small
problems before they become big problems” by
taking steps, including predesignating berthing
areas for isolation sick wards and having a
standing close contact list for all personnel.




Source: GAO analysis of Navy guidance (text); U.S. Navy/PO3 E.
Schaudt (photo). | GAO-21-321




                                                                 40Department of the Navy, Criminal Law Division, Code 20 Sidebar – COVID-19
                                                                 Pandemic Restriction of Movement Orders (ROM) & Their Enforceability (March 2020).
                                                                 41Under Secretary of Defense for Personnel and Readiness Memorandum, Force Health
                                                                 Protection Guidance (Supplement 9) - Department of Defense Guidance for Deployment
                                                                 and Redeployment of Individuals and Units during the Novel Coronavirus Disease 2019
                                                                 Pandemic (May 26, 2020); Under Secretary of Defense for Personnel and Readiness
                                                                 Memorandum, Force Health Protection Guidance (Supplement 14) – Guidance for
                                                                 Personnel Traveling During the Coronavirus Disease 2019 Pandemic (Dec. 29, 2020).




                                                                 Page 25                                            GAO-21-321 COVID-19 Military Health
vaccinated or recovered from a laboratory-confirmed diagnosis of COVID-
19 infection. 42

Command-level restriction of movement protocols are sometimes more
restrictive than DOD guidance or host nation requirements. For example,
according to U.S. European Command officials, even though Germany
waives its quarantine requirement for military travel, the commander
requires that servicemembers quarantine for 14 days upon arrival in
Germany in an abundance of caution. Naval Hospital Okinawa officials
told us that they require incoming personnel from outside the island to
conduct a 14-day restriction of movement upon arrival even if they had
completed a 14-day restriction of movement immediately before traveling
to Okinawa. This protocol, according to MTF officials, reduces the risk of
infections from personnel traveling through high-risk locations (i.e., those
with a high incidence of COVID-19) and provides assurance to the
Okinawan Prefectural Government.

Host nation requirements can also be more restrictive about entry
requirements than DOD generally requires with its restriction of
movement procedures. For example, according to U.S. Indo-Pacific
Command officials, the Republic of Palau agreed to let U.S. Marine
Forces Pacific enter for training exercises if they followed strict
procedures––specifically, all servicemembers were tested, sent out to sea
for 21 days, tested again, quarantined for 14 more days, and then tested
again before gaining entry.

Establish COVID-19 testing protocols. Detection of COVID-19 through
testing is a key element of DOD’s force health protection strategy. Yet,
senior DOD officials explained to us that testing is but one component of
a broader strategy in which the prevention and risk mitigation measures
discussed previously are paramount. This is because a negative test can
only be interpreted as a failure to detect the virus at a single point in time.



42Under Secretary of Defense for Personnel and Readiness Memorandum, Force Health
Protection Guidance (Supplement 20) – Department of Defense Guidance for Personnel
Traveling During the Coronavirus Disease 2019 Pandemic (Apr. 12, 2021). In addition, in
May 2021, DOD updated guidance for personnel deploying or redeploying to permit
certain limited exemptions to restriction of movement periods, or reduced periods of
restriction of movement. Under Secretary of Defense for Personnel and Readiness
Memorandum, Force Health Protection Guidance (Supplement 16) Revision 1 –
Department of Defense Guidance for Deployment and Redeployment of Individuals and
Units During the Coronavirus Disease 2019 Pandemic (May 4, 2021).




Page 26                                              GAO-21-321 COVID-19 Military Health
That is, a negative test could be accurate or false and does not predict
future infection.

DOD is using three types of COVID-19 tests—diagnostic, screening, and
surveillance—to separate infected individuals from healthy populations,
determine the disease incidence, and break the chain of transmission.
Separately, certain DOD laboratories are also performing serology tests
to identify the number of servicemembers with COVID-19 antibodies, and
sequencing tests—a specific type of surveillance test—to identify
variations of the virus circulating among servicemembers.

DOD’s diagnostic, screening, and surveillance testing protocols generally
align with CDC guidance. For example, DOD requires that confirmation of
a COVID-19 diagnosis should be performed with a molecular test. 43 We
also found that DOD’s testing strategy is consistent with FDA guidance
for diagnostic and screening testing. 44 For example, DOD’s force health
protection guidance directs DOD components to use FDA-certified
laboratories and COVID-19 tests with an emergency use authorization
(EUA) from the FDA.

DOD prioritizes diagnostic testing for all individuals with COVID-19
symptoms or exposure, consistent with CDC guidance. Doing so allows
health care providers to document a COVID-19 infection in
servicemembers’ medical records and continue or begin isolation and
other mitigation steps.

Further, the nature of SARS-CoV-2 in terms of its transmission rate
among asymptomatic individuals prompted DOD to include screening and
surveillance testing as part of its strategy, according to DOD officials. 45 As
a result, the department has executed testing on a scale never needed
nor envisioned for a disease prior to COVID-19. However, persistent
global supply shortages have led DOD to adopt a resource-informed
testing approach. In accordance with the tiered framework described

43Molecular tests are typically performed in a laboratory to detect the virus’s genetic
material. Polymerase-chain reaction technology is an example of a molecular test. The
CDC defines a confirmed case as meeting confirmatory laboratory evidence for COVID-19
(i.e., a positive molecular test).
44FDA, COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Feb. 18, 2021).

45Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes
the disease COVID-19.




Page 27                                                 GAO-21-321 COVID-19 Military Health
previously in table 2, screening tests are performed for certain
servicemembers before deployment or training, in order of priority.
Randomized surveillance tests are last in order of priority, as the
availability of testing resources allow. 46

Figure 5 shows that DOD has generally increased its overall weekly tests
from about 10,000 during the last week of March 2020, to 65,000 tests
per week by the last week of July 2020. After decreasing numbers of tests
through the end of August 2020, DOD generally increased its overall
weekly tests again from about 50,000 in late September, to about 80,000
during the last week of November 2020. Where data on test type were
available, clinical/diagnostic tests made up the largest shares of the tests,
followed by screening tests. Surveillance tests made up the smallest
shares of the tests.




46Under Secretary of Defense for Personnel and Readiness Memorandum, Force Health
Protection Guidance (Supplement 11)- Department of Defense Guidance for Coronavirus
Disease 2019 Surveillance and Screening with Testing (June 11, 2020).




Page 28                                           GAO-21-321 COVID-19 Military Health
Figure 5. Department of Defense Weekly COVID-19 Tests in 2020, by Type, for Active-Duty Servicemembers




                                        Notes: Data in the figure represent the total number of tests conducted in a given week, including
                                        those for servicemembers who were tested more than once. Thus, the total numbers of
                                        servicemembers tested each week are generally lower than the numbers in this figure. The data
                                        include members of the active components of the military services, and Reserve and National Guard
                                        members serving on active duty at the time of the test. Clinical/diagnostic tests are clinically indicated
                                        for patient care; screening tests are performed prior to group movements or engagement in activities;
                                        and surveillance tests are performed to identify incidence of COVID-19 in a specified population or
                                        geographic location. All tests prior to standardized reporting are labeled “Unknown.” According to a
                                        DOD COVID-19 Task Force official, the Task Force did not report data on test by type for those
                                        conducted over the winter holidays the weeks of December 13 and December 20, 2020. Lower
                                        testing numbers in December may be due to fewer individuals seeking testing during the holidays.


                                        According to DOD officials, tests for servicemembers in tiers 1 and 2 have
                                        comprised the majority of screening tests each week because limitations
                                        in supplies have constrained available tests for tiers 3 and 4. The officials
                                        attributed this to a lack of predictability in the monthly supply chain,
                                        persistently high global demand, and market competition. We have
                                        previously reported on similar challenges with COVID-19 testing as part
                                        of the whole-of-government response. In September 2020, we found that
                                        the FDA and the Federal Emergency Management Agency identified


                                        Page 29                                                         GAO-21-321 COVID-19 Military Health
shortages, and officials from seven of eight states we interviewed in July
and August 2020 identified previous or ongoing shortages of testing
supplies—challenges that we found to be attributed to a supply chain with
limited domestic production and high global demand. 47

DOD officials stated that, even if resources were unconstrained, testing
every servicemember every week would not be helpful or feasible for
improving outcomes. Notwithstanding persistent challenges, officials
stated that they are exploring ways to increase weekly screening tests for
servicemembers in tiers 3 and 4, and surveillance tests. Yet, a precise
number of ideal weekly tests is difficult to determine due to tradeoffs
between the speed, accuracy, and cost of tests by type, as well as lack of
consensus in the scientific community about the best testing protocol.
Similarly, in January 2021 we found that the Department of Health and
Human Services—a lead federal agency for the COVID-19 response—
has not issued a comprehensive and publicly available national testing
strategy. 48 We recommended that the department develop and publish a
strategy, which we believe could be done efficiently and flexibly. As of
March 2021 it had not yet done so.

