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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. A study published last week tested a promising new malaria vaccination strategy that aims to boost immunity through bites from mosquitoes carrying a genetically engineered version of the malaria parasite, which could pave the way for improved malaria vaccines. There are two approved vaccines for malaria, but they are only about 75 percent effective and require booster shots. In a trial, researchers exposed participants to bites from mosquitoes that had a version of the malaria parasite that was genetically modified to stop developing after delivery into a human, finding that nearly 90 percent of participants exposed to the modified parasites avoided contracting the disease after being bitten. The next step will be a larger trial to confirm this strategy as a viable candidate to advance malaria control efforts.A new study found that vaccines for diarrhea could reduce bacteria-associated diarrhea and antibiotic use among young children in low- and middle-income countries, which could also help reduce the emergence of antimicrobial resistance due to antibiotic overuse in low-resource settings where cases of diarrheal disease are most common. The research team used data from a previously published study exploring enteric infections and diarrheal illness in children in low- and middle-income countries and generated simulations to estimate the hypothetical impact of nine vaccine scenarios, including six single-pathogen vaccines and three combination vaccines. They found that, compared to the other single-pathogen vaccines, a vaccine against Shigella could cause the greatest reduction in antibiotic courses, and an adenovirus-norovirus-rotavirus vaccine could cause the greatest reductions in antibiotic use compared to the other combination vaccines.Last week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced $1.46 million in funding for PATH to develop antibody reagents for developing vaccines against Severe Acute Respiratory Syndrome, or SARS. Antibody reagents are critical for measuring and analyzing a vaccine’s potency and ability to induce an immune response. PATH will lead efforts to develop and test reagents, as well as collaborate with the Texas Children’s Center for Vaccine Development to select and scale up a SARS-CoV-1-specific antibody to ensure these reagents are available globally, particularly in low and middle-income countries. The project aims to strengthen global health security by allowing researchers and manufacturers the tools to develop and scale up vaccines quickly in the face of an outbreak or new variant.

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. A study published last week and presented at the American Society of Tropical Medicine & Hygiene’s (ASTMH’s) annual meeting found that the malaria parasite is acquiring partial resistance to artemisinin, a key drug used to treat children with severe malaria, meaning that infection takes longer to clear and is not always being completely cleared by the drug. The researchers found partial resistance to the drug in 11 of the 100 children treated in the study, with 10 patients “cured” of severe malaria having a resurgence of the same strain within a month of the original infection, implying that the first treatment did not fully eliminate the parasite. More studies are needed to determine how widespread artemisinin resistance is in Africa. Still, the findings underscore the need for novel or alternative drugs to be used in the treatment of severe malariaThe US Centers for Disease Control and Prevention (CDC) has awarded Alveo Technologies a contract to develop a molecular assay to detect and differentiate the H5 subtype of avian influenza A from seasonable influenza A and B viruses in humans, as the ongoing spread of H5N1 in animals across the United States raises concerns about a new pandemic as regular flu season looms. Currently, only CDC and US state and jurisdictional public health labs have access to CDC’s molecular test to detect the H5 strain of influenza A, which could lead to delays in diagnosis or treatment if we start to see transmission between humans. Decentralized testing capabilities at the point of care will be needed to ensure any spread between humans is detected and controlled quickly to avoid another pandemic, as well as to reduce the burden on centralized laboratories.  Last week, the endTB consortium announced the completion of the endTB-Q trial, the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant tuberculosis (pre-XDR-TB), with preliminary results demonstrating that a shorter, less toxic treatment strategy of four drugs achieved high cure rates overall, especially in those with non-severe cases of TB disease. Pre-XDR-TB has historically been treated with toxic regimens that last up to two years, are hard to tolerate, and are not very effective. This study tested a personalized medicine strategy, with disease severity and early treatment response used to decide between a six- or nine-month treatment regimen. The study included participants from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam.

The Global Health Technologies Coalition, FIND, Medicines for Malaria Venture, IAVI, PATH, and TB Alliance welcome the establishment of the G20 Global Coalition for Local and Regional Production, Innovation and Equitable Access.We are particularly supportive of the focus on innovation to develop the missing health tools needed by some of the world’s most neglected communities—including those facing historically neglected diseases, such as leishmaniasis, Chagas disease, and dengue, as well as more common poverty-related diseases such as HIV, tuberculosis, and malaria.We are encouraged by the Coalition’s focus on strengthening local and regional production to promote more equitable access to safe, affordable, quality, and effective health products and technologies. Shifting the center of gravity of innovation, manufacturing, and production to countries and regions that carry the greatest burden of disease will help reduce disparities and build resilience into health systems. Current outbreaks like mpox highlight the need for manufacturing capacity in all regions. G20 countries are uniquely situated to mobilize the necessary scientific and financial resources to make this Coalition a success and build upon knowledge, as well as match capabilities and needs across G20 countries and other invited countries and partners.We commend Brazil for its leadership, and we urge leaders to ensure civil society and community voices have a seat at the table. Our organizations stand ready to support the Coalition.

