U.S Commitment To Address Global Mpox Outbreak

We are prepared to commit at least $500 million to support African countries to prevent and respond to mpox and donate up to one million doses of mpox vaccines. We call on governments, charities and businesses to match our pledge, and make this a $1 billion commitment to the people of Africa.” – President Biden, September 24, 2024

The United States has led global efforts to combat infectious diseases, including mpox, for decades. Most recently in 2022, the Biden-Harris Administration mounted a robust response to the spread of clade IIb mpox by making vaccines available to those at risk, making testing more convenient and providing treatments to those who needed them both in the United States and worldwide.

In response to the ongoing mpox outbreak in Eastern and Central Africa, with several cases outside the region, the United States is acting quickly and decisively to support the response, and to prepare for potential cases domestically. On September 16, the White House welcomed key partners and community stakeholders working on mpox in the United States and around the world to a roundtable with U.S. Government leadership to exchange ideas, feedback and recommendations to inform the U.S. response to this global crisis.

This week, President Biden announced that the United States is committed to providingat least $500 million dollars, as well as one million mpox vaccine doses, to support African countries to prevent and respond to the current mpox outbreak.

United States investments in mpox preparedness and response will address a range of needs outlined in the Mpox Continental Preparedness and Response Plan jointly issued by the Africa Centers for Disease Control and Prevention (Africa CDC), and the World Health Organization (WHO), including training frontline health workers, disease surveillance, laboratory diagnostic supplies and testing, clinical case management, risk communication and community engagement, infection prevention and control, and research.

In addition to financial support and vaccines, the U.S. Government has surged dozens of staff, including epidemiologists, laboratorians, and risk communication experts to offer support to the mpox response in DRC and each of the countries surrounding DRC.

BUILDING STRONGER, RESILIENT HEALTH SYSTEMS

Investments in building stronger health systems are essential to a rapid and effective emergency response. Longstanding United States support, including through the President’s Emergency Plan for AIDS Relief (PEPFAR), helped to strengthen the systems that are now supporting the mpox response.

• Ongoing global health and health security investments – Since the start of the Biden-Harris Administration, the United States is said to have provided more than $50 billion to support global health and health security. The United States is the largest health donor in the Africa region, allocating more than $2.65 billion in bilateral health funding to countries in Central and Eastern Africa in FY 2023 alone.

• Global health security partnerships – In April 2024, the United States announced formal global health security partnerships with 50 countries, including Burundi, DRC, Kenya, and Uganda. Global health security investments make it possible for the United States to address country-identified gaps in their capacity to prevent, detect, respond to, and recover from health security threats. U.S. assistance to the government of DRC, which began in 2015, has bolstered the DRC’s efforts to contain five Ebola outbreaks since 2020, develop an antimicrobial stewardship work plan, and develop a community feedback system to address infectious disease threats.

• President’s Emergency Plan for AIDS Relief (PEPFAR) – For over 20 years, PEPFAR has supported more than 55 countries worldwide, saved more than 25 million lives, enabled 5.5 million babies to be born HIV-free, and prevented millions of new HIV infections. Longstanding PEPFAR investments in creating sustainable HIV care platforms have been leveraged for quick and effective response to cholera, COVID-19, Ebola, H1N1 influenza, tuberculosis, and other health threats. Given the increased risk of severe morbidity and mortality from mpox among people living with HIV, PEPFAR is ensuring program continuity to protect people living with HIV through the use of existing PEPFAR platforms through risk communication, laboratory and surveillance capacity, referral to care, HIV testing, and vaccination delivery to help prevent and respond to mpox.

SUPPORTING MPOX TESTING, VACCINATION, TREATMENT AND CARE

• Mpox vaccine research and development – Since 2007, the United States, through the Department of Health and Human Services (HHS), has invested more than $2 billion in the JYNNEOS vaccine as part of smallpox preparedness. Additionally, U.S. Government research institutions led the development of the JYNNEOS vaccine through preclinical evaluation, clinical trials, and advanced clinical evaluation platforms. These investments directly led to product licensure for both smallpox and mpox. On September 13, WHO announced pre-qualification of the JYNNEOS vaccine for global use, including in the Africa region in response to ongoing mpox outbreaks.

• Mpox vaccine donation – This week President Biden pledged that the United States will donate up to one million doses of the mpox vaccine. The first U.S.-donated vaccine doses arrived in Nigeria in August (10,000 doses), and in DRC in September (50,000 doses). The next installment of the U.S. commitment, 300,000 vaccine doses, will be available immediately for disbursement in coordination with Gavi, the Vaccine Alliance and the WHO Access and Allocation Mechanism. Additional mpox vaccine doses will be delivered in tranches (totaling up to one million) pending country progress in administering the vaccines, in coordination with Gavi.

