Katherine Bliss and J. Stephen Morrison. "Call to Action: Global Coordination to Scale Up Access to Covid-19 Therapies." CSIS Commission on Strengthening America's Health Security, Center for Strategic and International Studies, January 13, 2022. Accessed May 11, 2022. https://healthsecurity.csis.org/articles/call-to-action-global-coordination-to-scale-up-access-to-covid-19-therapies/
More than two years into the Covid-19 pandemic, there is a glaring global gap in the availability and distribution of effective Covid-19 therapies. This is exacerbated by a parallel gap in testing that makes it difficult for those with Covid-19 symptoms to access available treatments in a timely manner. A promising moment has arisen to make significant progress in advancing these essential companions: tests and therapies.
As it has become clear that fighting Covid-19 will involve a long war against a virus with multiple variants, therapies have emerged as an important weapon in the pandemic arsenal, paired with expanded testing. While equitable access to Covid-19 vaccines, including boosters, remains by far the most important intervention, it is no less critical that all people in every country have affordable access to Covid-19 tests and the full range of Covid-19 therapies that are available. As the world gains a greater understanding of how variants can evade vaccine-induced immunity, and how rapidly that immunity may wane, the vital role of tests and therapies is even better appreciated.
In the United States, access to Covid-19 diagnostics has improved since 2020 but is still not sufficient to meet demand, and investments in research and development of therapies have lagged far behind those dedicated to vaccine research and development. However, there have been several promising developments, and there are currently more than 330 treatments in development. These potential treatments utilize a variety of technology platforms to build diversification in supply and resilience and to mitigate drug resistance. They also involve “repurposed” treatments (medicines already in use or being investigated for treating other diseases), as well as drugs specifically designed to treat Covid-19.
Recognizing the need to prioritize prospects in the face of limited field trial capacity, the National Institutes of Health (NIH) launched the Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) partnership in April 2020 to coordinate research and fast-track promising treatments. In February 2021, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for Eli Lily’s monoclonal antibody therapies, bamlanivimab and etesevimab, and in May 2021 GSK-Vir received an EUA for the antibody sotrovimab, the only authorized monoclonal antibody treatment that retains activity against all current variants of concern, including Omicron. In June 2021 the United States announced the $3.2 billion Antiviral Program for Pandemics (APP), overseen by the National Institute of Allergy and Infectious Diseases (NIAID), with a focus on accelerating drug discovery and development. That was followed by the Biden administration’s $65.3 billion Pandemic Preparedness Plan, which proposes at least $11.8 billion for antiviral drug development, along with a focus on financing for therapies supply chains, stockpiles, and regulatory capacity.
In December 2021, the FDA granted an EUA to Pfizer’s experimental antiviral tablet, Paxlovid, which is reported to reduce the risk of hospitalization and death from Covid-19 in high-risk patients by 89 percent when administered within the first three days after the onset of symptoms. The United States has already committed to purchase 20 million treatment courses of the tablets. The FDA has also granted an EUA for Merck’s molnupiravir, an oral treatment from Merck & Co. Inc. and Ridgeback Biotherapeutics, reported to reduce hospitalization and death by 30 percent in individuals at high risk of hospitalization or death from Covid-19.
But despite progress in the financing, development, authorization, and licensing of Covid-19 therapies, there is still an urgent need to strengthen global coordination related to Covid-19 testing and therapies. One area is the international coordination of upstream research and development, including field trials. A second is regulatory harmonization and mutual recognition, including EUA processes, to expedite efforts to get therapies to patients who need them.
Any effort to rapidly scale up production in the United States and across diverse world regions will also require addressing supply chain constraints and improving consensus and coordination among governments and industry. To make their pills available in low-income countries, both Pfizer and Merck have reached agreements with the United Nations–backed Medicines Patent Pool to grant sublicenses to regionally based manufacturers. But production of these antiviral treatments in high-, middle-, and low-income countries alike will take time to scale up and meet demand, with Pfizer recently projecting that it will be able to produce just 120 million courses of the treatment through the end of 2022.
And to be effective, the push to expand access to Covid-19 therapies in all countries highlights the need for a comprehensive global surveillance and testing strategy. Indeed, if testing lags, it could become a major barrier to the successful uptake of therapies or lead to their misuse and the development of drug resistance.
The potential for drug resistance will require the development of combination therapies, made possible only through greater cooperation across industry, government, academia, and philanthropy. Lessons from several decades of global work developing effective combination therapies for HIV and tuberculosis (TB) underscore the importance of incentivizing pharmaceutical manufacturers to work together, in cooperation with government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), as well as the academic research community, to determine the ways in which combining their products may be most effective.
