GAO-23-105579, COVID-19: Usaid Plans to Share Lessons Learned from Efforts to Meet Global Vaccination Goal
- Issuer
- Government Accountability Office
- Document type
- Report
- Date
- 2023-07-05
Report — GAO-23-105579, COVID-19: Usaid Plans to Share Lessons Learned from Efforts to Meet Global Vaccination Goal, dated 2023-07-05, issued by Government Accountability Office.
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COVID-19 USAID Plans to Share Lessons Learned from Efforts to Meet Global Vaccination Goal Report to Congressional Addressees September 2023 GAO-23-105579 United States Government Accountability Office United States Government Accountability Office Highlights of GAO-23-105579, a report to congressional addressees September 2023 COVID-19 USAID Plans to Share Lessons Learned from Efforts to Meet Global Vaccination Goal What GAO Found The U.S. Agency for International Development (USAID) supports COVID-19 vaccine country readiness and delivery abroad by assisting a country’s capacity to receive and administer vaccines. As of March 2023, USAID obligated an estimated $904 million to support its COVID-19 country readiness and delivery efforts in 125 countries. USAID’s obligations for these efforts covered eight areas of technical assistance, including promoting demand for vaccination and supporting supply chain logistics. USAID, together with other U.S. agencies, host governments and other entities, helped vaccinate an average of 45 percent of the population across assisted countries as of July 2023. This average was in comparison to the global goal of 70 percent vaccination in each country. Close to two-thirds of the assisted countries had vaccination rates below 50 percent, and most of those rates have leveled off. Regional vaccination rates for countries that received USAID assistance ranged from an average of 28 to 63 percent (see figure). USAID stated that it could not measure its direct contribution to countries’ vaccination progress because, among other things, the agency is only one of many entities involved in these efforts. Average Fully Vaccinated Rate by Region for Countries Assisted by the U.S. Agency for International Development (USAID) as of July 5, 2023 Note: Vaccination rates reflect the efforts of USAID and other entities in assisted countries. USAID officials, citing World Health Organization guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. USAID assisted 125 countries; no vaccination data existed for two small USAID-assisted countries in Asia. The most recent vaccination rate data for most countries are prior to July 2023. USAID faced demand, supply, and other challenges in providing COVID-19 vaccine country readiness and delivery assistance. U.S. agency officials in assisted countries reported that demand issues have overtaken supply issues as the greatest challenge to these efforts. Demand issues included, for example, vaccine hesitancy and barriers associated with people getting to vaccine sites. As vaccine demand diminished, USAID and other partners shifted priorities to vaccinating vulnerable groups and incorporating activities into countries’ primary healthcare systems on the way to reaching the global 70 percent vaccination goal. USAID initiated several efforts to learn from these challenges, and has plans to disseminate the lessons learned, in accordance with agency guidance. View GAO-23-105579. For more information, contact Latesha Love-Grayer at (202) 512- 4409 or LoveGrayerL@gao.gov. Why GAO Did This Study To attain high population immunity from COVID-19 during the pandemic, the U.S. pledged to substantially contribute toward a 70 percent vaccination goal of the world’s population, initially by the end of 2022. USAID has partnered with other U.S. agencies, multilateral organizations, and donor countries on country readiness and delivery efforts to significantly increase assistance to countries around the world to meet the vaccination goal. The CARES Act includes a provision for GAO to monitor the federal government’s response to the COVID- 19 pandemic. This report examines (1) the assistance USAID has provided to support COVID-19 vaccine country readiness and delivery abroad, (2) progress USAID has made in its efforts to support COVID-19 vaccine country readiness and delivery abroad, and (3) any challenges USAID has faced and how it has addressed them. GAO reviewed laws, funding, and guidance documents from USAID, the Department of State, the Centers for Disease Control and Prevention, and the World Health Organization. GAO analyzed publicly available data to obtain global vaccination rates. GAO also interviewed USAID officials in Washington, D.C., and USAID officials and other local stakeholders in three countries: Guatemala, Malawi, and South Africa. GAO selected these countries based on factors such as the amount of estimated country readiness and delivery assistance USAID obligated for each country. Page i GAO-23-105579 COVID-19 Vaccine Delivery Abroad Letter 1 Background 4 USAID Provided More Than $900 Million for CRD Efforts in 125 Countries 6 USAID Contributed to Vaccination Assistance That Fell Short of the Global Goal, and the Agency Faced Difficulties Measuring Its Progress 11 USAID Shifted Its Priorities in Response to CRD Challenges, and Plans to Disseminate Its Lessons Learned 20 Agency Comments 25 Appendix I Objectives, Scope, and Methodology 30 Appendix II Countries Receiving U.S. Agency for International Development COVID- 19 Vaccine Country Readiness and Delivery Assistance 35 Appendix III Comments from the U.S. Agency for International Development 37 Appendix IV GAO Contact and Staff Acknowledgments 44 Table Table 1: List of Countries Receiving USAID Assistance for COVID-19 Global Country Readiness and Delivery, by Region, 2023 35 Figures Figure 1: U.S. Agency for International Development (USAID) Total COVID-19 Allocations and Obligations and Estimated Obligations for Global COVID-19 Vaccine Country Readiness and Delivery (CRD) Efforts, as of March 2023 7 Figure 2: U.S. Agency for International Development (USAID) Estimated Obligations for COVID-19 Vaccine Country Readiness and Delivery by Region, as of March 2023 8 Contents Page ii GAO-23-105579 COVID-19 Vaccine Delivery Abroad Figure 3: U.S. Agency for International Development (USAID) Areas for COVID-19 Vaccine Country Readiness and Delivery Technical Assistance 9 Figure 4: Percentage of Population Fully Vaccinated in Countries Assisted by the U.S. Agency for International Development (USAID) as of July 5, 2023 12 Figure 5: Average Fully Vaccinated Rate by Region for Countries Assisted by the U.S. Agency for International Development (USAID) as of July 5, 2023 13 Figure 6: Percentage of Population Fully Vaccinated in Global VAX Surge Countries Assisted by the U.S. Agency for International Development (USAID), May 2021–June 2023 14 Page iii GAO-23-105579 COVID-19 Vaccine Delivery Abroad Abbreviations CDC Centers for Disease Control and Prevention COVAX COVID-19 Vaccines Global Access CRD country readiness and delivery DEC Development Experience Clearinghouse Global VAX Initiative for Global Vaccine Access UNICEF United Nations International Children’s Emergency Fund USAID United States Agency for International Development WHO World Health Organization This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. Page 1 GAO-23-105579 COVID-19 Vaccine Delivery Abroad 441 G St. N.W. Washington, DC 20548 September 27, 2023 Congressional Addressees COVID-19 has adversely affected the health of populations around the world. The pandemic has also killed millions of people both at home and abroad. The U.S. government has prioritized mitigating the public health impacts of COVID-19, slowing the transmission of the virus, deterring the emergence of new virus variants, and saving lives through vaccination. At the height of the COVID-19 pandemic in 2021, the United States pledged to substantially contribute toward a global goal of vaccinating 70 percent of the population of each country by the end of 2022. To stop the spread of the virus and attain high population immunity, the United States, led by the U.S. Agency for International Development (USAID), moved to the forefront of the pandemic global response. This response included building and strengthening countries’ readiness for and delivery of vaccines (country readiness and delivery, or CRD).1 To achieve the global goal of vaccinating 70 percent of the population of each country against COVID-19, the U.S. established the Global Response and Recovery Framework (the Framework) in July 2021. The Framework established a set of objectives to end the pandemic, mitigate its harms, support the global recovery, and strengthen pandemic threat readiness.2 The first objective of the Framework was to accelerate widespread and equitable access to and delivery of safe and effective COVID-19 vaccinations. In December 2021, the USAID Administrator announced a new, whole-of-government response, guided by the Framework, called the Initiative for Global Vaccine Access (Global VAX). Global VAX combined the capabilities of USAID and a number of other U.S. government agencies to respond to the evolving COVID-19 crisis in an effort to significantly enhance assistance to many countries, especially 1USAID defines CRD as the support needed to ensure that the infrastructure is in place and the technical assistance is available to make certain COVID-19 vaccines can be safely delivered to all those who need them. According to USAID guidance, this assistance involves financial support, training, and technical assistance provided by USAID-funded implementing partners. 2White House, “U.S. COVID-19 Global Response and Recovery Framework,” July 1, 2021. See https://www.whitehouse.gov/wp-content/uploads/2021/07/U.S.-COVID-19- Global-Response-and-Recovery-Framework.pdf. Letter Page 2 GAO-23-105579 COVID-19 Vaccine Delivery Abroad low-income ones, which remained under-vaccinated and unprepared for a new variant or a surge in infections.3 The CARES Act includes a provision for GAO to report on ongoing monitoring and oversight efforts related to the receipt, disbursement, and use of funds made available to prepare for, respond to, and recover from the COVID-19 pandemic.4 This report examines the (1) assistance USAID has provided to support COVID-19 vaccine CRD abroad, (2) progress USAID has made in its efforts to support COVID-19 vaccine CRD abroad, and (3) any challenges USAID has faced in its efforts to support COVID- 19 vaccine CRD abroad and how it has addressed them. To respond to these three objectives, we reviewed relevant federal laws, regulations, and USAID planning, funding, and guidance documents. We also conducted interviews with officials from USAID, the Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC), the Department of State, and other U.S. government officials in Washington, D.C. In addition, we selected three countries, Guatemala, Malawi, and South Africa, for a series of interviews with multiple stakeholders. These stakeholders included officials from USAID, CDC, State, other interagency partners and multilateral organizations, as well as from host government health offices and local organizations. We selected these countries based on several factors, including their receiving greater amounts of estimated CRD obligations and, in order to understand vaccination challenges, their having lower COVID-19 vaccination rates. To identify the types of assistance provided for COVID-19 vaccine CRD abroad, we obtained data on all USAID CRD assistance funded from appropriations to prevent, prepare for, and respond to COVID-19 and other appropriations obligated to address COVID-19. We obtained and analyzed additional CRD funding data from CDC and State officials. We interviewed relevant agency officials with knowledge of global vaccine CRD obligations and types of assistance and reviewed agency responses to our questions about the data. We reviewed related documentation and 3The other agencies included, among others, the Department of Health and Human Services’ Centers for Disease Control and Prevention, the Department of State, the Office of the Global AIDS Coordinator, the Department of Defense, the Peace Corps, the Development Finance Corporation, and the Department of the Treasury. 