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The Honorable Xavier Becerra Secretary of the Department of Health and Human Services The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 RE: Support for an FDA Emerging Pathogens Preparedness Program Dear Secretary Becerra, We thank you for your leadership and contribution towards the United States’ pandemic preparedness strategy. In light of the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), we write to express our strong support for the FDA’s proposal to create an Emerging Pathogens Preparedness Program within the FDA's Center for Biologics Evaluation and Research (CBER). The FDA’s Summary of FY 2024 Legislative Proposals puts forward a plan for an Emerging Pathogens Preparedness Program that would “defend against emerging pathogens so the agency is better positioned to respond to identified threats of concern and focus experienced resources to work quickly on medical countermeasure development.” The increased regulatory capacity CBER provided to review COVID-19 vaccines was crucial to the success of Operation Warp Speed. According to Paul Mango’s Warp Speed memoir, CBER director Peter Marks “restructured his team and its internal processes to work around the clock to accelerate the evaluations.” A permanent office within CBER to handle preparedness and response would enhance this capacity for future pandemics. The reauthorization of PAHPA offers the perfect opportunity to do so, by embedding the regulatory successes of Operation Warp Speed in a more sustainable way. An IMF paper recently estimated that each day of the COVID-19 pandemic in 2020 and 2021 cost the U.S. economy $26 billion. 1 The massive value of preventing or shortening pandemics makes it critical to prepare for “Disease X” – a future catastrophic biological risk that could in theory be far worse than COVID. This has led to proposals by the G7 2 and the Coalition for Epidemic 2United Kingdom Cabinet Office. (2021). 100 Days Mission to Respond to Future Pandemic Threats. 1Baker, J., Chaudhuri, A., & Kremer, M. (2021). Accelerating Vaccinations. Finance & Development, 58(1). Preparedness Innovations 3 for a “100 Day Mission” to roll out vaccines and other countermeasures within a hundred days of the start of the next pandemic. To do this will require conducting early clinical trials on prototype vaccines against pathogen families with pandemic potential before an emergency occurs. These trials will need close supervision by the FDA and proactive guidance of how their data would be used in the event of a pandemic. Providing dedicated regulatory capacity at the FDA for this purpose is crucial to achieving these important goals. Finally, a dedicated CBER office could be used to facilitate future programs in the model of Operation Warp Speed. By ensuring rapid regulatory decision-making for target product categories whose social value greatly exceeds their market value, the proposed office could build a “warm base” of regulatory capacity that could be drawn on in the event of an emergency. We have been excited to see the announcement of President Biden’s “Project NextGen.” Creating an office like the one described can ensure that the next generation of coronavirus vaccines receive the same regulatory capacity and accelerated development that was so crucial to vaccines approved during Operation Warp Speed. The anticipated annual cost of an office to support the FDA’s proposed program is about $10-15 million, but its value in supporting preparation and response for the next pandemic is immense. Merely providing 1% of Project Next Gen’s $5 billion would ensure strong coronavirus vaccine review capacity for the next several years. Therefore the signatories below express our strong support for the program’s creation and funding. Sincerely, 1Day Sooner American Society for Microbiology BIO Coalition to Stop Flu Critical Path Institute Federation of American Scientists Global Health Technologies Coalition Infectious Diseases Society of America Institute for Progress International Vaccine Institute 3 Coalition for Epidemic Preparedness Innovations. (2022). CEPI 100 Days Report: Building a More Prepared World to Stop Pandemics. Medical Countermeasures Coalition National Foundation for Infectious Diseases Research!America Technologies for Pandemic Defense CC: Major General (ret) Paul Friedrichs Inaugural Director of the Office of Pandemic Preparedness and Response Policy (OPPR) and Principal Advisor on Pandemic Preparedness and Response. CC: Ms. Dawn O’Connell Assistant Secretary for Preparedness and Response (ASPR).

