Since Day One, the Biden-Harris Administration has worked to ensure the United States is better prepared for the next pandemic. U.S. national security and prosperity depend on countries around the world being prepared to prevent outbreaks when possible, and to rapidly detect and respond to emerging infectious disease threats when they occur. Detecting infectious disease threats quickly, and sharing that information widely, is critical to limit global transmission, and to rapidly develop necessary diagnostics, vaccines, treatments, personal protective equipment, and other countermeasures. Once available, facilitating equitable domestic and global access to medical countermeasures, like vaccines, tests and treatments, is the best way to minimize global morbidity and mortality, as well as to reduce economic and other disruptions. Collectively, these actions will make the United States, and the world, safer from the risk posed by pandemics and other biological events.
Coupled with broader investments in health, the United States is supporting countries around the world to expand access to quality medical countermeasures (MCMs), including vaccines, tests, and treatments, to end long-standing threats such as HIV, growing threats such as measles, and novel threats like COVID-19. These investments built on decades of global health and health security leadership by the United States. In the first three years of the Biden-Harris Administration, the United States invested nearly $32 billion globally to: better prepare for the next pandemic; fight existing epidemics like HIV/AIDS, tuberculosis (TB), and malaria; and ensure high-need communities have access to essential health services like routine childhood immunization and maternal and child healthcare. Starting in 2021, the United States also invested $16 billion in the global COVID-19 response, including sharing nearly 700 million COVID-19 vaccine doses with countries around the world. The President's FY 2025 Budget includes nearly $10 billion to continue these investments in critical global health programs, strengthen health systems, and enhance pandemic preparedness.
The Biden-Harris Administration remains committed to expanding access to MCMs around the world, including through investments in innovation, research and development; building sustainable global manufacturing and supply chain capacity; providing vaccines, tests and treatments and support for their delivery; expanding pandemic response financing for MCMs; and strengthening legal and regulatory systems. Examples include:
Investing in Innovation, Research and Development
The U.S. government invested billions of dollars in mRNA technology in advance of the COVID-19 pandemic. These public investments translated into millions of lives saved in the United States and around the world, and were crucial to developing the mRNA vaccine technology that can be leveraged in a future pandemic, as well as potentially treating other diseases.
The Biden-Harris Administration's historic investments in science and technology, from basic science to piloting innovative financing mechanisms to real-time research during health emergencies, are transforming the tools and approaches we use to detect, contain and respond to health threats. This work is often done in partnership with biopharmaceutical innovators and manufacturers that have unique roles to play in global health security. Examples include:
- Public-private partnership on the Ebola virus. Public-private partnerships through the Biomedical Advanced Research and Development Authority (BARDA), resulted in a licensed Ebola vaccine, two licensed monoclonal antibody treatments, and one cleared diagnostic for Ebola; technologies that are now being applied to other viruses such as Marburg.
- Support for the Coalition for Epidemic Preparedness Innovations (CEPI), which is working to accelerate the development of life-saving vaccines against emerging disease threats, and to transform capability for rapid countermeasure development in response to future threats. Notable achievements include: the market authorization of the world's first Chikungunya vaccine; the advancement through clinical development of vaccine candidates against Lassa, Nipah, and coronaviruses, among others; and the launch of a new Disease X Vaccine Library with six viral families prioritized as high risk.
- Innovation in TB and HIV prevention and treatment. Pretomanid, a treatment for drug-resistant TB, developed with support from the National Institutes of Health (NIH) and the U.S. Agency for International Development (USAID), has reduced TB treatment time from up to 18 months to 6 months and dramatically improved outcomes. New long-acting HIV/AIDS prevention options such as cabotegravir, a single bi-monthly injection, could avert many new future HIV infections in low- and middle-income countries. The dapivirine vaginal ring, a long-acting HIV prevention tool, is a breakthrough innovation that offers women another method of discreet protection.
- New products to address drug-resistant infections. BARDA is investing over $2 billion in new products to address drug-resistant infections that have resulted in 10 therapeutics and diagnostics receiving Food and Drug Administration (FDA) approval or clearance and revitalizing late-stage antimicrobial product development across dozens of products for both adults and children.