4Pub. L. No. 116-136 § 19010(b), 134 Stat. 281, 580 (2020). The American Rescue Plan Act of 2021 also includes a provision for GAO to conduct oversight of the COVID-19 response. Pub. L. No. 117-2, § 4002, 135 Stat. 4, 78. All of GAO’s reports related to the COVID-19 pandemic are available on GAO’s website at https://www.gao.gov/coronavirus. Page 3 GAO-23-105579 COVID-19 Vaccine Delivery Abroad performed data reliability checks, and determined that the data were sufficiently reliable for estimating obligation amounts. To describe the progress USAID made in meeting global COVID-19 vaccination goals and to identify factors that affected the measurement of this progress, we reviewed relevant USAID documents and interviewed officials as described above. To determine the overall vaccination progress in USAID-supported countries—reflecting the efforts of USAID, the host government, and other donors and entities—we reviewed COVID-19 vaccination and other data from the Our World in Data COVID- 19 vaccination dataset.5 This dataset draws on data from the World Health Organization (WHO), United Nations World Population Prospects, direct reports from country governments, and other sources. To assess the reliability of this dataset we conducted testing to identify any missing data or logical errors. We determined that the data were sufficiently reliable for the purposes of measuring overall vaccination progress. Finally, to identify any challenges USAID has faced in its efforts to support COVID-19 vaccine CRD abroad and how the agency addressed them, we analyzed agency documents, including surveys of U.S. overseas staff, mitigation strategies, and plans for monitoring, evaluating, and assessing lessons learned. In addition, we interviewed officials from USAID, CDC, State, WHO, United Nations International Children’s Emergency Fund (UNICEF), other international partners and multilateral organizations, and host government health offices and local organizations. We asked about the challenges in CRD assistance and mitigation strategies. We also asked USAID officials about plans for developing and disseminating lessons learned from USAID’s CRD efforts. We assessed USAID’s efforts against its Program Cycle Operational Policy.6 See appendix I for a full description of our scope and methodology. We conducted this performance audit from January 2022 to September 2023 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 5Our World in Data is an open access and open source non-profit organization that vets the source data for accuracy and consistency. It provides data on multiple variables, including people fully vaccinated (total and per capita data for people who received all doses prescribed by the initial vaccination protocol), COVID-19 cases, confirmed deaths, and numerous other COVID-19-related and broader socio-economic variables. 6USAID Automated Directives System 201 Program Cycle Operational Policy. Page 4 GAO-23-105579 COVID-19 Vaccine Delivery Abroad that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. In response to the spread of COVID-19 globally, the WHO declared COVID-19 a public health emergency of international concern in March 2020. Since then, COVID-19 has killed millions of people, infected hundreds of millions more, and adversely affected the health of populations around the world. Providing safe and effective vaccines to protect people from COVID-19 was crucial to mitigating the public health and economic impacts of the virus and to ending the pandemic as a public health emergency. In addition to limiting severe illness and death, slowing transmission of COVID-19 through vaccination—particularly of high-risk populations—was critical to deterring the emergence of new virus variants. The United States and global partners have assisted countries around the world to access vaccine supply and receive and administer vaccine doses. These efforts were conducted in collaboration with international partners, such as COVID-19 Vaccines Global Access (COVAX), a WHO- backed effort initiated in April 2020 to rapidly develop and provide equitable access to vaccines.7 In October 2021, COVAX partners anticipated that once vaccine supply constraints were alleviated, other factors, such as countries’ abilities to absorb and administer vaccines, as well as waning vaccination demand and vaccine hesitancy, could significantly affect vaccination efforts. In May 2023, WHO declared an end to the public health emergency phase of the COVID-19 pandemic but also stated the disease remains an ongoing global health issue. As the COVID-19 pandemic enters a new phase, ensuring equitable access to and administration of COVID-19 vaccines continues to be essential to protect vulnerable populations and to prevent surges of new variants. Since the early stages of the pandemic response, the U.S. government, through USAID, State, CDC, and others, has supported global COVID-19 vaccination efforts. These efforts first helped to improve the equitable allocation, access, and distribution of COVID-19 vaccines across the globe and subsequently provided technical assistance in priority areas to support CRD. In March 2021, USAID established a COVID-19 Program and Operations Strategy Task Force to advance and to coordinate the administration’s COVID-19 response and recovery efforts. The objectives 7In addition to WHO, other COVAX partners included the Coalition for Epidemic Preparedness Innovations; GAVI, the Vaccine Alliance; and UNICEF. Background The COVID-19 Pandemic and Global Vaccination Efforts U.S. Efforts to Support COVID-19 Vaccinations Abroad Page 5 GAO-23-105579 COVID-19 Vaccine Delivery Abroad were to coordinate USAID’s development and humanitarian assistance response to COVID-19 as well as existing efforts to support global workforce well-being, safety, security, and continuity of operations amid the pandemic. The Task Force’s Vaccine Access and Delivery Initiative was established to advance equitable access to and delivery of COVID- 19 vaccinations globally. Following the establishment of the task force, the White House published the U.S. government’s COVID-19 Framework in July 2021. USAID, CDC, and State led the interagency development of the Framework, which provides objectives and lines of effort to guide the United States in a coordinated, strategic response to the global COVID-19 pandemic. The first objective was to accelerate widespread and equitable access to and delivery of safe and effective COVID-19 vaccinations. It had a target of substantially contributing to help achieve the global goal of vaccinating 70 percent of the population of each country, initially by the end of 2022.8 Updated in September 2022, the Framework now places greater emphasis on vaccinating and boosting high-risk and hard-to-reach populations and integrating COVID-19 vaccines into routine primary healthcare. USAID’s November 2022 Technical Priorities Update for USAID’s COVID-19 Response reinforced the 70 percent global vaccination goal but did not specify a timeframe. This update also focused on fully vaccinating priority populations, including healthcare workers and older adults, and recognizing vaccination targets set by countries. Following the establishment of the Framework, USAID and CDC began to jointly plan COVID-19 vaccine CRD efforts once it became clear that vaccines would become available and significant resources would be needed to distribute them at scale. With USAID’s announcement of the Global VAX initiative in December 2021, the U.S. government sought to boost international coordination for vaccination assistance, such as identifying and rapidly overcoming barriers to vaccine access and demand. Global VAX encompassed efforts to increase uptake of COVID- 19 vaccines in 125 countries. These efforts complemented the expansion of the global vaccine supply, but focused on ensuring that partner countries were ready to deliver and administer the donated vaccines. 8This report focuses on activities and results associated with the Framework’s first line of effort—specifically, USAID’s efforts to support COVID-19 vaccine CRD. Other Framework objectives included reducing disease and death from COVID-19; addressing acute needs driven by COVID-19 to build resilience; bolstering economies and other critical systems affected by COVID-19; and strengthening the international health security architecture to prevent, detect, and respond to pandemic threats. Page 6 GAO-23-105579 COVID-19 Vaccine Delivery Abroad CDC worked in close coordination with USAID on CRD efforts. CDC also provided technical support and assistance to national governments to support implementation of their vaccination plans.9 State supported CRD efforts through interagency coordination of dose deliveries, engaging with host governments, and promoting messaging in support of vaccination.10 Other interagency partners involved in CRD assistance included the Department of Defense, the Department of the Treasury, the Peace Corps, and the White House, among others. In addition, U.S. government agencies worked with implementing partners, including non-governmental organizations, local civil society organizations, and public international organizations, such as WHO and UNICEF. As of March 2023, USAID had obligated an estimated $904 million in awards to support CRD efforts in 125 countries.11 USAID allocated a total of $13.6 billion for COVID-19 mitigation efforts, of which it obligated $8.7 billion in awards and $4 billion for a contribution to Gavi, the Vaccine 9CDC allocated an estimated $296 million for CRD assistance from fiscal year 2020 to January 2023, according to CDC officials. Of this amount, CDC allocated about $118 million to specific countries and $178 million for cross-cutting mechanisms that supported multiple countries, according to CDC officials. 