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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).

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

GHTC submitted the following comments in response to a World Health Organization (WHO) public consultation seeking input on its draft guidance for best practices for clinical trials. WHO is developing this guidance in response to the adoption by the 75th World Health Assembly of a resolution on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.Please provide general comments on addressing context-specific issues, considerations, and implications for adapting and implementing the guidance, as well as identifying gaps in the evidence that should be addressed through future research. Please also provide any comments about the strengths of the draft guidance. Feedback to specific content to enhance clarity, address technical errors, and provide any missing information will be in the suggested amendments. The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofits, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. GHTC’s Secretariat has gathered input from members to contribute to the public consultation on World Health Organization (WHO) guidance for best practices for clinical trials. In particular, the coalition asked its members to assess additional ways the guidance on clinical trials could be strengthened, with a particular eye towards equity and inclusion, leveraging existing resources, and connecting the work on clinical trials to broader capacity-building initiatives.Please provide general comments for Section A: Key scientific and ethical considerations for good clinical trials. Clinical data requirements for licensure need to be clearly defined. Placebo-controlled, randomized, double-blind studies are typically used to demonstrate the efficacy and safety of new vaccines but are not always needed for licensure. In some circumstances, like the Ebola outbreak, it would be considered unethical to administer a placebo to at-risk individuals. The design of clinical trials must consider these regulatory and ethical requirements.Good clinical trials are collaborative and transparent (section A, 2.3), and the text of the guidance should refer more explicitly to the importance of integrating ethical considerations into trial design and execution.Section A, 2.3.3 on transparency alludes to the need for transparency in data sharing. However, the guidance should also touch upon transparency in sharing knowledge, skills, and benefits, as well as on the need for equity in data sharing to ensure that the data generated from trials conducted in resource-limited settings are accessible to all partners and to foster a collaborative approach to knowledge dissemination.There must also be stronger mandates for trial registration from the outset, including data sharing requirements with platforms like WHO’s International Clinical Trials Registry Platform (ICTRP) and other internationally recognized platforms. Concerning the size of the clinical trials (section A, 2.1.3), expanding on what is recommended for pediatric trials in section A, 4.3, reference should be made to using, whenever appropriate, newly available technologies, notably modeling and simulation techniques (pharmacometrics), to implement decentralized trials and consolidate trial design. For example, synthetic control arms should be used to minimize exposure to a well-documented intervention, reduce sample size, and maximize the value of the research.Please provide general comments for Section B: Guidance on strengthening the clinical trial ecosystem. As for section A, section B should also include reference to the need for equity in representation at all levels, including in governance and management, to ensure that a wide range of perspectives and experiences are incorporated. The guidance should also touch on ways to improve international collaboration and coordination among member states on key research priorities and multiregional clinical trials, where appropriate. At present, effective coordination mechanisms are lacking for clinical trials, and funding for clinical trials across all WHO regions and disease areas is insufficient. Furthermore, improved coordination around global research agendas could enable more timely capacity-building of clinical trial sites.The WHO guidance should also support new trial modalities, such as decentralized and paperless clinical trials that incorporate patient perspectives, mobile technologies, and telemedicine, and increased use of adaptive, multicountry platform trials.Investing in research capacity-strengthening in low- and middle-income countries (LMICs) is critical to effectively combating disease. This could also entail investing in training and strengthening scientific capacity at the local level, as well as building or upgrading physical infrastructure. In section B, 3.1.1l discussing the physical infrastructure, the role of central laboratories should be added, as well as the need to set up central/reference laboratories for certain assessments to ensure standardization (for example, for pharmacokinetics and microbiology assessments).This encompasses investing in building regulatory capacity in LMICs, including further building on progress across the African Medicines Regulatory Harmonization programme and supporting the operationalization of the African Medicines Agency. Continued investment in regulatory strengthening will be critical to expanding clinical trial capacity in LMICs.Please provide general comments for Section C: Addressing under-represented subpopulations. GHTC was pleased that the guidance includes a full section focused on addressing underrepresented subpopulations in clinical trials. Women, girls, and other gender-diverse persons of childbearing potential remain vastly underrepresented in research and clinical trials, particularly those who are pregnant and lactating. At a time of rapid medical innovations, this exclusion limits data, prevents understanding of sex- and gender-based differences in health outcomes, and restricts the availability of therapeutic options for more than half the global population.In addressing the need for enabling clinical trials in resource-limited settings (section C, 4.1), local regulators should be encouraged to develop guidelines for investigational plans for underrepresented populations, such as children, women, and gender-diverse persons who are pregnant and lactating, and such plans should be a requirement for marketing authorization approval.GHTC strongly supports the emphasis on the need to address the underrepresentation of pregnant and lactating women in clinical trials, with the objective of broadening the availability of therapeutic options for these populations and allowing equitable and timely access to crucial interventions. We would nevertheless broaden the scope of this group to include pregnant and lactating girls because adolescents are often underrepresented in clinical trials, as well as gender-diverse persons, because not all persons of childbearing potential identify themselves as women. Referring to women and gender-diverse persons of childbearing potential facilitates the inclusion of transgender and nonbinary persons who are also underrepresented in key clinical research areas. For diseases with high fatality for which no alternative treatments are available, preclinical animal reproductive-toxicity studies should be expedited, and pregnant individuals should be included in the very early pre-licensure clinical trials of new treatment (for example, diseases such as Ebola, and the early stages of the SARS-CoV-2 pandemic).The guidance for pregnant and lactating individuals should also look to leverage relevant resources, evidence, and data points to ensure a comprehensive approach. This includes integrating the guidelines on the Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, as well as excerpts from the Journal of the International AIDS Society that included specific recommendations on how to accomplish this pre-drug approval, as well the critical need for surveillance of maternal and neonatal outcomes with drug use in pregnancy.The pediatric section does include some more robust references, though we would suggest adding the WHO Toolkit for Research and Development of Pediatric Antiretroviral Drugs and Formulations, as well as the report from the Paediatric HIV and TB: Rome Action Plan, which came from the High-Level Dialogue convened by the Vatican.Please provide general comments for ANNEX 2: Recommendations for Member States, research funders and researchers. We are not sure that the last recommendation in 2.11, which calls for the establishment of pregnancy registries in LMICs, should be included. It may not be the best way to look at surveillance of pregnancy outcomes, as there is no “control” of unexposed individuals to which to compare findings in exposed individuals, making the data much less useful.

