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Seasonal malaria chemoprevention (SMC) is one of the best ways to protect children from malaria. No one knows this better than community health volunteers who go door to door helping families protect their children from malaria by administering medicines.SMC reached approximately 56 million children in 2025 in sub-Saharan Africa. Its success depends on community participation, from local volunteers to parents administering treatment at home.Community members have long been essential to the successful delivery of interventions like SMC. Researchers are increasingly recognizing the value of bringing their perspectives into research much earlier.Bringing community perspectives into researchCommunities are not just participants in research; they are experts of their lived experiences. Their insights help shape not only the delivery of interventions, but also their design and development to ensure that interventions fit the realities of the communities they are intended to serve. Civil society organizations like Impact Santé Afrique, product development partnerships, and research institutions are working to make community engagement an integral part of health research and innovation. Meaningful engagement means more than being invited to comment on decisions; communities must have opportunities to raise concerns, challenge assumptions, and see how their input has influenced research. This may include engaging communities before protocols are finalized, ensuring equitable representation in decision-making structures and, crucially, showing them what impact their input has had.This ethos is reflected in international research guidance. The Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines, and World Health Organization guidance on clinical trials increasingly recognize the importance of meaningful engagement with patients and communities. Putting community engagement into practiceThis approach has been applied in the ongoing Safety of Antimalarials in the FIRst TrimEster (SAFIRE) consortium’s clinical trials. This project is conducting clinical research in Burkina Faso, Mali, and Kenya to evaluate the efficacy and tolerability of several first-line antimalarials to treat women in their first trimester of pregnancy.At the start of SAFIRE, Medicines for Malaria Venture and other consortium partners conducted formative research, exploring community perspectives and cultural sensitivities that could influence participation in the study. As a result, the SAFIRE team refined communication materials to be more accessible across different literacy levels as well as culturally responsive to each country context. These insights also directly influenced trial design, informing participant identification methods, recruitment, informed consent, voluntary participation, and retention strategies. Building on the community advisory board model long used in HIV research, the Drugs for Neglected Diseases initiative has established regional Community Advisory Committees in Africa, Asia, and Latin America. These committees bring together patient advocates and people with different lived experiences of disease. Their role is not simply to react to research once decisions have been made, but to bring community perspectives into the decisions and materials that shape how studies are designed and experienced. Recent consultations show what this can mean in practice: for a Phase 3 dengue trial, community members and people with lived experience reviewed the informed consent and assent materials and made recommendations to improve the process by shortening consent forms, reducing repetition and technical language, and making the research process and goals clearer to participants, alongside what they should expect in terms of care, safety, and rights. Community engagement becomes meaningful when listening leads to action and communities can see how their input has shaped decisions and contributed to how interventions are developed and delivered. Engaging communities before decisions are made Community participation can begin even earlier, before decisions are made about developing, testing, or introducing a new intervention. Between 2024 and 2026, Mali’s University Clinical Research Centre conducted sociological research to assess communities’ understanding of genetically modified mosquitoes (GMMs) as a potential malaria control strategy. Although Mali is not yet using GMMs, this type of research helps generate evidence that can inform future scientific and policy decisions. Researchers engaged a broad range of stakeholders—including health workers, people living in both urban and rural communities, religious leaders and youth—in focus group discussions to gather qualitative data. Study participants were viewed as contributors rather than research subjects, with researchers soliciting their experiences, recommendations, and views on challenges and solutions that could arise in deploying this intervention.The findings showed that perceptions of GMMs varied according to factors such as gender, education levels, and trust levels in scientific and health institutions. At the same time, common ground also emerged, particularly around the need for transparent information, credible scientific data, trustworthy institutions, community consultation and meaningful participation in decision-making.Scientific innovation alone is not enoughScientific efficacy alone is not sufficient to ensure the acceptance of new interventions. They must also be perceived as socially and culturally legitimate and implemented through governance mechanisms that consider communities’ concerns, expectations, and values. Early engagement is also critical for building trust and supporting sustained, meaningful interactions with communities throughout scientific and clinical research.When advancing innovations to improve global health outcomes, product developers must treat communities as indispensable partners whose perspectives can improve the relevance, acceptability, and impact of new public health interventions. Communities have long played a role in delivering health interventions. They should also have a role in shaping them.