To increase weekly testing across its approximately 2.1 million active-duty
and reserve forces, DOD has taken two key actions. First, DOD
expanded and diversified its testing capabilities. Due to supply constraints
associated with COVID-19 tests, the department added new testing
technologies to its toolkit. As a result, DOD testing platforms now include
laboratory-based molecular tests, point-of-care molecular tests, point-of-
care antigen tests, as well as contracts with commercial laboratories.
Second, DOD increased testing capacity by expanding the number of
laboratories. In July 2020, DOD had 125 department laboratories certified
for COVID-19 testing around the globe with the capacity to conduct over
200,000 tests per week. By November 2020, the number of operational
DOD laboratories had increased to 158 with the overall capacity to
conduct nearly 300,000 tests per week. As a result, the median time
between tests (specimen collection) and delivery of results for DOD in-
house laboratory tests has been less than 24 hours since late August
2020.

Establish protocols to prioritize and distribute antivirals and
vaccines. DOD recommends a limited number of supplemental

47GAO-20-701.

48GAO-21-265.




Page 30                                      GAO-21-321 COVID-19 Military Health
therapeutics to treat COVID-19 infection in accordance with National
Institutes of Health guidelines, including remdesivir for hospitalized
patients with severe disease and dexamethasone for patients who require
supplemental oxygen. 49 DOD is currently researching additional
therapeutics including monoclonal antibodies, polyclonal antibodies,
plasma-related products, antivirals, and other small molecules. We
discuss DOD’s research and development programs later in this report.

DOD developed an implementation plan to provide COVID-19 vaccines to
eligible personnel, including servicemembers and their dependents, DOD
civilian employees, military retirees, and DOD contractor personnel. Due
to initial limited supply, the vaccine implementation plan established a
prioritization scheme mirroring CDC guidance that focuses first on
personnel providing direct medical care, critical and essential support
personnel, deploying forces, and those at highest risk for developing
severe illness from COVID-19. 50

According to DOD officials, the COVID-19 vaccine implementation plan is
based on the department’s influenza vaccine plan. However, officials
noted that this vaccination project is unprecedented in recent history and
involves several unique logistical challenges. For example, unlike
influenza vaccines, the first two COVID-19 vaccines that the FDA
authorized for emergency use (manufactured by Pfizer-BioNTech and
Moderna) require two doses per person and a temperature-controlled
supply chain. In addition, there are typically one or two influenza vaccines
that DOD distributes in a given year; whereas five or more COVID-19
vaccines could be authorized or approved by the FDA for use in the same
year (including the two vaccines authorized for emergency use in
December 2020, and a third vaccine, manufactured by Johnson &
Johnson, authorized for emergency use in February 2021). Despite these
complexities, DOD officials stated that they believe the experience and
knowledge gained from annual influenza vaccine distribution will help the
department distribute the COVID-19 vaccines.



49Remdesivir is an antiviral medication approved October 22, 2020 by the FDA for
treatment of certain COVID-19 patients requiring hospitalization. Dexamethasone is a
steroid with anti-inflammatory effects.
50We discuss DOD’s vaccine plan, including its prioritization scheme, in more detail in
GAO-21-387. Our next government-wide report on the federal response to COVID-19 will
be issued in July 2021 and will include information about DOD’s vaccination efforts.




Page 31                                              GAO-21-321 COVID-19 Military Health
DOD initially made COVID-19 vaccination voluntary due to federal law
that says a vaccine released under an EUA cannot be made mandatory. 51
However, the President has authority to waive this provision and require
members of the armed forces to take a vaccine released under an EUA in
the interests of national security. 52 According to DOD officials, DOD will
revisit its decision to make vaccination voluntary if the FDA gives a
vaccine full approval.

DOD began limited distribution of the Pfizer-BioNTech vaccine to the first
of 16 locations on December 11, 2020 to gather lessons learned, make
adjustments, and improve its process for subsequent distribution.
According to DHA officials involved in overseeing the vaccine plan
implementation, factors affecting the rate of vaccine administration have
varied over time and by location. For example, the holidays in late
December 2020 through mid-January 2021 and winter weather slowed
vaccination efforts at U.S. sites. Officials stated that differences in the
populations served by vaccination site (e.g., reserve or active component)
has been another factor.




5121 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III).

5210 U.S.C. § 1107a(a).




Page 32                                      GAO-21-321 COVID-19 Military Health
DOD Oversight
Mechanisms for
COVID-19 Health
Protection Measures
Include Leadership
Attention, Data
Tracking, and
Lessons Learned
Analyses
Senior Leaders and Local   Consistent with the Secretary of Defense’s pronouncement in early 2020
Commanders Oversee         that DOD’s top priority is protecting its workforces from COVID-19, we
                           found that senior leaders and task-organized forums across the
COVID-19 Protection
                           department at various levels continuously oversee and monitor
Measures and Adapt to      implementation of force health protection measures. On the basis of our
Changing Conditions        interviews with DOD officials, we also found that DOD’s oversight priority
                           for COVID-19 reflects officials’ concerns about the potential for
                           servicemembers to become complacent or fatigued with COVID-19 and
                           restrictive protocols. Officials told us they are concerned that
                           complacency could contribute to outbreaks, which can jeopardize
                           readiness and relationships with host and partner nations. DOD officials
                           have acknowledged that mistakes occurred early in the pandemic when
                           less was known about asymptomatic transmission. Officials also stated
                           that mistakes may invariably continue given the consequences of even
                           one person’s noncompliance—an assumption that underscores the
                           imperative of effective oversight.

                           Key tenets of the department’s oversight structure include 1) sustained
                           leadership attention, including enterprise-level policy-making and
                           monitoring, and 2) a concept called “mission command,” which, applied to
                           COVID-19, allows local commanders to adapt force health protection
                           guidance to their mission and local conditions as needed and ensure
                           compliance.

                           Sustained leadership attention. The Secretary and Deputy Secretary of
                           Defense oversee COVID-19 response efforts in consultation with other
                           senior leaders, such as the Chairman of the Joint Chiefs of Staff and the
                           Under Secretary of Defense for Personnel and Readiness. According to


                           Page 33                                      GAO-21-321 COVID-19 Military Health
DOD officials, the Secretary convened the first meeting on COVID-19 in
early January 2020 to discuss the developing emergency and prepare
initial guidance. In February, the Secretary established a COVID-19 Task
Force, with the Deputy Secretary of Defense and the Vice Chairman of
the Joint Chiefs of Staff serving as co-chairs, according to Task Force
members. The Task Force has facilitated enterprise-level oversight
across all lines of effort, ranging from force health protection to DOD
support to other federal agencies and U.S. states, territories, and
commonwealths (known as defense support of civil authorities). After a
new Secretary of Defense was sworn in on January 22, 2021, one of the
first items on his agenda was to chair a meeting of the COVID-19 Task
Force.

According to DOD officials, the Secretary and other leaders have
continuously leveraged medical expertise from subject matter experts,
such as the ASD(HA) and the Joint Staff Surgeon. For example,
according to the Joint Staff Surgeon, he briefs the Secretary and the
Chairman of the Joint Chiefs of Staff on COVID-19 updates at least
weekly. The Joint Staff Surgeon stated that he also convenes a COVID-
19 medical synchronization meeting up to 3 days per week—a forum that
brings together medical experts from across DOD, including
representatives from the Office of the ASD(HA), combatant commands’
surgeons, the military departments, the DHA, the Defense Logistics
Agency, the DOD COVID-19 Task Force, and DOD’s CDC liaison. The
group discusses the disease trajectory, scientific updates, changes to
health protection guidance, and implementation challenges.

To inform their ongoing guidance development and assess the COVID-19
response, DOD leaders and medical experts monitor scientific updates
and force health metrics. This information ranges from U.S. and global
health data and the numbers, locations of COVID-positive cases among
servicemembers and their severity, and numbers and types of tests
conducted, to the numbers of available MTF hospital beds and staff and
inventories of personal protective equipment and medical supplies.
According to senior DOD leaders, they use this information to evaluate
their strategy, the implementation of force health protection measures,
and any effects on force readiness. By doing so, leaders can adjust
implementation measures. For example, following outbreaks on underway
ships, the Navy issued detailed risk-reduction procedures to fleet
commanders in April 2020, as discussed previously in this report.

