Breakthroughs Blog

A vaccine candidate that has now advanced into a Phase 2 trial could offer a new tool for preventing invasive nontyphoidal Salmonella and typhoid fever, life-threatening bacterial infections that disproportionately affect young children in low- and middle-income countries. There are currently no licensed vaccines against invasive nontyphoidal Salmonella. GSK’s vaccine candidate, which was supported by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) through preclinical and Phase 1 development, combines a new vaccine formulation for invasive nontyphoidal Salmonella with an existing typhoid conjugate vaccine. The trial, funded by Wellcome, marks the first time a CARB-X-supported vaccine candidate has reached Phase 2 development. An independent expert group convened by the World Health Organization has recommended that two Ebola vaccine candidates join an ongoing clinical trial in the Democratic Republic of the Congo amid the country’s ongoing outbreak of the Bundibugyo strain of Ebola, for which there are no specific vaccines. Based on evidence from preclinical and early clinical studies, the University of Oxford and the Serum Institute of India’s ChAdOx1 and Moderna’s mRNA-1469 candidates will be added to the trial, pending national approval. The trial is designed to test multiple vaccine candidates concurrently, prioritizing contacts of people with confirmed disease, with Ervebo, a vaccine currently approved for the more common Zaire strain of Ebola virus, already being evaluated for potential efficacy against Bundibugyo. Initial findings are expected within months, with results expected early next year.Last week, a trial of the first-ever long-acting injectable for malaria prevention launched in Rwanda. MMV371, developed by Medicines for Malaria Venture (MMV) in partnership with Quotient, has been shown to provide protection for around three months and could be a critical new weapon in the fight against malaria alongside vector control, vaccines, and preventive medicines. Climate change-induced changes in mosquito range and rising antimicrobial resistance have complicated malaria control efforts, and current malaria vaccines are only for very young children and require four doses. A long-acting injectable like MMV371 could offer a complementary long-acting prevention option for the broader population, including older children, adolescents, adults, and pregnant women. The developers are working to make the injection affordable in malaria-endemic countries and are also advancing a second-generation injectable that could provide year-long protection.

Last week, the Global Health Innovative Technology (GHIT) Fund announced that it has awarded PATH and iBody JPY 99 million to support the development of a diagnostic tool to enable early detection of Nipah and Hendra virus outbreaks in rural and low-resource settings. Nipah and Hendra are high-priority zoonotic viruses with pandemic potential for which there are no specific medical countermeasures available, including diagnostics. Current diagnosis depends on centralized laboratory testing, which is slow, costly, and inaccessible in low-resource settings, which can delay diagnosis, increasing transmission risk and mortality, especially in outbreak scenarios. The partners aim to develop a rapid, point-of-care test that can detect and differentiate infections caused by the two viruses, which could help identify cases and outbreaks more quickly. IAVI, Hilleman Laboratories, SK bioscience, and IDT Biologika recently announced that IAVI has been awarded funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to advance development of its one-dose vaccine candidate against Bundibugyo virus. Bundibugyo is the rare strain of Ebola virus behind the ongoing outbreak in the Democratic Republic of the Congo (DRC) for which there are no approved specific treatments or vaccines. IAVI will lead clinical and regulatory activities for the candidate, including its potential inclusion in a planned trial in the DRC following Phase 1 evaluation, and then, depending on its continued success, Hilleman Laboratories will support initial manufacturing and technology transfer, SK bioscience will lead manufacturing scale-up, and IDT Biologika will support final manufacturing for stockpiling. The US National Institutes of Health has announced $16.4 million over five years to establish a new center bringing together researchers across research universities and institutions to accelerate hepatitis C vaccine research and development. Chronic hepatitis C infection, which affects around 50 million people globally, can lead to severe disease. While antiviral drugs can successfully cure most infections, gaps in diagnosis, reinfection, and ongoing transmission persist, underscoring the need for a preventive vaccine. The virus has proved a challenging target for vaccine design because it is constantly mutating, making it hard to develop a broadly effective vaccine that can target regions of the virus that remain relatively stable across variants. Researchers from Scripps Research, the National Institute of Diabetes and Digestive and Kidney Diseases, the University of Pennsylvania, and the Oregon National Primate Research Center will collaborate to investigate how the virus escapes immune responses and design vaccine candidates using various platform technologies. The funding will also support the development of an online hepatitis C virus immune response database to inform the center’s work, which will also be made available to the broader hepatitis C vaccine development community to guide other research efforts. 

