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Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last month, Brazil became the first country in the world to introduce tafenoquine, the first new single-dose treatment for P. vivax malaria developed in 70 years. Tafenoquine, developed by GSK and Medicines for Malaria Venture (MMV) in partnership with local researchers in Brazil, improves upon the previous treatments, which had major issues with adherence due to higher complexity and longer duration. The local Brazilian research partners also developed a new point-of-care test to identify a hereditary condition that can cause hemolytic anemia in those who take tafenoquine or one of the previous treatments, primaquine. After the approval and registration of tafenoquine in Brazil in 2019, field studies conducted over the last few years found extremely high levels of compliance with the new treatment protocol of routine testing to inform treatment, and similar feasibility studies are starting around the world, which will hopefully provide further evidence to improve global and national malaria guidelines and programs.The world’s first trial for a potential treatment for Crimean-Congo hemorrhagic fever has launched in Turkey. There are currently no specific approved drugs or vaccines and limited funding for R&D for the virus, which was named a priority pathogen by the World Health Organization. It is endemic in many countries in Africa, the Middle East, and Asia and has a mortality rate as high as 40 percent. The phase 1 trial will test the safety and potential dosages of two different drugs in multiple combinations, hopefully leading to more advanced trials or at least initiating momentum for more research to address the virus.This week, the US Food and Drug Administration approved a monoclonal antibody, Beyfortus, to protect infants and young children from respiratory syncytial virus (RSV). The single-injection antibody therapy, developed by AstraZeneca and marketed in the United States by Sanofi, showed strong results in phase 3 clinical trials. If the treatment gets a further recommendation from the Centers for Disease Control and Prevention, the drug could greatly reduce hospitalizations and deaths caused by RSV, which is the leading cause of hospitalization of babies in the United States. Beyfortus, has already been licensed in the European Union, the United Kingdom, and Canada, and other technologies for RSV, including a vaccine for pregnant people are also aiming to reduce the global burden of the virus.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the World Health Organization (WHO) prequalified the first conjugate vaccine to protect against the five dominant causes of meningococcal meningitis in Africa. The vaccine, MenFive, which was developed through a collaboration between the Serum Institute of India Private Limited and PATH, with financial support from the UK’s Foreign, Commonwealth, and Development Office, demonstrated a high level of safety and immunogenicity in extensive clinical studies in The Gambia, India, and Mali. WHO’s prequalification will allow MenFive to be procured by United Nations agencies and Gavi, offering a promising tool that could avert the annual outbreaks and epidemics in the African countries with the most meningitis cases and deaths.A multisite phase 1 HIV vaccine clinical trial carried out by the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership concluded with preliminary analysis demonstrating strong results. The novel mosaic HIV vaccine candidate, HIVconsvX, demonstrated the ability to trigger a strong and specific immune response that targets a broad range of HIV-1 variants, making it potentially applicable for HIV strains around the world. Researchers say it also represents an innovative approach within a pipeline of vaccine candidates that needs to be diverse to maximize the chances of success. The full reporting of the primary findings from the trial is expected later this year followed by further in-depth analysis.Last week, a joint statement from the United Nations Food and Agriculture Organization, WHO, and the World Organization for Animal Health warned that the H5N1 avian flu virus could adapt to more easily infect humans and urged multisector, international partnership and cooperation to protect both animal and human populations. The current H5N1 clade 2.3.4.4b has been circulating since 2020, causing unprecedented deaths around the world across different animal populations, especially in wild birds and increasingly, mammals. Although human cases have been only sporadic, maintaining and strengthening surveillance capability to be able to detect viral changes and human cases, as well as testing the currently circulating viruses for resistance to available antiviral drugs, will be essential to avoid further devastation.

