Sustaining U.S. Support for Gavi: A Critical Global Health Security and Development Partner

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THE ISSUE

In June 2020, the United Kingdom will host a pledging conference at which Gavi, the Vaccine Alliance, will seek funding to support an ambitious work plan for 2021-2025. Gavi is seeking at least $7.4 billion to reach its goal of delivering more than 3.2 billion doses of routine immunizations to children and families while continuing to fund emergency vaccine stockpiles and support the delivery of the inactivated polio vaccine in eligible countries. The United States, one of the top donors to Gavi, has supported the alliance’s efforts since its inception 20 years ago and made annual commitments of $290 million in FY 2018 and 2019. In promoting health security, contributing to economic development, and engaging implementing countries and the private sector in the move toward fully self-financed immunization programs, Gavi’s work is closely aligned with U.S. interests.

The United States has recently announced a commitment of $1.16 billion to Gavi over four years, essentially sustaining the annual commitments of $290 million through FY 2023. This sends a strong message to other donors, as well as eligible countries, that the United States remains confident in Gavi’s ability to deliver results. To reinforce its support, the United States should also: (1) encourage other donor countries to sustain or even increase their support for Gavi over a multi-year period; (2) identify opportunities to strengthen bilateral engagement on immunization programs, advocacy activities, and the mobilization of domestic resources for vaccines in priority countries; and (3) continue to support Gavi as it navigates the challenges to immunization programs posed by demographic change, urbanization, conflict, and migration over the 2021-2025 period and beyond.



This video serves as a companion to the full brief, explaining how Gavi works and how U.S. support for Gavi in 2020 and beyond helps protect the health of future generations in the United States and around the world.

INTRODUCTION

Recent decades have seen enormous progress in getting lifesaving vaccines to children in the world’s poorest and most remote settings. From 1980 to 2012, the percentage of children worldwide receiving the recommended three doses of diphtheria, tetanus, and pertussis (DTP3) vaccine, a key indicator of immunization system reach and quality, rose from 47 percent to 89 percent.1 Yet in some countries, immunization coverage has stagnated or even declined in recent years. And some communities have never had access to vaccines at all. In 2018, 20 million infants worldwide did not receive any doses of DTP3 vaccine.2

Several factors affect immunization coverage at the national and local levels. Persistent high fertility in some settings means an ever-greater cohort of babies who must be immunized each year. Urbanization and migration, as well as intensifying cycles of natural disasters, can make it difficult to locate and reach the most vulnerable populations. Conflicts and emergencies, including outbreaks and other health crises, can threaten the financial stability and quality of immunization programs and undermine community trust in the health sector. In this context, sustaining progress, while working to reach a growing number of never-immunized children with an increasing number of available vaccines, is a significant challenge, and one that Gavi, the Vaccine Alliance, will seek to address over the next five years with renewed donor support.

GAVI AT 20: A MATURE INVESTMENT

In January 2020, Gavi celebrated its twentieth anniversary at the World Economic Forum (WEF) in Davos, where the alliance was launched two decades ago. Since its inception, Gavi has proven to be a high-impact and resilient public-private partnership, involving donor countries, implementing countries, the private sector, and civil society organizations in the effort to make vaccines available to children in the world’s lowest income settings. Gavi achieves this in large part by helping governments procure vaccines at very low cost. Having mobilized nearly $21 billion in funds between 2000 and 2019, it has supported the immunization of more than 760 million children and made available to them some of the newest and most costly vaccines, many of which might not have otherwise reached those populations for 30 years or more. In 2019, Gavi estimated that it facilitated the purchase and delivery of vaccines to nearly 50 percent of the world’s children.3

Since its inception in 2000, Gavi has grown to support the introduction of vaccines against 17 different infectious diseases.