Undoubtedly, any expanded focus on therapies will also encounter significant political challenges, including fatigue about financing further pandemic response capacity and systemic misinformation driven by the dissemination of rumors and conspiracy theories via social media. There is already a formidable movement advocating for the use of non-proven medications such as ivermectin, a broad-spectrum anti-parasitic therapy that has gained popularity as an alternative treatment for Covid-19.
To bolster the research and development of a range of Covid-19 treatment options; accelerate product approvals, licensing, and production in diverse world regions; and support equitable access to Covid-19 tests and treatment options in all countries, the CSIS Commission on Strengthening America’s Health Security offers the following recommendations to the administration and Congress:
Make Covid-19 testing and treatment access among the highest global priorities.
The United States should prioritize an international operational planning and budgeting effort and press for increased and sustained funding for Covid-19 therapy research, including “end-to-end” research to develop, ensure access to, and deliver effective Covid-19 therapies, paired with a parallel testing effort.
There are currently no budget lines for testing or therapies in the U.S. international global health security accounts. The Access to Covid-19 Tools Accelerator envisions that treating 120 million cases in low-income, lower-middle-income, and some upper-middle-income countries will require up to $3.5 billion for the period from October 2021 to September 2022 (some funds originally provided to the Global Fund may be available for use on authorized therapies in 2022). The White House Global Covid-19 Summit encouraged up to $3 billion in commitments through 2022. If the U.S. commitment is roughly one-quarter of the global estimates, which were derived using U.S. estimates, that suggests a budget line for therapies of approximately $750 to $762 million. The White House will need to devote attention to the task of winning higher commitments from Congress over multiple years to meet the $11.8 billion goal over the next decade while pressing other G7 and G20 countries to prioritize funding for global Covid-19 testing and treatment efforts.
Designate a lead U.S. agency.
The United States should designate a lead federal agency, working closely with the White House, to coordinate international assistance on Covid-19 tests and therapies.
Until now, U.S. government efforts on Covid-19 therapies have been carried out by a handful of agencies within the Department of Health and Human Services (HHS). The NIH leads work on research and the ACTIV field trials, in coordination with BARDA and the FDA, while the U.S. Centers for Disease Control and Prevention (CDC) provides guidance on the use of available therapies. But as more Covid-19 treatments are authorized and efforts to produce and deliver them globally scale up, a new set of agencies will assume greater importance.
The U.S. Agency for International Development (USAID) is well situated to lead U.S. bilateral efforts to support countries in distributing Covid-19 therapies and can incorporate funding such activities into its existing Covid-19 response strategy. But in doing so, it should work in coordination with HHS and other federal agencies. BARDA should continue to lead U.S. efforts to accelerate testing and treatment development and support expanding the industrial base for manufacturing in the United States. The CDC can play a key role in researching, standardizing, issuing recommendations for, and promoting appropriate and accurate testing in countries around the world to help ensure the effective use of therapies. The U.S. Department of Defense has considerable planning, contracting, and logistics capabilities to offer to the U.S. international response. At the same time, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has considerable experience delivering antiviral therapies. Its role representing the United States on the board of the Global Fund, which currently finances the greatest amount of non-vaccine Covid-19 interventions for low- and lower-middle-income countries, points to a prominent role for PEPFAR in helping to ensure U.S. bilateral approaches to Covid-19 testing and treatment complement multilateral agencies’ strategies.
Strengthen diplomatic engagement and coordination.
The United States should use upcoming meetings, including the heads of state summit planned for early 2022 and the Global Fund replenishment, which it will host in the second half of 2022, to actively press for greater support for Covid-19 therapies research, development, production, and distribution.
At the Global Covid-19 Summit in late September 2021, the White House urged global alignment around ensuring low- and lower-middle-income countries’ access to high-quality, safe, and effective therapies in 2021, along with strengthening those countries’ access to treatments as new products come online in 2022. The summit also called for the establishment of a mechanism for equitable therapies procurement and delivery. Building on the summit discussions, the United States should argue for empowering existing intuitions that already have experience delivering antivirals to low- and lower-middle-income countries, such as the Global Fund, to use expanded resources and play a leading role in activities focused on distributing tests and therapies to eligible countries, keeping in mind the importance of sustaining existing support for initiatives focused on HIV, TB, and malaria.
