Vaccine development, especially during public health emergencies, requires collaborative, multi-sectoral, and international efforts, with private pharmaceutical companies teaming up with governmental and nongovernmental agencies, philanthropies, and academic laboratories. For example, the recently approved Ebola vaccine is a result of a close collaboration between the pharmaceutical company Merck, Canadian and U.S. governmental agencies, and the World Health Organization (WHO) (Felter, 2020). When severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and began spreading across the world, the global community mobilized rapidly to start developing and mass-producing effective vaccines. As some high-income countries start securing vaccine allotments through bilateral agreements with pharmaceutical companies, it is clear that an inequitable distribution of vaccines at the global level will ultimately fail to eliminate the risk of new outbreaks in the future. As recently highlighted in a report from the Bill & Melinda Gates Foundation, “According to modeling from Northeastern University, if rich countries buy up the first 2 billion doses of vaccine instead of making sure they are distributed in proportion to the global population, then almost twice as many people could die from COVID-19” (Bill & Melinda Gates Foundation, 2020, p. 16; Chinazzi et al., 2020).
The United States has already made large investments through Operation Warp Speed (OWS) to accelerate the development, manufacturing, and domestic distribution of coronavirus disease 2019 (COVID-19) vaccines. While the United States has yet to actively engage with global vaccine devel-
opment and allocation efforts, it has officially acknowledged and welcomed them. Indeed, on May 4, 2020, the U.S. Department of State stated that the
United States is bringing together the brightest minds in U.S. government agencies, the private sector, universities, and overseas partners to develop vaccines and therapeutic interventions to protect the world from COVID-19. The United States is using its G7 Presidency to catalyze the power and resilience of the world’s leading democracies and free economies in this effort. The United States welcomes efforts by other countries to mobilize resources to mitigate and ultimately end the COVID-19 pandemic, efforts like the pledging conference in Europe which, among other things, will support investments in the Coalition for Epidemic Preparedness Innovations (CEPI) and the United Kingdom’s June 4 pledging conference for the Global Alliance for Vaccines and Immunization (GAVI). (U.S. Department of State, 2020)
Unfortunately, the current tension between the United States and WHO over its initial response to the pandemic, including a halt to U.S. funding and formal notification of the United States’ intent to withdraw from membership in the World Health Assembly, has further complicated these multilateral discussions. As highlighted in the above quote, the U.S. government is a long-term supporter of Gavi, the Vaccine Alliance and, indeed, one of the vaccine alliance’s largest donors.1
This chapter will explore existing multilateral strategies to accelerate and equitably deploy future vaccines needed to address the COVID-19 pandemic internationally, as well as the United States’ potential leadership role in supporting global vaccine access mechanisms.
Global Preparedness Monitoring Board
The 2014–2016 Ebola outbreak in West Africa uncovered important gaps in the global community’s capacities to effectively prepare, detect, respond to and recover from emerging and re-emerging infectious disease outbreaks. In the wake of this unprecedented crisis and in response to recommendations by the United Nations Secretary-General’s Global Health Crises Task Force, the Global Preparedness Monitoring Board (GPMB) was created. In 2018, the GPMB was formally launched by the World Bank
1 The United States is also the largest donor to The Global Fund to Fight AIDS, Tuberculosis and Malaria. While the Global Fund does not have a role in the ACT-A Vaccines Pillar, it has played a leading role in the Diagnostics and Therapeutics Pillars, as well as the Health Systems connector.
and WHO as an independent body tasked with monitoring and evaluating epidemic and pandemic preparedness around the world (GPMB, 2019).
In September 2019, the GPMB released its first comprehensive annual report, A World at Risk (GPMB, 2019). The report highlighted key actions for global leaders to take. The report warned, “Countries, donors and multilateral institutions must be prepared for the worst” (GPMB, 2019, p. 8). Specifically:
A rapidly spreading pandemic due to a lethal respiratory pathogen (whether naturally emergent or accidentally or deliberately released) poses additional preparedness requirements. Donors and multilateral institutions must ensure adequate investment in developing innovative vaccines and therapeutics, surge manufacturing capacity, broad-spectrum antivirals and appropriate non-pharmaceutical interventions. All countries must develop a system for immediately sharing genome sequences of any new pathogen for public health purposes along with the means to share limited medical countermeasures across countries. (GPMB, 2019, p. 30)
While retrospectively prescient, the GPMB’s recommendation was based on knowledge of the certainty of the periodic, but unpredictably sudden, emergence of new pandemic influenza strains. The board recognized that, while some progress had been made in recent years in preparedness for local emerging infection outbreaks, such as Ebola, the global preparedness for a rapidly moving respiratory pathogen had lagged.