To carry out this work, Gavi has built an alliance that draws on its network of partners, including the World Bank, World Health Organization (WHO), and UNICEF country offices; as well as host governments, bilateral donors, private sector organizations, and civil society groups. It requires even the poorest implementing countries to co-finance vaccines procured with Gavi support as a means of building sustainable budgets for immunization programs over the long term. Gavi also provides technical assistance to help eligible countries strengthen and better integrate immunization programs into routine health services.4

In the early years, Gavi was hosted by UNICEF and located at that agency’s campus in Geneva, but the organization became an independent international institution under Swiss law in 2009.5 In 2018, Gavi relocated to the Geneva Global Health Campus and is now housed in a building with other high-profile public-private health partnerships, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid, Roll Back Malaria, and the Stop TB Partnership.6

Gavi’s internationally recognized management practices help it realize an ambitious set of goals. In 2008, Gavi was a founding member of the International Aid Transparency Initiative (IATI), and in 2012, it was lauded for its commitment to transparency and accountability by the Publish What You Fund Index.7 Gavi continues to make external evaluations of its programs and materials from its board meetings publicly available through its website, and its most recent financial report shows that overhead expenses for management and fundraising were just 2.53 percent of the organization’s total budget in 2018.8 That year, Gavi was also certified by the Equal Salary Foundation as an Equal Salary gender employer, making Gavi the “first international not-for-profit organization to commit to equal pay for men and women.”9 In September 2019, Gavi was also recognized for its efforts to improve health and well-being in the world’s poorest countries with the prestigious Lasker-Bloomberg Public Service Award.10

Over time, the Gavi approach has evolved in important ways, with the alliance demonstrating a consistent ability to adapt to changing global circumstances. For the first five years, eligible countries were defined as those with an annual gross national income (GNI) per capita of $1,000 or less, with 74 countries initially qualifying for support. In 2009, Gavi adopted a graduation policy to chart a path away from assistance for countries that were developing economically and moving from being classified as low-income under World Bank criteria to lower-middle income. Recognizing the struggles that even countries on the cusp of lower-middle income status were facing as they sought to secure vaccines for their populations, Gavi raised the eligibility threshold in 2011 to an annual GNI per capita of $1,500. The eligibility threshold now takes inflation into account and is updated on a yearly basis. Countries with a three-year average annual GNI per capita of $1,630 or less are currently eligible to apply for Gavi assistance.11

To reinforce assistance for countries as they move beyond eligibility, Gavi adopted a new transition policy in 2015 to more clearly articulate the stages through which lower- income countries must pass as they progress toward fully self-financing national immunization programs. Using the three-year average of GNI per capita as the reference for eligibility, Gavi now classifies countries as “initial self-financing,” in “preparatory transition,” or in “accelerated transition.” In the initial self-financing phase, countries pay $0.20 per dose of vaccine. As a country’s annual GNI per capita increases, it enters the preparatory transition phase, and as it approaches the eligibility threshold, it moves to the accelerated transition phase. During the latter, countries remain eligible for support to procure and introduce new vaccines, but as their economies grow, they must co-finance a greater percentage of each vaccine dose.12

The multi-phase transition process introduced in 2015 represented an important step in enabling Gavi countries to move toward fully self-financing vaccine purchases, but it neglected to take the potential for a country to experience economic instability into account. In 2017, Gavi further refined its transition policy, acknowledging the potential for a country to experience a sharp economic downturn. Ideally, over the five-year accelerated transition process, countries assume 20 percent more financing responsibility each year so that by the end they are paying the full cost for the vaccines initially procured with Gavi assistance. However, countries may regain eligibility for support if their annual GNI per capita dips below the threshold.13 In rare cases, the Gavi board has approved a multi-year extension to the time a country will spend in the accelerated transition phase. This was the case for Papua New Guinea, which was expected to transition out of support by the end of 2020 thanks to rapid economic growth fueled by mining and extractive industries. But because it has low vaccine coverage, has experienced recent outbreaks of polio and measles, and has high rates of child mortality, the country now has until 2025 to complete the transition process.14 The commitment by some vaccine manufacturers to extend low prices to fully-transitioned countries for a period of time also provides a financial cushion for some governments struggling to fully self-finance immunization programs.15 (See map on transition).


Over the past two decades, many of the countries originally eligible for Gavi support have transitioned out of assistance and taken on full financial responsibility for their vaccine programs. Data reflects country eligibility and transition status as of the end of 2019.