Building Sustainable Global Manufacturing and Supply Chain Capacity
The United States is investing in sustainable and resilient global medical manufacturing and supply chain capacity. Robust systems for production and delivery of MCMs not only helps improve health - ensuring more people are able to routinely receive life-saving vaccines and therapeutics like antiretrovirals (ARVs) - they also serve as an essential foundation for effective emergency response. Sustainable systems must provide the infrastructure, resilience, quality assurance, operational efficiency, steady demand, and public confidence necessary to respond promptly and effectively to emergencies while ensuring the continuity of essential healthcare services. Examples of United States investments in sustainable manufacturing systems include:
- U.S. Development Finance Corporation (DFC) finances and catalyzes investments by the private sector and other development finance institutions in health commodity manufacturing and supply chain for MCMs in developing countries, with a focus on Africa. DFC, along with International Finance Corporation and other like-minded development finance institutions (DFIs), is supporting the Institut Pasteur de Dakar in Senegal to become a key hub in the African Union's vaccine production network. DFC previously provided a $3.3 million technical assistance grant for early-stage project development and is evaluating additional financing for expansion of the industrial-scale facility. DFC is also working with peer DFIs to provide working capital to regional manufacturers to enable producers to pivot and scale up efforts during a health emergency.
- Accelerating the expansion of vaccine manufacturing in Africa. The United States is supporting Gavi, the Vaccine Alliance (Gavi), working in collaboration with the Africa Centres for Disease Control and Prevention (Africa CDC), to establish the African Vaccine Manufacturing Accelerator, a $1 billion advanced market commitment financial instrument that would provide financial support over the next ten years to accelerate the expansion of commercially viable vaccine manufacturing in Africa.
- Sourcing MCMs from African manufacturers. The United States is sourcing MCMs from African producers to address African needs through programs such as the President's Emergency Plan for AIDS Relief (PEPFAR) and the President's Malaria Initiative (PMI). PEPFAR aims to procure 15 million HIV tests produced in Africa by 2025, and work alongside other partners to shift 2 million patients on first-line ARV treatments to African-produced products. Since 2023, PEPFAR has procured nearly 100,000 HIV tests from the Africa-based manufacturers towards that goal, and has worked with the World Health Organization (WHO), the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) and Unitaid to launch an open Expert Review Panel for Diagnostics for African manufacturers of HIV rapid tests to accelerate the availability of HIV rapid tests produced in Africa. PMI is committed to building a more resilient supply chain and is leveraging its procurement volume to accelerate growth in African regional manufacturing. PMI is actively working, in coordination with partners like the Global Fund and Medicines for Malaria Ventures, to increase the number of African suppliers they procure from and their share of PMI's total procurement. In FY 2023, PMI doubled the share of its procurements sourced from Africa to 10 percent.
- Medical supply chain studies in the Americas Region. Through the Americas Partnership for Economic Prosperity, the United States is working closely with the Inter-American Development Bank to carry out supply chain competitiveness studies in three critical sectors: clean energy, semiconductors, and medical supplies.
Providing Vaccines, Tests and Treatments and Supporting Delivery
The Biden-Harris Administration provides MCMs for ongoing and emergency health threats, and makes significant long-term investments to support country readiness to receive, deliver and effectively use vaccines, tests, PPE and treatments. These investments range from bed nets to protect children and families from malaria, to ARVs for those living with HIV, to supporting skilled health workers, and to MCMs to support outbreak response. Examples include:
- Provision of HIV treatment. The PEPFAR program continues to support the African continent with the provision of more than $700 million in health commodities to African HIV programs in 2023, alongside the more than $2.1 billion in health commodities provided to Africa in 2023 through the Global Fund, to which the United States is the largest donor.
- Provision of and improvement in Ebola treatments. Since the 2014-2016 outbreak of Ebola in West Africa, the Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) has worked with impacted nations to supply the standard-of-care treatments for Ebola patients. In 2018, HHS made existing therapeutics available to support the international response to the second largest Ebola outbreak in history, partnering with researchers in the Democratic Republic of the Congo (DRC) on a randomized controlled trial that demonstrated superior efficacy of two therapeutics. The United States has since made those treatments available to impacted nations and WHO in every outbreak of Ebola in Africa since 2018. This includes an outbreak in Guinea in February 2021 in which U.S.-supplied therapeutic doses were available for use in a remote Guinean treatment facility less than one week after the identification of the first case.
- Public-private partnerships to deliver vaccines. Project Last Mile collaborates with regional Coca-Cola bottlers and suppliers to strengthen public health systems capacity in supply chain. This partnership between the Coca-Cola Company and Foundation, the Bill and Melinda Gates Foundation, the Global Fund, and USAID applies Coca-Cola's expertise in route-to-market, cold chain, and marketing for improved vaccine distribution and uptake.
