Breakthroughs Blog

A new study has found that five human cases of a mysterious, bat-borne virus in Bangladesh, initially thought to be Nipah virus, were actually caused by another emerging bat-borne virus called Pteropine orthoreovirus (PRV). Between late 2022 and early 2023, five patients were admitted to hospitals with severe symptoms, all of whom had consumed raw date palm sap, which is also consumed by bats. Health care workers thought they had the Nipah virus, for which bats are a known vector, but they all tested negative. Several of the patients continued to experience severe symptoms after being discharged, and one ultimately died the following year. Human PRV cases have been reported other countries, but typically resulted in much milder respiratory illness, suggesting that the virus may have undergone genetic changes, making it more transmissible and virulent. These findings underscore the need for robust, vigilant surveillance of emerging diseases, particularly bat-borne pathogens. Last week, the Population Council announced that it has executed a global, exclusive license agreement for the Nestorone®/Testosterone (NES/T) male contraceptive gel, transferring the program to Contraline Inc., which will lead late-stage development toward potential global regulatory approvals as the first reversible contraceptive drug for men. The product, if approved, could transform contraception, enabling men to take on a responsibility that has historically fallen on women. NES/T is the most advanced investigational male contraceptive in the pipeline, and the Phase 3 clinical trial being planned is expected to be the first-ever Phase 3 trial of a hormonal male contraceptive. It is a daily topical gel that suppresses sperm production while maintaining normal testosterone levels, which was co-developed by the Population Council and the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health.  An early-stage trial evaluating a nasal spray vaccine for H5N1 bird flu found that the vaccine generated a strong immune response in rodents, a significant first step toward a vaccine capable of slowing the spread of bird flu, which in recent years has continued its worrying global spread among animal populations, with occasional human cases. While traditional injected flu vaccines are highly effective at preventing serious illness, they are less effective at reducing infection in the first place. Nasal vaccines, which work at the place of infection, can more effectively stop infections and prevent onward transmission to others. They are also believed be more effective against rapidly mutating viruses because they train the immune system differently than traditional vaccines, stimulating mucosal immunity in the nose and upper airway, and can respond to features of the virus that are shared across different strains, meaning they can remain effective for longer without needing updating. There are H5N1 vaccines stockpiled in several countries, but most of these were developed to target previously circulating strains of the virus and are poorly matched to the newer, rapidly mutating strains we have seen in recent years. 

Women are steadily reshaping the landscape of global health research. In 2022, they made up 41 percent of researchers worldwide, representing considerable progress toward closing the gender gap in science. Yet women remain underrepresented in many scientific fields and in senior roles, are published and cited less frequently than men, and file far fewer patent applications. Despite these systemic barriers, women researchers are having an outsized impact on global policy and progress. Research led by women is more likely to address topics aligned with the Sustainable Development Goals, and publications with women authors are more frequently cited in policy documents.  Expanding women’s participation and leadership in science is not just a matter of equity, it is essential to ensuring research priorities reflect women’s lived experiences. Although women spend more of their lives in poor health than men, only 1 percent of global health research and development funding targets female-specific conditions beyond cancer. Even as gaps persist, women scientists are already at the forefront of innovation, driving cutting-edge technologies that could transform the future of global health. Advancing promising HIV vaccine strategies Developing an HIV vaccine capable of preventing infection has long challenged researchers due to the virus’s extraordinary ability to mutate and evade the immune system. Still, many experts believe such a vaccine will be essential to ending the global pandemic.A Phase 1 trial, launched in August of last year, is evaluating an investigational HIV vaccine candidate designed to induce an immune response scientists believe could effectively target vulnerable parts of HIV-infected cells. Three distinguished female principal investigators—Dr. Tariro Makadzange of the Mutala Trust, Dr. Theodorah Rirhandzu Ndzhukule of the Desmond Tutu Health Foundation, and Dr. Limakatso Lebina of the Africa Health Research Institute—are overseeing the study across clinical trial sites in Harare, Zimbabwe; Cape Town, South Africa; and Durban, South Africa, respectively.  