10State also allocated $850 million for the Bureau of Population, Refugees, and Migration, the agency office focused on humanitarian efforts, to respond to COVID-19, but could not specify how much supported CRD efforts. State also noted that it provided $280 million in funds appropriated by the American Rescue Plan Act of 2021 to WHO, a portion of which supported vaccine-related pharmacovigilance and demand generation; $170 million to UNICEF, of which $125 million was intended to support operational costs of vaccine delivery; and $75 million to the Pan-American Health Organization to help implement and monitor COVID-19 vaccinations. Additionally, State transferred about $14 million for CRD assistance to USAID, CDC, and other agencies involved in the global COVID-19 response as of February 2023, according to State officials. 11USAID officials said they were unable to isolate a specific subset of obligations for CRD activities from funding for broader COVID-19 efforts because its financial management system is not designed to track spending at this level of detail and many activities involving CRD also included non-CRD assistance. Instead, officials provided estimates of the agency’s CRD obligations by analyzing regional bureaus’ program records and country missions’ implementation plans. USAID Provided More Than $900 Million for CRD Efforts in 125 Countries USAID Obligated about $904 Million in CRD Awards to 125 Countries Page 7 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Alliance, for vaccine procurement and delivery.12 The $904 million in estimated CRD obligations represents about 10 percent of funds USAID obligated for COVID-19 efforts. Figure 1 shows USAID allocations to address COVID-19, its total COVID-19 obligations, and estimated obligations for CRD efforts. Figure 1: U.S. Agency for International Development (USAID) Total COVID-19 Allocations and Obligations and Estimated Obligations for Global COVID-19 Vaccine Country Readiness and Delivery (CRD) Efforts, as of March 2023 Note: The circles in the figure are not proportional. The $13.6 billion includes $4 billion in appropriations for vaccine procurement that, pursuant to direction contained in the Consolidated Appropriations Act, 2021, USAID contributed to Gavi, the Vaccine Alliance, a multilateral body that increases equitable and sustainable use of vaccines. Amounts that USAID did not obligate for awards to address COVID-19 or for a contribution to Gavi went to operating expenses, international disaster assistance, and other efforts. USAID funded CRD activities in 125 countries around the world. The amount of estimated CRD obligations varied by country, from a high of about $75 million to a low of $100,000. Geographically, the vast majority of USAID’s CRD funding supported countries in Africa (see fig. 2). 12Gavi, the Vaccine Alliance, is a multilateral body that increases equitable and sustainable use of vaccines. USAID made the $4 billion contribution to Gavi pursuant to direction contained in the Consolidated Appropriations Act, 2021. Pub. L. No. 116-260, 134 Stat. 1182, 1821 (2020). Amounts that USAID did not obligate for awards to address COVID-19 directly or for a contribution to Gavi went to operating expenses in support of COVID-19 response efforts, international disaster assistance programs to mitigate the impact of the pandemic on ongoing humanitarian crises, and other efforts to prevent development backsliding due to the pandemic. Page 8 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Figure 2: U.S. Agency for International Development (USAID) Estimated Obligations for COVID-19 Vaccine Country Readiness and Delivery by Region, as of March 2023 Note: Dollars do not sum to $904 million and percentages do not sum to 100 due to rounding. To optimize CRD assistance, the Global VAX initiative, led by USAID in close partnership with CDC, invested more of its COVID-19 vaccination financial, technical, and diplomatic efforts in a subset of 11 countries with significant need and the potential for rapid vaccination progress.13 An estimated $379 million, or 42 percent, of USAID’s CRD obligations supported these 11 Global VAX “surge” countries. All 11 countries are located in sub-Saharan Africa. Ten of them are classified as either low or lower-middle income by the World Bank, while one, South Africa, is classified as upper-middle income. USAID has provided CRD assistance for eight identified areas of technical assistance to facilitate the delivery of COVID-19 vaccines.14 The 13USAID, COVID-19 Fact Sheet, Global VAX: An ‘Initiative for Global Vaccine Access’ To Turn Vaccines In Vials Into Vaccinations In Arms Around the World, May 12, 2022. USAID previously referred to Global VAX surge countries as Tier One countries, and had identified six other countries—which the agency had designated Global VAX Tier Two countries—for intensified focus. According to USAID’s COVID-19 Global VAX Field Guide, these six countries demonstrated high needs, regional or strategic importance to overall vaccine progress, and political or security complications that would first require diplomatic engagement followed by intensified investments. 14USAID officials said they were unable to break out the amount of funds obligated to each of these areas of technical assistance because its financial management system is not designed to track spending at this level of detail. USAID Supported Various Forms of CRD Assistance Page 9 GAO-23-105579 COVID-19 Vaccine Delivery Abroad agency grouped these technical assistance areas into three categories: planning, implementing, and monitoring (see fig. 3). Figure 3: U.S. Agency for International Development (USAID) Areas for COVID-19 Vaccine Country Readiness and Delivery Technical Assistance Page 10 GAO-23-105579 COVID-19 Vaccine Delivery Abroad To conduct CRD assistance, USAID awarded funding to implementing partners and has coordinated closely with CDC and other U.S. government agencies to support these efforts.15 USAID and these partners align technical assistance with the countries’ National Deployment and Vaccination Plans, a framework established by WHO and UNICEF to help countries plan their vaccination strategies.16 USAID mission staff, implementing partners, host government health ministry officials, and other stakeholders we interviewed in three countries identified various examples of USAID-supported CRD assistance at the country level. Some of those examples are listed below. • Demand and community engagement: In Guatemala, the USAID- supported Pan-American Social Marketing Organization encouraged demand and community engagement by using “micro-influencers” (such as well-known athletes and musicians in particular regions) to generate demand over social media for the COVID-19 vaccine among vaccination-hesitant youth. 15USAID provided assistance primarily through agreements with awardees—including nongovernmental organizations and universities—that it refers to as implementing partners. International organizations such as UNICEF may also act as implementing partners for USAID. 16A National Deployment and Vaccination Plan constitutes a country’s overall plan to deploy vaccines and deliver vaccination to identified target populations. A country can use the plan with the World Bank and other donors. Completion of a National Deployment and Vaccination Plan is a requirement to receive vaccine donations from COVAX. Encouraging Demand and Community Engagement in Malawi by Vaccinating a Community Leader Against COVID-19 U.S. Agency for International Development (USAID) implementing partners promoted demand for vaccinations by meeting with traditional leaders and by vaccinating them and other influential community members. Source: USAID implementing partner Right to Care. | GAO- 23-105579 Page 11 GAO-23-105579 COVID-19 Vaccine Delivery Abroad • Service delivery: In Malawi, UNICEF, acting as a USAID implementing partner, supported service delivery through Vaccinate My Village, a project that trained healthcare workers to report vaccination data by text message and provided mobile vaccination units to reach isolated communities. • Evaluation and health information systems: In South Africa, USAID implementing partner Right to Care supported health information systems by developing a data registry for the National Department of Health to track vaccination progress by geography and demographics. Right to Care also created “Find My Jab,” an app which shows users the closest vaccination centers and what brands of vaccines they offer. As of July 5, 2023, USAID, together with host governments, multilateral organizations, and other donors, had contributed to fully vaccinating an average of about 45 percent of the population across 123 assisted Supporting Service Delivery in Guatemala by Vaccinating Indigenous Communities Against COVID-19 Guatemalan COVID-19 vaccination brigades supported by the U.S. Agency for International Development (USAID) visited indigenous communities in rural areas to vaccinate the population. Source: USAID implementing partner Breakthrough Action. | GAO-23-105579 USAID Contributed to Vaccination Assistance That Fell Short of the Global Goal, and the Agency Faced Difficulties Measuring Its Progress USAID Contributed to Vaccinating 45 Percent of the Population in Assisted Countries, Short of the 70 Percent Goal Page 12 GAO-23-105579 COVID-19 Vaccine Delivery Abroad countries,17 falling short of the global 70 percent goal.18 Seventy-six (close to two-thirds) of these countries had vaccination rates below 50 percent (see fig. 4). Figure 4: Percentage of Population Fully Vaccinated in Countries Assisted by the U.S. Agency for International Development (USAID) as of July 5, 2023 Note: These vaccination rates reflect the efforts of USAID, host governments, and other entities in assisted countries. USAID officials, citing World Health Organization (WHO) guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. While WHO updated its guidance in July 2022 to recommend booster doses in addition 17No vaccination data exist for two USAID-assisted countries: the Marshall Islands and Micronesia. USAID officials noted that one implementing partner may have multiple CRD activities in one country or similar activities implemented across multiple countries, and that implementing partners may not be currently assisting all 125 countries. For example, partners in some countries may have already completed activities. According to Our World in Data, just under 65 percent of the world’s total population was fully vaccinated as of July 11, 2023. 