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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. In a new study, researchers from the Baylor College of Medicine and partner institutions found that a novel, nonhormonal sperm-specific approach showed promise in mice as a reversible male contraception option. The researchers identified a small molecule that would inhibit a key protein, STK33, required for fertility in both mice and human males and generated modified versions of STK33 inhibitors to make them more stable, potent, and selective, eventually testing the most effective compound they generated in mice. The researchers hope to further evaluate the inhibitor and similar compounds to determine effectiveness as a potential contraception option. There has been research into a variety of different strategies for male contraception, but there are currently no approved options for men beyond male condoms.Tens of thousands of genetically modified mosquitoes have been released in Djibouti to stop the spread of Anopheles stephensi mosquitoes that transmit malaria as part of the pilot phase of a partnership between Oxitec, the government of Djibouti, and Association Mutualis. The modified mosquitoes carry a gene that kills female offspring, the only mosquitoes that bite and transmit malaria, before they can reach maturity. If successful, the modified mosquitoes will be tested in larger field trials, and operational deployment will continue through next year, hopefully boosting malaria control efforts. This partnership is the first time that modified mosquitoes have been released in East Africa and the second time on the African continent, although similar technology has been successfully used in Brazil, the Cayman Islands, Panama, and India, with more than one million modified mosquitoes released around the world since 2019.The Administration for Strategic Preparedness and Response at the US Department of Health and Human Services is moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine, as the current outbreak's second human case in the United States was identified this week. The two vaccine candidates are currently in bulk form, with one of the two candidate vaccine viruses reportedly well-matched to the currently circulating strain. Health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish, which will take a couple of months to complete. Agency officials are also coordinating with mRNA vaccine makers Pfizer and Moderna about their potential involvement in vaccine development. There are additional ongoing interagency discussions about what would trigger vaccine deployment, including a change in transmission propensity, like human-to-human or animal-to-human spread; any sign of increased illness severity; a change in the complexion of the cases, like a human infection with no tie to the affected dairy farms; or the identification of a mutation in the virus.

GHTC submitted the below response to a request for information (RFI) to inform the new five-year strategic plan of the US National Institutes of Health's National Institute for Allergy and Infectious Diseases (NIAID).To Whom It May Concern: We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input to the National Institute of Allergy and Infectious Diseases’ (NIAID’s) strategic plan, which will guide NIAID’s priorities over the next five years. The National Institutes of Health (NIH) has long been a cornerstone of basic and early-stage biomedical research, playing a pivotal role in driving scientific discoveries that pave the way for the creation of lifesaving global health technologies by the private sector, nonprofits, and other US agencies. In its new five-year strategic plan, GHTC advises that NIAID further integrate its global impact into its core mission and stated priorities. Within the five priority areas highlighted in the request for information, several jump out as opportunities to incorporate global health research and development (R&D) in both policy and practice. It is our opinion that these opportunities to include global health R&D should be seized, especially considering new economic data. A recent study by GHTC and Policy Cures Research revealed that between 2007 and 2022, the US government invested $46 billion in global health R&D, yielding $104 billion in direct returns and creating more than 600,000 jobs. Additionally, these investments are projected to generate $255 billion in future economic gains. Notably, NIH, predominantly through NIAID, accounted for three-quarters of this funding, solidifying NIAID's position as the world’s largest funder of global health R&D. Priority 1 highlights the need to better understand the immune system and its limitations. On this priority, our membership is interested in research aimed at improving our understanding of genetic mutations that play a role in drug resistance. This research would allow for the scale-up and development of drug susceptibility tests that can help inform patients with drug-resistant infections of their treatment options. Drug resistance is an issue for tuberculosis (TB) treatment as well as the treatment of other neglected diseases worldwide. The R&D undertaken for this priority should pay close attention to how new technologies and protocols can be used in low-resource settings for historically underserved populations like women and children.  