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the National Institute of Allergy and Infectious Diseases awarded Kephera Diagnostics two Small Business Innovative Research grants, totaling $5.7 million, for the development and testing of immunoassays for Lyme disease and Chagas disease. The company’s Lyme disease immunoassay could simplify diagnosis by eliminating the need to perform one of the two steps now used in the screening and confirmatory testing process. Kephera’s immunoassay for Chagas disease is designed to monitor treatment response in patients, as current drugs vary in efficacy in adults with chronic infections. It is being developed both for laboratory use and use in the field.A phase 1 trial evaluating a novel preventive HIV vaccine candidate, VIR-1388, has begun enrollment in the United States and South Africa. VIR-1388 is designed to prompt the immune system to produce T cells that can recognize and signal an immune response to prevent the virus from establishing chronic infection. It delivers vaccine material using a cytomegalovirus (CMV) vector, whose discovery and development was funded by the National Institute of Allergy and Infectious Disease (NIAID). Because CMV, while harmless, remains detectable in the body for life, researchers hope this vector will help the body retain the vaccine material for a longer period of time, overcoming the waning immunity seen with other candidate vaccines. The trial is sponsored by Vir Biotechnology with support from NIAID and the Bill & Melinda Gates Foundation.Last week saw the launch of a third phase 1 clinical trial of the ChAdOx1 vaccine candidate for Middle East Respiratory Syndrome (MERS). If eventually approved, the vaccine would be a game-changing tool against the viral illness, for which there are no approved vaccines or treatments, and which is recognized by the World Health Organization as a priority pathogen with epidemic potential, especially in light of new cases reported this year. The University of Oxford’s Pandemic Sciences Institute started developing the vaccine for MERS before the COVID-19 pandemic, and the research for ChAdOx1, which was put on pause during the pandemic, enabled the rapid development of the Oxford/AstraZeneca vaccine for COVID-19.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A study published last week found that a subset of cells in dormant HIV reservoirs spontaneously produce HIV RNA and proteins, prompting the need for further research into the consequences for the immune system of these ongoing viral interactions in people living with HIV and receiving treatment. This research suggests that the RNA and proteins produced by the reservoirs could be behind inflammation, accelerated cardiac disease, frailty, and premature osteoporosis, which can persist in people who are otherwise successfully treated for HIV. Future studies will need to examine these reservoirs in more diverse populations, but this research could lead to the identification of new ways to target these remaining active viruses in people receiving HIV treatment to ensure that the virus does not rebound and to address their potential health consequences.New research has identified the spread of new strains of malaria parasites in Ethiopia that are resistant to current artemisinin-based treatments and indetectable by common diagnostic tests. This discovery follows the recent identification of strains in other regions of Africa that were resistant to either treatment or testing, although the Ethiopia strain is the first identified resistant to both. The spread of these strains could be a major challenge to efforts to eliminate malaria globally. This most recent finding also underscores the urgent need for both close monitoring of the spread of resistance among malaria parasites, as well as development of new therapies and vaccines.Last week, GARDP announced a sublicense agreement with the Indian company Orchid Pharma to manufacture Shionogi’s antibiotic cefiderocol, enabling Orchid to produce the drug more cheaply for low- and middle-income countries in the face of global gaps in access to antibiotics and rising rates of antimicrobial resistance. This agreement builds on a partnership between GARDP, Shionogi, and the Clinton Health Initiative, which granted GARDP the license last year. Cefiderocol is on the World Health Organization’s Model List of Essential Medicines and is considered globally to be an important weapon against difficult-to-treat, multidrug-resistant infections, but it has not yet been made commercially available in the majority of low- and middle-income countries.