Armed conflicts and other humanitarian emergencies create conditions of insecurity which affect the health sector and can make it difficult for governments to deliver vaccines through public mechanisms. In 2018, UNICEF reported that many of the nine countries with the lowest DTP3 coverage included countries in crisis or states of fragility, such as the Central African Republic, Chad, Somalia, South Sudan, Syria, and Ukraine.16 Recognizing these challenges, the Gavi board approved a new policy on Fragility, Emergencies, and Refugees in 2018. This framework allows “Gavi to adjust its support and processes to better meet each country’s specific needs, working in close collaboration with partners and humanitarian actors.”17 The policy recognizes that operating in such insecure settings carries higher financial and security risks than in more stable contexts, and it offers Gavi the flexibility to work directly with civil society actors in regions of Gavi-eligible countries where there may be limited official presence.18 To encourage eligible countries to provide immunization services for refugees within their borders, the Fragility, Emergencies, and Refugees policy allows eligible countries a greater range of options for financing the procurement of vaccines for these special populations than would otherwise be allowed. It also permits governments hosting refugees to opt not to pay co-financing for products offered to migrant populations fleeing disorder in their home countries.19

A newer area of consideration for Gavi is the extent to which it may be possible to support middle-income countries that have never been eligible for Gavi support but which nevertheless struggle to deliver vaccines and maintain high levels of immunization coverage for their populations. Of the 10 countries that account for 60 percent of un- or under-immunized children, for example, Brazil and the Philippines are classified under World Bank criteria as middle-income and have never had Gavi support; Angola, Indonesia, and Vietnam are also on the list of countries with high numbers of un- and under-immunized children and have already transitioned away from Gavi assistance.20 To address these challenges, the Gavi board asked the Gavi secretariat in 2019 to “explore approaches to engaging with self-financing lower middle-income countries.”21 For formerly eligible countries, Gavi has made a commitment to strengthen post-transition coordination to ensure the sustainability of programs previously supported by Gavi. But for non-eligible countries, one option under consideration is to identify separate pathways to assistance for two different groups: those with an annual GNI per capita above the $1,630 threshold but below $4,000 and those with an annual GNI per capita between $4,000 and $6,000. Without changing the long-established Gavi eligibility model that prioritizes the lowest-income countries, the ideas under review could enable Gavi to provide technical advice to these more economically developed countries and potentially allow them to benefit from Gavi-negotiated vaccine prices through an innovative vaccine procurement facility. While the Gavi board continues to study how the organization can best address the problem of stagnating or declining immunization coverage rates in middle-income countries, it has allocated up to 3 percent of the planned operating expenses between 2021-2025 to the issue.22

A HISTORY OF U.S. SUPPORT AND ENGAGEMENT

The United States has supported Gavi since the very beginning. As of the end of September 2019, U.S. contributions and pledges to Gavi totaled nearly $2.5 billion, making the United States one of the top three donors to Gavi, behind the United Kingdom and the Bill & Melinda Gates Foundation.23 Recognizing the effectiveness of Gavi programs in getting vaccines to children in low- income settings, the United States has increased its support over the years, with annual commitments of $290 million in 2018 and 2019 reflecting bipartisan commitment to Gavi's mission.24 During Gavi’s 2016-2020 phase of work, U.S. contributions made up 15.4 percent of all direct funding to the organization.25

Beyond its financial contributions, which flow through maternal and child health accounts at the U.S. Agency for International Development (USAID), the U.S. government is involved with Gavi governance through several different mechanisms. It joins Australia, Japan, and the Republic of Korea on one of several seats reserved for donor countries. Currently, the United States is the anchor donor for that constituency and through USAID represents the group on the Gavi board. The USAID representative has also served on the Program and Policy Committee, the Market-Sensitive Decisions Committee, and the Audit and Finance Committee in recent years. The U.S. Centers for Disease Control and Prevention (CDC) currently participates on the Gavi board’s constituency for Research & Technical Health Institutes.26

USAID maternal and child health priority countries, CDC global immunization priority countries, and Gavi eligible countries overlap in several regions. In USAID and CDC priority countries, U.S. efforts complement Gavi assistance through broad support to national immunization programs, including routine and supplemental immunization activities; through strengthening immunization policy development; and by supporting the introduction of new vaccines, among other activities. The United States also provides technical assistance for outbreak support when countries request it.27


This map shows the overlap between countries that are a priority for immunization programs within the U.S. government (CDC or USAID), and those that are eligible for Gavi support.