Priority 3 is a core priority of GHTC in pursuit of the development of effective treatment strategies for neglected diseases like HIV/AIDS. We urge NIAID to acknowledge underserved populations like women and children, including lactating women, who are an especially underrepresented community in clinical trials, at the outset of the R&D process. We also urge NIAID to prioritize establishing plans for access early in the R&D process to avoid barriers to uptake often seen in low- and middle-income countries, especially for products for diseases like HIV/AIDS that can carry stigma. NIAID received an award from GHTC for its work on cabotegravir long acting for HIV prevention because, among other reasons, it is fit for use in low-resource settings and simpler for patients because it can be taken bimonthly rather than daily. Moving forward, we hope that all HIV and non-HIV research is conducted with low-resource communities in mind, which is important for domestic and foreign settings alike. GHTC is pleased to see Priority 5 as a key topic for NIAID since it will bolster the critical work NIAID has done in the past to take basic science research and apply it to the most pressing health challenges of the day. We saw in the global responses to SARS, Zika, Ebola, and, of course, COVID-19 that NIAID-led research provided a vital cornerstone. Within this priority, GHTC hopes to see a specific mention of how this work is globally relevant and will position US-funded global health R&D as the front line against future threats, both known and unknown. Affirming NIAID’s work on neglected diseases, as well as new and emerging infectious diseases is core to GHTC’s goals for the institute. Like the other issue areas, it is important to incorporate equity and access into the R&D process for Priority 5, since in the case of a pandemic, it is in our best interests that technologies made to test, treat, and heal US citizens can also be applied globally to effectively mitigate the spread of a pathogen with pandemic potential. GHTC was also happy to see the inclusion of many new themes NIAID is considering incorporating into its strategic plan. Of course, the theme of global health should be central to the work of NIAID since infectious diseases are not and have never been a one-country issue. Additionally, the interconnectedness of the world we currently live in, coupled with shifts in the environment because of climate change, have contributed to a modified disease landscape in the United States, forcing us to grapple with diseases once labeled as “tropical” or not of consequence to US citizens. For example, just last summer, we saw local malaria transmission in the United States for the first time in decades, and this summer, we are already seeing the rise of fungal infections in the United States and dengue in Central America, South America and, more recently, Miami. These developments should inspire action within the R&D community, especially since we need more and better tools and treatments to address these threats. We also see room to grow in these themes through the lens of clinical trials. The themes of Diversity, Equity, Inclusion, and Accessibility; Women’s Health; Research Inclusivity; and Health Disparities should be considered in ensuring diversity in clinical trial participants, which will help lead to new global health technologies that are applicable and accessible in low-resource settings, suitable for racially diverse groups, and that address the needs of underserved populations like lactating woman and children—to name a few key issue areas. Increasing NIAID’s global health mandate will serve the institution well in the fight against emerging infectious diseases and neglected diseases at home and abroad. By learning from past successes at NIAID, the world grows to be stronger and healthier. The global health R&D community has consistently advocated for NIAID’s mission and prominence in a crowded field of global health champions. It is our hope that NIAID consistently maintains interagency coordination with other government agencies and partners, not just in times of crisis. We hope our advisement is considered when the new strategic plan is forged, and we are happy to provide consultation on the strategy throughout the strategy development process.  Sincerely,  Alex Long  US Policy & Advocacy Officer  Global Health Technologies Coalition (GHTC)  