Unfortunately, the world’s leaders had less than 6 months to act on the recommendations of the GPMB before the emergence of SARS-CoV-2 and its rapid spread throughout the world. The GPMB’s recommendation urged leaders to identify the “means to share limited countermeasures across countries” and cautioned that, “limited medical countermeasures are shared inequitably at times and are likely to be prioritized for domestic use during a pandemic” (GPMB, 2019).
COVID-19 Vaccine Nationalism
The GPMB’s concern about the domestic prioritization of medical countermeasures has proved perceptive, as the world has seen a rush to what has been called “vaccine nationalism” in response to the COVID-19 pandemic (Weintraub et al., 2020). Many high-income countries, including the United States, the United Kingdom, and those in the European Commission, have sought to quickly secure reservations of scarce capacities for vaccine production for their domestic deployment, often in return for size-able investments in research and development or at-risk scaling of vaccine manufacturing capacity (HHS, 2020a,b; Rockoff and Hopkins, 2020).
The current approach has several obvious inefficiencies. Few countries will have enough resources to invest in a full portfolio of vaccine constructs.
Consequently, most countries will place very specific bets on individual vaccine partnerships. Given the uncertainties regarding the immunology of the novel SARS-CoV-2 virus, the highly diverse range of potential vaccine constructs, and the low risk-adjusted probability of the technical and regulatory success of any specific vaccine, they simply may not pick the winner(s).
Additionally, both the time and costs of ultimately meeting the world’s needs will likely increase with highly fragmented pursuits of countermeasures against the virus. Countries may make redundant investments; fail to efficiently harness global capacities for sourcing key supplies, vaccine production, and fill/finish facilities; and be slowed by the lack of regulatory harmonization, integrated post-marketing surveillance, and coordinated management of product liability.
Another obvious problem with the vaccine nationalism approach relates to the global nature of the pandemic. In a global economy, people, goods, and services move rapidly around the world. We have seen the devastating economic consequences of the slowdown of global trade and travel caused by the COVID-19 pandemic (CRS, 2020). There is a strong urge to get back to some semblance of normal economic and social activity, which will be difficult to attain if there remain areas of the world where the virus is circulating widely. Countermeasures to control and contain the COVID-19 outbreak are needed everywhere, not just in those countries that are able to finance and secure scarce supplies. Global solidarity in ensuring rapid access to and deployment of vaccines is not just the right approach, it is also the best strategic approach for interrupting the pandemic.
Finally, if successful vaccines are developed in high-income countries and not equitably shared with low- and middle-income countries, we will continue to see differential morbidity and mortality, as well as economic and social shocks that will further increase global inequities—and with them global instability, displacement, large-scale migration, and, ultimately, insecurity.
Access to COVID-19 Tools Accelerator
On April 24, 2020, the president of the European Commission, Ursula van der Leyen, and President Macron of France, together with the director general of WHO and a host of other development partners and heads of states issued a Call to Action for the Access to COVID-19 Tools (ACT) Accelerator (ACT-A) (WHO, 2020c). At subsequent pledging events on May 4, 2020, and June 27, 2020, a wide range of countries, industries, civil society, and development partners pledged significant resources to support
The ACT-A is a global initiative to:
speed up an end to the pandemic by supporting the development and equitable distribution of the tests, treatments and vaccines the world needs to reduce mortality and severe disease, restoring full societal and economic activity globally in the near term, and facilitating high-level control of COVID-19 disease in the medium term. (WHO, 2020a)
The ACT-A initiative is primarily a coordinating mechanism to bring together governments, health organizations, scientists, businesses, civil society, and philanthropists for concerted action in order to efficiently pair resources with the organizations best placed to accelerate and deploy the key countermeasures needed to address the COVID-19 pandemic. The initiative has three “pillars” focused on vaccines, therapeutics, and diagnostics, as well as a health systems “connector” that focuses on identifying and solving the limitations of weak health systems that may delay or frustrate the effective delivery of these vital countermeasures. One of the early benefits of this initiative has been its ability to consolidate an “investment case,” highlighting the resource needs required to accelerate the global availability of COVID-19 tools (WHO, 2020a,b,c). The vaccine pillar of the ACT-A estimates a need of $15.9 billion over the next 18 months to secure two billion doses of vaccines for global use by the end of 2021. The vaccine pillar of ACT-A, also referred to as COVAX, is convened by CEPI and Gavi, the Vaccine Alliance (2020c). CEPI is leading the development of a robust portfolio of vaccine development partnerships. They currently have 10 separate partnerships with a range of companies and, if fully financed, will have potentially the largest portfolio of COVID-19 vaccines under development, increasing the likelihood that one or more will achieve technical and regulatory success. Gavi, the Vaccine Alliance is leading the work on vaccine procurement and financing. Together, CEPI and Gavi, the Vaccine Alliance are working closely with WHO and its Strategic Advisory Group of Experts (the apical vaccine advisory body within WHO), which is leading the development of a framework for fair and equitable allocation and prioritization of COVID-19 vaccines together with the member states of the World Health Assembly.