Page 1 of 4 Dear Leaders Schumer and McConnell, Speaker Johnson, and Leader Jeffries, On behalf of the undersigned organizations, we write to urge you to include a comprehensive reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) in a legislative package before the end of the 118th Congressional Session. The Senate and House health committees have each passed reauthorization bills that make critical improvements to our nation’s health security programs, originally authorized in PAHPA. These programs at the Department of Health and Human Services, such as the Assistant Secretary for Preparedness and Response (now the Administration for Strategic Preparedness and Response) and the Biomedical Advanced Research and Development Authority (BARDA), will be called upon to prevent, prepare for, and respond to any national health security threats. These threats—whether they emerge from advances in biotechnology and artificial intelligence, naturally occurring outbreaks, major storms, deliberate attacks, or accidents—require an agile, authorized, responsive government infrastructure. The PAHPA framework, which was originally authorized 17 years ago, expired on September 30, 2023, requiring stopgap, temporary extensions in prior continuing resolutions. However, we urge you to pass a comprehensive PAHPA reauthorization package, one that includes key new provisions that strengthen US preparedness and response capabilities, before the end of the year. The last three PAHPA reauthorization packages shared major recurring themes: they all adjusted to the changing threat landscape, focused on challenges identified since the prior bill, and strengthened our nation’s health security with each reauthorization. A new reauthorization bill would continue to do that by strengthening existing programs and continuing to adapt and improve America’s health security infrastructure for new and future challenges. Failing to reauthorize PAHPA now would have serious effects on our country’s economic wellbeing, national security, and health given the rapidly changing threat landscape. For example, Congress would leave critical preparedness programs—like the Strategic National Stockpile, medical supply chain resilience, and hospital preparedness programs—without clear direction and oversight. November 13, 2024 The Honorable Charles Schumer Majority Leader US Senate S-221 Capitol Building Washington, DC 20510 The Honorable Mike Johnson Speaker of the House US House of Representatives H-232 Capitol Building Washington, DC 20515 The Honorable Mitch McConnell Minority Leader US Senate S-230 Capitol Building Washington, DC 20510 The Honorable Hakeem Jeffries Minority Leader US House of Representatives H-204 Capitol Building Washington, DC 20515 Page 2 of 4 We are hopeful that PAHPA will remain a strong bipartisan legislative framework, as it has always been. We stand ready to assist you however we can to help get this important law reauthorized this year. Thank you for your attention to this critical matter; please contact Joel Straus at joel.straus@jhu.edu with any questions. Sincerely (in alphabetical order), 1Day Sooner Acadian Companies Adjuvant Capital, LP AdvaMed Aequor Inc. American Academy of Pediatrics American Ambulance Association American Clinical Laboratory Association American College of Emergency Physicians American College of Physicians American College of Surgeons American Lung Association American Medical Manufacturers Association (AMMA) American Public Health Association American Society for Microbiology Antheia, Inc. Arizona Bioindustry Association, Inc. (AZBio) Association of American Medical Colleges Association of Maternal & Child Health Programs Association of Public Health Laboratories Asthma and Allergy Foundation of America ATCC Atea Pharmaceuticals, Inc. Bavarian Nordic Big Cities Health Coalition BIO Biocom California BioCT BioForward Wisconsin BioNJ BioUtah BluZoneBio LLC Bugworks California Life Sciences Cencora (formerly AmerisourceBergen) Civitas Networks for Health Codagenix Colorado BioScience Association Council of State and Territorial Epidemiologists Council of State Bioscience Associations Dentec Safety Specialists Elusys Therapeutics, Inc. Emergent BioSolutions Federation of American Hospitals FluGen Inc. Genentech, a member of the Roche Group Georgetown University Georgia Bio Gerontological Society of America Global Health Investment Corporation (GHIC) Global Health Technologies Coalition GSK Page 3 of 4 Hamilton Grace LLC Harvard Kennedy School, Belfer Center for Science and International Affairs Health Industry Distributors Association Health Supply US Healthcare Distribution Alliance Healthcare Information and Management Systems Society (HIMSS) Helix, Inc. High Alert Institute, Inc. HIV Medicine Association IAVI Illinois Biotechnology Innovation Organization, iBIO Indiana Life Sciences Association Infectious Diseases Society of America Institute for Progress Johns Hopkins Center for Health Security Life Science Tennessee Life Sciences Pennsylvania Maryland Tech Council Mass General Brigham Massachusetts Biotechnology Council (MassBio) Maxter Healthcare Inc Medical Alley Medical Countermeasures Coalition Michigan Biosciences Industry Association (MichBio) Missouri Biotechnology Association Montana BioScience Alliance Mount Sinai Health System NC Life Sciences Organization Neuroene Therapeutics New Mexico Biotechnology & Biomedical Association New Orleans BioInnovation Center NewYorkBIO Ohio Life Sciences Oregon Bioscience Association Premier Inc. Public Health Accreditation Board READDI, Inc. Recce Pharmaceuticals Ltd Research!America Roche Diagnostics SAB Biotherapeutics, Inc. Sanofi Scbio Scorpius Biomanufacturing Shionogi Inc. SIGA Technologies, Inc. SoCalBio Society for Public Health Education South Dakota Biotech Association SPOC Proteomics, Inc. Texas Healthcare & Bioscience Institute Tonix Pharmaceuticals, Inc Trinity Health TrippBio, Inc. Trust for America’s Health United Safety Technology Inc. University of Nebraska System Valneva USA Vaxxas Inc VIDA