Breakthroughs Blog: Pandemic preparedness

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. 

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. 

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.