• Clinical care and protecting health workers – In DRC, the U.S. Government has procured and delivered medical kits containing antibiotics, oral hydration, and wound care supplies to support government facilities to offer mpox patients relief from their symptoms free of charge, which bolsters community trust and connection with the health care system. The U.S. Government is expanding health care worker capacity to treat mpox and offer psychosocial support to patients, while simultaneously training the workers to protect themselves through use of infection prevention and control best practices.

• Diagnostic tests and training – The U.S. Government is also supporting mpox-affected countries with laboratory expertise and diagnostic supplies. This includes: providing over 40,000 individual test assays and reagents that ensured that countries in the region had the capacity to detect clade I mpox when it crossed their borders; training dozens of laboratory personnel on the use of mpox test kits and procedures to enhance laboratory safety, hygiene, and waste management; strengthening the reach and availability of rapid diagnostic testing capacity; expanding specimen transportation routes; and establishing platforms for laboratory data management.

• Development and testing of effective therapeutics – The United States Government is leading the ongoing “Study of Tecovirimat for Human Mpox Virus” clinical trial for mpox treatment in the United States and other countries affected by clade II mpox.

• Identifying mpox research priorities. To help prioritize mpox research, the United States released an update on mpox research priorities, focusing on four objectives: (1) increasing knowledge about the biology of all clades, including how the virus is transmitted and how people’s immune systems respond to it; (2) evaluating dosing regimens of current mpox vaccines to stretch the vaccine supply and developing novel vaccine concepts; (3) advancing existing and novel treatments, including antivirals and monoclonal antibodies; and (4) supporting strategies for detecting the virus to facilitate clinical care and epidemiological surveillance.

LEVERAGING STRONG MULTILATERAL PARTNERSHIPS

As with investments in health systems, building stronger and more effective multilateral institutions between emergencies is essential to ensuring the world is prepared to respond effectively in times of crisis. The United States supports the critical roles of WHO and Africa CDC in leading the mpox response, and we call on those institutions to utilize the strong partnerships that are already in place, including with other multilateral institutions, to protect the health and wellbeing of people living in the affected countries.

• World Health Organization – Among his first acts in office, President Biden declared the United States would reengage with WHO, highlighting our nation’s commitment to advancing multilateral cooperation in a global health crisis. Beyond health emergencies, the United States is collaborating with WHO on a wide range of global health issues such as childhood immunization, nutrition, polio eradication, and strengthening the global health workforce to achieve universal health coverage. Since the beginning of the Biden-Harris Administration, the United States has provided nearly $1.9 billion of support to WHO. In addition, since March 2024, the United States has already provided more than $7.7 million to WHO to support mpox response activities, and $450,000 for building sustainable capacity for mpox elimination in DRC, Burundi, Central African Republic, Republic of Congo, Rwanda, and Uganda.

• Africa CDC – The United States welcomes and supports the role of Africa CDC as a continent-wide public health institution, established in 2016. In 2022, the U.S. Government signed a Memorandum of Cooperation to Promote Public Health Partnership with the African Union, accompanied by a U.S.-Africa CDC Joint Action Plan outlining shared global health priorities and areas for collaboration. In addition to substantial U.S. bilateral and multilateral support aligned with Africa CDC’s five-year strategic plan and Agenda 2063, the United States provided more than $3 million in direct support to the Africa CDC in the form of in-kind assistance last year alone.

• Gavi, the Vaccine Alliance – Gavi holds essential expertise in effective vaccine procurement, distribution, and administration, which should be leveraged immediately in the mpox response. Since its inception in 2000, the United States Government has invested or announced: 1) over $3.6 billion to improve equitable access to new and underutilized vaccines in low- and middle-income countries; 2) a $4 billion dollar contribution to Gavi’s COVAX Advance Market Commitment; 3) an annual contribution to Gavi’s core budget, including $300 million in 2024 ; 4) and pledged at least $1.58 billion towards USG’s first-ever five-year pledge to Gavi’s next replenishment cycle, subject to Congressional approval. U.S. funding is included in Gavi’s $500 million First Response Fund, which is supporting procurement, delivery, and deployment of 500,000 JYNNEOS doses in response to the mpox outbreak. Finally, affected countries, WHO, Africa CDC, and Gavi recently established the Access and Allocation Mechanism (AAM) as a platform to increase equitable access to mpox response resources and contributions.