In addition, through a COVID-19 Testing Task Force that reports to the
DOD COVID-19 Task Force, senior leaders oversee and standardize the


Page 34                                    GAO-21-321 COVID-19 Military Health
implementation of DOD’s COVID-19 tiered testing strategy and intervene
when needed. Military department and combatant command officials alike
stated that department-wide oversight from the Testing Task Force has
been helpful to mitigate challenges within DOD’s control—such as
redistributing supplies in accordance with demand—and external
challenges, such as supply chain constraints faced more broadly
throughout the United States and across the world.

DOD officials also stated that enterprise-level monitoring has helped
conserve and prioritize DOD’s force health protection capabilities as the
department contributes to the whole-of-government response to COVID-
19. For example, DHA officials stated that the Secretary of Defense
approved the release of materials from the DOD stockpile to the federal
government for the public health response, having been assured from
DOD’s data and monitoring that sufficient supplies remained available for
MTFs. 53

Mission command and authorities of local commanders. According to
an April 2020 Secretary of Defense memorandum, COVID-19 impacts are
different in the many places the department operates and leaders at all
echelons must be proactive in protecting local servicemembers, civilians,
and families. 54 Commanders should also exercise mission command by
making rapid decisions to upgrade health protection conditions; take
measures suited to the needs of their organizations, informed by their
assessments and reflective of conditions in the surrounding communities
and direction from the CDC; and coordinate between installation
commanders within local commuting areas. DOD Instruction 6200.03
directs commanders to make decisions to change health protection
conditions in consultation with experts, including the installation public
health emergency officer and local MTF commander. Consistent with the
Secretary’s memorandum and DOD Instruction 6200.03, on the basis of
our interviews we found that COVID-19 force health protection is a high
oversight priority among combatant commands and selected MTFs, which
make decisions based on conditions in their respective regions.




53In June 2020, we reported that, according to the Federal Emergency Management
Agency, DOD had distributed almost 14 million N95 respirator masks from its inventory to
cities, states, and the Department of Veterans Affairs. GAO-20-625.
54Secretary of Defense Memorandum, Guidance for Commanders on the Implementation
of the Risk-Based Responses to the COVID-19 Pandemic (Apr. 1, 2020).




Page 35                                              GAO-21-321 COVID-19 Military Health
According to officials from geographic combatant commands, their
command headquarters have each established a task-organized COVID-
19 forum, including medical staff and other directorates, to centralize all
COVID-19 information. These forums meet at least weekly to discuss
policy updates and data on testing and COVID-19 cases. In addition,
combatant command staff explained that they work to educate their
component commanders and other subordinate command leaders on
how to implement specific force health protection measures in the context
of operations, especially social distancing and restriction of movement.

Likewise, MTF officials identified examples of collaboration between their
installation leadership, MTF leaders, public health emergency officers,
commanders of tenant commands, and other stakeholders. Together,
these personnel monitor and oversee their local response and
continuously reevaluate the health protection condition for the installation.
For example, public health emergency officers we interviewed at selected
MTFs stated that they perform compliance checks across their installation
and recommend improvements. Through contact tracing, officials stated
that they can typically identify the sources of transmission and whether an
outbreak or disease cluster resulted from a violation, such as attending a
party. Military personnel who violate commanders’ health emergency and
protection orders may be punished under Article 92 of the Uniformed
Code of Military Justice. 55

Combatant command and MTF officials alike acknowledged to us that, as
the pandemic endures, they confront challenges sustaining COVID-19
vigilance among personnel. However, they stated that they consistently
reinforce the criticality of protective measures for health and readiness.
According to combatant command and MTF officials, military culture has
been both a help and a hindrance in this regard. For example, conforming
with leadership direction and peers is a normative military behavior that
aids compliance with COVID-19 protection measures, according to
officials. However, other cultural norms are disadvantages in the
pandemic environment, including reticence about illness and reluctance
to stay home from work out of concern for the impact on others.
Combatant command and MTF officials explained that they leverage
oversight, messaging, peer pressure, and enforcement to reverse this
norm.




5510 U.S.C. § 892.




Page 36                                       GAO-21-321 COVID-19 Military Health
DOD Uses Case and         According to senior DOD leaders, the readiness of servicemembers for
Testing Data to Monitor   overseas deployments is the ultimate indicator of the department’s
                          effectiveness in implementing its force health protection strategy. Yet,
the Effectiveness of
                          given DOD’s goals of protecting workforces and minimizing the spread
Protection Efforts        and severity of the pandemic, senior leaders also monitor their strategy’s
                          effectiveness by evaluating data on COVID-19 cases and testing.

                          DOD organizations at many levels gather and report health surveillance
                          data on servicemembers and provide updates daily or multiple times per
                          week to commanders and senior DOD leaders to monitor the degree of
                          transmission in the military population. Examples of key data points
                          include daily and weekly changes in COVID-positive case counts among
                          servicemembers as a whole and by locations, hospitalizations, and the
                          rate of positive COVID-19 tests relative to the total number of COVID-19
                          tests conducted.

                          From January 1, 2020 through December 31, 2020, there were over
                          93,000 reported cases of COVID-19 among active-duty servicemembers
                          (about 7 percent of the total 1.3 million active component
                          servicemembers) and over 800 were hospitalized during this time.
                          Overall, our analysis found that the peaks in cases among
                          servicemembers were within a couple of weeks of the peaks identified in
                          cases among the overall U.S. population from March through December
                          2020. Specifically, as shown in figure 6, DOD’s COVID-19 cases peaked
                          and declined prior to peaks in the U.S. population that occurred in April,
                          July, and December 2020. Of note, DOD tracks COVID-19 cases based
                          on specimen collection dates, while national data are based on dates
                          laboratory-confirmed and probable cases are reported to the CDC. For
                          DOD laboratories, the median time between specimen collection and
                          laboratory confirmation has been less than 24 hours since late August
                          2020 but may be up to 2 weeks. Figure 6 also shows that hospitalizations
                          have comprised a small portion of confirmed servicemember cases of
                          COVID-19 over time, having not exceeded 3 percent since June 2020.




                          Page 37                                      GAO-21-321 COVID-19 Military Health
Figure 6. COVID-19 Cases and Hospitalization Rates among Active-Duty Servicemembers, March 2020 through December
2020




                                      Notes: The data show the number of confirmed and probable COVID-19 cases per day based on the
                                      lab collection dates and the weekly percentage of new hospitalizations of the number of cases.
                                      National case lines represent the highest 7-day moving average of cases in the United States
                                      between April to June, July to September, and October to December, based on the date the case was
                                      reported to the Centers for Disease Control and Prevention (CDC) as a confirmed or probable case,
                                      as of data available from the CDC Data Tracker on January 26, 2021.


                                      According to DOD officials, the number of servicemembers infected with
                                      SARS-CoV-2 and those hospitalized at any one time have remained
                                      manageable and small in scale relative to their initial projections of the
                                      virus’ spread and to infection and hospitalization rates in surrounding
                                      civilian communities. DOD officials stated that they believe that rates of
                                      infection and low mortality among servicemembers demonstrate the
                                      effectiveness of the department’s force health protection strategy.

                                      We found that these results could also be attributed, in part, to favorable
                                      characteristics in servicemember demographics. For example,
                                      servicemembers are generally younger than the general population of the
                                      United States. Table 4 shows that only 1 percent of DOD
                                      servicemembers are 55 years of age or older, compared to 17 percent of
                                      the U.S. population in that demographic.




                                      Page 38                                                   GAO-21-321 COVID-19 Military Health
Table 4. Characteristics of the U.S. and DOD Servicemember Populations Aged 17
to 62

                                                              U.S. population                    DOD servicemembers
 Characteristic                                                 (percentage)                             (percentage)
 Age (years)
       17-24                                                                       17                                          35
       25-34                                                                       23                                          38
       35-44                                                                       21                                          20
       45-54                                                                       20                                            6
       55-62                                                                       17                                            1
 Sex
       Male                                                                        50                                          81
       Female                                                                      50                                          19
Source: GAO analysis of U.S. Census Bureau, Centers for Disease Control and Prevention, National Center for Health Statistics, and
Department of Defense (DOD) data. | GAO-21-321

Notes: U.S. population data is from the Vintage 2019 Bridged-race Postcensal Population Estimates.
DOD servicemember data include the total DOD force (active component, reserve, and National
Guard) in October 2020. Percentages may not sum to 100 percent because of rounding.