Gavi’s work aligns with and reinforces U.S. global health security goals in several ways. Immunizations are a key component of the 2019 U.S. Global Health Security Strategy, which states that U.S. agencies will “help selected countries strengthen their national immunization systems to improve their response to existing and new infectious disease threats.”28 And immunization is one of several key thematic “action packages” that are part of the Global Health Security Agenda, with the United States, the Republic of South Korea, and the Kingdom of Saudi Arabia serving as financial contributors to the activity.29 Gavi’s provision of assistance to help countries deliver vaccines within the context of quality health services at the community level helps build local capacity to prevent, detect, and respond to outbreaks.30 At the same time, Gavi’s management of global stockpiles of cholera, meningitis, and yellow fever vaccines makes these products available for rapid deployment as soon as they are needed.31 At its December 2019 meeting, the Gavi board approved a global emergency stockpile of Ebola vaccines, signaling its continued commitment to supporting efforts to address health emergencies.32

The Gavi model is also consistent with U.S. government development approaches. The current framework for U.S. development assistance, the “Journey to Self-Reliance,” focuses on “empowering host country governments and our partners to achieve locally sustained results, helping countries mobilize public and private revenues, strengthening local capacities, and accelerating enterprise- driven development.”33 Gavi’s emphasis on country co- financing and a transition to fully self-financing national immunization programs complements the U.S. emphasis on country-led advancement. At the same time, recent research showing that “each $1 invested in immunization delivers a return of $54 to the countries, including broader societal benefits,” suggests that the savings that countries realize when they improve vaccine programs may contribute to their longer-term economic development.34

Finally, Gavi’s comprehensive integration of the private sector into its activities is consistent with U.S. diplomatic efforts to showcase U.S.-based innovation and entrepreneurship abroad. Some of Gavi’s earliest private-sector partners included U.S.-based vaccine manufacturers, which agreed to lower the prices for their products for the Gavi-eligible countries given the potential for aggregated demand and a guaranteed market. Gavi has since integrated medical device manufacturers into its cohort of private-sector partners, along with providers who can help address “bottlenecks to immunization delivery” in Gavi’s work.35 Newer partners include U.S.-based Mastercard, the UPS Foundation, and Google.org, which contribute to Gavi by making direct cash contributions or by providing their expertise within the implementing country context.36

Gavi’s emphasis on incentivizing innovation in the immunization sphere helps introduce U.S.-based approaches to data management, service delivery, and sustainable business practices overseas as well. Gavi’s INFUSE (Innovation for Uptake, Scale and Equity in Immunization) program, for example, connects business start-ups that have developed products useful for vaccine delivery with well- established Gavi partners with the goal of helping the new companies bring these promising approaches to scale in Gavi- eligible countries. U.S.-based start-ups—including Zenysis, an artificial intelligence company; Parsyl, which promotes supply chain integrity; and Zipline, a battery-powered drone delivery service—have all been highly engaged with INFUSE as “pacesetters.” As Gavi works to help eligible countries strengthen their immunization systems, U.S. technology, engineering, and business expertise help them build and sustain progress in the longer term.37

GAVI 5.0: A RENEWED FOCUS ON EQUITY

Last June, the Gavi board approved a new strategic framework for the next phase of Gavi’s activities between 2021 and 2025. The board determined that equity, and reaching never-immunized children and missed communities with vaccines, will be a priority during the next phase. In so doing, the board recognizes that even with great successes in improving access to vaccines worldwide, 1 out of every 10 children across the world still does not have access to immunization services. While ensuring equitable access to vaccines has been part of Gavi’s mission since the beginning, during the next work phase, Gavi will place an even stronger emphasis on “strengthening primary healthcare systems, building and sustaining community demand, and using innovation” to ensure that immunization services reach the world’s most marginalized children.38 Reflecting the understanding that access to immunizations and primary health services improves both health security and economic development, Gavi anticipates that its new work plan will enable it to help provide immunizations for an additional 300 million children and contribute $80-100 billion in economic benefits, including savings of over $900 million in vaccine prices, during the 2021-2025 period.39

