Biden Admin Reaffirms Global Mpox Outbreak Response

For decades, the United States has been a leader in combatting infectious diseases. During the 2022 global outbreak of clade II mpox, the Biden-Harris Administration mounted a robust response by making vaccines, tests, and treatment available to those at risk in the United States and abroad. Now, the Democratic Republic of the Congo (DRC) is experiencing its largest mpox outbreak ever recorded, with more than 50,000 suspect cases in 2024. Multiple neighboring countries have confirmed their first ever mpox cases, and some are also experiencing widespread outbreaks. A handful of travel-related cases have also been recorded in countries outside the Africa region. As we face this outbreak in Central and Eastern Africa, the United States is again acting quickly to respond. At the UN General Assembly in September, President Biden announced that the United States is prepared to commit at least $500 million and to donate up to one million doses of mpox vaccines to support African countries in preventing and responding to this outbreak. We are delivering on that commitment, with two-thirds of our global mpox funding pledge fulfilled, and all of our pledged vaccine doses available now for countries that are ready to receive the doses.

The United States is also prepared to respond to clade I and clade II mpox cases domestically, with early detection and a robust testing landscape across the country, increased clinician education and community outreach, and widely available mpox vaccines in retail pharmacies and clinics. Travel-associated cases have been detected in Canada, Germany, India, Sweden, Thailand, and the United Kingdom. In November 2024, the United States also identified one case of clade Ib mpox in a California resident who had recently traveled to an affected country. No further domestic detections have occurred as of December 5, 2024, and the risk to the general public remains low.

Update on the United States' Support for the Global Mpox Response

The Biden-Harris Administration is working closely with countries, as well as regional and global partners, to address the mpox outbreak in Central and Eastern Africa.

President Biden's announcement of United States' support to the global mpox response aligned with the United States' longstanding partnership with countries around the world to prepare for health emergencies and to rapidly respond when they occur. To facilitate more effective global and regional collaboration on the mpox response, the United States has worked with partners, including the World Bank, the World Health Organization, and Brazil as G20 President, to transparently compile and share all pledges to support the mpox response, identifying resources that are currently available and remaining financing gaps. This information, captured in the WHO/World Bank Mpox Financial Tracking Mechanism (FTM), will help donors and response countries to more easily identify remaining gaps and sources of financing to fill those gaps. More than 90% of the financing needs for the response have been met.

Key Updates on U.S. Support to the Global Mpox Response:

1. Delivering on Our Commitment to Vaccine Donations: The U.S. government is delivering on our commitment to ensure mpox vaccines get to those most at risk, including by making more than one million vaccine doses available for distribution in countries that are ready to receive them. Vaccine administration is underway using U.S.-donated vaccines. On November 6, WHO and Africa Centres for Disease Control and Prevention (Africa CDC) allocated the first 305,000 mpox vaccine doses from President Biden's one million dose commitment to recipient countries via the Access and Allocation Mechanism (AAM). With support from Gavi, the Vaccine Alliance and its partners, these doses are being shipped as soon as recipient countries have accepted the offer of vaccines and confirmed their ability to receive, store, and use the vaccine to protect those at risk. The remaining 695,000 vaccine doses are also available for allocation through the AAM, and will be distributed by the United States as soon as impacted countries are ready to receive them. The U.S. Government has already delivered 50,000 mpox vaccines to Democratic Republic of the Congo (DRC) and 10,000 mpox vaccines to Nigeria. Beyond donating vaccine doses, the United States is working with partner governments to get those vaccines to the people who need them most. For example, in DRC, the U.S. government is supporting risk communication and community engagement to raise awareness about mpox vaccination and help reach priority populations, and coordinating with PEPFAR and other programs to leverage existing service delivery channels to reach high-risk populations.
2. Increasing Testing and Treatment Capacity: In addition to financial resources and vaccines, the United States has provided in-kind donations of more than 65,000 individual mpox tests to countries in the region, along with donations of other laboratory supplies and personal protective equipment. For example, in DRC the U.S. Government has trained 80 field epidemiologists working to detect cases, trace and monitor contacts, and increase community awareness of mpox. These epidemiologists are collecting and sending samples to labs for testing, and at the same time, training additional healthcare workers how to do this work. In Burundi, the U.S. government is working with partners to expand mpox treatment capacity at hospitals in the hardest-hit districts, enabling patients to receive the highest-quality clinical care, nutrition, and psychosocial support closer to home.
3. Delivering on Our Commitment of Financial Support to Mpox Preparedness and Response: The United States Government, through the U.S. Agency for International Development (USAID) and the U.S. Centers for Disease Control and Prevention (CDC), are providing more than $57 million to directly support mpox-specific response activities, including disease surveillance, laboratory diagnostic supplies and testing, clinical case management, risk communication and community engagement, infection prevention and control, access to vaccines, and research. This funding is in addition to the more than $487 million in bilateral global health security (GHS) preparedness and response support provided by the United States to mpox-affected countries through USAID and CDC. Ongoing global health security investments protect the health and livelihoods of people living in other countries and prevent health emergencies from threatening the United States. The country-by-country breakdown of U.S. support to mpox preparedness and response is included in the WHO/World Bank Mpox Financial Tracking Mechanism.
4. Strengthening Global Health Security: The United States is working with more than 50 countries around the world - including most mpox-affected countries and those at-risk of an mpox outbreak - to build stronger global health security capacities, ensuring countries are better prepared to prevent, detect, and respond to health emergencies while protecting U.S. national and homeland security. These ongoing partnerships in mpox-affected countries were in place before the current outbreak, and have played a critical role in supporting the response, especially in the early days before mpox-specific response funding became available. Examples of how this U.S. global health security support has been used to prevent, detect, and respond to the mpox outbreak include:

1. In DRC, building on multi-year investments to strengthen laboratory capacity, the United States supported mpox laboratory capacity building and biosafety and biosurveillance training in provincial labs, enabling these labs to safely test for mpox. In addition, the U.S. Government supported the Ministry of Health to develop a national Mpox Risk Communication and Community Engagement Strategy, which was rapidly adapted for the clade I mpox outbreak.

1. When mpox cases were detected in Rwanda, U.S. Government-supported partners deployed epidemiologists to 10 high-risk districts to provide technical guidance to Public Health Emergency Management Committees and to train 17 Rapid Response Teams. The U.S. Government also supported procurement of test kits and provided training for over 12,600 frontline health workers across 20 districts in infection prevention and control, mpox screening, and case management.

1. When the mpox outbreak spread to Burundi, U.S. Government-supported partners immediately deployed a mobile laboratory to provide faster mpox testing. U.S. Government support for building mpox laboratory capacity continues in Burundi with the recent delivery of additional supplies and training and support to decentralize laboratory testing for mpox and improve the speed of laboratory confirmation.

1. The U.S. Government has partnered with countries in the region to help prepare for potential mpox cases before they occur, including training in surveillance, lab capacity, and risk communication activities. Last month, the Ministry of Health in Angola was facing a severe shortage of mpox testing kits. Without these essential supplies, the country would have had limited, if any, visibility into the size of the outbreak. U.S. Government representatives delivered diagnostic kits to assist in testing nearly 500 suspect mpox cases, helping to confirm the first mpox cases in the country. The U.S. Government is supporting Liberia's mpox preparedness, including technical assistance for surveillance and laboratories as part of broader activities responding to zoonoses in Liberia. The U.S. Government is supporting Mozambique to develop an Mpox Contingency Preparedness and Response Plan, and supporting the Ministry of Health to conduct mpox outbreak simulation exercises for 11 provinces to help prepare for Mozambique's potential first case.

1. Investing in Research to Advance Mpox Preparedness: U.S. Government research investments to advance mpox preparedness have been ongoing for decades. International researchers, including some from the U.S. Government, have identified three critical areas of research needed to support the mpox response: 1) reduce mpox transmission, 2) optimize mpox treatment to save lives, and 3) accelerate the development of mpox vaccines, therapeutics, and diagnostics. Recent U.S. Government investments in each of these areas include:

1. Reducing Mpox Transmission: Research partnerships between the United States Government and the Government of DRC led to the identification of the newly-emerged clade Ib mpox, which is driving the current regional and global spread of mpox. During the current outbreak, the U.S. Government is investing in research to: improve case detection, understand clade-specific transmission dynamics, identify at-risk populations, characterize mpox disease including length of viral shedding to inform vaccination strategies, as well as determine the most effective public health interventions to stop transmission. Before the current outbreak, U.S. Government investments and technical expertise led to the development of existing investigational antivirals and the JYNNEOS mpox vaccine which, when used broadly in the United States during the height of 2022 mpox outbreak, significantly reduced the spread of mpox and contributed to the drop in new cases reported from hundreds per day in 2022 to single digit figures over the last two years.