Further, servicemembers generally have fewer preexisting conditions and
better access to healthcare overall than the U.S. general population.
These factors could contribute to lower mortality and fewer severe cases
of COVID-19 among servicemembers. For example, our analysis found
that the number of predicted COVID-19 deaths through December 31,
2020, based on U.S. COVID-19 provisional death rates and the size and
composition (location, sex, and age) of DOD servicemembers, was more
than 175––a number that was significantly higher than the 15 actual
COVID-19 deaths among the servicemember population in 2020. 56 The
Navy, in particular, has also observed that demographic characteristics
are associated with COVID-19 cases being mild or asymptomatic. For
example, based on their investigation of a March 2020 outbreak of
COVID-19 aboard the USS Theodore Roosevelt, the Navy and the CDC
reported that the outbreak was characterized by widespread transmission
with relatively mild symptoms and asymptomatic infection among a

56We calculated the number of expected deaths in the servicemember population using
provisional COVID-19 death counts from the National Center for Health Statistics and the
indirect standardization method, which accounted for differences in the state, sex, and age
distributions of the U.S. and servicemember populations. Our analysis did not account for
other factors related to the COVID-19 death rate, such as access to health care or
comorbid conditions. Provisional death may not be complete due to reporting delays,
especially for the most recent weeks.




Page 39                                                                        GAO-21-321 COVID-19 Military Health
sample of mostly young, healthy adults. 57 Navy guidance states that
roughly 35 percent of infected sailors within the Navy population exhibit
few to no symptoms. 58

To better understand the effectiveness of its strategy, DOD also monitors
weekly data on total COVID-19 tests, numbers of cases among
servicemembers, percentage of confirmed or probable cases among
servicemembers tested, and tests by type. Based on our analysis of DOD
COVID-19 testing and case data, the weekly rate of confirmed or
probable COVID-19 cases among active-duty servicemembers tested
remained below 7 percent from March to November 2020, but increased
from November through December to about 10 percent (see fig. 7). 59
Higher positivity rates in December may be attributed, in part, to fewer
asymptomatic individuals seeking testing during the holidays.




57Payne DC, Smith-Jeffcoat SE, Nowak G, et al., “SARS-CoV-2 Infections and Serologic
Responses from a Sample of U.S. Navy Service Members — USS Theodore Roosevelt,”
April 2020. MMWR Morb Mortal Wkly Rep 2020;69:714–721. In this investigation, the
Navy and the CDC studied a convenience sample of 382 young adult servicemembers
aboard the USS Theodore Roosevelt. In a later study of the outbreak, the Navy found that
out of 1,271 Roosevelt crew members with laboratory-confirmed infections, 55 percent
experienced symptoms (i.e., 45 percent remained asymptomatic). Of 1,331 with confirmed
or suspected COVID-19, 23 were hospitalized, four received intensive care, and one died.
Kasper, M, Ph.D., Geibe, J., M.D., et al., “An Outbreak of Covid-19 on an Aircraft Carrier,”
Dec. 17, 2020. N Engl J Med 2020; 383:2417-2426.
58NAVADMIN 298/20, U.S. Navy COVID-19 Standardized Operational Guidance Version
3.1 (Nov. 4, 2020).
59The World Health Organization advises governments that before reopening, rates of
positivity in testing (i.e., out of all tests conducted, how many came back positive for
COVID-19) should remain at 5 percent or lower for at least 14 days. Testing rates help
gauge the spread of COVID-19 and show whether enough testing is occurring.




Page 40                                                GAO-21-321 COVID-19 Military Health
Figure 7. Percentage of Confirmed or Probable COVID-19 Cases among Active-Duty Servicemembers Tested, Weeks of March
29, 2020 through December 27, 2020




                                      Notes: Data in the figure represent the number of unique individuals who were tested. Some
                                      servicemembers were tested more than once. Thus, the total numbers of tests conducted each week
                                      are generally higher than the numbers in this figure. The data include members of the active
                                      components of the military services, and Reserve and National Guard members serving on active
                                      duty at the time of the test. The tests performed included diagnostic, screening, and surveillance
                                      tests.


                                      DOD’s COVID-19 Task Force, DHA, combatant commands, and
                                      installation commanders and their emergency working groups also collect
                                      and review more specific data points on a daily and weekly basis to
                                      identify local trends and ascertain the causes of outbreaks or clusters of
                                      positive COVID-19 cases. For example, at the installation level, selected
                                      MTF and command officials we interviewed stated that they work
                                      continuously to maintain data on probable and confirmed COVID-19
                                      cases and identify, through contact tracing, the methods of transmission
                                      so they can stop an outbreak or disease cluster from growing and apprise
                                      commanders of patterns to enable corrective actions.




                                      Page 41                                                    GAO-21-321 COVID-19 Military Health
DOD Is Analyzing Lessons   Another oversight mechanism that we identified in our review is DOD’s
Learned from Its COVID-    evaluation of lessons learned from the COVID-19 response, which
                           include lessons germane to force health protection among others, such
19 Response to Identify
                           as force readiness. Lessons learned collection and reporting was an early
Best Practices and         leadership-driven focus within DOD in its pandemic response. In April
Corrective Actions for     2020, the Secretary instructed combatant commanders to exchange best
Challenges                 practices and unanticipated challenges in organizing the Joint Force to
                           execute the departments’ three priority missions (the first of which is
                           protection of military and civilian personnel and their families). The
                           Secretary directed U.S. Northern Command to consolidate and share
                           these lessons. 60 In May 2020, the Deputy Secretary of Defense
                           announced a department-wide lessons learned line of effort. 61 The same
                           month, the DHA Director announced the start of after-action planning
                           across the military health system in preparation for the next major public
                           health emergency. 62

                           Some of DOD’s earliest lessons learned efforts were initiated earlier than
                           DOD leaders directed. In March 2020, for example, U.S. Forces Korea
                           disseminated across DOD its recommendations and principles learned
                           from the command’s early experience near the epicenter of the COVID-19
                           outbreak. Among other things, the command’s principles emphasized an
                           “all-hands” approach to early and frequent prevention and mitigation
                           measures, and treating the response like a combat operation.

                           The military departments’ medical organizations have also been collecting
                           lessons learned. In March 2020, for example, the Navy launched a
                           lessons learned initiative of its fleet-wide response to COVID-19 shortly
                           after the first cases were identified aboard the USS Theodore Roosevelt.
                           The assessment was designed to address future pandemic influenza and
                           infectious disease events by identifying gaps and capability
                           improvements, and informing new investments for future budgets. Some
                           of the recommendations identified in a July 2020 briefing of the study’s
                           results related to force health protection, such as improving unit capacity,
                           knowledge, and expertise in health protection, and improving science-

                           60Secretary of Defense Memorandum, Guidance for Commanders on the Implementation
                           of the Risk-Based Responses to the COVID-19 Pandemic (Apr. 1, 2020).
                           61Deputy Secretary of Defense Memorandum, DOD Coronavirus 2019 Task Force –
                           Lessons Learned (May 29, 2020).
                           62Defense Health Agency Memorandum, Defense Health Agency, Coronavirus 2019 After
                           Action Event Planning (May 22, 2020).




                           Page 42                                         GAO-21-321 COVID-19 Military Health
based testing and guidance on restriction of movement. 63 Separately, in
learning from its experience with the COVID-19 outbreak aboard the USS
Theodore Roosevelt, the Navy identified and implemented best practices
for the short-term by issuing guidance to the fleet in April 2020. 64 Later in
August 2020, the Navy’s Bureau of Medicine and Surgery concluded its
own review of the COVID-19 response aboard the Roosevelt, determining
that the April 2020 guidance, as updated in June 2020, appropriately
reinforced best practices.

According to DOD officials, a key lesson learned from early in the
pandemic was the need for timely and specific data on COVID-19 cases
among not only servicemembers, but civilian and contractor personnel.
These personnel often serve in mission-essential or key enabling
occupations across many functions of the department and typically serve
alongside servicemembers. Such data requirements exceeded the
capabilities of the department’s health information databases because
many civilian and contractor personnel receive their health care outside
the military health system. In addition, DOD’s health databases provide
medically-validated data, but do not consistently provide certain timely
and specific data, such as locations of infections, that would enable
commanders and leaders to understand the scope and nature of
outbreaks in real time. On the basis of our interviews with DOD officials,
we found that the department quickly developed mitigation strategies to
provide location data and other details to senior leaders until a permanent
solution is established for the long-term.