The Honorable Christopher Coons Chair Committee for Appropriations Subcommittee for State, Foreign Operations, and Related Programs U.S. Senate Washington, DC 20510 The Honorable Mario Diaz-Balart Chair Committee for Appropriations Subcommittee for State, Foreign Operations, and Related Programs U.S. House of Representatives Washington, DC 20515 May 22, 2024 The Honorable Lindsey Graham Ranking Member Committee for Appropriations Subcommittee for State, Foreign Operations, and Related Programs U.S. Senate Washington, DC 20510 The Honorable Barbara Lee Ranking Member Committee for Appropriations Subcommittee for State, Foreign Operations, and Related Programs U.S. House of Representatives Washington, DC 20515 Dear Chairman Coons, Chairman Diaz-Balart, Ranking Member Graham, and Ranking Member Lee: On behalf of the organizations listed below, we ask that you fund global HIV/AIDS programs in the Fiscal Year (FY) 2025 no less than $6.79 billion for Global Health Programs at the Department of State, including $5.14 billion for the President’s Emergency Plan for AIDS Relief (PEPFAR), $1.65 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as ensure that the programs are governed by policies that expand access to health care, uphold human rights, and help to put the world on track to end AIDS by 2030. We also request $350 million to fund USAID HIV/AIDS programs and $60 million for the Joint United Nations Programme on HIV/AIDS (UNAIDS). We recognize that the impact of international conflicts puts pressure on U.S. foreign aid budgets, but we would like to take this opportunity to reiterate the importance of continuing to build upon the lifesaving progress realized through U.S. investments in global HIV/AIDS programs. Failure to do so will result in the loss of hard-won progress and the numbers of HIV infections and AIDS-related deaths rising, and will risk two decades of U.S. strategic investments in this critical area of global health security, human rights, and America’s global leadership. In his 2003 State of the Union address, George W. Bush announced the President’s Emergency Plan for AIDS Relief. Now, over 20 years later, PEPFAR has proven to be one of the most remarkable global health successes of our time. It has long been a uniting cause in Congress, enjoying bipartisan support across four presidential administrations, and is a shining example of U.S. global health leadership. Through innovative, targeted, and science-based HIV prevention and treatment programming, PEPFAR has saved over 25 million lives, helped stabilize nations through health infrastructure investments, and fundamentally changed the course of the HIV pandemic. Its impact extends well beyond the fight against HIV and AIDS. Decades of expertise, diplomacy, and infrastructure were deployed throughout the COVID-19 pandemic, enabling the delivery of diagnostics, care, and vaccines to populations that may not otherwise have been reached. It proved what can be done with a strong framework and a whole-of-government approach. It demonstrated its capacity to be a critical asset in building systems to prepare for health threats we may face down the line. We recognize that this request represents a significant increase over enacted budgets for the PEPFAR program in previous years. The reality is that PEPFAR has continued to operate with essentially flat funding for fifteen years, while expanding successful programs, greatly reducing the number of new HIV infections, continuously increasing the number of people on life-saving HIV treatment, and rapidly scaling up new and innovative prevention, testing and treatment methods. Without increased funding, PEPFAR simply will not be able to operate at the level of effectiveness and efficiency that millions of people around the world depend on, and the failure to end HIV/AIDS as a public health threat by 2030 will be written in stone. With the additional funding requested, PEPFAR could improve and expand upon programs that work and repair and rebuild programs that have been set back by global health crises. Critical Gaps in the Global HIV/AIDS Response UNAIDS estimates that if HIV service coverage is held constant at current level, the world will see an estimated 7.7 million additional AIDS-related deaths between 2021 and 2030. Success in the fight against HIV remains deeply unequal across populations due to discrimination, stigma, violence, and inequity. The majority of new infections are in sub-Saharan Africa, where women and girls account for 63% of all new infections. In 2022, 4000 adolescent girls and young women acquired HIV each week. Overall, key populations and their partners accounted for 71 percent of new HIV infections worldwide in 2021 and 49 percent of new infections outside of sub-Saharan Africa. HIV treatment access for mothers and children continues to lag, with 1 in 5 pregnant or breastfeeding women living with HIV are not receiving antiviral treatment and just half of HIV positive children receiving the treatment they need to survive and thrive. Despite the success of many of PEPFAR’s prevention interventions, they are still not at a scale to make the necessary impact on the global rate of new HIV infections and get the world on track to end AIDS by 2030. The UNAIDS Global AIDS Strategy, reinforced by the 2021 UN High Level Meeting Political Declaration on HIV/AIDS (adopted by the majority of member states, including the United States) calls for a substantial increase of investments in HIV prevention efforts and structural interventions to eliminate barriers to service utilization and contribute to reducing inequities in HIV incidence. The urgency of investing in HIV prevention is made greater by the introduction of new prevention technologies, including the dapivirine vaginal ring (DVR) and long-acting