1. Optimizing Mpox Treatment to Save Lives: The U.S. Government is conducting research, in partnership with the Government of DRC, to understand how this disease affects adults, children, infants, and pregnant women, as well as the risk factors for severe disease. This knowledge is critical to improving standards of care and developing safe and effective post exposure prophylaxis. A U.S. Government and Government of DRC-supported randomized controlled trial (PALM 007) of TPOXX (an antiviral drug developed and approved to treat smallpox) in adults and children with clade I mpox found no evidence of faster clinical improvement in the TPOXX arm compared to the placebo arm. However, PALM 007 did find that optimized standard of care resulted in reduced mortality for adults and children with clade I mpox. These learnings are being applied to the current outbreak.

1. Accelerating the Development of Mpox Vaccines, Diagnostics, and Therapeutics: Currently, there are no licensed mpox vaccines for children and adolescents, who are disproportionately impacted by the current mpox outbreak in Africa. The U.S. Government study of the JYNNEOS mpox vaccine showed that adolescents in the U.S, ages 11-17 years, have similar immune responses to the vaccine as adults. This led to the accelerated emergency approval of JYNNEOS for adolescents by the European Medicines Agency (EMA) and approval through WHO's pre-qualification process. JYNNEOS has been available in the United States for individuals under 18 years through an Emergency Use Authorization issued by the FDA in August 2022. The U.S. Government is also investing in new mpox diagnostics and mpox therapeutics. For example, CDC is working on a new test to better differentiate mpox clade I from clade II that can be used by both public and commercial laboratories. To improve our current investigational therapeutic options, NIH and ASPR are supporting the development of new orthopoxvirus monoclonal antibody therapeutic products.

Key Updates on Domestic Preparedness for Mpox: The Biden-Harris Administration has led numerous efforts to prevent and prepare for clade I mpox in the United States:

1. Providing ongoing communication and education: In December 2023, the U.S. CDC issued a Health Alert Network (HAN) advisory to U.S. clinicians, public health departments, and partners. CDC has since issued multiple HAN Health Updates to further increase awareness of clade Ib mpox, its distinction from clade II mpox and the less common clade Ia, and to provide updated recommendations to prevent, detect, and treat both clades of mpox. Following the first case of clade I mpox diagnosed in the United States, CDC released an updated HAN advisory on November 18, 2024 and a Dear Clinicians letter on December 5, 2024 to promote the importance of mpox vaccination and increase mpox detection nationwide.

1. Assessing risk through modeling: Throughout the outbreak in Central and Eastern Africa, CDC has conducted modeling to assess the level of risk to the U.S. public. The risk to the general U.S. public remains low, and the risk to men who have sex with men (MSM) and people who have sex with MSM is low to moderate (updated November 18, 2024). CDC further modeled the risk of transmission of clade I mpox if introduced into MSM networks in the United States. Simulations of 50 U.S. counties identified that counties with lower population-level immunity had a greater chance of large or prolonged outbreak. CDC is applying these findings to target outreach for vaccination promotion efforts to counties at higher risk.

1. Strengthening surveillance: The United States monitors for the virus that causes mpox in wastewater samples, which can provide an early warning of mpox activity and community spread. In addition, aircraft wastewater samples are collected at select U.S. airports for early detection of mpox in the U.S. State and commercial laboratories have put in place a robust mpox diagnostic testing capacity for both clades, and the United States continues to work with public health partners to further increase domestic surveillance and diagnostic testing capacity.

1. Minimizing risk to travelers: CDC issued an updated Level 2 Travel Health Notice (THN) for travelers to Central and Eastern Africa recommending that travelers practice enhanced precautions and be aware of mpox exposure risks and symptoms. The THN also includes vaccination recommendations for travelers to affected countries who are eligible for vaccination.
2. Vaccination and treatment: During the 2022 mpox outbreak, the Administration for Strategic Preparedness and Response (ASPR), part of the Department of Health and Human Services (HHS), distributed more than one million vials of JYNNEOS mpox vaccine across the United States. Now, the JYNNEOS mpox vaccine is commercially available. Individuals interested in vaccination can consult CDC's guidance and should contact their physician, local retail pharmacy, health department or community health center for mpox vaccine availability in their community. Clinicians should refer to CDC's clinical considerations for use of vaccine to prevent mpox in both adults and children. The high standard of care in U.S. health care can greatly improve mpox outcomes relative to other parts of the world. Symptomatic individuals are highly encouraged to seek care for further evaluation and treatment if needed.