OPEN LETTER TO THE PRESIDENT AND MEMBERS OF THE 78th UN GENERAL ASSEMBLY 13 September 2023 CALL TO ACTION TO WORLD LEADERS IN 2023-24 ON PANDEMIC PREVENTION, PREPAREDNESS & RESPONSE Pandemic threats are increasing in frequency and severity, posing an existential threat to the global economy, achievement of the Sustainable Development Goals (SDGs) and the collective security and survival of humanity. The undersigned organizations call on world leaders and Ministers to bring new urgency and political resolve to prevent the next pandemic crisis and commit to the following agenda for action and report back at UNGA in September 2024 on progress: Elevate, facilitate, and sustain political leadership and multi-stakeholder engagement on pandemic Prevention, Preparedness, and Response as an urgent global, regional, and national priority, taking a whole-of-government and whole-of-society approach. ● The Pandemic PPR HLM should catalyze sustained leadership by Heads of State and Government to drive political momentum, continued vigilance, and a timely global response to current and future health crises and pandemic threats. ● Leaders should promote improved mechanisms for international cooperation on pandemics beyond the health sector. ● Decision-making must be inclusive of all nations and engage non-governmental actors, with diverse geographical and gender representation, including health workers and vulnerable communities. Implement a set of robust and independent pandemic PPR monitoring and accountability mechanisms. ● As with climate change, we urge Heads of State and Government to commit to review global progress on pandemic PPR at the UN on an annual basis, starting with embedding pandemic PPR to the 2024 UNGA Summit for the Future and the High-Level Meeting on Antimicrobial Resistance (AMR) agendas. ● We also urge governments to reach consensus on a new Pandemic Accord and amendments to the International Health Regulations by May 2024 to strengthen Member State obligations for pandemic PPR. ● All Member States should commit to support an independent monitoring and accountability framework and strengthening of existing pandemic PPR-related assessments, including e.g., developing, publishing, implementing, and regularly updating Joint External Evaluations and National Action Plans for Health Security. Reach consensus on a global, standing platform to ensure timely, equitable, and affordable universal access to, and delivery of, pandemic countermeasures (PCM). ● A PCM platform should be designed and convened by low- and middle-income country (LMIC) partners and ensure equity in access from research and development (R&D) to delivery, including through enabling knowledge sharing, capacity-building, technology transfer, and investments in R&D hubs, clinical trials and manufacturing in LMICs, in mutually respectful and beneficial contexts.● A PCM platform should link public financing for medical research to equitable access provisions and remove trade-related barriers in the event of a crisis. ● A PCM platform should prioritize protection for frontline health workers, with commitments to gender equity, respect and safe working conditions, and to prioritize the rights of those at higher risk or in vulnerable situations. ● A PCM platform should include non-medical interventions and identify and facilitate synergies with disease-specific programs and other related areas, including, for example, AIDS, tuberculosis, malaria, cholera, non-communicable diseases, and AMR. Commit to secure the additional, long-term financing needed to close critical pandemic PPR funding gaps as a global public good. Pandemic PPR investments must be in addition to existing health and development financing. ● Member States should commit to fully and sustainably finance the Pandemic Fund’s annual goal of USD $10.5 billion in new international financing. ● Member States should fully finance the Coalition for Epidemic Preparedness Innovations (CEPI)’s and other global finance mechanisms advancing Pandemic PPR. ● Member States should establish and appropriately resource a global pandemic surge response financing mechanism that will trigger immediate release of funds to the aforementioned PCM platform and affected countries in the event of a future Public Health Emergency of International Concern (PHEIC) declaration. ● As their economies grow, Member States should mobilize additional, long-term domestic pandemic PPR financing. Accelerate multisectoral pandemic PPR approaches and investments to build better prepared cross-government systems, as well as end-to-end public health and life science ecosystems that are “always on.” As climate change and migration increase pandemic threats, urgent action is needed to prevent or contain virus spillover and ensure early outbreak detection in