The US Agency for International Development (USAID) recently released a new five-year strategy to guide its global health research and development (R&D) efforts. Informed by the input of more than 150 stakeholders, the latest strategy continues the agency’s core focus on developing, introducing, and scaling up health technologies and approaches; advancing implementation science; and strengthening R&D systems while more intentionally embedding approaches of partnership, local leadership, monitoring and evaluation, and adaptive learning into its work.Why it matters:  The release of the strategy represents a renewed commitment by the agency to R&D. For more than 50 years, USAID has played a pivotal role in saving and improving lives around the world through its R&D programs. With its strong in-country presence, relationships with government and community leaders, and extensive knowledge of local context and development constraints, USAID is uniquely qualified to advance interventions that are affordable, accessible, scalable, and responsive to the needs of affected communities worldwide.What’s included: The strategy outlines a mission, vision, four objectives, 16 key actions, four approaches, and four principles that will guide its R&D work. View the slide deck below to get a summary overview.Our take: GHTC applauds USAID for developing this comprehensive strategy and for its inclusive design approach, which considered the input of a broad spectrum of US and global stakeholders. We are pleased to see this renewed commitment to R&D and the strategy’s increased emphasis on local leadership; inclusive innovation; and meeting the needs of women, children, and other vulnerable populations.

July 11, 2023Chair Cathy McMorris RodgersEnergy & Commerce Committee2125 Rayburn House Office BuildingWashington, DC 20515Representative Brett GuthrieChair, Subcommittee on HealthEnergy & Commerce Committee2434 Rayburn House Office BuildingWashington, DC 20515Representative Richard HudsonMember, Subcommittee on HealthEnergy & Commerce Committee2112 Rayburn House Office BuildingWashington, DC 2051Ranking Member Frank PalloneEnergy & Commerce Committee2125 Rayburn House Office BuildingWashington, DC 20515Representative Anna G. EshooRanking Member, Subcommittee on HealthEnergy & Commerce Committee272 Cannon House Office BuildingWashington, DC 20515Re: The Urgent Need to Reauthorize PAHPADear Chair McMorris Rodgers, Ranking Member Pallone, and Representatives Guthrie,Eshoo, and Hudson,Thank you for all of the careful and important bipartisan work that each of you and yourstaffs have already put into the upcoming reauthorization of the Pandemic and All-HazardsPreparedness Act (PAHPA), set to expire September 30, 2023.Many of the undersigned organizations have had the privilege of testifying before Congressand the Energy and Commerce Committee over the last 17 years—when the original PAHPAwas passed, for its previous reauthorizations, and for the current reauthorization—andhope to continue serving in this trusted capacity. We are writing to express our strongdesire to see PAHPA reauthorized this year in the same bipartisan tradition.Our nation’s changing health security threat landscape and responsibility to protect theAmerican people demand that we work together now to find a strong bipartisan pathforward to reauthorize this critical legislation. Whether the next health security threat isnaturally occurring, the result of an accident, or intentionally caused, our country must bein a better position to prevent, prepare for, and respond to such incidents.We are concerned that if no bipartisan path is reached this year, the opportunity for PAHPAreauthorization will not be resumed until 2024. In that case, forging a bipartisan pathforward will be even more difficult given the expected political landscape of an electionyear. We worry that in such a case, PAHPA reauthorization may not be achieved until 2025.This would have serious effects on our country’s economic, national, and health security.Page 2 of 21Day SoonerAmerica’s Essential HospitalsAmerican Academy of PediatricsAmerican Lung AssociationAmerican Society for MicrobiologyAssociation for Professionals in InfectionControl and EpidemiologyAssociation for the Advancement of Bloodand Biotherapies (AABB)Association of Maternal & Child HealthProgramsAssociation of State and Territorial HealthOfficialsBig Cities Health CoalitionBipartisan Policy CenterCSL SeqirusFederation of American ScientistsFluGen Inc.Georgetown University Center for GlobalHealth Science and SecurityGlobal Health Technologies Coalition(GHTC) Gryphon ScientificHealthcare ReadyHelixInternational Safety Equipment AssociationJohns Hopkins Center for Health SecurityNational Immigration Law CenterNational Rural Health AssociationNew Orleans BioInnovation CenterResolve to Save LivesSanofiSave the ChildrenSecureBio and MIT Sculpting EvolutionGroupSociety for Healthcare Epidemiology ofAmericaThe Gerontological Society of AmericaThe Institute for ProgressTrust for America’s HealthValneva USA