18USAID officials, citing WHO guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. While WHO updated its guidance in July 2022 to recommend booster doses in addition to the primary vaccine series, we are using the term “fully vaccinated” to mean the primary series only, in part because the protocol for booster doses continues to evolve. USAID issued updated guidance in November 2022 (Technical Priorities Update for USAID’s COVID-19 Response, last updated November 30, 2022) that was grounded in WHO’s Global COVID-19 Vaccination Strategy in a Changing World: July 2022 Update. The updated WHO strategy reinforced the goal of fully vaccinating 70 percent of the total population of each country, with a focus on fully vaccinating 100 percent of priority populations, including healthcare workers and older adults, and increasingly recognized vaccination targets set by countries. Page 13 GAO-23-105579 COVID-19 Vaccine Delivery Abroad to the primary vaccine series, we are using the term “fully vaccinated” to mean the primary series only, in part because the protocol for booster doses continues to evolve. USAID assisted 125 countries, but Our World in Data lacked vaccination data for two USAID-assisted countries: the Marshall Islands and Micronesia. The most recent vaccination rate data for most countries are prior to July 2023. Vaccination rates varied by region. Figure 5 shows average fully vaccinated rates across all USAID-assisted countries in each of five regions as of July 5, 2023. Asia had the highest average rate (63 percent), while the Middle East and North Africa had the lowest (28 percent). Figure 5: Average Fully Vaccinated Rate by Region for Countries Assisted by the U.S. Agency for International Development (USAID) as of July 5, 2023 Note: These vaccination rates reflect the efforts of USAID, host governments, and other entities in assisted countries. USAID officials, citing World Health Organization (WHO) guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. While WHO updated its guidance in July 2022 to recommend booster doses in addition to the primary vaccine series, we are using the term “fully vaccinated” to mean the primary series only, in part because the protocol for booster doses continues to evolve. USAID assisted 125 countries, but Our World in Data lacked vaccination data for two USAID-assisted countries in Asia: the Marshall Islands and Micronesia. The most recent vaccination rate data for most countries are prior to July 2023. As of July 5, 2023, the fully vaccinated rates for the 11 Global VAX surge countries averaged 34 percent—well below the 70 percent goal—and progress had slowed in most countries. None of these countries had a vaccination rate above 50 percent as of July 5, 2023, despite the countries being the focus of roughly half (42 percent) of USAID’s CRD assistance. The rates for most of the surge countries began to plateau in 2022 or early 2023. Some showed a sharp increase in their respective rates between May 2021 and December 2022, and one remained relatively flat, with a rate of less than 10 percent (see fig. 6). Page 14 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Figure 6: Percentage of Population Fully Vaccinated in Global VAX Surge Countries Assisted by the U.S. Agency for International Development (USAID), May 2021–June 2023 Note: Global VAX surge countries are 11 African countries USAID identified as having significant need and the potential for rapid acceleration of vaccine uptake. These vaccination rates reflect the efforts of USAID, host governments, and other entities in assisted countries. USAID officials, citing World Health Organization (WHO) guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. While WHO updated its guidance in July 2022 to recommend booster doses in addition to the primary vaccine series, we are using the term “fully vaccinated” to mean the primary series only, in part because the protocol for booster doses continues to evolve. The most recent vaccination rate data for most countries are prior to July 2023. Page 15 GAO-23-105579 COVID-19 Vaccine Delivery Abroad According to USAID officials, various factors contributed to the vaccination rate trends in these countries. For example: • Tanzania: USAID officials stated that vaccination efforts in Tanzania had a slow start because at the time vaccines became available, political leadership had cast doubt on the safety of vaccines and prohibited them from entering the country. This trend changed when a new president was sworn into office in March 2021 and the country received its first tranche of over one million U.S. government-donated vaccine doses.19 The officials said a series of USAID-supported music events in five regions from late July through August 2022 drove demand for more than 40,000 vaccinations in 5 weeks. According to an article in The Lancet, the Tanzanian government began an intensive campaign to vaccinate all eligible adults older than 18 years of age in September 2021.20 • Lesotho: USAID officials said that anticipated regional travel regulations in Lesotho restricting border crossings for the unvaccinated may have contributed to an increase in the country’s vaccination rate in late 2021. The officials said vaccination coverage leveled off in mid-2022, due in large part to the government’s lifting of all COVID-19 restrictions, including masking and proof of vaccination for traveling, prior to the fall elections. As a result of these changes, officials said that people no longer perceived COVID-19 as a threat. According to the officials, the country’s national COVID-19 coordinating body also disbanded in mid-2022, leaving its work to the health ministry, which has many other responsibilities. • Senegal: USAID officials attributed the relatively low, flat vaccination rate in Senegal to a change in the way the government managed COVID-19 vaccination efforts. The officials said resources committed to these efforts declined when those resources were moved from an emergency operations center—which coordinated activities across all relevant ministries and with local leaders—to the country’s national vaccination program, which lacked this level of coordination. Low demand and data backlogs also contributed to the country’s stagnant 19Tanzania has a population of 65 million people, according to Our World in Data, which sources its population data from United Nations World Population Prospects. 20The Tanzanian government’s campaign to vaccinate all eligible adults focused on combatting vaccine hesitancy, especially among healthcare workers, and included one- on-one engagements with stakeholders to address concerns, surge staffing to maximize the effect of vaccination drives, and U.S. government agencies’ leveraging of existing HIV, tuberculosis, and other service delivery infrastructure to provide vaccinations nationwide. See Tanzania’s COVID-19 vaccination strategy: lessons, learning, and execution, The Lancet, Vol 401, May 20, 2023, p.1649. Page 16 GAO-23-105579 COVID-19 Vaccine Delivery Abroad vaccination rate, according to USAID officials. For example, they said perceptions among people that COVID-19 posed minimal risk, due in part to low case rates, depressed demand. They also said strikes among healthcare workers reduced the reporting of COVID-19 vaccination data, and thus the reported vaccination rate. USAID officials also provided detailed information on factors affecting vaccination progress in two non-Global VAX surge countries. For example: • Malawi: USAID officials in Malawi credited policy changes and vaccine campaigns for the country’s improved vaccination rate, which rose from 6.4 percent of the targeted population in March 2022 to almost 20 percent in the fall of that year.21 The USAID officials noted that policy changes allowed individuals who received a first dose from one vaccine manufacturer to receive a second dose from another manufacturer and lowered eligibility for the Pfizer vaccine from 18 to 12 years of age. The vaccine campaigns included a shift from administering vaccines at fixed vaccination sites to door-to-door campaigns and mobile clinics that brought the vaccine to individuals where they live. • Haiti: Persistent political instability, high levels of gang violence, and fuel shortages contributed to Haiti’s lack of vaccination progress by creating a difficult operating environment for providers, according to USAID officials. The officials said the August 2021 earthquake and tropical storm, followed by a late 2022 cholera outbreak, posed additional challenges and redirected scarce resources away from COVID-19 vaccination. They noted that low demand due to widespread misinformation and disinformation also slowed Haiti’s vaccination rate, which remained below 4 percent as of July 5, 2023. More broadly, USAID officials attributed variation in vaccination rate trends across countries to a variety of factors, including the strength of their underlying healthcare systems; physical environment, such as transportation infrastructure, electricity grid, geography, and natural disasters; and demographic characteristics, such as population mobility, 21Malawi’s national vaccine task force, on which USAID, its implementing partners, and other donors serve, facilitated these policy changes. The targeted population consisted of groups at high risk of contracting COVID-19 and experiencing hospitalization and death from the disease, such as healthcare workers, social workers, and individuals with underlying medical conditions that put them at increased risk of severe disease from COVID-19, and those 60 years of age and older. According to Our World in Data, Malawi’s fully vaccinated rate as a percentage of the country’s total population rose from just under 5 percent in March 2022 to about 15 percent in the fall of that year and to just over 20 percent in July 2023. Page 17 GAO-23-105579 COVID-19 Vaccine Delivery Abroad median age, density, and displacement. Officials added that conflict and instability can depress vaccinations and outbreaks of other diseases can shift priorities and redirect resources. They also noted that political leadership is an important factor, as it can lend credibility to vaccination drives by marshaling resources to support them, or undermine them by helping to spread misinformation. USAID faced difficulties measuring its direct contribution to vaccination progress. According to USAID, as of September 30, 2021, at least 7.7 million people had received a first recommended dose of an approved COVID-19 vaccine and at least 2.9 million had received a last recommended dose22 with USAID direct support (those injections that would not have occurred without USAID).23 By December 31, 2022, the number of people receiving these two types of doses with the agency’s direct support rose to at least 158 million and 167 million respectively.24 USAID faced several difficulties measuring its contribution, some of which it had anticipated before it began providing support. The anticipated issues included: 22The initial COVID-19 vaccine protocol requires two doses for most vaccines and does not include booster doses. USAID implementing partners report to USAID on the number of people who received a first recommended dose and the number of people who received a last recommended dose with USAID direct support. According to USAID, its implementing partners use a variety of systems to record vaccinations at different sites, and many countries have deployed vaccination cards similar to those used in the United States. USAID officials noted, however, that these cards may not be consistently used, retained, or tracked. 