As of January 2021, according to DOD officials, organizations across the
department were continuing to gather and document lessons and best
practices for improving the continuing response to the COVID-19
pandemic and future pandemic preparation. For example, senior DOD
officials told us that U.S. Northern Command is rewriting its 2013 Global
Campaign Plan—a portion of which includes execution guidance for force
health protection to prepare for a pandemic. A key assumption from the
most recent plan that COVID-19 experiences invalidated, according to
DOD leaders, is that particular regions could rely upon support from
unaffected areas. The revised plan, according to senior leaders, will


63U.S. Fleet Forces Command, Coronavirus 2019 Pandemic Lessons Learned Collection
and Assessment (July 22, 2020).
64Navy and Marine Corps Public Health Center, Guidance for Underway Evaluation and
Management of Suspected Persons under Investigation (PUI) for Coronavirus Disease
2019 (COVID-19) (updated June 24, 2020).




Page 43                                           GAO-21-321 COVID-19 Military Health
                      consolidate lessons learned during the COVID-19 pandemic, including
                      recent DOD guidance on force health protection.

                      Given the ongoing nature of DOD’s wide-ranging lessons learned efforts
                      for COVID-19 with respect to force health protection, it remains to be
                      seen to what extent these lessons and any corrective actions identified
                      from them will be fully institutionalized and shared within and across the
                      department to relevant stakeholders.

                      Since January 2020, when COVID-19 cases were increasing in Asia
DOD’s COVID-19        among the general population, DOD has leveraged its research and
Research and          development infrastructure and investments in preexisting infectious
                      disease research to advance medical countermeasures that prevent,
Development Efforts   treat, and detect COVID-19. DOD’s experiences with SARS-CoV-1 in
Aim to Advance        2003 and Middle East Respiratory Syndrome (MERS) in 2014 facilitated
                      rapid progress with COVID-19 research. More broadly, according to DOD
Prevention and        officials, scientists and program managers have drawn upon decades of
Treatment Methods     experience in research, development, and acquisition for infectious
                      diseases and biological defense to conduct studies and acquisition efforts
and Improve           across the continuum of medical countermeasures capabilities required to
Detection among       combat COVID-19.
Servicemember         According to DOD officials responsible for shaping the COVID-19 medical
Populations           countermeasures strategy, they agreed in January 2020 to adopt a three-
                      pronged approach to protect and treat servicemembers by pursing new
                      vaccines, therapeutics, and diagnostic methods. In February 2020, to
                      help expedite early expansion of research and development efforts, DOD
                      received a sample of SARS-CoV-2 and used it to prepare a “master
                      stock” for testing countermeasures.

                      Another early step in DOD’s strategy for developing COVID-19
                      countermeasures, according to DOD officials, was to ensure the
                      department’s investments would be complementary to government-wide
                      efforts by coordinating with agencies within the Department of Health and
                      Human Services that were beginning their own research and




                      Page 44                                      GAO-21-321 COVID-19 Military Health
development. 65 During 2020, DOD’s portfolio of projects grew to expand
knowledge about SARS-CoV-2 and COVID-19, and to diversify the
number and types of countermeasures projects, including the science and
technologies behind them. DOD leaders explained that this scope and
diversity of efforts is necessary because there are no guarantees of
success and the risks are high.

DOD’s research and development activities for COVID-19
countermeasures have involved research laboratories (DOD’s and those
of academic and commercial research partners), its clinical trial network,
manufacturing facilities, and epidemiology and health surveillance entities
(see fig. 8).




65Separately from the projects focused on servicemembers and discussed in the scope of
this report, DOD has also partnered with the Department of Health and Human Services
since June 2020 through Operation Warp Speed to accelerate the development,
manufacturing, and distribution of COVID-19 vaccines and therapeutics. For more
information on Operation Warp Speed, see GAO, Operation Warp Speed: Accelerated
COVID-19 Vaccine Development Status and Efforts to Address Manufacturing
Challenges, GAO-21-319 (Washington, D.C.: Feb. 11, 2021); COVID-19: Federal Efforts
Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on
Emergency Use Authorizations, GAO-21-207 (Washington, D.C.: Nov. 17, 2020); and
GAO-21-191.




Page 45                                             GAO-21-321 COVID-19 Military Health
Figure 8: Examples of Department of Defense Medical Research and Development Capabilities for COVID-19
Countermeasures




                                       As of March 2021, DOD’s portfolio of countermeasures included dozens
                                       of projects in varying stages of maturity. Many organizations within DOD’s
                                       research and development enterprise have led or collaborated on projects
                                       involving partners from industry and academia. Examples of ongoing
                                       efforts related to vaccines, therapeutics, diagnostic testing, and
                                       complementary research studies are described in detail below.

                                       Vaccines. According to DOD briefings on the progress of research and
                                       development, DOD’s vaccine investments seek a longer-term solution to
                                       the COVID-19 pandemic with diverse efforts to ensure effectiveness. To



                                       Page 46                                         GAO-21-321 COVID-19 Military Health
that end, each of DOD’s four vaccine projects (ongoing as of March 2021)
applies a different platform or technology. 66 The vaccines also offer
certain unique and specific applications for the servicemember
population, including storage in deployed environments and application
for future coronaviruses. Two of these projects, sponsored by the Naval
Medical Research Center, were in preclinical development and testing as
of March 2021. DOD officials told us that one of the two Navy projects—a
phage-display vaccine—offers the advantages of rapid formulation,
reformulation, manufacturing at scale, and easy storage. The other Navy
project—a psoralen-inactivated vaccine—leverages a simple and flexible
method that does not require extensive knowledge of a virus or bacterium
(unlike the knowledge of coronaviruses that has facilitated other COVID-
19 vaccines), has potential application for future infectious diseases that
have not been studied, and may produce longer-lasting immunity than
other vaccine types, according to DOD officials.

DOD’s other two vaccine projects for COVID-19 are more mature than the
Navy projects.

•   DNA vaccine. The JPEO CBRND is working with partners—Ology
    Bioservices and Inovio Pharmaceuticals—to develop a DNA vaccine
    that provides logistical advantages to DOD. The vaccine candidate in
    development would be stable at room temperature for more than a
    year and stable at 37 degrees Celsius for more than a month,
    according to a news release from Inovio. 67 Moreover, the vaccine has
    a projected 5-year shelf life at normal refrigeration temperature and
    does not need to be frozen during transport or storage. DOD’s
    Advanced Development and Manufacturing facility began producing
    the vaccine in early 2020. This manufacturing capability provides
    priority access for DOD’s emergency requirements, allowing rapid
    production to meet a surge in vaccine demand. Phase 1 clinical trials,
    which began in April 2020, found the vaccine to be safe, tolerable,
    and 100 percent immunogenic in all 38 trial participants. 68 Combined
    Phase 2 and 3 clinical trials began in November 2020 and are
    expected to conclude in September 2022. The Walter Reed Army

66DOD has contributed funding to a fifth vaccine candidate as part of Operation Warp
Speed, manufactured by Novavax.
67In contrast, the Operation Warp Speed vaccine candidates have shipping and storage
temperature requirements ranging from negative 80 degrees Celsius to 8 degrees Celsius.
68P. Tebas et al., “Safety and immunogenicity of INO-4800 DNA vaccine against SARS-
CoV-2: A preliminary report of an open-label, Phase 1 clinical trial,” EClinicalMedicine
(2020), https://doi.org/10.1016/j.eclinm.2020.100689.