• The Quad – The Quad partnership was established in 2020 between the United States, India, Japan and Australia as a global force for good, including working together to help partners address pandemics and disease. During a September 21 Quad Summit, leaders agreed to coordinate efforts to promote equitable access to safe, effective, quality-assured mpox vaccines, including where appropriate expanding vaccine manufacturing in low and middle-income countries.

• Coalition for Epidemic Preparedness Innovations (CEPI) – CEPI 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.To date, the U.S. Government has invested $117 million through CEPI to accelerated the development of vaccines and other biologic countermeasures against epidemic and pandemic threats. CEPI has funded two scientific studies in Africa (the DRC and Uganda) focused on the JYNNEOS vaccine; it has also supported early clinical development of BioNTech’s next-generation mRNA-based pox vaccine and providing funding to support Bavarian Nordic’s MVA-BN® mpox vaccine clinical trials in DRC, Uganda, and Nigeria through the SMART trial.

• The Global Fund to Fight AIDS, Tuberculosis and Malaria – The Global Fund is working to defeat HIV, TB and malaria and ensure a healthier, safer, more equitable future for all. The U.S. is the largest donor to The Global Fund, and President Biden led the largest Global Fund replenishment ever in 2022. In August 2024, in response to the evolving mpox outbreak, the Global Fund quickly pivoted to update its guidance in order to direct grant funds to help eligible countries to prevent, detect, and respond to mpox outbreaks. Earlier this month, Global Fund committed an additional $9.5 million to support DRC’s mpox response.

• UNICEF – As the lead UN agency for children, UNICEF works in over 190 countries to save children’s lives and to support health and development. To date, the U.S. has provided UNICEF with more than $1.4 million to support clade I mpox preparedness and response activities in DRC, Burundi, and the Republic of Congo. UNICEF supports risk communication and community engagement, clinical services, psychosocial support, and coordination.

• United Nations High Commission for Refugees (UNHCR) – As the lead UN agency for refugees, UNHCR provides vital protection and assistance to refugees, asylum-seekers, internally displaced and stateless people. Through UNHCR, the United States has provided nearly $9 million in humanitarian assistance this year to address urgent mpox-related needs among refugees, internally-displaced persons, host communities and other vulnerable populations in 14 countries throughout Africa.

• International Federation of Red Cross and Red Crescent Societies (IFRC) – IFRC is the world’s largest humanitarian network working in more than 190 countries through a network of more than 16 million volunteers. To date, the U.S. Government has provided IFRC with $800,000 to support clade I mpox preparedness and response activities in DRC. IFRC supports risk communication and community engagement, clinical services, psychosocial support, and coordination.

EXPANDING HEALTH EMERGENCY FINANCING

In addition to ongoing bilateral and multilateral support to build stronger health systems, respond to ongoing health challenges, and pivot to address the current mpox crisis, the United States supports expanded sources of financing for response to health emergencies. Many of these have been developed and launched since the COVID-19 pandemic to address gaps identified through that response.

• The Pandemic Fund – As the only multilateral fund fully focused on prevention and preparedness, the Pandemic Fund has a critical role to play in building capacity to end the current outbreak and prevent the next one. The Pandemic Fund has taken quick action to support mpox preparedness efforts, approving $129 million to support 10 countries impacted by the disease to strengthen laboratory, surveillance, and human resources capacities. The selected projects meet needs articulated in the joint WHO-Africa CDC Mpox Continental Preparedness and Response Plan for Africa. The awards will be implemented over multiple years enabling an effective transition from crisis to long term preparedness. To continue its critical work, the Pandemic Fund is engaged in a concurrent resource mobilization round, with the goal of raising at least $2 billion in new funding through 2026. The United States has committed to provide up to $667 million, subject to Congressional appropriations and the availability of funds.

• 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.

• U.S. Development Finance Corporation (DFC) Health Emergency Financing: The DFC finances private-sector led solutions to health services, supply chain, and technology challenges in low- and middle-income countries. These solutions improve health system resilience and pandemic preparedness through: 1) a $1 billion-dollar rapid financing facility applicable to a full spectrum of vaccines (COVID-19, childhood vaccine-preventable diseases, and future outbreaks); 2) investments in regional, Africa-based vaccine manufacturing, including Aspen Pharmacare (South Africa) and Institute Pasteur de Dakar (Senegal); and 3) a G7 Surge Financing Initiative for Medical Countermeasures that supports Gavi and regional vaccine manufacturers.

• Multilateral development bank (MDB) evolution. MDBs have a key role to play in helping countries address global challenges, such as climate change, pandemics, and fragility and conflict. 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 global challenges with sufficient speed and scale. The United States is pleased to see the close coordination between the World Bank, IMF, and regional development banks with WHO and affected countries on how to best utilize or reprogram resources to aid the mpox response.