Gavi, the Vaccine Alliance’s Global Vaccine Procurement Strategy
Gavi, the Vaccine Alliance has developed a financing approach through the COVAX Facility for the global procurement of COVID-19 vaccines (Gavi, the Vaccine Alliance, 2020b). The facility is designed to provide all countries with an opportunity to participate in securing initial access to
vaccine supply sufficient to cover at least 20 percent of their population. Once an allocation of 20 percent for all countries participating in COVAX is met, additional allocations will be made to all participating countries using a weighted allocation framework that balances a country’s threat of infection and the vulnerability of its population and health system. This more complex allocation schema is described in the working draft of the Fair Allocation Mechanism for COVID-19 Vaccines Through the COVAX Facility published by WHO (2020e). WHO estimates that vaccines for 20 percent of the population should be enough to immunize frontline health care workers, other essential workers, older adults, and those with significant comorbid conditions that increase the risk of serious COVID-19 illness in most countries. Vaccines for low- and lower-middle-income countries would be financed through an advanced market commitment (AMC) funded from traditional sources of overseas development assistance. Ninety-two lower- and lower-middle-income countries are eligible for vaccine financing through the AMC. High- and upper-middle-income countries would self-finance vaccines through the facility. Gavi, the Vaccine Alliance would use these combined financing streams to issue contingent volume guarantees to specific countries to scale vaccine production, as well as to provide a strong demand signal to the vaccine industry in general. These types of market-shaping interventions have proven successful as part of Gavi, the Vaccine Alliance’s innovative financing for other vaccines needed by low- and middle-income countries over the past 20 years (e.g., the successful pneumococcal conjugate vaccine AMC [Gavi, the Vaccine Alliance, 2019]). The COVAX Facility provides all countries a mechanism to pool procurement, reduce prices, and minimize the risk of not having any effective vaccines. As of September 21, 2020, 64 higher-income nations have officially joined the COVAX Facility, including commitments from 35 countries, as well as the European Commission, representing the 27 European Union member states plus Norway and Iceland. These 64 self-financing economies are joined by 92 lower-income economies who are eligible for financial support through the AMC. A total of 156 economies, representing more than two-thirds of the global population, are now either committed to or eligible for the COVAX Facility—with more expected to follow (Gavi, the Vaccine Alliance, 2020a; WHO, 2020d). It should be noted that some of these countries also have separate bilateral partnerships with vaccine developers to acquire vaccines directly.
The United States and the COVAX Facility
Despite a long history of leadership in global health, particularly with regard to issues of global health security, the United States has yet to engage
in any significant manner in the global discussions regarding the ACT-A. On September 2, 2020, the White House announced it would opt out of the COVAX Facility.
Unfortunately, the international impression is that the United States has decided to go its own way, with its large investments through OWS tied to reservations of manufacturing capacity for exclusively domestic use. While certainly not alone among high-income countries in this type of “vaccine nationalism” approach, the speed, size, and extent of the U.S. investments with specific vaccine manufacturers may have set the example that others have followed, resulting in the fragmented global response that ACT-A and COVAX are trying to resolve.
Reasons to Support and Engage with Current Global Allocation Efforts
There are several compelling reasons why the U.S. government could reconsider engaging in the discussions on global vaccine allocation and, in particular, the ACT-A and COVAX facilities, as a complement to the efforts currently pursued through OWS.