GHTC responded to Senator Ben Cardin's (D-MD) request for information (RFI) on strengthening global health systems through local partnerships post-pandemic by emphasizing the need to invest in innovative product development and the broader innovation ecosystem, as well as strengthening research and manufacturing capacities, especially in low- and middle-income countries.To the attention of:Senator Benjamin L. CardinCOVID-19 cast the importance of a strong, unified, and fully financed global health architecture into sharp relief. However, while the pandemic dominated headlines, progress toward the Sustainable Development Goals and other health priorities has stalled, underscoring the need to reaffirm the importance of investments in ongoing epidemics, including in tuberculosis, malaria, HIV, neglected tropical diseases, and other neglected infectious diseases. To regain our global footing on these diseases, known and unknown, investments by the government in Health Systems Strengthening (HSS) must include catalyzing product development for new drugs, vaccines, diagnostics, vector control products, and other health tools, as well as strengthening research and manufacturing capacities and ensuring more direct investment in existing innovation ecosystems, especially in low- and middle- income countries (LMICs).According to the same Lancet Commission on Investing in Health paper cited in the RFI, even if our current health technologies were scaled widely, the world could still not achieve our Sustainable Development Goals for health. True HSS must address future supply chain issues and dependence on a handful of stakeholders for vital health products, and global and regional leaders must make a concerted effort to strengthen local production and technical capacities to enhance regional manufacturing capabilities. Investments should be made in regional hubs that can serve multiple countries, especially during major outbreaks, but also for ongoing health threats from poverty-related and neglected diseases.The US Agency for International Development (USAID) is a leader in global health and development, making them uniquely poised to not only conduct HSS but also to invest in the research and development of technologies for global health on a disease-agnostic level. Congress should seek to invest in USAID’s mandate to both bolster the human and infrastructural resources of health systems and vest those systems with the capacity to innovate and build next-generation technologies that are fit for use in LMICs.Sincerely,Alex Long