- Responding to mpox outbreaks. The Biden-Harris Administration is currently working to make a vaccine available to African nations where mpox is endemic. For all donations, technical experts from ASPR, the U.S. Centers for Disease Control and Prevention (CDC) and NIH are supporting the recipient nation in the development of vaccination strategies based on local epidemiology. Discussions about vaccine donations are ongoing with multiple countries, including DRC, which is responding to an unprecedented surge in mpox cases.
- Supporting access to medicines in Ukraine. Since the start of Russia's full-scale war against Ukraine on February 24, 2022, the United States has focused on meeting Ukraine's urgent needs, while maintaining support for long-term development goals. For example, in March 2022, USAID rapidly expanded support for Ukraine's public health supply chain systems, enabling Ukraine to transparently and efficiently receive, distribute and account for more than $400 million in medicines and supplies donated from around the world during the first six months of the war, helping to sustain access to lifesaving medicines.
Expanding Pandemic Response Financing
Since Day One, the Biden-Harris Administration has prioritized transforming the global financing architecture to better support pandemic prevention, preparedness and response. One of the causes of disparities in delivery times for vaccines and medical countermeasures in the COVID-19 response was that many health organizations and national health systems lacked the capital they needed to place early orders with vaccine manufacturers. Ensuring funding is available to accelerate MCM access during health emergencies is vital for achieving health security.
- Supporting multilateral development bank (MDB) evolution. MDBs have a key role to play in helping countries address global challenges. The United States is working with other shareholders to evolve the visions, incentive structures, operational approaches, and financial capacity of the MDBs to equip these institutions to respond to transboundary global challenges with sufficient speed and scale. The United States and other shareholders have urged the World Bank to prioritize pandemics along with climate change and fragility, and in response it has expanded its crisis preparedness and response toolkit and announced a Global Challenge Program aimed at enhancing health emergency prevention, preparedness, and response. The United States is also exploring how the World Bank can strengthen partnerships, enable coordinated and right-timed financing in the event of a pandemic, and help client countries assess critical pandemic preparedness gaps.
- G7 partnership on surge financing. The DFC is partnering with G7 DFIs to transform institutional capacity individually and collectively to effectively provide surge financing for procurement, production, and delivery of medical countermeasures in low- and middle-income countries. This partnership is working toward the launch of at least two new DFI-led and shared MCM surge financing facilities in 2024 and is working to develop viable options, with the G7 DFIs, including the European Investment Bank and IFC, to enhance pooled procurement instruments and delivery of tests, treatments, supplies and vaccines, by the end of 2024.
- Support for Gavi's Day Zero Financing Facility. The United States has supported Gavi, the Vaccine Alliance in establishing the Day Zero Financing Facility, a suite of tools that will mobilize, for example, up to $2 billion in risk-tolerant surge and contingent capital to enable Gavi to quickly meet the demand for vaccines in a pandemic. The United States also supports the roles of CEPI, the Global Fund, and other regional and multilateral organizations in the development of analogous capacity to surge financing for MCMs.
- Support for the Access to COVID-19 Tools Accelerator (ACT-A). The United States was the world's largest donor to ACT-A and provided global leadership to raise additional billions in critical funding through the U.S.-hosted and co-hosted Global COVID-19 Summits to save lives globally, end the pandemic, and build stronger health security.
Strengthening Regulatory and Legal Systems
Under President Biden's leadership, the United States is working to promote and strengthen global regulatory and legal systems to better prepare for health emergencies and otherwise ensure the safety, efficacy and accessibility of MCMs. Examples include:
- Strengthening regulatory systems. FDA advances multi-lateral and bilateral regulatory systems strengthening by providing technical support to FDA counterparts in foreign countries and international organizations as part of cooperative regulatory activities. The United States also actively engages in diverse multilateral health and regulatory forums such as the International Coalition of Medicines Regulatory Authorities, International Convention on Harmonization of Technical Requirements for Pharmaceuticals of Human Use, and the International Medical Device Regulators Forum to inform internationally recognized technical guidance documents, standards and scientific principles, common or similar practices and procedures, related to MCMs. FDA also provides technical assistance to WHO's efforts.
- Support for the Legal Preparedness Action Package. The HHS Office of Global Affairs (OGA) and CDC co-Chair the Global Health Security Agenda (GHSA) Legal Preparedness Action Package to develop and promote guidance and capacity building tools on legal mapping, regulatory strengthening, and liability risk management with a network of experts from around the world to support efforts in strengthening legal preparedness, including to promote equitable access to medical countermeasures.