Page 47                                                GAO-21-321 COVID-19 Military Health
    Institute of Research is one of 16 trial locations for the vaccine. The
    other 15 sites are civilian facilities in the United States.
•   Spike ferritin (protein) nanoparticle vaccine. The Walter Reed Army
    Institute of Research has led the development of a unique vaccine
    candidate that leverages an existing nanoparticle platform it tested
    prior to the emergence of SARS-CoV-2. An advantage of this vaccine
    is its potential application as a universal vaccine for future
    coronaviruses. This vaccine uses nanoparticles of an iron-containing
    protein called ferritin. Researchers attach a certain type of spike
    protein to a polymerized version of ferritin. The spike protein is what
    SARS-CoV-2 uses to enter human cells. The Army began
    manufacturing vaccine doses for testing at the Walter Reed Army
    Institute of Research Pilot Bioproduction Facility. Researchers
    conducted preclinical development and testing for most of 2020 in
    coordination with the U.S. Army Medical Research Institute of
    Infectious Diseases using its small- and large-scale animal models.
    The Walter Reed Army Institute of Research chose the vaccine as the
    most promising prototype among more than 2 dozen others it began
    developing in January 2020. As of March 2021, the Army had not
    announced a start date for a Phase 1 clinical trial, but had identified
    industry partners for development through Phase 2 trials.
In addition to sponsoring and leading development of the aforementioned
vaccines, DOD has used its clinical trial infrastructure to test vaccines in
development by other federal agencies or nonfederal entities. For
example, DOD announced in September 2020 that it would support
Phase 3 clinical trials at five of its MTFs for the AstraZeneca vaccine for
COVID-19, which is sponsored by the Department of Health and Human
Services under Operation Warp Speed. In November 2020, DOD began
enrolling health care providers as study participants at two MTFs and the
Uniformed Services University of the Health Sciences in support of a
Phase 3 clinical trial of a COVID-19 vaccine study sponsored by the
Henry M. Jackson Foundation for the Advancement of Military Medicine. 69




69The study, titled “Novel Use of an Existing Vaccine (BCG) Alliance: The NUEVA Trial,”
will evaluate the efficacy of the BCG LIVE strain of the BCG vaccine by Merck (indicated
for tuberculosis) in reducing the incidence of infection of SARS-CoV2 and severity of
COVID-19 disease. This study focuses on health care workers, 18-64 years of age, who
are likely to care for patients with COVID-19 illness, and are eligible for care in DOD
facilities.




Page 48                                               GAO-21-321 COVID-19 Military Health
DOD’s Role in Remdesivir COVID-19                                Therapeutics. According to DOD’s spend plan for its research and
Treatment Evolution                                              development investments, therapeutic treatment solutions were a critical
Gilead Sciences, Inc., began researching                         part of the near-term response to COVID-19 in the absence of a vaccine
remdesivir in 2009 for use against hepatitis C and
respiratory syncytial virus. DOD began                           to prevent illness. 70 However, DOD officials stated that treatments will
investigating remdesivir during the early stages of              continue to be essential countermeasures even after vaccines are
research and development when antiviral profiling
suggested its potential as a broad-spectrum anti-                available.
viral against emerging viruses, such as Ebola and
Marburg. Prior to the FDA’s authorization of
remdesivir for emergency use to treat severe
                                                                 One component of DOD’s research and development efforts in
COVID-19 infection, DOD fielded remdesivir as an                 therapeutics for COVID-19 has included screening, evaluation, and
investigational product used to treat COVID-19 in                clinical trials of new and existing drugs that could be repurposed to treat
military personnel, prior to FDA approval, and
leveraged existing industry relationships to                     COVID-19, including antiviral and other small molecule drugs. According
accelerate efforts to repurpose remdesivir as a                  to DOD officials, novel drug development efforts, in concert with
COVID-19 treatment.
                                                                 repurposing of therapeutics to combat COVID-19, enables a multi-layered
 Timeline of Remdesivir Approval for                             defense approach for effective medical countermeasures development
 COVID-19
                                                                 and delivery. To that end, for example, the Defense Advanced Research
  May 1,       Food and Drug Administration                      Projects Agency has programs in place to facilitate drug discovery
  2020         (FDA) issued an emergency use
               authorization (EUA) for severe                    through known and unknown molecules that may address emerging
               COVID-19 infection.                               threats, including COVID-19. One such program funds the development
  August       FDA expanded EUA, allowing                        of new approaches using artificial intelligence techniques to accelerate
  28,          treatment for all hospitalized                    the discovery of drugs to combat SARS-CoV-2, including synergistic
  2020         patients regardless of severity.
                                                                 combination therapies and those that inhibit the virus. 71
  October      FDA approved remdesivir for the
  22,          treatment of COVID-19 patients
  2020         requiring hospitalization and                     The U.S. Army Medical Research Institute of Infectious Diseases has
               weighing at least 40 kilograms,                   used a system to screen thousands of chemical compounds at a time for
               and revised the EUA to authorize
               treatment for children.                           potential therapeutic use—the same system that identified the antiviral
                                                                 drug remdesivir as a potential therapeutic for Ebola virus. In March 2020,
                                                                 the U.S. Army Medical Materiel Development Activity announced a
                                                                 partnership with Gilead Sciences to obtain remdesivir and initiate an
                                                                 expanded access study for investigational use of the drug to treat eligible
                                                                 patients in MTFs. DOD joined a Phase 3 clinical trial for remdesivir use in
                                                                 adults hospitalized with COVID-19, sponsored by the National Institute of
                                                                 Allergy and Infectious Diseases, with five participating MTFs. Preliminary
Source: GAO analysis of Department of Defense (DOD) and FDA
information (text); Tobias Arhelger/stock.adobe.com (photo). |
GAO-21-321




                                                                 70Under Secretary of Defense, Comptroller, Department of Defense Spend Plan For
                                                                 Funding Received in the Coronavirus Aid, Relief, and Economic Security “CARES” Act
                                                                 (P.L. 116-136) (May 29, 2020).
                                                                 71A combination of drugs is synergistic when the combined effect is larger than the
                                                                 additive effect of each individual drug.




                                                                 Page 49                                               GAO-21-321 COVID-19 Military Health
results in April 2020 led to the FDA issuing the first EUA for remdesivir. 72
These MTFs and others have participated in subsequent Phase 3 trials
evaluating remdesivir paired with other drugs. 73

In addition to remdesivir, DOD has funded ongoing studies of at least
eight other drugs (including antiviral drugs and others) to investigate their
efficacy for COVID-19. These studies include a mixture of new drugs, and
ones evaluated or FDA-approved for other indications.

DOD also studies therapeutic applications for drugs, including antibody
treatments, that are distinct from the needs of the general population—
namely, the use of therapeutic agents for pre- and postexposure
prophylaxis to prevent disease onset. For example, according to DHA
officials, if a sailor becomes ill with COVID-19 on a ship or submarine,
treating other sailors prophylactically can help limit the spread of the
disease. In general, prophylaxes are a DOD-specific priority for medical
countermeasures because of their significance for protecting
servicemembers from infectious diseases and chemical, biological,
radiological, and nuclear threats. Antibody treatments are useful for their
prophylactic applications. Accordingly, antibody research and related
products comprise a large share of DOD’s therapeutics development
portfolio for COVID-19.

As of March 2021, DOD had at least 11 antibody-related therapeutic
projects underway for applications to COVID-19, including monoclonal
antibodies, as well as plasma and polyclonal antibodies. DOD’s
investments in such projects include studying and manufacturing initial
antibody doses, and studying plasma-related products. For example:

•   Gene-encoded monoclonal antibodies. As one of several DOD
    projects focused on monoclonal antibodies as a COVID-19 treatment,
    JPEO CBRND and the Defense Advanced Research Projects Agency
    are leading a study of gene-encoded monoclonal antibodies.
    According to DOD officials, this project uses the technology for its
    DNA vaccine (as previously discussed) to generate prophylaxis and

72Enrollment for the study, entitled Adaptive COVID-19 Treatment Trial, began on
February 21, 2020. The study concluded on May 21, 2020. J.H. Beigel et al., “Remdesivir
for the Treatment of Covid-19—Final Report,” The New England Journal of Medicine 383,
No. 19 (October 2020): 1813-26, https://doi.org/10.1056/NEJMoa2007764.
73These studies include Adaptive COVID-19 Treatment Trial 2, Adaptive COVID-19
Treatment Trial 3, and Adaptive COVID-19 Treatment Trial 4. All three studies are
sponsored by the National Institute of Allergy and Infectious Diseases.