23USAID’s COVID-19 Saving Lives Now & Global Vaccine Access Initiative Indicators: a Compendium of Indicator Reference Sheets for COVID-19 Reporting by USG Projects, updated in February 2023, defines “USAID direct support” as operational support to vaccine delivery sites, provided in part or in full by a U.S. government-funded implementing partner, to strengthen service delivery approaches required to reach target populations equitably and rapidly. The Compendium states that without U.S. government support, the site would not be able to operate. It further states that this support may include but is not limited to the establishment and operation of alternative vaccination sites; provision of items such as syringes, personal protective equipment, and masks; rental costs; and monetary or non-monetary support for personnel. It does not include indirect support for vaccine service delivery, such as guidance and technical assistance, planning, training, and supervision. 24According to USAID, the number of last doses reported exceeded the number of first doses reported because individuals may have received their last dose at a USAID- supported site, where doses administered were captured in USAID implementing partner reporting. However, these individuals may have received their first dose in a government- run or other setting not directly supported by USAID, where doses administered were not included in implementing partner reporting. In addition, a number of implementing partners reported the single-dose Johnson & Johnson vaccine as a last dose only, contributing to the higher number of recorded last doses. USAID Faced Difficulties Measuring Its Contribution to Vaccination Progress Page 18 GAO-23-105579 COVID-19 Vaccine Delivery Abroad • The unprecedented nature of COVID-19. USAID had to establish a new set of indicators for its COVID-19 support that could provide detail but also evolve over time, according to USAID officials. • Attribution. According to USAID’s Annual Evaluation Plan for Fiscal Year 2022, it would be difficult for USAID to precisely quantify or attribute the impact of its support because of the complexity of the pandemic and the international response, as well as challenges to establishing valid baseline information. For example, USAID officials in Malawi noted that the pandemic created an emergency situation in which it was difficult for donors and others engaged in CRD activities to measure the progress of vaccination campaigns because they were focused on vaccinating people as quickly as possible, rather than distinguishing implementer efforts, ascertaining baselines, and setting targets. According to USAID, the agency also faced other difficulties measuring vaccination progress once it began providing CRD support. These issues included: • Incomplete vaccination information. Implementing partners were unable to determine, with full accuracy, the number of individuals who received all recommended doses of an approved COVID-19 vaccine with USAID direct support, according to USAID officials. The officials said that with few exceptions, USAID implementing partners did not have the information needed to determine if the people they supported in receiving a last dose also received a first dose with USAID direct support. For example, implementing partners generally do not collect the personally identifiable information used to track the people that they helped the country’s government vaccinate because doing so is expensive and therefore not sustainable. • Voluntary reporting. One of the reasons USAID was unable to determine how many people received vaccine doses with its direct support was because it made COVID-19 vaccination reporting by implementing partners voluntary. This approach meant that reporting was therefore limited.25 USAID opted to keep reporting voluntary because of the high estimated cost and technical difficulties of producing mandatory, high-frequency reporting and a determination 25According to USAID, the agency’s vaccination progress data “significantly undercount” the number of people who received first or last doses with USAID direct support because reporting by implementing partners is voluntary. In addition, doses administered by public international organizations, such as UNICEF, are not generally included in the totals— even when they are acting as a USAID implementing partner—because public international organizations are not required to report this information, according to agency officials. Page 19 GAO-23-105579 COVID-19 Vaccine Delivery Abroad that doing so would have yielded marginal results.26 However, according to USAID, reporting rates were low. To address the gap in data, USAID transitioned to mandatory reporting in April 2023 for a subset of large awards in Global VAX surge countries and seven additional countries. The seven countries—Ethiopia, Haiti, Liberia, Madagascar, Malawi, Mozambique, and the Philippines—received the highest estimated CRD obligations of non-Global VAX surge countries in fiscal year 2022. • Multiple entities supporting CRD efforts. USAID was unable to isolate its contribution to a country’s vaccination rate and to measure its progress independent of other actors because it is one of many entities involved in CRD activities. These entities included the host government, other bilateral donors, and multilateral, private-sector, and nongovernmental organizations. • Difficulties determining vaccination results from indirect support. According to USAID, the agency cannot link certain CRD activities to specific vaccination results. For example, USAID reported progress for CRD activities that might indirectly contribute to people getting vaccinated, such as those designed to generate demand for vaccination or to provide training in COVID-19 vaccine-related topics.27 However, agency officials said they were unable to measure how many people actually received vaccinations as a result of these activities. For instance, it was not possible for USAID to determine how many people were motivated to get vaccinated by USAID- supported radio messages. The officials also said USAID faced difficulties quantifying how its technical assistance for policy and training contributed to an increase in vaccination. 26USAID’s Automated Directives System 201.3.5.1 allows for exceptions to otherwise applicable monitoring requirements. USAID documented the voluntary reporting decision in an October 25, 2021, Action Memo approved by the Executive Director of the agency’s COVID Task Force. USAID officials said that, according to an agency assessment, the largest implementing partners with the greatest volume of programming typically submit progress reports on CRD indicators. 27According to USAID, the number of people reached through USAID-supported mass media and social media with COVID-19 vaccine-related messaging increased from 37 million in September 2021 to almost 178 million in November 2021. Similarly, the number of people trained in COVID-19 vaccine-related topics with USAID support increased from about 33,000 healthcare workers and other staff in October 2021 to more than 127,000 in November 2021. Page 20 GAO-23-105579 COVID-19 Vaccine Delivery Abroad According to multiple stakeholders,28 USAID, together with other U.S. government partners, host governments, multilateral organizations, and other donors, faced a variety of challenges in providing COVID-19 vaccine CRD assistance. These challenges varied by country and evolved over time. For example, initially, supply issues were the largest challenge. However, by mid-2022, U.S. agency officials in assisted countries reported that demand issues had overtaken supply issues as the greatest challenge to CRD efforts. A July 2022 survey of U.S. overseas staff found that the most frequently cited challenge was a decrease in vaccine demand caused by vaccine hesitancy and a perceived low risk of COVID-19 transmission. An earlier survey in January 2022 had found that supply chain logistics such as cold chain storage were the most frequently cited challenges, which hindered delivery to vaccination sites. Ultra-cold chain storage (for the Pfizer vaccine, which must be kept at a very low temperature) in some countries was limited at the national level and in others at the local level. Even when such storage was available, challenges existed with staff expertise and reliable electricity or backup power. The various types of challenges USAID and other entities faced included the following: • Demand challenges hampered the demand and community engagement area of CRD technical assistance. These challenges included: • misinformation and disinformation • mistrust of government efforts 28These included USAID, CDC, and State officials; USAID implementing partners; host government officials; and other bilateral donors in the three countries we selected, as well as headquarters-based USAID, CDC, WHO, and UNICEF officials. USAID Shifted Its Priorities in Response to CRD Challenges, and Plans to Disseminate Its Lessons Learned USAID Faced CRD Challenges Related to Countries’ Vaccine Demand, Supply, and Other Issues Page 21 GAO-23-105579 COVID-19 Vaccine Delivery Abroad • “COVID fatigue” (vaccine hesitancy and apathy because of a perceived low risk of infection or severe disease and the lifting of COVID-19 prevention policies by some governments) • refusal of some healthcare workers to be vaccinated • initial exclusion from vaccination planning of trusted local, religious, and traditional leaders in certain communities • confusion over evolving vaccine protocols and changing COVID- 19 messages • dissemination of outdated information • lack of information in local languages • travel costs and lost income associated with getting to vaccination sites • Supply challenges constrained the human resources for health, service delivery, and cold chain and supply chain logistics areas of CRD technical assistance. These challenges included shortages of trained healthcare workers, expiration of vaccine doses, difficulties storing vaccines at required temperatures because of unreliable power grids, and limited tracking of vaccine doses as they moved through the supply chain, according to stakeholders we interviewed in the three selected countries and documents we reviewed. In addition, we found that in Malawi healthcare workers were stretched thin due to competing outbreaks of cholera and polio. • Other challenges affected the policy planning and coordination and the evaluation and health information systems areas of CRD technical assistance. These challenges included host country laws and regulations, data backlogs, and weak information management systems, according to multiple stakeholders. In Guatemala, for example, USAID and implementing partner officials said laws and regulations made it difficult for the government to obtain WHO- approved vaccines in a timely manner, lowering trust in the government’s provision of vaccine doses that were not approved by WHO. By the time some vaccines were received, they were near expiration, which further lowered public trust and demand. In addition, multiple stakeholders in Guatemala stated that, in some cases, laws holding vaccine suppliers—from national procurement officials to local healthcare workers—liable for expired doses reduced the willingness of these suppliers to obtain new doses, thereby decreasing the supply of doses at both the national and local levels. Meeting