injectable pre-exposure prophylaxis (PrEP), which reduces the risk of getting HIV through sexual transmission by 99 percent. Rapid scale up of these tools is needed to maximize their impact and cost-effectiveness. Additionally, investment in the research and development of an HIV/AIDS vaccine is essential – and has already contributed to the swift development of highly effective mRNA vaccines for covid-19. Vaccines are the most powerful and cost-effective tools for controlling the spread of any virus, and without a vaccine and a cure, an end to this devastating epidemic will remain out of reach. State of Our Investments Global resources to fight HIV and AIDS have decreased since 2017, leaving a 30 percent shortfall for what is needed to fully address the epidemic. UNAIDS now estimates that annual investments will need to rise to $29.3 billion (in 2019 dollars) by 2025 to get the AIDS response back on track in low- and middle-income countries. While domestic contributions make up 57 percent of all resources available, global financial support is still a critical element of success, and the contributions of the United States play a leading role in leveraging the commitments of other donors. Increasing PEPFAR funding by $750 million dollars in FY25 would show the U.S.’s commitment to ending AIDS as a public health threat, and support closing the funding gap. This investment would make a significant down payment in the fight to end AIDS and will motivate other funders to step up as well. An investment of $1.65 billion in FY2025 would support the extraordinary work of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which has saved helped save 59 million lives since 2002. We are grateful to Congress for consistently providing robust funding to the Global Fund and to the administration for its bold pledge for the Global Fund’s three-year replenishment. The Administration’s $1.2 billion FY25 request, if funded by Congress, would fulfill the three-year U.S. pledge, assuming the 2:1 match requirement is based on non-U.S. donations toward a Global Fund replenishment, as is the standard practice. Congress has the option to provide additional support, beyond the $1.2 billion request, if it chooses. A robust contribution would avert 41.8 million new cases and infections from the three diseases—providing HIV screening and testing to 70.8 million people, providing malaria treatment and care to 26.8 million people, and screening 30.1 million people for TB. That translates into an estimated 510,000 additional lives saved over the estimated level that could be achieved based on the budget request. U.S. investments in global health, including the Global Fund, advance the health security of all Americans by helping to build health infrastructure in countries around the world, enabling them to quickly identify new disease threats, bring them under control, and prevent them from spreading to other countries. Global health investments also help nurture trade relationships with other countries. A $1.65 billion contribution from the U.S. would produce an estimated $47.8 billion in economic returns created by health gains. The success of PEPFAR is due in part to its unique structure that allows it to utilize the strengths and vast knowledge and experience of USAID and the Department of State to effectively address the global AIDS pandemic. The $350 million in funding allocated to USAID for HIV/AIDS programs supports multi-country, cross-cutting initiatives critical to the success of the PEPFAR. Funding from this account directly supports technical leadership and program assistance to field programs efforts that will be even more critical as the PEPFAR continues to build country-level capacity and transition programs to country-led counterparts. Without strong funding for this account, USAID’s investment in the new prevention tools such as long-acting injectable PrEP, and development of multipurpose prevention technologies and an effective HIV vaccine, could be in jeopardy. Finally, we ask specifically that you protect the critical role the Joint United Nations Programme on HIV/AIDS (UNAIDS) plays in the global HIV response by including $60 million in funding for UNAIDS. Support for UNAIDS is an important and abiding commitment the United States has made to the global fight against HIV/AIDS for more than two decades. With offices in over 70 countries, and 70 percent of its staff based in the field, UNAIDS has a unique on-the-ground presence, providing critical support for PEPFAR and the Global Fund investments and programs at the country level which cannot be duplicated or substituted. UNAIDS leads the coordination of global efforts to end AIDS by 2030, provides technical support for effective implementation of national programs and coordination of international efforts, and generates the only global set of HIV/AIDS data which is mandated by PEPFAR legislation. UNAIDS data and annual global report are essential for effective strategic planning and allocation of resources and efforts, including by the United States, and mobilizes political commitment in affected countries and among other donors globally, including to increase domestic financing for