Page 50                                              GAO-21-321 COVID-19 Military Health
    treatments that trigger the human body to produce life-saving
    antibodies against SARS-CoV-2. By doing so, DOD officials state that
    they can avoid otherwise time-consuming and expensive
    manufacturing processes involved in producing other antibody
    treatments..
•   Plasma products. One of DOD’s studies of plasma-related products
    for therapeutic application in COVID-19 evaluates the efficacy of
    convalescent plasma (i.e., plasma removed from the blood of a
    person who has recovered from the disease and transfused into a
    patient with the same disease). The JPEO CBRND executed an
    agreement with Johns Hopkins University in July 2020 to conduct two
    nationwide clinical trials that will help researchers determine whether
    convalescent blood plasma therapy can effectively treat people in
    early stages of COVID-19 illness by reducing symptoms or preventing
    infection altogether. Prior to this study, in May 2020 the U.S. Army
    Medical Materiel Development Activity received FDA authorization to
    implement an expanded access protocol for COVID-19 convalescent
    plasma, and within a month began providing the investigational
    treatment to for use at approved MTFs across the military health
    system, and operational units such as aircraft carriers.
Diagnostics. According to DOD officials, testing will continue to be
critical for protecting servicemembers from COVID-19 even after vaccines
and therapeutics are developed because of DOD’s global operating
posture, including countries where COVID-19 may persist as a public
health threat. DOD investments seek speed, capacity, and portability for
COVID-19 testing in support of operational readiness. The diagnostic
testing-based projects underway as of March 2021 include a mixture of
molecular, antigen, and serology tests. 74

Molecular tests comprised DOD’s earliest investments in diagnostic
testing capabilities. According to DOD officials, existing relationships with
industry partners expedited EUAs in March 2020 from the FDA for DOD’s
initial diagnostic testing capabilities—the BioFire COVID-19 Test and
Cepheid’s Xpert Xpress SARS-CoV-2. DOD officials stated that they
quickly delivered hundreds of these platforms and over 300,000 tests
across DOD. DOD continued to acquire additional molecular-based
testing instruments and kits as they received EUAs during 2020. More
recent investments in diagnostic testing have included portable and rapid
74Molecular diagnostic viral tests detect the presence of genetic material from SARS-CoV-
2, the virus that causes COVID-19. Antigen viral tests detect the presence of a protein that
is present in SARS-CoV and SARS-CoV-2. Serology tests detect antibodies produced in
the blood of patients who have had a previous COVID-19 infection.




Page 51                                                GAO-21-321 COVID-19 Military Health
point-of-care tests, both molecular and antigen-based. DOD is also
evaluating its testing technologies in use to inform its overall testing plan,
such as pooled testing techniques to conserve limited testing resources.

In addition, DOD’s research and development efforts to advance testing
capabilities include expanding its range of antibody testing. According to
DOD briefings on the status of the COVID-19 medical countermeasures
portfolio, evaluating the development of antibodies and their role in
protection is critical to inform what antibody tests mean, and how, when,
and where to use them, such as determining return to duty status for
servicemembers who have had COVID-19. DOD has transferred a CDC
serology test to Navy, Air Force, and Army laboratories to expand
capabilities. The department is also monitoring the FDA’s issuance of
EUAs for new serology tests.

Complementary research studies. According to DOD officials, studies
to expand knowledge of COVID-19 began in January 2020 when, for
example, they decided to repurpose an ongoing influenza study by the
Uniformed Services University of the Health Sciences to understand the
natural history, immune response, and biomarkers of COVID-19. 75 DOD
had numerous other research studies ongoing in 2020 aimed at 1)
improving knowledge about SARS-CoV-2 and COVID-19 in
servicemember populations (e.g., transmission, incidence, disease
course, and immunological response); 2) evaluating and informing the
use of testing technologies; and 3) developing “adjunctive” technologies
(such as predictive modeling for emergency triage of patients with acute
respiratory symptoms related to COVID-19—a project led by the Air
Force) and wearable sensors, such as those for disease detection.

In the summer of 2020, the DHA developed a COVID-19 registry—a
collection of data on all COVID-19 positive and suspected symptomatic
cases evaluated by a medical provider within the military health system.
The registry was designed to track the epidemiology of the disease and
help the military health system improve clinical performance and patient
outcomes. Moreover, the registry is intended to facilitate evaluation of the
safety and effectiveness of COVID-19 treatments and support DOD and



75The study, entitled “Epidemiology, Immunology, and Clinical Characteristics of Emerging
Infectious Diseases with Pandemic Potential,” is a multi-year, observational study of
active-duty servicemembers and others eligible to receive care in the military health
system. As of March 2021, the study was still enrolling participants.




Page 52                                              GAO-21-321 COVID-19 Military Health
                  civilian research and medical teams who seek insights to future
                  advancements in vaccines and therapeutics.

                  We provided a draft of this product to DOD for review and comment. DOD
Agency Comments   concurred without comment on the draft report and provided technical
                  comments, which we incorporated as appropriate.

                  We are sending copies of this report to the appropriate congressional
                  committees, the Secretary of Defense, the Under Secretary of Defense
                  for Policy, the Acting Assistant Secretary of Defense for Health Affairs,
                  the Director of the Defense Health Agency, the Secretary of the Army,
                  and the Acting Secretaries of the Navy and the Air Force. In addition, the
                  report is available at no charge on the GAO website at
                  http://www.gao.gov.

                  If you or your staff have any questions about this report, please contact
                  me at (202) 512-3604 or farrellb@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 key contributions to this report
                  are listed in appendix II.




                  Brenda S. Farrell
                  Director, Defense Capabilities and Management




                  Page 53                                      GAO-21-321 COVID-19 Military Health
List of Addressees

The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate

The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate

The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Gary C. Peters
Chair
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate

The Honorable Rosa L. DeLauro
Chairwoman
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives

The Honorable Frank Pallone, Jr.
Chair
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives


Page 54                                  GAO-21-321 COVID-19 Military Health
The Honorable Bennie G. Thompson
Chair
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives

The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives

The Honorable Richard E. Neal
Chairman
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives

The Honorable Jackie Speier
Chairwoman
Subcommittee on Military Personnel
Committee on Armed Services
House of Representatives

The Honorable Trent Kelly
House of Representatives




Page 55                              GAO-21-321 COVID-19 Military Health
Appendix I: Objectives, Scope, and
              Appendix I: Objectives, Scope, and
              Methodology


Methodology

              With regard to COVID-19, this report examines the Department of
              Defense’s (DOD) (1) strategy for protecting the health of military
              servicemembers, (2) oversight mechanisms for implementing its health
              protection strategy, and (3) research and development projects for
              vaccines, therapeutics, and testing.

              For each of our objectives, our scope included DOD’s actions to address
              the Coronavirus Disease 2019 (COVID-19) pandemic since January
              2020. For objectives one and two, we interviewed a nongeneralizable
              sample of five combatant commands and four military medical treatment
              facilities (MTF) to represent each geographic region of the world in which
              DOD operates, each military department, different populations served,
              and both hospitals and clinics. 1 From the combatant commands, we
              obtained their force health protection guidance for COVID-19 and
              examples of health surveillance update briefings. Our observations from
              these interviews and related documents provided illustrative examples of
              how commands and MTFs have implemented and overseen DOD’s
              strategy for protecting servicemembers. However, determining the degree
              to which DOD’s strategy has been consistently implemented over time
              and universally implemented across the entire active-duty population was
              outside the scope of our review.

              For objective one, to identify elements of DOD’s strategy we reviewed its
              force health protection policies and the COVID-19 specific guidance and
              planning documents issued through February 2021. We also reviewed
              COVID-19 force health protection guidance that DOD issued and made
              publicly available on the defense.gov website from March through May
              20, 2021 to determine whether key changes were made to previously
              issued guidance during the time that DOD was reviewing a draft of this
              report for comments. In addition, we reviewed DOD’s global pandemic
              campaign plan and an example of a regional campaign plan from U.S.
              Indo-Pacific Command—both published prior to the COVID-19
              pandemic—to understand their relevance to the COVID-19 health
              protection strategy by identifying measures that were similar to or



              1The five combatant commands included U.S. Northern Command, U.S. Southern
              Command, U.S. Indo-Pacific Command, U.S. Central Command, and U.S. European
              Command. The four MTFs we interviewed included the 60th Medical Group at David Grant
              Medical Center, Travis Air Force Base, California; Naval Health Clinic Corpus Christi,
              Naval Air Station Corpus Christi, Texas; Naval Hospital Okinawa, Camp Foster, Japan;
              Landstuhl Regional Medical Center, Kaiserslautern, Germany.




              Page 56                                            GAO-21-321 COVID-19 Military Health
Appendix I: Objectives, Scope, and
Methodology




different from those taken in accordance with DOD’s other force health
protection policies, guidance, and planning documents for COVID-19.