Supply Challenges in Malawi by Storing COVID-19 Vaccines at Required Temperatures The National Vaccine Storage Facility in Malawi contains ultra-cold chain equipment needed to store COVID-19 vaccines at required temperatures. Such equipment was provided with assistance from the U.S. Agency for International Development (USAID). Source: USAID. | GAO-23-105579 Page 22 GAO-23-105579 COVID-19 Vaccine Delivery Abroad In late 2022, as vaccine demand diminished and worldwide vaccination rates began to plateau, USAID shifted its global COVID-19 CRD priorities in line with WHO guidelines.29 These priorities included vaccinating vulnerable populations and incorporating COVID-19 vaccination activities into countries’ primary healthcare systems, on the way to reaching the global 70 percent vaccination goal. To support this shift in priorities, USAID adjusted its approach to its areas of CRD technical assistance and modified indicators for some of them. Consistent with WHO guidelines, USAID is working with assisted countries to incorporate the new COVID-19 priorities of vaccinating vulnerable populations and integrating CRD activities into countries’ healthcare systems.30 USAID is prioritizing vaccination of healthcare workers, older adults, and other groups most at risk for severe disease from COVID-19, in part to mitigate demand challenges related to low perceived risk of infection or severe disease among the general population. It has also begun incorporating COVID-19 vaccinations into routine immunization and primary healthcare systems to mitigate service delivery challenges, such as healthcare worker shortages. As the pandemic has drawn personnel and other resources away from countries’ immunization and healthcare systems, USAID is seeking to make those systems more efficient and sustainable over the long term, as discussed below. Officials have stated that these efforts will benefit both the current COVID-19 response and future pandemic responses.31 USAID adjusted its approach to CRD assistance as a result. In November 2022, to reflect updates to the Framework in response to the pandemic’s changing nature and evolving global needs, USAID identified four technical approaches that focus on increasing vaccination coverage among vulnerable populations and integrating vaccination activities into countries’ primary healthcare systems.32 According to USAID, these 29WHO, Global COVID-19 Vaccination Strategy in a Changing World: July 2022 Update. 30See WHO, Global COVID-19 Vaccination Strategy in a Changing World: July 2022 Update, and USAID, Technical Priorities Update for USAID’s COVID-19 Response, Last Updated November 30, 2022. 31UNICEF officials stated that a significant number of countries are now redirecting efforts away from the pandemic response toward addressing systemic issues, such as reversing the rollback of routine immunization coverage, which was significantly affected by the impact of the pandemic on healthcare systems. 32USAID, Technical Priorities Update for USAID’s COVID-19 Response, Last Updated November 30, 2022. USAID Shifted Its Priorities and Adjusted Its Approaches in Response to CRD Challenges Vaccinating Vulnerable Populations by Administering COVID-19 Vaccine to an Elderly Man in Malawi The U.S Agency for International Development (USAID) supported vaccination of elderly and other vulnerable populations. Source: USAID implementing partner Right to Care. | GAO- 23-105579 Page 23 GAO-23-105579 COVID-19 Vaccine Delivery Abroad approaches are meant to prioritize remaining resources to help countries achieve their vaccination goals and do not eliminate or replace any of the eight priority areas of technical assistance. The four approaches are as follows: • Advocacy to counter low risk perception from COVID-19 among host government officials, encourage sustained support for COVID-19 vaccination, support updating national vaccine policies to include all vulnerable groups, and prioritize the vaccination of these groups. • Demand generation, risk communication, and community engagement to address challenges like disinformation and perceived low risk of infection or of severe disease. For example, generating demand is critical to reaching vulnerable elderly and other populations now being prioritized for vaccination, according to USAID officials. USAID documented that it can be more difficult to reach these groups, who may require more tailored messaging because they might live in isolated rural areas and be less able to access fixed vaccination sites, and less able or inclined to use social media. • Ensuring the integration of gender equity into COVID-19 vaccination activities to address challenges like gender-specific misinformation campaigns and difficulties accessing vaccination sites. For example, USAID reported that targeted misinformation campaigns, such as false claims about COVID-19 causing infertility or sterility, have contributed to vaccine hesitancy, and gender-specific issues have added to difficulties for both men and women using fixed vaccination sites.33 33Specifically, USAID reported that women often work in the informal market, or are the primary caretakers of their families, which makes it hard for them to take time off for travel to fixed sites. Similarly, USAID reported that in some countries men work extended or odd hours, which makes it difficult for them to get to fixed sites during the hours of operation. Generating Demand for COVID-19 Vaccination in Johannesburg, South Africa The U.S. Agency for International Development (USAID) supported events in urban and rural communities to promote demand for COVID-19 vaccination. Source: USAID. | GAO-23-105579 Addressing Difficulties with Fixed Vaccination Sites Faced by Both Men and Women by Using a Mobile Clinic in Malawi The U.S. Agency for International Development (USAID) supported mobile clinics that use vans to bring vaccines to isolated communities. Source: USAID implementing partner Right to Care. | GAO- 23-105579 Page 24 GAO-23-105579 COVID-19 Vaccine Delivery Abroad • Strengthening data access, management, and utilization to address challenges like identifying and reaching priority populations, integrating COVID-19 vaccination data into countries’ existing health information systems, and eliminating data backlogs.34 In addition, USAID modified indicators for some CRD areas of technical assistance and did not create indicators for others. USAID officials said the agency did not create indicators to collect information for three areas of technical assistance: policy, planning and coordination; communications and advocacy; and evaluation and health information systems. The officials said USAID made this decision because indicators for these areas would provide no useful data and increase the reporting burden on implementing partners. Officials stated that they have modified indicators since their introduction in fiscal year 2021 to align with changes in the pandemic and the COVID-19 response, such as the introduction of booster doses, or simply to improve indicator quality. These changes have included, among others, adding an indicator to capture the number of people who have received a booster dose with USAID direct support, and revising an indicator that tracked the number of vaccine sites established with USAID support to one that tracked sites operating with ongoing USAID support. USAID has developed plans to learn from its CRD challenges, including plans to document and disseminate some lessons learned. USAID guidance states that lessons learned should be incorporated at several stages of agency project activities, including strategy development, implementation, and close-out.35 The guidance also requires these lessons and related information be posted to the Development Experience Clearinghouse (DEC), an agency repository of development assistance information.36 USAID maintains this clearinghouse as its primary institutional resource to provide staff and development partners 34According to UNICEF, there is limited population and coverage data for priority groups, which makes it difficult to locate and track vaccination progress for elderly and other vulnerable individuals. UNICEF also flagged countries’ weak health information systems and their struggle to manage large data backlogs that accumulated during the pandemic. 35See USAID Automated Directives System 201.3.2.9; 201.3.2.18.B; and 201.3.4.12. 36USAID Automated Directives System 540.3.2.3.b. This information includes, for example, reports that describe progress and accomplishments or document significant evaluation findings, lessons learned, development results, performance measures, or evaluative information and observations. See https://dec.usaid.gov/dec/home/Default.aspx. USAID Has Taken Some Actions to Identify Lessons Learned and Plans to Disseminate Them Page 25 GAO-23-105579 COVID-19 Vaccine Delivery Abroad with accurate, comprehensive, and timely information to support strategic planning. Given this agency guidance, we asked USAID for information about lessons learned. In response, USAID officials outlined several underway or completed efforts to learn from its provision of CRD assistance and to answer the following questions: • What factors have affected widespread access to safe and effective COVID-19 vaccinations? • How has USAID contributed to equitable vaccine distribution and delivery? • What approaches have been successful in combating disinformation and misinformation and in promoting vaccine uptake within and across diverse population segments? USAID officials said in May 2023 that they plan to deliver the results of these efforts in reports, slide decks, data sets, a blog post, and a draft paper for submission to a peer-reviewed publication, among others. USAID officials also stated that the agency plans to make the results of these efforts available on the DEC once they are completed.37 Given the challenges U.S. agencies and others have identified in implementing CRD assistance, USAID’s plans to use the DEC to disseminate lessons learned are an important step in making this information readily available in a centralized, designated place where agency staff and other stakeholders know how to access it. For example, UNICEF officials said they would welcome the opportunity to review key lessons learned with USAID to identify recommendations that can help improve routine immunization, primary healthcare measurement indicators, and public health emergency preparedness and response. Using the DEC as planned to disseminate lessons learned will help USAID’s headquarters staff, mission management, and global partners ensure they are better able to apply these lessons when responding to a future global health emergency. We provided a draft of this product to USAID, CDC, and State for review and comment. We received written comments from USAID (reproduced in 37USAID has posted one completed, publicly available study to the DEC—a report that assessed the efficacy of different interventions used to encourage vaccinations in South Africa. We verified that this report is on the DEC. We found the report by typing into the DEC’s search bar