HIV programs in partner countries. Increased U.S. government funding will also help ensure UNAIDS has the necessary resources to strengthen its capacity and coordination role to fully implement the Global AIDS Strategy (2021-2026), which was adopted with the strong support of the United States. UNAIDS plays a critical role in advancing the U.S.’ goals of saving lives, advancing epidemic control, and increasing burden sharing in focus countries and by other donors. As noted in PEPFAR’s 2022 Annual Report to Congress: “UNAIDS is a critical leader in driving a comprehensive international response to fight HIV/AIDS. ... UNAIDS’ policy framework and the political commitment to eradicate HIV/AIDS complements and enables PEPFAR and programmatic efforts of the Global Fund.” Over twenty years into the program PEPFAR continues to show the world the United States’ compassion, but also effectiveness in addressing the challenges of global HIV and AIDS through prevention, care and treatment programs and policies that are grounded in science and respect for human rights. PEPFAR improves and saves the lives of people around the world and continues to advance our national security and development goals. It is imperative that we leverage PEPFAR’s success by scaling up successful programs to reach the most vulnerable and ensure that hard-won gains over the last twenty years are not lost. Funding global HIV/AIDS programs in Fiscal Year 2025 no less than $6.79 billion for Global Health Programs at the Department of State, including $5.14 billion for the President’s Emergency Plan for AIDS Relief (PEPFAR), $1.65 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as $350 million for USAID HIV/AIDS programs, and $60 million for the Joint United Nations Programme on HIV/AIDS (UNAIDS) and ensuring that the program is governed by policies that expand access to health care and uphold human rights is critical for this effort. We welcome the opportunity to work with you and your staff on these crucial and timely issues. Should any questions arise, if you need additional information, or if you would like to meet with members of the GAPP to discuss these issues, please contact Co-Chairs Katie Coester (kcoester@pedaids.org), Shannon Kellman (kellmans@unaids.org), or Suraj Madoori (suraj@avac.org). We appreciate your leadership and look forward to your assistance in the fight against the HIV/AIDS epidemic. Sincerely, American Academy of Pediatrics AVAC Children's AIDS Fund International Council for Global Equality Elizabeth Glazer Pediatric AIDS Foundation Evangelical Lutheran Church in America FHI 360 First Focus Campaign for Children Funders Concerned About AIDS Global Health Council Global Health Technologies Coalition Global Network of Black People working in HIV Health GAP (Global Access Project) HIV+Hepatitis Policy Institute Human Rights Campaign IAVI Management Sciences for Health MPact Global Action NASTAD PAI PATH RESULTS Together for Girls Treatment Action Group World Vision The GAPP is a coalition of more than 70 advocacy and implementing organizations committed to expanding and improving global HIV/AIDS programming in order to reach the goal of ending AIDS as a public health threat by 2030

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. On Friday, the World Health Organization (WHO) released its updated Bacterial Priority Pathogens List 2024, which aims to guide investments and R&D in new antibiotics and promote international coordination to address the rising global threat of antimicrobial resistance (AMR). The updated list, which incorporates new evidence and expert insights, includes 15 families of antibiotic-resistant bacteria grouped into critical, high, and medium categories for prioritization based on their burden and ability to resist treatment and spread resistance to other bacteria. Five pathogen-antibiotic combinations were removed from the new list and four new combinations were added, reflecting the dynamic nature of AMR.Last week, WHO authorized a second vaccine for dengue, which will hopefully offer millions more worldwide protection against the mosquito-borne disease, which is currently behind a major outbreak in the Americas and rising cases globally. The two-dose vaccine, made by Takeda, protects against the four types of dengue and is recommended for use in children between six and sixteen years old in regions with high dengue rates. The decision opens the door for donors and other United Nations agencies to purchase the vaccine for high-burden countries.Last week, the US Food and Drug Administration approved the use of self-collected samples with Roche and BD’s HPV tests, a decision that hopefully will expand access and reduce barriers to HPV screening, allowing more people to detect and treat cervical cancer. Screening for HPV is used to identify those who may be at risk of developing cervical cancer, most cases of which are caused by persistent HPV infection. Traditional screening involves a speculum-involved pelvic exam to screen for cervical cancer, which can be painful or uncomfortable for many patients. Self-collection allows patients to collect their own vaginal samples for screening in a health care setting.