As an Insurance Policy
Participation in ACT-A and COVAX could ensure the highest likelihood of early access to a safe and effective vaccine to prevent and interrupt transmission of SARS-CoV-2 and reduce the morbidity and mortality of COVID-19 among those most susceptible to poor outcomes. Despite having the largest investments in the broadest portfolio of COVID-19 vaccines of any nation (six vaccine partnerships announced to date with more to come), the United States has not invested in every potential vaccine construct, including some of those that CEPI has within its portfolio and that are pioneered by non-U.S. companies. In the event that the first, or most effective, vaccine emerges from the ACT-A portfolio, the United States would be negotiating late and at a disadvantage for access. In the context of OWS, a modest investment in the COVAX Facility would be a reasonable hedge, a sort of insurance policy, to ensure access to any successful COVID-19 vaccine as soon as possible, at least for the highest-risk Americans.
A Disease Threat Anywhere Is a Threat Everywhere
Shaping the global allocation of COVID-19 vaccines should be of strong interest to the United States, given its global trade interests, foreign military deployments, and vital diplomatic alliances. The reality of the global pandemic is summed up in the truism that “no one is safe until everyone is safe.” A rapid U.S. economic recovery will most certainly depend on economic
recovery elsewhere, and thus on containing the COVID-19 pandemic around the world as quickly as possible. The United States also has the scientific expertise to potentially help shape the deployment of vaccines and other countermeasures in the most effective and timely manner. Most recently, the United States has played an important role in supporting the global response to the Ebola outbreak in West Africa in 2014–2015, where hundreds of Centers for Disease Control and Prevention assignees and many American volunteers joined in a historic response to a global health crisis. Similarly, as effective medical countermeasures (MCMs) become available, a U.S. engagement would speed their effective deployment and protect Americans, at home and abroad, and their interests, in the timeliest manner.
Global Health Security Agenda
Participation in ACT-A and COVAX is an important way to help shape the future of the global health security agenda. SARS-CoV-2 will not be the last—or potentially even the most severe—global health threat to emerge. The COVID-19 pandemic, for example, does not change the likelihood of emergence of the next influenza pandemic. Three influenza pandemics occurred in the 20th century and only one has occurred thus far in the 21st century. In March 2020, the World Economic Forum stated that COVID-19 “isn’t an outlier, it’s part of our interconnected viral age,” coinciding with globalization, urbanization, and climate change (Whiting, 2020). Following the large Ebola outbreak in West Africa in 2014–2015 there was a global effort to strengthen global health security. Numerous countries undertook Joint External Evaluations, budgets for preparedness were increased, and the International Health Regulations (IHR) were strengthened. But, as highlighted by the Johns Hopkins Global Security Index and the GPMB in its 2019 report, these steps were insufficient to stop the cycle of crisis and neglect (GPMB, 2019; Johns Hopkins Bloomberg School of Public Health and Nuclear Threat Initiative, 2019). There will undoubtedly be a deeper assessment in the wake of the COVID-19 pandemic, which is the worst global health security event in over a century. Those assessments will take many forms, including through the GPMB, The Independent Panel for Pandemic Preparedness & Response, which was called for at the most recent World Health Assembly and is to be chaired by Helen Clark, former Prime Minister of New Zealand, and Ellen Johnson Sirleaf, former President of Liberia (WHO, 2020f). The ACT-A and COVAX, however, provide a specific opportunity for focused lessons to be learned about how to most effectively and quickly harness science and technology in response to an emerging global health threat. Given the scientific strength of the United States, it has much to contribute to that discussion and the strengthening of future global health preparedness.
A Historic and Successful Partnership with Gavi, the Vaccine Alliance
COVAX could be an opportunity for the United States to further strengthen its partnership with Gavi, the Vaccine Alliance, one of the United States’ highest-return development partnerships. For the past 20 years the U.S. government has been one of the largest donors supporting Gavi, the Vaccine Alliance across multiple administrations. The return on this investment has been more than 7 million lives saved from vaccine-preventable disease, and those results have garnered strong, consistent, bipartisan support. The COVAX Facility will expand Gavi, the Vaccine Alliance’s innovative financing model to additional geographic regions (the Gavi, the Vaccine Alliance Board just approved the expanded eligibility for COVAX AMC financing to 92 countries), which provides an opportunity to expand the influence of one of the largest U.S. development partnerships.
