Breakthroughs Blog

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. 

The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $30 million to support the collaborative development of an updated Ebola vaccine, enhancing global preparedness against this deadly health threat. The updated vaccine will build on Merck’s vaccine, which has a complex and expensive manufacturing process that is vulnerable to supply chain disruptions, as well as logistical challenges, including an ultra-cold storage requirement, which is unsustainable in remote, low-resource settings that have a higher likelihood of outbreaks. The partners will update the current manufacturing processes, hopefully lowering costs and making the vaccine easier to manufacture and store. The reduced production costs are expected to enable Merck to make the vaccine available in low- and middle-income countries at a more affordable price. The updated vaccine will be compared against the current vaccine in a Phase 3 trial, also funded by CEPI. A new study led by the University of Cambridge suggests that mpox may be capable of spreading asymptomatically, meaning that transmission may be more widespread in Africa than previously thought. The researchers analyzed blood samples from 176 healthy adults with no known exposure or history of infection in Nigeria, which has experienced intermittent outbreaks of the virus for decades. At least five participants had mpox antibodies in their blood, suggesting recent infection, but none of them reported any symptoms. These findings will inform how public health authorities track the spread of the virus, which has been behind several major outbreaks in recent years. This research also underscores the urgent need for improved vaccines and other tools for mpox. ENABLE-2, an antibiotic drug development engine backed by the Swedish Research Council and the National Research Programme on Antibiotic Resistance, is supporting the Global Antibiotic Research & Development Partnership (GARDP) to develop a novel class of antibiotics. The researchers plan to use an innovative approach by targeting a specific protein complex that bacteria use to strengthen their outer membrane. The ultimate goal of the work is to develop a new treatment for priority antibiotic-resistant bacterial pathogens. GARDP also aims to ensure the new treatment can be made accessible globally, including in low- and middle-income countries, which face a particular threat from antibiotic resistance. 

The World Health Organization (WHO) stands at a crossroads—one that could redefine its role in global health and reshape the global health research and development (R&D) ecosystem. In 2025, WHO faced a tumultuous year as several member states—including the United States and Argentina—moved to step back from the organization, citing concerns over its early COVID-19 response and broader calls for reform. These withdrawals, coupled with unpaid dues, have exacerbated existing budget shortfalls and triggered a sweeping restructuring effort aimed at slimming budget and operations, reorganizing leadership, and overhauling the organization’s structure. Yet, how these parallel developments—member states’ retreat and WHO restructuring—are being managed by the health organization remains remarkably opaque. Decisions have unfolded largely behind closed doors, leaving researchers, product developers, regulators, and advocates struggling to understand where responsibilities now sit, how coordination is continuing—or not—and what critical functions may be falling through the cracks. Though WHO leadership has continued to express hope that the United States would reconsider its withdrawal, it is also unclear to what degree informal coordination between these two actors may continue, underscoring the uncertainty facing global health R&D at a moment when clarity and coordination are most needed.WHO plays an irreplaceable role in supporting global health R&D, from setting research priorities and supporting regulatory convergence to coordinating disease surveillance and establishing norms that guide research. As WHO restructures and member states withdraw, these R&D functions risk erosion, creating gaps that could slow innovation, weaken outbreak preparedness, and undermine access to essential health, including both worldwide and in the United States. This blog explores what’s at stake and the unanswered questions that remain. Function at risk: Technical and coordinative support for regulatory bodiesWHO’s research coordination role is reinforced—and amplified—through its technical and convening support for national and regional regulatory authorities. Argentina’s National Administration of Medicines, Food, and Medical Technology (ANMAT), for example, has been recognized by the Pan American Health Organization (PAHO)—WHO’s regional arm for the Americas—as a gold standard Regional Reference Regulatory Authority since 2011. In this capacity, ANMAT has advanced regulatory convergence, capacity-building, and reliance mechanisms across the Americas. Argentina’s retreat from WHO- and PAHO-led regulatory collaboration risks weakening a critical pillar of regional regulatory trust, slowing approvals of quality-assured medical products, and reducing timely access to medicines for patients throughout the region.Beyond regional leadership, WHO’s technical and regulatory functions are tightly linked to how countries approve and adopt new health technologies. Through its prequalification process, which relies on assessments performed by stringent authorities such as the US Food and Drug Administration (FDA), WHO helps countries by assessing product quality, safety, and efficacy more efficiently. In turn, WHO also has come to rely on technical expertise from the FDA and other national regulators. Weakening this symbiotic relationship risks slowing the global uptake of FDA-approved products, diminishing incentives for US innovators to invest in neglected diseases and pandemic threats, and delaying patient access to safe, effective, and affordable health technologies worldwide.  What’s at stake: With WHO’s role as a global regulatory harmonizer in question, will we see an increasingly fragmented regulatory landscape—slowing approvals, duplicating effort, and delaying access to lifesaving products for patients who need them most?  Function at risk: Setting research priorities for clinical and product development WHO convenes scientists, funders, and governments to set global research priorities, align investments, and streamline clinical trials—especially during public health emergencies. This coordination is critical to accelerating the development of vaccines, diagnostics, and treatments for diseases such as HIV, tuberculosis, malaria, and emerging pathogens. In particular, WHO’s development of target product profiles provides an evidence-based roadmap for product developers, helping ensure that new tools meet public health needs, are fit for use in diverse settings, and can interrupt outbreaks before they escalate. Diminishing WHO’s capacity could slow progress across these areas. Efforts may become fragmented or duplicative, and delays could ripple through the R&D pipeline—postponing the availability of lifesaving innovations. In an interconnected global economy, such delays affect all nations by heightening health risks and disrupting supply chains, and they could ultimately impose economic costs on the United States. What’s at stake: If WHO’s R&D programs are undermined, how will global research priorities be aligned and by whom? How will we ensure that scarce R&D resources are prioritized and coordinated to target the most urgent health threats?Function at risk: Disease surveillance and monitoring systems WHO coordinates some of the world’s most critical disease surveillance networks, including the Global Influenza Surveillance and Response System, which informs the development of the flu vaccines used by people around the world, including Americans. Budget cuts, staff reductions, and program relocations could threaten the speed and reliability of outbreak detection, data sharing, and global coordination, making it harder to identify and respond to emerging threats before they spread internationally. Member states that remove themselves from WHO-coordinated surveillance programs put themselves at risk as emerging outbreaks could cross borders and reach countries such as the United States or Argentina before national health authorities have early visibility. What’s at stake: If WHO's disease surveillance programs are hollowed out by member state withdrawals, to what degree will gaps in data and early warning signals delay vaccine development and leave the world less prepared for the next pandemic? Amid sweeping changes at WHO and the growing implications of member state withdrawals, vital questions remain around how and whether WHO can preserve its vital role in the R&D ecosystem. Moreover, there remains little clarity on how the United States and WHO will manage this transition, where critical gaps are already forming. We can look back to the COVID-19 pandemic and see that global health R&D moves faster and more effectively when countries align around shared priorities, pool evidence, and coordinate trials—functions WHO is uniquely positioned to lead. This lack of clarity creates risk: for global health R&D, for outbreak preparedness, and for American health security. WHO will continue its core governance and policy processes in 2026, beginning with its next Executive Board meeting in February. These moments must be used by the global health community to demand greater transparency amid sweeping institutional shifts and to continue pressing for sustained investment in R&D functions that cannot afford erosion. Put simply, if we don’t know what is being scaled back, restructured, or deprioritized, we cannot ensure that the systems that move health innovations from labs to patients remain protected.