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July 11, 2023 The Honorable Kay Granger Chairwoman House Appropriations Committee 1026 Longworth House Office Building Washington, DC 20515 The Honorable Rosa DeLauro Ranking Member House Appropriations Committee 2413 Rayburn House Office Building Washington, DC 20515 The Honorable Mario Diaz-Balart Chairman House Appropriations Subcommittee on State, Foreign Operations, and Related Programs 374 Cannon House Office Building Washington, DC 20515 The Honorable Barbara Lee Ranking Member House Appropriations Subcommittee on State, Foreign Operations, and Related Programs 2470 Rayburn House Office Building Washington, DC 20515 Dear Chairwoman Granger, Ranking Member DeLauro, Chairman Diaz-Balart, and Ranking Member Lee: Global Health Council (GHC) is the leading member organization with more than 120 members devoted to advancing global health priorities by uniting advocates, implementers, policymakers, and other stakeholders. As a community of global health and development advocates, we are deeply concerned with the steep cuts being proposed to the House State and Foreign Operations and Related Programs (SFOPS) budget at a time when the world is facing concurrent destabilizing events, such as the recovery from the COVID-19 pandemic, further instability and food insecurity caused by the war in Ukraine, and the continuous threat of emerging infectious diseases. The Fiscal Year (FY) 2024 budget being proposed by the House Appropriations SFOPS Subcommittee falls woefully short of the resources needed to address these converging crises and severely undercuts critical global health and humanitarian assistance programs, which are a key component of how the U.S. engages with the world. According to the U.S. Agency for International Development, these cuts would reverse gains made to combat infectious diseases, including through the President’s Emergency Plan for AIDS Relief (PEPFAR), programs to prevent maternal and childhood deaths, and funds to support health workers and global health security. This bill is a dangerous signal to the rest of the world that the U.S. is ceding leadership on the global stage. Therefore, as FY24 appropriations negotiations progress, GHC, and the undersigned organizations, strongly encourage robust funding for global health and humanitarian assistance programs within the International Affairs (150) account and, at a minimum, support investments for these programs in line with the FY23 enacted levels. Additional funds should come as an increase to the overall topline and not at the expense of any other accounts. If you have any questions about our recommendations, please feel free to contact the Global Health Council at advocacy@globalhealth.org. WWW.GLOBALHEALTH.ORG Sincerely, Abt Associates Action Against Hunger Advancing Synergy AHF Global Public Health Institute Aidsfonds American Academy of Pediatrics Amref Health Africa American Heart Association American Jewish World Service American Leprosy Missions American Society of Tropical Medicine and Hygiene AVAC Better World Campaign CARE Center for Biological Diversity ChildFund International Children's HeartLink Christian Connections for International Health CORE Group Drugs for Neglected Disease initiative (DNDi) Elizabeth Glaser Pediatric AIDS Foundation Fast-Track Cities Institute Global Health Council Global Health Technologies Coalition Global Justice Center Global Network of Black People working in HIV Heartland Alliance International Health GAP (Global Access Program) Helen Keller Intl HIV Medicine Association IADR - International Association for Dental, Oral, and Craniofacial Research International Association of Providers of AIDS Care International Center for Research on Women International Medical Corps IntraHealth International Ipas JSI Management Sciences for Health Marked By Covid Medical Impact MPact Global Action m2m WWW.GLOBALHEALTH.ORG NCD Alliance Operation Smile PAI Pandemic Action Network PATH Pathfinder International Planned Parenthood Federation of America Policy Cures Research Population Connection Action Fund Population Institute Preventing Pandemics At The Source (PPATS) Secretariat Project HOPE Public Citizen RESULTS RH Impact RTI International Save the Children Shot@Life Spark Street Advisors Stop TB USA Task Force for Global Health TB Alliance The END Fund Treatment Action Group (TAG) United to Beat Malaria University of Miami Health Policy Lab VillageReach WaterAid America WI-HER Women's Refugee Commission World Vision WWW.GLOBALHEALTH.ORG

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. Gavi, the World Health Organization (WHO), and UNICEF have announced that an initial 18 million doses of the world’s first malaria vaccine, RTS,S/AS01, will be rolled out in 12 African countries, where the risk of child illness and deaths from malaria is highest. The vaccine, which will be produced by GlaxoSmithKline and Bharat Biotech, is expected to arrive in the initial countries in late 2023. A further 16 countries have also asked for access and are expected to receive it once production has scaled up. Another malaria vaccine, R21, developed by Oxford University is currently awaiting WHO prequalification. In the coming years, both vaccines are expected to play a key role in the fight against malaria alongside other tools.A study published last week found that injections of broadly neutralizing antibodies in children living with HIV can improve the protective effects of antiretroviral drugs, marking the first time broadly neutralizing antibodies have been tested in combination with antiretroviral drugs in a pediatric population. The treatment suppressed cells that contained the virus and were capable of reactivating, paving the path to further research that could confirm the use of this method as a supplemental or alternative treatment for HIV in children. The publication of these findings follows recent research, which has focused on testing broadly neutralizing antibodies as a treatment for adults with HIV. Worldwide, about 1.7 million infants and children are living with HIV.Last week, Gavi confirmed that some of the $2.6 billion remaining in COVAX, the COVID-19 vaccine delivery initiative, could be redirected towards furthering investigational vaccine candidates for Marburg and Ebola Sudan, as well as a hexavalent vaccine that would offer protection against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and the inactivated polio vaccine. The investments for Marburg and Ebola Sudan will hopefully contribute to ensuring clinical trials in future outbreaks, especially after the scrapped trials during the recent Marburg and Ebola Sudan outbreaks.