An Investment in Future Domestic Pandemic Preparedness
Participating in the global allocation of COVID-19 vaccines, including the possibility of devoting some of the reserved capacity of the U.S. supply, could be a wise investment in future domestic preparedness. Per the 2018 U.S. National Biodefense Strategy, “an interconnected world increases the opportunity for pathogens to emerge and spread so that a disease threat anywhere is a disease threat everywhere” (The White House, 2018). Recent experiences with Ebola, SARS, Zika, Middle East respiratory syndrome, Nipah, and 2009 H1N1 have indeed proven repeatedly that new pandemic threats can emerge anywhere on the globe. Rapid sharing of information about emerging pathogens is essential for early containment and the expedient development of needed countermeasures (The White House, 2018). In 2009, the United States decided to proactively dedicate 10 percent of its domestic supply of H1N1 influenza vaccine for global deployment through WHO, both for global solidarity and to ensure the continued willingness of all countries to share viral samples and genetic sequences. The impressive scientific prowess of U.S. companies and academic institutions may become impotent if their researchers cannot obtain samples of novel pathogens as they emerge. Consequently, an investment in global solidarity is not only the right thing to do, but also a wise investment in national preparedness for future outbreaks. This will be especially true if the United States follows through with its intent to withdraw from WHO in 2021 and, presumably, the IHR, a treaty obligation of WHO member states and part of WHO’s global mandate. The IHR currently provides a framework, albeit imperfect, for the sharing of information concerning emergent pathogens (WHO, 2005). Without its guarantees, the United States will be solely dependent on diplomatic goodwill. This alone is a good reason for the United States to reconsider its decision to withdraw from WHO.
An Investment in National Security
Participation in ACT-A and COVAX might be an important way to help the United States meet the ambitious national security goals laid out in its 2018 National Biodefense Strategy. More specifically, contributions to the ongoing global efforts could help the United States meet one of its goals, namely, to “ensure biodefense enterprise preparedness to reduce the impact of bioincidents” (The White House, 2018). One of the key objectives underpinning this goal is to “strengthen international preparedness to support international response and recovery capabilities” (The White House, 2018). In the context of this particular goal, the 2018 National Biodefense Strategy makes clear that it is in the United States’ national security interest to
promote increased global capacities for research, development, evaluation, manufacturing, acquisition, stockpiling, deployment, and distribution of MCMs, including through collaborative arrangements,” and to “develop appropriate plans and agreements to facilitate the rapid international deployment and distribution of MCMs under the appropriate regulatory mechanisms, or for the rapid development, including clinical trials, of investigational MCMs during a crisis. (The White House, 2018, p. 21)
Even a comparatively modest investment in the ACT-A and COVAX Facility might allow the United States to quickly and most effectively meet key national security goals laid out in the 2018 National Biodefense strategy, while still pursuing separate bilateral partnerships with vaccine developers.
A Moral Duty
Re-engaging in discussions on global vaccine allocation, in particular with ACT-A and the COVAX Facility, would allow the United States to maintain its historical position as a leader in global health. The United States has earned this leadership position through long-standing successful humanitarian engagements across the globe, with strong bipartisan support in Congress across both Republican and Democratic administrations. The historic eradication of smallpox in the 1980s could not have happened without strong international partnerships and, importantly, U.S. leadership.
More recently, by providing logistical, technical, and financial support, including the purchase of vaccines, the U.S. government has been instrumental in the ongoing global efforts to eradicate polio (Bristol, 2012). Amid the catastrophic COVID-19 pandemic, the United States should consider it a moral duty, as a leading nation and member of the G7/G20, to embrace its humanitarian legacy by re-engaging and leading on the international stage in support of lower-resourced nations.
While the U.S. government works tirelessly to develop and eventually distribute safe and effective vaccines within its own borders, it is important to note that an inequitable distribution of vaccines among countries will ultimately fail to eliminate the risk of new outbreaks in the future. The U.S. government has made multiple large investments in a broad portfolio of COVID-19 vaccine partnerships. It is possible that several vaccines may succeed in achieving technical and regulatory success, including some that may not be included in the COVAX portfolio. It should be a matter of global health and national security that the United States embrace its long-held leadership role on the international stage and support ongoing global vaccine access strategies, such as the ACT-A and the COVAX Facility.
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