The Honorable Mike JohnsonSpeaker of the HouseU.S. House of RepresentativesWashington, DC 20515The Honorable Hakeem JeffriesHouse Minority Leader.U.S. House of RepresentativesWashington, DC 20515The Honorable John ThuneSenate Majority LeaderU.S. SenateWashington, DC 20510The Honorable Chuck SchumerSenate Minority LeaderU.S. SenateWashington, DC 20510November 10, 2026Dear House Speaker, House Minority Leader, Senate Majority Leader, and Senate MinorityLeader:The undersigned 71 organizations, representing public health, patients, clinicians and biomedicalresearchers, thank you for passing a Continuing Resolution that prevents the White House Officeof Management and Budget from implementing the proposed Regulation for Federal FinancialAssistance, and keeps federal biomedical research programs operating until December 11. Thisproposed regulation would undermine Congress’s constitutional role in directing the use oftaxpayer dollars by making unprecedented and comprehensive changes to the rules for federalgrants across federal agencies, including those within the Department of Health and HumanServices, like the National Institutes of Health and its National Institute of Allergy and InfectiousDiseases (NIAID). In the strongest possible terms, we urge you to act by December 11 to enact along-term policy that: 1) blocks the proposed regulation; and 2) protects against any executiveorder, regulations, or guidance that would put political appointees in charge of NIH grantmakingor making binding oversight decisions.Article 1 of the Constitution gives Congress the ultimate authority on how federal appropriationsare spent and administrations are expected to carry out these decisions. This proposed rule givescurrent and future administrations leeway to ignore those decisions. Thanks to Congressionalaction, patients with serious and life-threatening diseases and local communities have benefittedfrom peer-reviewed, evidence-based NIAID-funded research that has led to breakthroughs inpublic health practice, infectious diseases and allergy prevention, diagnosis, and treatment, asintended by Congress. If the proposed rule is implemented, progress to develop newbreakthroughs will be hindered.NIAID plays an essential role in addressing the impacts of allergy and asthma on human wellbeingand infectious disease threats such as antimicrobial-resistant infections, vector-bornediseases, HIV, viral hepatitis, sepsis, foodborne illness, tuberculosis, influenza, emergingpathogens and other infections that can seriously complicate cancer chemotherapy, organtransplantation and other medical procedures. NIAID supports research that helps explain howhuman behavior, social conditions and structural factors influence infectious disease prevention,treatment uptake, adherence and health outcomes. Additionally, NIAID funding is critical totraining the public health and scientific workforce. Students in NIAID-funded training programsand laboratories go on to work in public health agencies, clinical settings, academic research, andindustry.This proposed regulation would dramatically alter the way NIAID funding is allocated —placing grant decisions in the hands of political appointees instead of scientific experts andprioritizing political alignment over scientific merit and patient need. This will cause significantupheaval in medical research as biomedical discoveries take an average of 10 to 15 years frominitial laboratory discovery to availability for patient use and political priorities typically changewith every new president, if not more frequently.Further, political appointees often do not have the expertise necessary to determine which grantproposals are the most scientifically rigorous and most likely to deliver meaningful results forpatients. The proposed changes, along with the ability for grants to be canceled at any time, forany reason, will make it extremely difficult, if not impossible, to launch and sustain the type ofresearch needed to deliver new vaccines, diagnostic tests and treatments given the significantinfrastructure, staffing, expertise and time these studies require. The proposed rule would alsolikely have far ranging impacts beyond the intended goals of the current Administration. Theunprecedented authority that would be granted to OMB and federal agencies by this proposedrule would also be conveyed to future Administrations, which could use this authority for otherpolicy goals and preferences.Prohibiting the use of grant funds to publish findings in scientific journals and significantlylimiting the use of grant funds for scientific conferences will severely limit the ability ofresearchers to collaborate with other researchers, clinicians and patients and share their findingswith the public. This will dramatically curtail scientific progress and greatly slow the pace atwhich research findings become lifesaving new interventions for patients.Taken together, these changes will drive current and future researchers away from research oraway from the U.S., leaving our nation without the scientific workforce and infrastructure weneed to drive the innovation needed to improve the lives of Americans.Thank you for your attention to this issue and we strongly urge you to work with relevantcommittees and your colleagues to avoid this future by passing legislation that prohibitsimplementation of this proposed rule permanently, or at least for an extended period of time.Sincerely,#MEActionAIDS Action BaltimoreAlliance for Positive ChangeAmerican Academy of Allergy, Asthma & ImmunologyAmerican Academy of Family PhysiciansAmerican Academy of NursingAmerican Association of Colleges of PharmacyAmerican Association of ImmunologistsAmerican Association of Veterinary Medical CollegesAmerican Cancer Society Cancer Action NetworkAmerican College of Chest PhysiciansAmerican College of Preventive MedicineAmerican Institute of Biological SciencesAmerican Psychological Association ServicesAmerican Society for VirologyAmerican Society of Health-System Pharmacists (ASHP)American Society of HematologyAmerican Society of Tropical Medicine and HygieneAmerican Thoracic SocietyAPLA HealthASMAssociation for Professionals in Infection Control and Epidemiology (APIC)Association of Nurses in AIDS CareAsthma and Allergy Foundation of AmericaAutoimmune AssociationAVACBateman Horne Center of ExcellenceBiophysical SocietyCornell Reproductive Sciences CenterCornell UniversityCrohn's & Colitis FoundationCystic Fibrosis FoundationEntomological Society of AmericaFast-Track HealthFederation of Associations in Behavioral & Brain SciencesFive Horizons Health ServicesFoundation for Sarcoidosis ResearchGerontological Society of AmericaGlobal Health Technologies CoalitionHealthHIVHIV Medicine AssociationHROImmune Deficiency FoundationImmunize.orgInfectious Diseases Society of AmericaLupus Foundation of AmericaMosquito and Vector Control Association of CaliforniaNASTADNational Affordable Housing Management Association (NAHMA)National Association for Biomedical Research (NABR)National Coalition for LGBTQ HealthNational Eczema AssociationNational Environmental Health AssociationNational Foundation for Infectious DiseasesNational Working Positive CoalitionNMACNortheast Regional Center for Excellence in Vector Borne DiseasesOpen Medicine FoundationPeggy Lillis Foundation for C. diff Education & AdvocacyPenn State Health/Penn State College of MedicinePrevent BlindnessRockies and High Plains Vector Borne Diseases Training and Evaluation CenterSAGESan Francisco AIDS FoundationSave HIV funding campaignSociety for Healthcare Epidemiology of AmericaSociety for Scholarly PublishingSolve M.E.TB AllianceThe AIDS InstituteTreatment Action Group (TAG)

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.