This fall has brought a flurry of global forums, political negotiations, and shifting priorities that will shape the global health agenda through the end of the year and into the next. Across these discussions, one message has become increasingly clear: the global health architecture is changing, but the need for new and better health technologies has not diminished. If anything, the pressures facing health systems, the emergence of new infectious disease threats, and persistent gaps in access make sustained investment in research and innovation more important than ever. GHTC had the privilege to participate in a season of global forums, from the United Nations (UN) high-level meeting (HLM) on pandemic prevention, preparedness and response (PPPR) in New York City, New York to the World Health Summit (WHS) in Berlin, Germany. As we reflect on our takeaways and next steps from these forums, we see both opportunities and risks. There is considerable momentum to rethink how global health institutions operate, how resources are mobilized, and how countries shape their own health priorities while preserving the scientific expertise, partnerships, and predictable financing needed to develop and deliver lifesaving innovations.  UNGA and the unfinished business of PPPR Three years ago, UN member states gathered in New York for the PPPR HLM, amid a profound sense of global urgency emerging from the COVID-19 pandemic. This September, member states returned to the issue against a more complicated geopolitical backdrop, with renewed attention to pandemic preparedness alongside persistent disagreements over equity, intellectual property, and international cooperation, echoed in other ongoing processes forging pandemic priorities.  After months of negotiations, member states were unable to reach consensus on the PPPR political declaration ahead of September’s HLM, and the text was referred to the broader UN assembly this month, where it was subsequently adopted. Though there were some initial snags in its adoption, the declaration reaffirms the importance of international cooperation and advances several priorities for health innovation, including sustained investment in research and development, stronger public-private partnerships, and expanded regional manufacturing capacity. Together, these commitments reflect a comprehensive vision of preparedness that seeks to pair innovation with the manufacturing and partnerships needed to bring new tools to scale.These negotiations also highlight a challenge that extends beyond the political declaration: how to translate commitments on pandemic preparedness into the practical capabilities countries need to detect and respond to emerging threats. During HLM week, GHTC and Adjuvant Capital hosted a roundtable discussion with US Department of State Bureau of Global Health Security and Diplomacy and multilateral stakeholders examining lessons from Ebola, including the critical role of diagnostics, surveillance, and innovation in strengthening outbreak response. The multifaceted dialogue reinforced that preparedness is not simply a question of having the right technologies available; countries also need the systems, partnerships, and sustained resources to deploy those technologies effectively. Investments in R&D, surveillance, regulatory capacity, and access must therefore be understood as interconnected components of preparedness, rather than competing priorities.Topline takeaway: This fall’s PPPR discussions showed that broad support for pandemic preparedness can coexist with deep disagreements over international cooperation, making both sustained investment in vaccines, diagnostics and therapeutics and workable mechanisms for research coordination and equitable access all the more critical. The measure of progress will not be the strength of the next declaration, but whether countries are better equipped to detect, prevent, and respond to the next outbreak.  WHS and the innovation agenda The global health community gathered again in Berlin in October for WHS. Against a backdrop of evolving global health priorities, momentum for change, and pressure on traditional financing models, the summit offered a chance to consider how innovation can strengthen health systems, address persistent gaps in access, and support resilience in the face of emerging challenges.For GHTC, a particularly valuable discussion centered on the role of product development partnerships (PDPs) in advancing health innovations for diseases and populations too often overlooked by traditional commercial markets. GHTC co-moderated a session convened by Medicines for Malaria Venture, bringing together perspectives from PDPs and their partners on the evolving challenges of developing and delivering new health technologies. The discussion highlighted both the value of the PDP model and the pressures facing these partnerships as the global health financing landscape changes. PDPs have demonstrated what is possible when scientific expertise, public and philanthropic investment, and cross-sector partnerships are brought together around shared health priorities. Yet developing a new medicine, vaccine, or diagnostic is a long-term undertaking. Unpredictable financing can disrupt research pipelines, weaken scientific partnerships, and jeopardize years of progress.This concern extended well beyond the PDP discussion. Across conversations with funders, financing partners, and GHTC members, a recurring theme at the summit was the need for greater consistency and predictability in global health financing. While there is understandable interest in pursuing new financing models and greater efficiency, innovation cannot be sustained through short-term funding cycles alone. Predictable investment is essential to maintaining the research infrastructure, scientific talent, and partnerships that make progress possible.  