the exact title that USAID provided. Since stakeholders may be aware of the report but may not recall the exact title, we also used keywords like “South Africa” and “COVID-19” to try to locate it but were unable to do so. Agency Comments Page 26 GAO-23-105579 COVID-19 Vaccine Delivery Abroad appendix III) in which the agency highlighted its efforts to help countries vaccinate vulnerable groups and countries’ eligible populations. In addition, we received technical comments from USAID and CDC, which we incorporated as appropriate. State did not submit any comments. In its comments, USAID stated that it and other U.S. government partners initially aligned vaccination targets with WHO’s goal to vaccinate 70 percent of the total population in each country. USAID added that as the virus and pandemic evolved, WHO released an updated global COVID-19 vaccination strategy that reduced focus on the 70 percent target and prioritized vaccinating healthcare workers and high-risk populations. We note in our report USAID’s efforts to vaccinate these populations, but also that USAID reinforced the 70 percent goal in its November 2022 Technical Priorities Update. We therefore compared country vaccination rates to the 70 percent goal. USAID also provided new information regarding vaccination rates for healthcare workers, older adults, and eligible populations in the 11 Global VAX surge countries. We did not use USAID’s information for two reasons. First, these rates relied on information provided by USAID country teams, which was not independently verifiable by GAO. Second, as we note in appendix I, age cutoffs for vaccinating eligible populations may vary by country and over time as COVID-19 vaccine protocols change, making it difficult to arrive at comparable vaccination rates for eligible populations across countries. We therefore used the total population data compiled by Our World in Data, which allowed us to calculate comparable vaccination rates across countries. In addition, USAID described the impact of its support for countries’ vaccination targets. We note, however, that agency officials said it is not possible to isolate, attribute, or measure USAID’s direct contribution to countries’ COVID-19 vaccination progress for a variety of reasons, including that the agency is one of multiple entities involved in these efforts. We are sending copies of this report to the appropriate congressional committees, the USAID Administrator, the Secretary of Health and Human Services, the Acting Director of CDC, the Secretary of State, and other interested parties. In addition, the report is available at no charge on the GAO website at https://www.gao.gov. Page 27 GAO-23-105579 COVID-19 Vaccine Delivery Abroad If you or your staff have any questions about this report, please contact me at (202) 512-4409 or LoveGrayerL@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 IV. Latesha Love-Grayer Director, International Affairs and Trade Page 28 GAO-23-105579 COVID-19 Vaccine Delivery Abroad List of Addressees The Honorable Patty Murray Chair The Honorable Susan Collins Vice Chair 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 Bernard Sanders Chair The Honorable Bill Cassidy Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Gary C. Peters Chairman The Honorable Rand Paul, M.D. Ranking Member Committee on Homeland Security and Governmental Affairs United States Senate The Honorable Kay Granger Chair The Honorable Rosa L. DeLauro Ranking Member Committee on Appropriations House of Representatives The Honorable Cathy McMorris Rodgers Chair The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Page 29 GAO-23-105579 COVID-19 Vaccine Delivery Abroad The Honorable Michael McCaul Chairman Committee on Foreign Affairs House of Representatives The Honorable Mark E. Green, M.D. Chairman The Honorable Bennie G. Thompson Ranking Member Committee on Homeland Security House of Representatives The Honorable James Comer Chairman The Honorable Jamie Raskin Ranking Member Committee on Oversight and Accountability House of Representatives The Honorable Jason Smith Chairman The Honorable Richard Neal Ranking Member Committee on Ways and Means House of Representatives The Honorable Robert Menendez United States Senate Appendix I: Objectives, Scope, and Methodology Page 30 GAO-23-105579 COVID-19 Vaccine Delivery Abroad The CARES Act includes a provision for GAO to report on ongoing monitoring and oversight efforts related to the receipt, disbursement, and use of funds made available to prepare for, respond to, and recover from the COVID-19 pandemic.1 This report examines the (1) assistance the U.S. Agency for International Development (USAID) has provided to support COVID-19 vaccine country readiness and delivery (CRD) abroad; (2) progress USAID has made in its efforts to support COVID-19 vaccine CRD abroad; and (3) any challenges USAID has faced in its efforts to support COVID-19 vaccine CRD abroad and how it has addressed them.2 To respond to these three objectives, we reviewed relevant federal laws and regulations, and planning, funding, and guidance documents from USAID, the Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC), and the Department of State. We also conducted interviews with officials from USAID, CDC, State, and other U.S. government officials in Washington, D.C., to examine the extent of their global COVID-19 CRD efforts. In addition, we interviewed multiple stakeholders in three countries USAID supports with COVID-19 CRD assistance. These stakeholders included USAID, CDC, State, and other U.S. government officials, and officials from USAID implementing partners, beneficiaries, host governments, multilateral organizations, and other bilateral and private-sector donors. We also reviewed written responses to our questions from World Health Organization (WHO) officials in Geneva and United Nations International Children’s Emergency Fund (UNICEF) officials in New York. For all three objectives, we selected for in-depth analysis a non- generalizable sample of three case study countries that had received CRD assistance: Guatemala, Malawi, and South Africa. In selecting these countries, we primarily considered the following factors: (1) those with greater amounts of estimated CRD funds obligated by USAID through the first half of fiscal year 2022; (2) those with lower COVID-19 fully 1Pub. L. No. 116-136 § 19010(b), 134 Stat. 281, 580 (2020). The American Rescue Plan Act of 2021 also includes a provision for GAO to conduct oversight of the COVID-19 response. Pub. L. No. 117-2, § 4002, 135 Stat. 4, 78. All of GAO’s reports related to the COVID-19 pandemic are available on GAO’s website at https://www.gao.gov/coronavirus. 2USAID defines CRD as the support needed to ensure that the infrastructure is in place and the technical assistance is available to make certain COVID-19 vaccines can be safely delivered to all those who need them. According to USAID guidance, this assistance involves financial support, training, and technical assistance provided by USAID-funded implementing partners. Appendix I: Objectives, Scope, and Methodology Appendix I: Objectives, Scope, and Methodology Page 31 GAO-23-105579 COVID-19 Vaccine Delivery Abroad vaccinated rates, based on publicly available data sources;3 (3) countries that represented regional diversity; (4) demographic features, such as population and socio-economic status; (5) severity of the COVID-19 pandemic in each country, as expressed through total cases and deaths per population; and (6) countries recommended as case studies by USAID, CDC, and State officials, as well as other stakeholders with relevant expertise. We determined, based on these considerations, that the three countries we selected were reasonable for the purposes of our reporting objectives. Following our country selection, we conducted audit work for all three objectives in Washington, D.C., and virtually, through video-conferencing, in Guatemala, Malawi, and South Africa. To identify the types of assistance provided for COVID-19 vaccine CRD abroad, we obtained data on all USAID CRD assistance funded from appropriations to prevent, prepare for, and respond to COVID-19 and other appropriations obligated to address COVID-19 as of March 2023. We obtained and analyzed additional CRD funding data from CDC and State officials. We worked with the agencies to identify their estimated CRD-related obligations. To describe the types of CRD assistance USAID provided, we examined USAID policy and guidance documents, and agency presentations on global COVID-19 vaccination progress. We also interviewed agency officials to clarify information about this assistance. To assess the reliability of USAID, CDC, and State funding data, we reviewed agency responses to our questions about data reliability, noting the specific labeling required for COVID-19 vaccination funding. We also reviewed related documentation and performed data reliability checks (such as examining the data for missing values and checking values against other documentation). We interviewed relevant agency officials with knowledge of global CRD assistance from each agency’s appropriations, obligations, and types of assistance supported by the obligations. We also interviewed these officials to corroborate our interpretation of the data. From these steps, we determined that the data were sufficiently reliable for the purposes of this reporting objective. 3We chose countries that received larger amounts of estimated CRD funds. To ensure we chose countries that were experiencing vaccination challenges, we eliminated countries with more than a 50 percent vaccination rate. USAID officials, citing WHO guidance, defined “fully vaccinated” as a complete primary series, which may be one or two doses depending on the vaccine manufacturer. While WHO updated its guidance in July 2022 to recommend booster doses in addition to the primary vaccine series, we are using the term “fully vaccinated” to mean the primary series only, in part because the protocol for booster doses continues to evolve. Appendix I: Objectives, Scope, and Methodology Page 32 GAO-23-105579 COVID-19 Vaccine Delivery Abroad To describe the progress USAID made in meeting its global COVID-19 vaccination goals, and to identify factors that affected the measurement of this progress, we reviewed relevant USAID policies, procedures, reports, and guidance documents. We also interviewed USAID officials in Washington, D.C., and our three case study countries, as well as other stakeholders in these countries. Through the documentation and interviews, we were able to identify (1) USAID’s global vaccination goals; (2) how USAID defines “fully vaccinated”; (3) the indicators it uses to assess progress for the types of CRD assistance it provides and difficulties measuring progress against them; (4) how it defines “directly supported by USAID”; and (5) factors affecting the measurement of USAID’s progress. To determine the overall COVID-19 vaccination progress in USAID- supported countries—reflecting the efforts of USAID, host governments, and other donors and entities—we obtained and analyzed publicly available data. First, we obtained and analyzed COVID-19 vaccination and other data from WHO’s COVID-19 Dashboard. The Dashboard provides information about cumulative total vaccines administered and vaccine mix by country.4 Second, we obtained and analyzed COVID-19 vaccination data from the Our World in Data COVID-19 vaccination dataset.5 We ultimately decided to use the Our World in Data dataset because it is a more comprehensive source, drawing on data from WHO, United Nations World Population Prospects, direct reports from country governments, and other sources. We reviewed the reliability of both the WHO Coronavirus Dashboard and the Our World in Data dataset and determined that both are sufficiently reliable for the purposes of this reporting objective. Specifically, we cross checked the relevant fields in both sources and found no discrepancies. We also conducted manual and electronic testing to identify logical errors such as outliers and higher vaccination rates followed by lower rates— since the percentage of people vaccinated cannot decrease but only increase or stay the same over time—and found none. Using the Our World in Data website, we reviewed detailed information regarding sources, vetting, accuracy, completeness, consistency, and limitations. 