Another Phase 1 trial, launched just last month, is testing a different novel approach. Researchers are evaluating whether highly specialized vaccine immunogens, delivered in a specific sequence, can train the immune system to produce broadly neutralizing antibodies against HIV, widely considered one of the keys to achieving broad protection against the virus. The trial is led by Dr. Linda-Gail Bekker, CEO of the Desmond Tutu Health Foundation and a leading HIV clinician-scientist. These vaccines have the potential to transform the lives of women and girls, who bear a disproportionate burden of HIV and AIDS, particularly in sub-Saharan Africa. The leadership of these scientists underscores how women researchers are driving forward breakthroughs that address urgent global health needs. Trialing promising TB vaccine candidates New tuberculosis (TB) vaccine candidates also hold promise for reshaping global TB efforts, particularly as rising drug resistance makes the disease harder to fight. The only currently approved TB vaccine is more than 100 years old and is effective at preventing some forms of TB in infants but offers limited protection against pulmonary TB in adults.  One next-generation vaccine candidate, MTBVAC, was co-designed by Dr. Brigitte Gicquel of the Institut Pasteur, who is a pioneer in TB research. MTBVAC is the only live-attenuated candidate in the pipeline, meaning it contains a weakened form of the bacteria that causes TB, and aims to offer more effective, longer-lasting protection for newborns while also preventing TB disease in adolescents and adults, for whom no effective vaccine exists.In a Phase 1a/2b trial published last year, MTBVAC was found to be safe and capable of generating immune responses comparable to or stronger than the current TB vaccine. The study was led by Dr. Angelique Luabeya of the South African Tuberculosis Vaccine Initiative, who has considerable experience leading novel TB and COVID-19 vaccine trials. MTBVAC is now being evaluated in a Phase 2 trial in people living with HIV, co-chaired by the aforementioned Dr. Limakatso Lebina. Another leading vaccine candidate, M72/AS01E, is currently undergoing a large Phase 3 trial to determine whether it can protect adolescents and adults from pulmonary TB. Dr. Lee Fairlie of Wits RHI at the University of the Witwatersrand, an infectious disease expert with extensive experience leading major clinical studies, is serving as national principal investigator for the trial in South Africa. These vaccine candidates could dramatically alter the trajectory of the global TB epidemic, reflecting the critical contributions of women researchers in advancing solutions to one of the world’s oldest and deadliest infectious diseases. Driving forward antimalarial drugs for a long-excluded group Last fall, a global consortium launched the first-ever Phase 2 adaptive platform trial evaluating the efficacy and safety of antimalarial drugs during the first trimester of pregnancy. This landmark study addresses a long-standing gap in safe and effective evidence-based treatment options for pregnant women at risk of malaria. Pregnant women, particularly those in early pregnancy, have historically been excluded from clinical trials, leaving major unanswered questions about how best to treat malaria and other conditions in this high-risk group.  Among the study’s co-principal investigators are Dr. Myriam El Gaaloul from the Medicines for Malaria Venture, Dr. Stephanie Dellicour from the Liverpool School of Tropical Medicine, and Dr. Hellen Barsosio of the Centre for Global Health Research at the Kenya Medical Research Institute, who bring deep expertise in clinical trials, malaria, and maternal and newborn health. This trial has the potential to not only reshape care for pregnant women at risk of malaria but also set a powerful precedent for more inclusive research. It illustrates how greater gender diversity in research leadership can help ensure studies prioritize and better reflect the needs of the people they aim to serve. Across the global health innovation pipeline, women scientists are driving transformative progress. Accelerating gender diversity across research teams, investing in early-career women researchers, and strengthening pathways to leadership will advance gender equity while ensuring that scientific breakthroughs are more inclusive, accessible, and reflective of the needs of all people. 