Innovation remains central to the global health agenda, but the changing financing landscape also raises difficult questions about who will support research for diseases and health needs that remain underserved by commercial markets. As traditional donors reconsider their commitments to global health assistance and countries face competing demands on limited resources, there is a risk that important research priorities will be deprioritized precisely when sustained investment is needed most. New financing approaches are welcome, but they must complement rather than simply replace the long-term public and philanthropic commitments that have historically made much of this research possible.Topline takeaway: Innovation remains central to the global health agenda, but translating scientific advances into meaningful health outcomes requires more than promising technologies. Sustainable financing, effective partnerships, supportive policy environments, and equitable access must remain part of the conversation. For GHTC and its members, WHS reinforced the importance of connecting R&D priorities with the broader systems and policies needed to bring innovations to the people who need them. Looking ahead: Keeping innovation central The implications of this fall’s global forums will extend well beyond the declarations adopted and discussions held. Several interconnected processes, including ongoing negotiations on the Pathogen Access and Benefit-Sharing annex to the Pandemic Agreement, the Accra Reset, and Lusaka Agenda, will help shape how global health institutions operate, how research is funded, and how countries participate in developing and accessing new technologies. As these reform efforts advance, it will be important to ensure that research and innovation are not overlooked in discussions that often focus primarily on health financing and service delivery. These evolving mechanisms are also starting to take shape as the World Health Organization prepares to elect a new Director-General, one who will face consequential questions about which technical capacities to preserve, where to focus investment, and how to maintain the expertise and global coordination that underpin innovation and access. As these conversations continue, several priorities stand out. Global health institutions must become more effective and responsive without sacrificing the scientific and technical capacities that underpin progress. Financing reforms must recognize that research and innovation require long-term, predictable investment. And efforts to strengthen country ownership must create meaningful opportunities for countries to shape research agendas, build scientific capacity, and benefit from the innovations they help advance. Perhaps most importantly, global health R&D cannot be treated as a secondary consideration in debates about governance and financing. New vaccines, diagnostics, medicines, and other health technologies are essential to achieving the very goals these reforms are intended to advance. For our coalition, the task ahead is to work with our members and partners to ensure that innovation remains central to these discussions, that commitments are translated into practical action, and that the global health ecosystem emerging from this period of change is better equipped to deliver for the people and communities it serves.

The Coalition for Epidemic Preparedness Innovations (CEPI) has launched a critical Phase 2/3 clinical trial to evaluate vaccine candidates for the Bundibugyo strain of Ebolavirus, which is responsible for the current outbreak in the Democratic Republic of the Congo and currently has no approved vaccine. The trial will assess the safety, immune response, and efficacy of multiple vaccine candidates in parallel, beginning with Merck’s Ervebo, which is approved for Ebola Zaire, with two Bundibugyo-specific candidates from Moderna and the University of Oxford/Serum Institute of India expected to enter the trial shortly. The organizers hope the trial will help curb transmission and save lives during the current outbreak, while strengthening preparedness for future outbreaks. Weill Cornell Medicine recently announced that it has received a four-year, $8.2 million grant from the National Institute of Child Health and Human Development at the US National Institutes of Health to further development of an experimental on-demand male contraceptive pill that temporarily renders sperm immobile. There is an urgent global need for new contraceptive options for men beyond condoms and vasectomy to enable men to share contraceptive and family planning responsibilities more equally with female partners and reduce the burden that has historically fallen on women. The researchers will now work toward advancing the technology into a Phase 1 trial, developing an oral formulation, setting manufacturing protocols, and establishing safety. A new study from a team of international researchers evaluating experimental methods to improve mRNA vaccine delivery identified a promising needle-free vaccination method, which could offer a new delivery method for mRNA technology, which is continuing to show promise across a range of health areas, as well as reduce unwanted inflammation. The method, which combines a high-pressure liquid jet that delivers mRNA alongside two substances that strengthen the immune response, was able to protect against the viruses that cause COVID-19 and flu in mice. The researchers will now evaluate the method in larger animals and, if it continues to prove successful, in human trials.