4WHO pools data from numerous sources, including direct reports from member states and other publicly available official data collated by third-party sites. 5Our World in Data is an open access and open source non-profit organization that vets the source data for accuracy and consistency. It provides data on multiple variables, including people fully vaccinated (total and per capita data for people who received all doses prescribed by the initial vaccination protocol), COVID-19 cases, confirmed deaths, and numerous other COVID-19-related and broader socio-economic variables. Appendix I: Objectives, Scope, and Methodology Page 33 GAO-23-105579 COVID-19 Vaccine Delivery Abroad We also reviewed USAID documents that use Our World in Data as a source for country COVID-19 vaccination rates,6 as well as scientific studies on COVID-19 vaccination that use Our World in Data. We used data showing fully vaccinated rates per capita from Our World in Data for each country that received USAID CRD assistance7 to (1) determine the number of countries falling within certain vaccination rate ranges, (2) arrive at average vaccination rates for these countries by region, and (3) produce vaccination trend lines for 11 countries identified by USAID as Global VAX surge countries.8 Finally, we interviewed USAID officials to corroborate our interpretation of the data presented from this source. To identify any challenges USAID has faced in its efforts to support COVID-19 vaccine CRD abroad and how the agency addressed them, we reviewed policy and guidance documentation from USAID and WHO. We also reviewed other documentation from USAID and its implementing partners, surveys of U.S. overseas staff compiled jointly by State, USAID, and CDC,9 and written responses to our questions from WHO and UNICEF. In addition, we interviewed USAID officials in Washington, D.C., and in our three case study countries, as well as CDC and State officials, USAID implementing partners, host government officials, other bilateral donor officials, representatives from private sector donors and local organizations, and other stakeholders in these countries. We derived the information on foreign law in this report from interviews and not from our original analysis. We reviewed these documents and interviews using content analysis to identify demand, supply, and other challenges, along with more specific 6These rates reflect the COVID-19 vaccination efforts of all entities in a given country, including the host government, USAID, other donors, and other entities. 7Our World in Data has vaccination data for 123 of the 125 USAID-assisted countries. There are no data for the Marshall Islands or Micronesia. 8Countries have been vaccinating their populations over a certain age, according to COVID-19 vaccine protocols and their own guidelines. However, age cutoffs for eligible populations may vary by country and over time as protocols change. Our World in Data’s total population data, drawn from United Nations World Population Prospects, and its country vaccination data, drawn from host governments, WHO, and other sources, allowed us to arrive at comparable vaccination rates across countries. 9We reviewed the results of two surveys, one based on responses received as of January 24, 2022, and the other, based on responses received as of July 30, 2022. The earlier survey was administered to officials in 111 countries and officials in 80 countries responded. The later survey was administered to officials in 63 countries and officials in 51 countries responded. Appendix I: Objectives, Scope, and Methodology Page 34 GAO-23-105579 COVID-19 Vaccine Delivery Abroad challenges within each of these categories. To conduct the content analysis, two analysts independently identified examples of the challenges in the documents and interviews, and a third checked their findings.10 In addition, we reviewed USAID’s mitigation strategies, including its plans for monitoring, evaluating, and lessons learned. We compared USAID’s efforts to its internal guidance, which states that lessons learned should be incorporated at several stages of agency project activities, including strategy development, implementation, and close-out,11 and requires that these lessons and related information be posted to the Development Experience Clearinghouse, an agency repository of development assistance information.12 We assessed USAID’s efforts to systematically document and disseminate lessons learned against this guidance. We conducted this performance audit from January 2022 to September 2023 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. 10Specifically, we conducted a content analysis of our interviews with multiple stakeholders in our three fieldwork countries and written responses from headquarters officials at USAID, CDC, WHO, and UNICEF. We did so to identify challenges in implementing COVID-19 vaccination country readiness and delivery activities in the three countries (and worldwide, in the case of responses from headquarters officials). We iteratively identified patterns to develop a set of three broad challenges—demand, supply, and other challenges—and more specific challenges within each broad category. Two analysts coded the interviews and responses to group the challenges within each broad category and in more specific themes within each category. A third analyst independently reviewed and verified this organization of the challenges into these broad categories and subcategories. 11See USAID Automated Directives System 201.3.2.9; 201.3.2.18.B; and 201.3.4.12. 12USAID Automated Directives System 540.3.2.3.b. This information includes, for example, reports that describe progress and accomplishments or document significant evaluation findings, lessons learned, development results, performance measures, or evaluative information and observations. Appendix II: Countries Receiving U.S. Agency for International Development COVID-19 Vaccine Country Readiness and Delivery Assistance Page 35 GAO-23-105579 COVID-19 Vaccine Delivery Abroad The U.S. Agency for International Development (USAID) provided COVID-19 vaccine country readiness and delivery (CRD) assistance to 125 countries in five regions.1 Table 1 shows the countries receiving USAID’s CRD assistance for COVID-19 by region. Table 1: List of Countries Receiving USAID Assistance for COVID-19 Global Country Readiness and Delivery, by Region, 2023 USAID- assisted regions Countries Africa (47) Angola Benin Botswana Burkina Faso Burundi Cameroon Cape Verde Central African Republic Chad Comoros Cote d’Ivoire Democratic Republic of the Congo Djibouti Eswatini Ethiopia Gabon Gambia Ghana Guinea Guinea- Bissau Kenya Lesotho Liberia Madagascar Malawi Mali Mauritania Mauritius Mozambique Namibia Niger Nigeria Republic of the Congo Rwanda Sao Tome and Principe Senegal Seychelles Sierra Leone Somalia South Africa South Sudan Sudan Tanzania Togo Uganda Zambia Zimbabwe Asia (31) Afghanistan Bangladesh Cambodia Federated States of Micronesia Fiji India Indonesia Kazakhstan Kiribati Kyrgyzstan Laos Malaysia Maldives Marshall Islands Mongolia Myanmar Nauru Nepal Pakistan Papua New Guinea Philippines Sri Lanka Solomon Islands Tajikistan Thailand Timor-Leste Tonga Tuvalu Uzbekistan Vanuatu Vietnam Latin America and the Caribbean (25) Antigua and Barbuda Bahamas Barbados Bolivia Brazil Colombia Costa Rica Dominica Dominican Republic Ecuador El Salvador Grenada Guatemala Guyana Haiti Honduras Jamaica Nicaragua Paraguay Peru Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Suriname Trinidad and Tobago 1USAID defines CRD as the support needed to ensure that the infrastructure is in place and the technical assistance is available to make sure COVID-19 vaccines can be safely delivered to all those who need them. According to USAID guidance, this assistance involves financial support, training, and technical assistance provided by USAID-funded implementing partners. Appendix II: Countries Receiving U.S. Agency for International Development COVID-19 Vaccine Country Readiness and Delivery Assistance Appendix II: Countries Receiving U.S. Agency for International Development COVID-19 Vaccine Country Readiness and Delivery Assistance Page 36 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Europe and Eurasia (12) Albania Armenia Bosnia and Herzegovina Bulgaria Georgia Kosovo Moldova Montenegro North Macedonia Romania Serbia Ukraine Middle- East and North Africa (10) Algeria Egypt Iraq Jordan Lebanon Libya Morocco Syria West Bank and Gazaa Yemen Source: GAO analysis of US Agency for International Development (USAID) information. | GAO-23-105579 aThe West Bank and Gaza are territories not recognized by the U.S. as independent states. Appendix III: Comments from the U.S. Agency for International Development Page 37 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Appendix III: Comments from the U.S. Agency for International Development Page 38 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Page 39 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Page 40 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Page 41 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Page 42 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix III: Comments from the U.S. Agency for International Development Page 43 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Appendix IV: GAO Contact and Staff Acknowledgments Page 44 GAO-23-105579 COVID-19 Vaccine Delivery Abroad Latesha Love-Grayer at (202) 512-4409 or LoveGrayerL@gao.gov In addition to the contact named above, Joyee Dasgupta (Assistant Director), Carolina Morgan (Analyst in Charge), Eli Dile, Kay Halpern, Kathleen Monahan, Jason Bair, Gergana Danailova-Trainor, Mark Dowling, Justin Fisher, Christopher Keblitis, Danny Lee, Amanda Miller, and Aldo Salerno made key contributions to this report. 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