Sino Biological, Inc. recently announced an effort to accelerate the development of critical research tools to support the global scientific community in advancing Nipah virus research, as new cases of the deadly pathogen have raised international concerns. Sino Biological has launched a series of proteins, which researchers can use in the lab to better understand how the virus infects cells and how to design antibodies that might successfully target the virus. These proteins are based on the currently circulating Nipah virus strains, so could help boost the accuracy and relevance of research efforts. There are currently no approved vaccines or specific antiviral treatments for Nipah, underscoring the importance and urgency of research and development efforts to advance vaccines and therapies. Newly shared results from the first blinded, randomized non-inferiority trial comparing one versus two doses of HPV vaccine show that a single dose provided similar protection to the two-dose schedule. These results verify a previous study, which undergirded the World Health Organization’s 2022 recommendation of the lower-dose regimen, which has since led to its adoption by almost 90 countries. The lower-dose regimen can help boost access and uptake of the HPV vaccine by reducing the cost and complexity of vaccination for public vaccine procurers, health care providers, and patients. Specifically, the researchers found that a single dose was 97 percent effective against HPV infections in a large study with 20,000 participants, who were studied for up to five years post-vaccination. Last week, the Drugs for Neglected Diseases initiative (DNDi) announced a new memorandum of understanding with the African Population and Health Research Center aimed at helping translate African-led research into transformative innovations and health policies. Specifically, the agreement involves coordination to promote joint research, advance evidence-based programming and policymaking, and facilitate capacity-building. The memorandum also outlines collaborative commitments to ethical, value-enhancing data-sharing activities, including generating high-quality evidence and creating a robust system to preserve and share findings. 

Congress is advancing a six-bill spending package that would maintain significant global health assistance and increase funding for medical research, demonstrating continued bipartisan support for areas the administration previously targeted for cuts. The package also includes important provisions to limit recent changes to biomedical research grant policies, strengthen oversight of global health programs, and establish, for the first time, a new global health research and development (R&D) initiative at the State Department, a significant milestone consistent with longstanding GHTC advocacy. Last Thursday, the House approved the fiscal year 2026 (FY26) package, which still needs to clear the Senate and be signed by the President before the January 30 deadline to avert another government shutdown. While initially this process appeared on track, the timeline for final passage has now become uncertain. Stalled negotiation surrounding the bill’s funding for the Department of Homeland Security, combined with severe winter weather limiting Senators’ ability to return to Washington, DC, may delay action. As a result, the United States could be headed to a partial government shutdown, with only half of the twelve appropriations bills passed by the deadline.  Major wins for global health R&D at State Department despite topline reductions The FY26 budget package provides $9.4 billion for Global Health Programs, now housed at the State Department following the July integration of programs at the US Agency for International Development (UASID) into State. This represents a reduction of $615 million from fiscal year 2025 (FY25) enacted levels. While a cut is rarely ever good news, the funding remains $5.6 billion above the President’s Budget Request (PBR) and includes resources for areas targeted for elimination by the administration, including reproductive health, neglected tropical diseases, and a US contribution to Gavi, the Vaccine Alliance. Although the overall Global Health Programs budget declined, the bill contains several significant victories for the global health R&D community and opportunities to shape the State Department’s expanding role in global health going forward. A new $50 Million Prevention, Treatment, and Response InitiativeThe bill establishes for the first time a $50 million Prevention, Treatment, and Response Initiative for the prevention and treatment of HIV/AIDS, malaria, and other infectious diseases in alignment with the America First Global Health Strategy. This new initiative, which is intended to support the research, development, and delivery of technologies, closely mirrors a GHTC-led proposal to create a disease-agnostic global health R&D fund at USAID that was taken up in bipartisan legislation introduced in fall 2023. Given the termination of almost all USAID’s R&D work early last year, Congress’s decision to direct funding to State to explicitly support global health R&D activities is a major win.Guardrails and oversight for the Innovation Fund and bilateral agreements  The package also introduces key guardrails, consistent with priorities long advanced by GHTC, to inform the State Department’s implementation of a newly proposed Innovation Fund supporting biomedical and health systems innovation, in alignment with the America First Global Health Strategy. While the fund concept remains in a nascent stage, Congress is already exercising oversight to ensure funds are administered through a transparent, competitive process, approved by Congress, that includes a broad range of partners. Budget directives require a briefing from the Secretary of State outlining planned activities for the fund and encourage partnerships with both private companies and nonprofit organizations.  