While Gavi has had a gender policy in place for more than 10 years, the new plan will put a sharper focus on the gender and household dynamics that can determine a child’s access to immunizations.40 Recognizing that many of the world’s “zero dose” children are missing critical vaccines because of “demand-related challenges,” including caregivers’ poor understanding of the science behind immunizations, concerns over vaccine safety, and challenges getting to and from health clinics, Gavi will focus on educating and empowering mothers, who it recognizes are often the family decisionmakers when it comes to children’s health.41

Several new themes and global trends will shape Gavi’s potential to achieve this ambitious equity agenda over the next five years. High fertility and larger birth cohorts in Gavi-eligible countries have created an expanding population of children who need vaccines each year, making the sustainability of immunization coverage in those contexts a persistent challenge. Urbanization and the growth of informal settlements, as well as migration driven by conflict and, increasingly, climate change, can make it difficult for public health officials to locate and track children who need immunizations.42 The promise of new vaccines for malaria and tuberculosis, as well as the potential urgency of disseminating new products developed for emerging health security threats, such as the novel coronavirus or a pandemic strain of influenza, may require tough decisions about additional funding. At the same time, recent problems with the supply of some products, such as the human papillomavirus (HPV) vaccine, and the decision of at least one supplier to suspend production of the pentavalent vaccine because the price dropped too low for it to justify continued production, signal the importance of regular check-ups on the health of the vaccine marketplace.43

With more than 168 cases of wild polio virus in 2019, and ongoing outbreaks of vaccine-derived poliovirus in several countries, Gavi’s work to support global polio eradication efforts will need to accelerate in the next phase. Gavi has worked with the Global Polio Eradication Initiative (GPEI) to support the introduction of the inactivated polio vaccine (IPV) since 2014, when it was first introduced in Nepal. As of May 2019, all 73 Gavi-supported countries had introduced it.44 Continued support of the polio initiative is crucial to prevent a reversal of progress made over the three decades since the launch of the GPEI in 1988. By working closely with the GPEI and the Polio Oversight Board (POB), which Gavi CEO Seth Berkley joined in 2019, Gavi’s work can help address the rising number of polio cases and resolve the unfinished business of polio eradication.45 By coordinating more closely with the GPEI, Gavi can integrate data, tools, and lessons from the decades of work on polio into its efforts to help eligible countries strengthen immunization services.

WHAT IS AT STAKE FOR THE UNITED STATES IN GAVI’S NEXT STRATEGIC PERIOD?

U.S. priorities on global health security, economic development, and a strengthened private sector are all well met with the proposed focus of Gavi 5.0. The plan’s overarching focus on equity is directly related to global health security, as it will ensure greater immunization coverage, particularly among difficult-to-reach, never-immunized populations. In this way, U.S. citizens abroad and at home are better protected from vaccine-preventable diseases. Gavi’s support for efforts to strengthen the capacity of health workers to deliver immunizations as part of an integrated suite of health services contributes to the quality of primary health care at the local level and helps ensure the success of other U.S. investments in core areas of maternal and child health, HIV, tuberculosis, and malaria. At the same time, it strengthens countries’ outbreak preparedness and response capabilities, key elements of the U.S. Global Health Security Strategy. In that context, Gavi’s funding for, and maintenance of, emergency stockpiles of vaccine that can be readily mobilized and deployed in the event of an outbreak is crucial.

Gavi’s work also closely aligns with the U.S. development agenda by helping countries be more self-reliant and plan for the requirements of self-financing health and social projects. Indeed, Gavi estimates that country co-financing contributions will rise from $1.6 billion over the 2016-2020 strategic period to $3.6 billion between 2021 and 2025. Beyond co-financing obligations, implementing countries are expected to spend $6.3 billion in domestic financing on service delivery costs over the next phase of work.46

Finally, Gavi’s increasing engagement with global polio efforts through supply of IPV and participation on the POB helps protect longstanding U.S. support for the GPEI. The United States has been a longtime donor and instrumental partner to the GPEI and provides considerable bilateral technical assistance on polio through both the CDC and USAID. Between 2010 and 2019, annual U.S. funding for work on global polio efforts rose from $136 million to $235 million.47 Having already invested a great deal in the global polio eradication agenda, the United States can support Gavi in finishing the task.