GHTC submitted comments to the Senate Health, Education, Labor and Pensions (HELP) Committee in regard to the Senate's July 3 Pandemics and All-Hazards Preparedness Act (PAHPA) Discussion Draft, urging the committee to take the opportunity to reaffirm commitments to supporting innovative global health research and development.To the attention of: Bernard Sanders, Chair, Senate HELP Committee Bill Cassidy, M.D., Ranking Member, Senate HELP Committee Robert P. Casey, Jr., Member, Senate HELP Committee Mitt Romney, Member, Senate HELP Committee We, as the Global Health Technologies Coalition (GHTC), are writing today to submit comments on the discussion draft of the Senate’s 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). Like many other global health stakeholders, our coalition of nonprofits, industry leaders, and academic institutions see the reauthorization of PAHPA as a must-pass piece of legislation. PAHPA presents a critical opportunity to reaffirm our commitment to tackling emerging disease threats, as well as strengthen our current slate of medical countermeasures (MCMs) to meet the goals of the 21st century through innovative global health research and development (R&D). Below we list opportunities for improvement to the bill as it is written. We appreciate your attention to our suggestions. Authorize an Emerging Infectious Disease (EID) Division at the Biomedical Advanced Research and Development Authority (BARDA) with a dedicated funding line. We are pleased by the inclusion of more expansive language like “emerging infectious diseases” and “viral pathogens with a significant potential to cause a pandemic”—which recognizes the fuller spectrum of potential threats for which MCMs are needed. To further this aim, we urge policymakers to create a dedicated EID Division within BARDA to enable the agency to take a more proactive rather than reactive approach to MCM development for EIDs. While we understand the fiscal environment is difficult, if established, this division should receive around $775 million per year in dedicated funding.Direct BARDA to provide regular public reports on its product-level investments. We are supportive of the bill text directing the Assistant Secretary for Preparedness and Response to provide Congress with reports on a coordinated strategy for MCMs to address chemical, biological, radiological, and nuclear (CBRN) threats. In addition to this reporting requirement, we believe there should be additional language directing BARDA to regularly and publicly report on its product-level investments to the greatest extent possible without compromising national security, and as part of that reporting, to detail the funding amount, threat area, product type, and phase of development for each MCM. This policy would be a minimal burden to the agency since it already provides comprehensive reporting including funding on its website for COVID-19 and some level of information on CBRN threats. Prioritize deliverability in low-resource settings. We welcome the bill text expanding MCM research initiatives to include technologies to improve production and use of MCMs, like manufacturing, transport, storage, and administration technologies. For these initiatives to reach their full potential in expanding access to lifesaving tools, we believe there should also be language included that stipulates that all R&D efforts for new vaccines, drugs, diagnostics, and other tools prioritize applicability in low-resource settings. This objective could also be furthered by: requiring the Administration for Strategic Preparedness and Response to conduct a study on barriers to low resource deliverability, including the Administrator for the US Agency for International Development in the Public Health Emergency Medical Countermeasures Enterprise, and authorizing BARDA to support community engagement activities during MCM development. Further prioritize antimicrobial resistance (AMR) research by attaching the PASTEUR Act. We appreciate the specific language in the draft bill that reinforces a mandate to “conduct research to promote strategic initiatives, such as … broad-spectrum antimicrobials.” By attaching PASTEUR, it would create a program in the Department of Health and Human Services to incentivize the development of new AMR drugs through a subscription-based payment model. Eliminate the sunset for the medical countermeasure innovation partnership (MCIP). The 21st Century Cures Act authorized BARDA to enter a partnership with a nonprofit entity to accelerate MCMs through venture capital practices. BARDA has since entered a successful partnership that has leveraged matched external funding to sponsor at least eight promising innovations. Policymakers should extend this authority without a sunset in the reauthorization of PAHPA.Authorize loan authorities, like those available to the Department of Energy. This would give BARDA an additional mechanism to finance large-scale projects that could better prepare the United States and the world for future biological threats. Thank you for your work on this critical legislation and for providing an opportunity for input. Alex Long Policy and Advocacy Officer

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 Bill & Melinda Gates Foundation and Wellcome Trust announced that they will jointly invest more than $500 million in phase 3 trials for the GSK-developed M72/AS01E tuberculosis (TB) vaccine, which could become the first new tuberculosis vaccine in 100 years. 2018 phase 2b trials showed that the vaccine was 50 percent effective, but after GSK pulled out because they did not see a commercial market for the vaccine, the company passed the license to the Bill & Melinda Gates Medical Research Institute in 2020. The phase 3 trials will involve 26,000 people in Africa and Southeast Asia, hopefully confirming the vaccine’s viability as TB cases and deaths rise around the world.A new initiative led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations will work to stockpile experimental vaccines for infectious diseases with epidemic potential to improve preparedness for future outbreaks. This global virtual pooled inventory will initially focus on Marburg and the Sudan strain of Ebola, for which there are no existing vaccines or proven treatments. Last year’s outbreaks in Africa of these two hemorrhagic fevers saw aborted attempts to move forward clinical trials for vaccines, losing crucial opportunities to gather essential data on potential tools and highlighting the need for this kind of stockpiling, preparation, and partnership.The Medicines Patent Pool recently announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Shionogi’s COVID-19 antiviral treatment in low- and middle-income countries, improving availability and equitable access in these countries, even after the end of the Public Health Emergency of International Concern. The oral antiviral, Ensitrelvir, is currently only approved in Japan, although it is being considered in the United States and all 117 countries in the agreements. Medicines Patent Pool previously signed sublicensing agreements with Pfizer in 2021 to manufacture and distribute its treatment, Paxlovid, in 95 low- and middle-income countries.