Additionally, in anticipating the challenge of drug resistance, the United States should engage global partners in coordinating incentives for pharmaceutical manufacturers to cooperate with each other and with government and the academic research sector in developing combination therapies.
Launch a Covid-19 therapy communications initiative.
The United States should launch a special global communications initiative, led by the CDC and in partnership with USAID, to train health workers at the community level to communicate clearly about the roles of Covid-19 testing and treatments (alongside vaccination).
At home and abroad, there is an urgent need to develop far more sophisticated and effective social media tools and communications programs to combat misinformation, disinformation, and politicization of Covid-19 therapies that impede uptake of proven therapies. Existing U.S.-supported programs, such as the Field Epidemiology Training Program (FETP) and Stop Transmission of Polio (STOP) activities, could be expanded to include a focus on communications for Covid-19 therapies. Networks of practitioners including the FETP and the Task Force for Global Health, along with the CORE Group Polio Project, could also be mobilized to train health workers and support efforts to de-politicize therapies for Covid-19.
As the Covid-19 pandemic moves into its third year, ensuring all populations, in all countries, and at all income levels, have affordable access to Covid-19 tests and treatment has become an urgent priority. The United States has taken important steps to support research and development, as well as regulatory authorization, of Covid-19 therapies domestically, but much more needs to be done in the global context to advance access to the essential companions: tests and therapies. That will depend on greater international financing of research and development on therapies; convening global efforts to harmonize countries’ regulatory processes and strengthen their production capacities; and supporting health systems in testing for, treating, and communicating about Covid-19. Parallel gains in these areas will both respond to immediate needs and lay the groundwork for long-term pandemic preparedness and response.
Asaf Bitton is the executive director of Ariadne Labs, a joint center for health systems innovation at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health.
Katherine E. Bliss is a senior fellow and director of immunizations and health systems resilience with the CSIS Global Health Policy Center.
Susan W. Brooks is an accomplished former congresswoman and former U.S. attorney who has driven key legislation to reform emergency response, healthcare, manufacturing, technology innovation, higher education, and public safety.
Rear Admiral (Ret.) Thomas R. Cullison is a senior associate with the CSIS Global Health Policy Center. During his 38-year naval career, culminating as deputy surgeon general of the Navy, he was active in disaster management, international health engagement, graduate medical education, and health policy.
Ambassador Mark Dybul is the faculty director of the Center for Global Health Practice and Impact at the Georgetown University Medical Center and previously served as head of both the Global Fund to Fight AIDS, Tuberculosis and Malaria and PEPFAR.
Nikolaj Gilbert is the president and chief executive officer of PATH and managing director of PATH’s Swiss subsidiary, Foundation for Appropriate Technology in Health.
Mark Godfrey is the director of global public policy at Eli Lilly and Company.
Margaret “Peggy” Hamburg is interim vice president of global biological policy and programs at the Nuclear Threat Initiative and previously served as commissioner of the U.S. Food and Drug Administration (FDA) from 2009 to 2015.
Rajesh Gupta is the vice president of the global health portfolio and public-private partnerships at Vir Biotechnology Inc.
Ambassador Karl Hoffman is the president and CEO of Population Services International (PSI) and was previously a career American diplomat for 23 years.
Seth G. Jones is a senior vice president, Harold Brown Chair, director of the International Security Program, and director of the Transnational Threats Project at CSIS.
Shira Kilcoyne is the director of international government affairs at GSK.
Ramneek Mahal is the vice president of global corporate government affairs and policy at GSK.
J. Stephen Morrison is a senior vice president at CSIS and director of its Global Health Policy Center.
Adrienne Parrish-Fuentes is the director for global health policy at Thermo Fisher Scientific.
This call to action conveys a majority consensus of the signatories who are participating in their individual capacity, not as representatives of their respective organizations. No expert is expected to endorse every single point contained in the commentary. In becoming a signatory to the commentary, panelists affirm their broad agreement with its findings and recommendations. Language included in this commentary does not imply institutional endorsement by the organizations that participants represent.
Special thanks to the participants in the CSIS commission’s meetings on Covid-19 therapies in the fall of 2021; to Humzah Khan and Michaela Simoneau for their support of the CSIS Commission on Strengthening America’s Health Security and the commission’s Covid-19 Therapies Working Group; and to Courtney Burks and Michael Rendelman for their research assistance.
This commentary is a product of the CSIS Commission on Strengthening America’s Health Security, generously supported by GSK.
Commentary is 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).
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