RECOMMENDATIONS

To support Gavi’s work in the 2021-2025 Strategic Period, the United States should take several steps:

Encourage other donors to sustain or increase funding commitments to Gavi over a multi-year period: The United States has recently pledged $1.16 billion to Gavi between FY 2020 and 2023, essentially sustaining its recent annual commitments of $290 million. This sends a strong message to other donors, as well as eligible countries, that the United States remains confident in Gavi’s ability to deliver results. The United States should encourage other longstanding Gavi supporters to make strong multi-year pledges and work through embassies in emerging markets to encourage first- time support at the Gavi pledging conference.

Continue to support Gavi governance activities: The United States should use its roles on the Gavi board and sub-committees to encourage Gavi to continue to address tough issues, such as how to support non-eligible middle- income countries, particularly where the United States has historically supported immunization and health initiatives and may be able to share contacts, networks, and advice.48 Through service on Gavi’s board and sub-committees, and by working at the country level to support eligible countries’ engagement with Gavi, the United States can share its agencies’ scientific and development expertise and ensure a high return on U.S. global health investments.

Given the promise of new vaccines on the horizon for malaria, tuberculosis, and HIV, the United States can also support a stronger relationship between Gavi and the Global Fund to Fight AIDS, Tuberculosis and Malaria to make sure new products are made available to the neediest populations. Should the United States decide to join CEPI, the public-private consortium formed in 2017 to develop and disseminate new vaccines to prevent epidemics in the future, continued U.S. support for Gavi will help ensure a ready mechanism for getting those products to the lowest-income countries when they are needed.49

Redouble bilateral support for immunization programs: Gavi’s model of a Geneva-based secretariat and no field staff often means reliance on WHO and UNICEF country offices to support health ministries in gathering data and crafting proposals for support. But depending on the capacity of governments and these multilateral partners to devote resources to preparing for Gavi programs, the support provided can be uneven. In Gavi-eligible countries where the United States has a strong bilateral presence on maternal and child health, USAID and CDC officials should strengthen collaborative efforts with other in-country partners to support national immunization programs by offering health ministries technical assistance, by strengthening the capacity of civil society groups to advocate for and deliver improved immunization programs, and by supporting regular communication between finance and health ministries to fund immunization activities and anticipate the need for increased immunization budgets as the Gavi transition process gets underway.

The United States has supported Gavi’s vaccine financing, market-shaping, and health systems strengthening since the organization’s inception 20 years ago in Davos. U.S. annual contributions have risen over time, and the United States provided $290 million in 2018, 2019, and again in 2020. In promoting health security, contributing to economic development, and engaging implementing countries and the private sector in the move toward fully self-financed immunization programs, Gavi’s work is closely aligned with and supports U.S. priorities. Ahead of the 2020 replenishment, the United States has made a multi-year commitment of at least $290 million per year to Gavi. By identifying opportunities to strengthen bilateral engagement on immunization programs, advocacy activities, and the mobilization of domestic resources for vaccines in priority countries, the United States can further support Gavi as the organization navigates the challenges of reaching the most vulnerable children and families with vaccines in a context of increasing urbanization, migration, deepening violence and conflicts in some areas, and demographic change.


Katherine E. Bliss is a senior fellow with the Global Health Policy Center at the Center for Strategic and International Studies in Washington, D.C.

The author thanks Sara Allinder, Nellie Bristol, J. Stephen Morrison, Michaela Simoneau, Erin Fry Sosne, and staff at USAID, CDC, and Gavi for their advice, assistance, and comments on earlier drafts.

This brief is made possible through the support of the Bill & Melinda Gates Foundation.

CSIS Briefs are produced by the Center for Strategic and International Studies (CSIS), a private, tax-exempt institution focusing on international public policy issues. Its research is nonpartisan and nonproprietary. CSIS does not take specific policy positions. Accordingly, all views, positions, and conclusions expressed in this publication should be understood to be solely those of the author(s).

© 2020 by the Center for Strategic and International Studies. All rights reserved.

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Katherine E. Bliss
Senior Fellow and Director, Immunizations and Health Systems Resilience, Global Health Policy Center