humans, domestic animals, and wildlife. ● Member States should develop “always on,” end-to-end, climate- and pandemic-resilient public health and life science ecosystems, operating continuously to, for example, identify new pathogens, increase global manufacturing, and deploy clinical research capabilities so that when a pandemic threat emerges, countries and their capacities across government and society can pivot effectively. ● Member States should directly address the root causes and drivers of zoonotic outbreaks and spillover events through a One Health approach in implementing these efforts via technical collaboration, expertise and/or financial support. ● Member States should align their National Action Plans for Health Security with their climate change adaptation and biodiversity action plans. ● The World Bank, International Monetary Fund, other MDBs, and development finance institutions must evolve to step up action on global challenges, and prioritize joint new investments in climate- and pandemic-resilient health systems. ● New pandemic PPR investments must advance Universal Health Coverage and leave a legacy of strong and resilient primary health care systems that protect essential health services in a crisis.We urge you to commit to these priorities on Pandemic PPR and deliver on them to help protect humanity from another devastating pandemic crisis. Yours sincerely, Access Challenge Access Health International Action for Animal Health Action Group for Health, Human Rights, and HIV Advocacy Coalition for Health Research and Development Afe One Health Africa Center for Health Systems and Gender Justice Africa Civil Society Platform for Health Afrihealth Optonet Association Africa Japan Forum AIDs Healthcare Foundation Aminu Saleh College of Education, Azare Amis des Étrangers au Togo Amref Health Africa Association for Promotion Sustainable Development Barokupot Ganochetona Foundation Brain Builders Youth Development Initiative Brighter Green Burundi Secours Campaigns in Global Health Center for Asia-Pacific Resilience and Innovation Center for Indonesia's Strategic Development Initiatives Centre for Emergency and Development Support The Christian Spiritual Youth Ministry of Tanzania Community Initiative Action Group Kenya Conservation International Consortium for the Advancement of Rights for Key Affected Populations Consortium of Reproductive Health Associations Disability Peoples Forum Uganda Dream Weaver Organization Dr. Uzo Adirieje Foundation Eastern Africa National Networks of AIDS and Health Service Organizations Every Breath Counts Coalition EX TB Gambia Foundation for Environmental Watch Four Paws Friends of the Global Fight Fundacion Huesped Gavi CSO Constituency Global Alliance for Surgical, Obstetric, Trauma & Anaesthesia Care Global Citizen Global Health Advocacy Incubator Global Health Security Agenda ConsortiumGlobal Health Technologies Coalition Health and Global Policy Institute Health and RIghts Initiative Heart That Cares For Better Health Organization Hepatitis Aid Organization HOMES Foundation IAVI Intrahealth International International Treatment Preparedness Coalition Janaudyog Jhpiego Joncaring Foundation Journalists Association Against AIDS Kamukunji Paralegal Trust Kenya Liaison Livewell Initiative Living Goods Uganda London School of Hygiene & Tropical Medicine Malaria Youth Army Champion Management Sciences for Health Marked by COVID Mbungonet MJ Foundation Murang'a County Government Kenya Nigerian Women Agro Allied Farmers Association Nyaama ONE Campaign One Health Bangladesh ONG Plus de SIDA dans les Familles Organization of Christian Writers Pandemic Action Network Panoplia Laboratories PATH Pour Demain Preventing Pandemics at the Source Secretariat PREZODE Project HOPE Queen Elizabeth Central Hospital Rashida Foundation Sightsavers Sister’s Hand Liberia Social Good Summit Society for Conservation and Sustainability of Energy and Environment in Nigeria South African Health Technologies Advocacy Coalition South Eastern Europe Regional TB and HIV Community Network Spark Street Advisors Speak Up Africa Supported by Living Goods Uganda SwastiTask Force for Global Health Teenaid International Organization Tinada Youth Action Africa Transparency and Development Information Initiatives Uganda Child and Aid Development Foundation United for Global Mental Health (UGMH) Uganda National Institute of Public Health Uganda Peace Foundation United Nations Association of the United States of America United Nations Major Group for Children and Youth VillageReach WaterAid Youth and Women for Change in Eswatini Youth Projects Development Platform WACI Health Wider Aid & Development Agency-South Sudan Women Against AIDS and Poverty Mbulu Tanzania Women in Global Health Women With A Mission Zimbabwe Community Competence Trust