The inclusion of nonprofit organizations, who bring deep expertise as implementors of USAID global health R&D programs and a firm commitment to global access, is key to ensuring that technologies and approaches supported by the Innovation Fund are globally relevant and accessible.  To ensure visibility into the new bilateral country agreements being actively negotiated under the new global health strategy, the bill directs the State Department to report to Congress on the structure and content of the agreements and on all activities funded under Global Health Programs, safeguarding transparent and robust implementation of the strategy. Strengthening coordination across the US government and multilaterallyFinally, the bill reinforces the importance of global health collaboration across the US government and with global partners. There are strong budget directives supporting State Department collaboration with the US Centers for Disease Control and Prevention (CDC) and other relevant agencies to ensure strong technical components in the implementation of the global health strategy.  Beyond the United States, the bill includes funds for US contributions to the Pandemic Fund and the Coalition for Epidemic Preparedness Innovations, the latter to advance vaccines to counter pandemic threats, and requires the department to brief Congress on its plans to maintain essential multilateral health engagement activities like disease monitoring and data sharing, among others. These provisions will hopefully help ensure that the State Department’s global health activities are coherent, technically grounded, and not duplicative of other US government or multilateral efforts. Medical research and global health funding protected at HHS In contrast to the administration’s funding proposal and the sweeping policy changes it has implemented across the Department of Health and Human Services (HHS) that have reshaped the US biomedical and public health apparatus, the funding package includes increased funding for HHS agencies to support medical research and global health technical assistance, as well as new budget directives to limit changes to the grantmaking process.  The package provides a one percent increase to the National Institutes of Health (NIH) budget from FY25, which also represents a $21.21 billion or 77 percent increase from the PBR. The NIH National Institute of Allergy and Infectious Diseases, which supports critical research to advance technologies to address longstanding and emerging global infectious disease threats, also received a modest 0.35 percent boost, which represents a $2.41 billion or 58 percent increase from the PBR. The Fogarty International Center, which advances international research training and collaborations; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which supports critical advancements in reproductive and women’s health technologies; and the Office of Research on Women’s Health, which supports research and cross-cutting approaches to advance the health of women—all of which were absorbed into other entities or outright eliminated in the PBR— received flat or increased funding from FY25. The Office of Research on Women’s Health saw a significant $30 million or 39 percent increase from FY25.  At the CDC, the spending package maintains flat funding for the Global Health Center, which provides critical technical assistance in implementing global health programs and tracking emerging threats. It was eliminated entirely in the PBR and cut significantly in the House’s health spending bill. It also provides a 3 percent boost to the National Center for Emerging and Zoonotic Infectious Diseases, which supports the development of diagnostic technologies.  Finally, the Biomedical Advanced Research and Development Authority, which supports the development of medical countermeasures against emerging pandemic and epidemic threats, received a 3 percent increase from FY25, which is more than 50 percent above the budget proposed in the PBR. It is encouraging to see that congressional appropriators are still strongly supportive of these offices and centers that lead and fund critical research on global health and women’s health. Bill language provides some guardrails on new funding limitations, hiring practices, and grant terminations The package also introduces new guardrails to preserve the integrity of the research grantmaking process at NIH. During the funding negotiations, congressional appropriators raised concerns about a practice NIH deployed last year to forward fund grants by providing all funds for multiyear grants up front rather than on a yearly basis, which had the effect of reducing total awards made. In the conferenced bill, Congress limits NIH spending on forward funding to the percentage spent in 2025, which was 39 percent. This issue was a sticking point in negotiations, and the language ultimately represents a compromise outcome, with the Senate wanting stricter prohibitions on forward funding and the House more responsive to pushback from the administration. The conferenced bill text also prohibits the administration’s attempts to implement blanket changes on indirect cost rates, which support overall research infrastructure on which individual projects rely. The language highlights the importance of indirect costs in sustaining US scientific leadership and urges the agency to work with Congress to reform the indirect cost process. Similarly, the JES includes language responding to the large number of grant terminations that have taken place over the past year, directing HHS to consult with Congress prior to terminating grants and calling attention to the significant consequences of these actions. Looking ahead This spending package creates the foundation for restoring US leadership in global health innovation. If enacted, GHTC is eager to build on this momentum and will continue working closely with department officials and congressional appropriators to ensure these provisions and funding translate into meaningful action. While many unanswered questions remain as these new provisions take shape, utilizing the groundwork that has been laid out in this FY26 package to inform the road ahead in fiscal year 2027 will be essential.