We compared DOD’s strategy with our prior work on key considerations
for agencies returning to the workplace during pandemics to determine
how the actions aligned and whether there were deficiencies or additional
steps DOD has taken beyond those key considerations. 2 Specifically,
federal agencies should consider doing the following: prioritize leadership
attention and continuous communication across the organization; make
decisions about reentry based on local conditions; identify mission-
essential functions and employees, and classify their exposure risk level;
implement social distancing and other appropriate protection measures
for employees; establish COVID-19 testing protocols; and establish
protocols to prioritize and distribute antivirals and vaccines. We refer to
these as “key considerations” because they are not an exhaustive list of
steps that federal agencies must take to ensure effective planning. We
developed them by reviewing prior work on pandemic response and
planning. All but two of the key considerations (prioritizing leadership
attention and establishing COVID-19 testing protocols) are based on our
June 2020 testimony on key considerations for agencies as their
employees reenter workplaces during pandemics. 3 We testified that these
considerations were drawn from surveys on influenza pandemic
preparedness that we conducted in 2012 and 2009 with the 24 agencies
covered by the Chief Financial Officers Act of 1990. To ensure these key
considerations were comprehensive and relevant as knowledge of the
COVID-19 pandemic increased later in 2020, we also reviewed our more
recent reports on COVID-19. 4 On the basis of those reports, we identified
leadership attention (in conjunction with communicating to employees)
and testing protocols as other critical factors for protecting employees.

To assess consistency between DOD’s guidance and that of the Centers
for Disease Control and Prevention (CDC), we selected for comparison
purposes a range of COVID-19 protection measures discussed in DOD’s

2GAO, Federal Workforce: Key Considerations for Agencies Returning Employees to
Workplaces during Pandemics, GAO-20-650T (Washington, D.C.: Jun. 25, 2020).
3GAO-20-650T.

4See GAO, COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and
Other Challenges Require Focused Federal Attention, GAO-21-265 (Washington, D.C.:
Jan. 28, 2021); COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
Response, GAO-21-191 (Washington, D.C.: Nov. 30, 2020); and COVID-19: Federal
Efforts Could Be Strengthened by Timely and Concerted Actions, GAO-20-701
(Washington, D.C.: Sept. 21, 2020).




Page 57                                             GAO-21-321 COVID-19 Military Health
Appendix I: Objectives, Scope, and
Methodology




force health protection guidance. Specifically, to cover a range of topical
areas, we selected nine measures that we categorized as day-to-day
protections, six that we categorized as infection mitigation measures
(listed in table 3 of the report), and measures that were aligned with
DOD’s three types of testing protocols (i.e., clinical diagnostic, screening,
and surveillance). We compared these selected measures from DOD
guidance with guidance from the CDC website to identify consistency or
any differences.

To further our understanding of the strategy for health protection, we
interviewed DOD officials, including senior leaders and representatives
from the military department medical organizations, combatant command
representatives, and personnel from selected MTFs. We identified
common steps taken and challenges to protecting servicemembers from
COVID-19 that officials noted in interviews, along with mitigation steps
that the officials had taken.

For objective two, we reviewed key documentation on oversight activities,
including briefing documents from working groups within DOD on the
progress of health protection measures, along with commanders’ orders
for health emergencies. We reviewed these documents to identify DOD’s
methods for assessing compliance and the consistency and uniformity of
implementation. We also analyzed DOD data from January 1 through
December 31, 2020 on confirmed positive cases, hospitalizations, and
deaths of servicemembers to identify trends, and compared our findings
with statements by DOD leaders regarding their assessment of the
effectiveness of health protection actions. We calculated a 7-day rolling
average of positive cases among active-duty servicemembers (including
activated reservists and National Guard), calculated as the sum of cases
from the current day plus the 6 preceding days, divided by seven. We
compared trends in the number of cases among the DOD population with
those of the overall US population by identifying the dates of the peaks in
COVID-19 cases nationally in each 3-month period: April-June, July-
September, and October-December 2020. We calculated the percent
hospitalized per week by dividing the total hospitalizations for the week by
the weekly sum of the 7-day rolling average of cases among active-duty
servicemembers.

To compare COVID-19-related deaths in the military versus U.S.
populations, we used an indirect standardization method because of the
small number of deaths in the military population. We calculated the
number of expected deaths in the servicemember population using
provisional COVID-19 death counts from the National Center for Health


Page 58                                       GAO-21-321 COVID-19 Military Health
Appendix I: Objectives, Scope, and
Methodology




Statistics and U.S. population estimates from the National Center for
Health Statistics, and the U.S. Census Bureau, which accounted for
differences in the state, sex, and age distributions of the U.S. and
servicemember populations. Our analysis did not account for other factors
related to the COVID-19 death rate, such as access to health care or
comorbid conditions. Provisional death may not be complete due to
reporting delays, especially for the most recent weeks. The U.S.
population estimates were from the Vintage 2019 Bridged-race
Postcensal Population Estimates. DOD servicemember data includes the
total DOD force (active component, reserve, and National Guard) in
October 2020.

We also analyzed DOD data from 2020 on number of tests by type,
positive tests, and positivity rate among active-duty servicemembers to
describe DOD’s testing strategy and identify trends. We determined the
data were sufficiently reliable for our purposes to describe trends over
time and provide examples of analyses DOD leaders use to monitor
efforts to protect servicemembers from COVID-19 by (1) reviewing the
databases for errors, (2) cross-checking data with other DOD
documentation and reporting, and (3) interviewing DOD officials and
contractors knowledgeable about the data.

Finally, we reviewed lessons learned reports and interviewed DOD
officials, including personnel from selected MTFs, about oversight
mechanisms they employ to assess their health protection efforts.

For objective three, we reviewed DOD briefing documents from periodic
progress updates on all COVID-19 medical countermeasures research
and development projects initiated since January 2020. We also identified
and reviewed public press releases on individual projects, updates to
ClinicalTrials.gov, and scientific journal articles. Together with interviews
of DOD officials, we analyzed and described DOD’s overall strategy for
leveraging its research and development capabilities along with those of
academic and industry partners. We also identified DOD-unique aspects
of the various project investments, including benefits to the
servicemember population that differ from the needs of the general
population.

We conducted this performance audit from May 2020 to June 2021 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that


Page 59                                       GAO-21-321 COVID-19 Military Health
Appendix I: Objectives, Scope, and
Methodology




the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.




Page 60                                    GAO-21-321 COVID-19 Military Health
Appendix II: GAO Contact and Staff
                  Appendix II: GAO Contact and Staff
                  Acknowledgments


Acknowledgments

                  Brenda S. Farrell, (202) 512-3604 or FarrellB@gao.gov
GAO Contact
                  In addition to the contact named above, Lori Atkinson (Assistant Director),
Staff             Melissa Blanco (Analyst in Charge), Mariel Alper, Alexandra Gonzalez,
Acknowledgments   Kaitlyn (Kaitie) Hunter, Amie Lesser, Patricia Powell, William Tedrick,
                  Sirin Yaemsiri, and Lillian M. Yob made key contributions to this report.




                  Page 61                                      GAO-21-321 COVID-19 Military Health
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             Combat Fraud Is Crucial as the Pandemic Enters Its Second Year.
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             Status and Efforts to Address Manufacturing Challenges. GAO-21-319.
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             Concerted Actions. GAO-20-701. Washington, D.C.: September 21, 2020.

             COVID-19: Opportunities to Improve Federal Response and Recovery
             Efforts. GAO-20-625. Washington, D.C.: June 25, 2020.

             Federal Workforce: Key Considerations for Agencies Returning
             Employees to Workplaces during Pandemics. GAO-20-650T.
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             Response. GAO-20-638T. Washington, D.C.: June 9, 2020.

             Infectious Disease Modeling: Opportunities to Improve Coordination and
             Ensure Reproducibility. GAO-20-372. Washington, D.C.: May 13, 2020.

             Science & Tech Spotlight: COVID-19 Vaccine Development.
             GAO-20-583SP. Washington, D.C.: May 2020.

             Emerging Infectious Diseases: Actions Needed to Address the
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             Page 62                                     GAO-21-321 COVID-19 Military Health
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           Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be
           Incorporated into Future Planning. GAO-11-632. Washington, D.C.: June
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           Accountability, Funding, and Communications Need to be Clearer and
           Focused Departmentwide. GAO-06-1042 Washington, D.C.: September
           21, 2006.




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           Page 63                                   GAO-21-321 COVID-19 Military Health
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