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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

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 new, first-of-its-kind trial will assess the safety and immunogenicity of Bavarian Nordic’s MVA-BN mpox vaccine in pregnant and breastfeeding women and infants under two years old, two populations at risk of severe complications from mpox but not currently eligible for vaccination. MVA-BN is the only vaccine for mpox prequalified by the World Health Organization and is currently approved for healthy adults and adolescents, but additional data from this trial could help expand access for additional key populations amid the ongoing mpox outbreak. The trial, which will start early next year, is jointly funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and Global Health EDCTP3.Researchers from the University of Glasgow have developed a new drug that could help combat the spread of treatment-resistant malaria, as the disease continues to kill more than 600,000 people every year and Plasmodium falciparum, a mosquito vector that spreads malaria, grows increasingly resistant to artemisinin, the frontline malaria treatment. The drug, adapted from a cancer treatment approach, works by permanently disabling a protein that P. falciparum uses to duplicate itself in humans. The researchers behind the drug think it could be more effective than current drugs at all stages of malaria infection, potentially with only one dose.A research team from the University of California, Santa Barbara has found a way to potentially reduce the spread of mosquito-borne diseases by disrupting male mosquitoes’ ability to hear, which is essential for them to mate and breed. Male mosquitoes rely on the sound of female mosquitoes’ wingbeats in order to find and mate with them. By altering a genetic pathway that male mosquitoes use for hearing, the researchers were able to stop them mating entirely, preventing female mosquitoes, the ones that spread diseases to humans, from having babies and reducing overall mosquito populations. Specifically, the researchers studied Aedes aegypti mosquitoes, which spread diseases including dengue, yellow fever, and Zika.

The mission of the Global Health Technologies Coalition (GHTC) is to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. The next Administration and Congress will have the opportunity to catalyze a new era of biomedical innovation through investing in the United States’ global health research and development (R&D) apparatus, which is underpinned by the lifesaving work happening at the US Agency for International Development, National Institutes of Health, Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, and many other government entities. This new era could tackle legacy issues of malaria, tuberculosis, and HIV/AIDS; shift the balance in the fight against antimicrobial resistance; and prepare us for new and emerging health threats at home and abroad. At this crucial pivot point, GHTC stands ready to work with decision-makers of both parties to ensure US support for global health R&D remains integral to US foreign and domestic policy. GHTC is committed to ensuring that the gains we have already made on neglected and emerging health challenges are not only sustained but also strengthened to combat a more troubling and evolving health landscape. We know strong support for global health R&D is central to our country’s national security, diplomatic efforts, and economic interests. But above all, US support to create the next generation of global health technologies saves lives and bolsters the health and well-being of everyone everywhere.  GHTC will continue to work with our more than 45 member organizations to articulate these needs to the new slate of political leaders and reinvigorate the United States’ role as a global health leader.

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. Recently published research found that a new, noninvasive test for malaria could provide a more reliable, safer, quicker, and more sensitive diagnostic option in low- and middle-income countries. The Cytophone, a tabletop printer-sized device, uses targeted lasers and ultrasound to detect malaria-infected cells in the bloodstream via a small, noninvasive probe placed on the back of a person’s hand. Malaria-infected red blood cells accumulate a by-product with unique properties that can be distinguished from normal red blood cells when they pass through a laser. The test, which provides results within minutes, was found to be as good or better at detecting symptomatic Plasmodium falciparum malaria infections than the current gold standard point-of-care methods for malaria testing, which require blood samples and special laboratory equipment. The next phase of testing the device will also investigate whether the device can detect and distinguish between other species.Last Tuesday, Bavarian Nordic announced the start of a clinical study of the MVA-BN® mpox/smallpox vaccine in children between 2 and 11 years old, who are highly vulnerable to infection during the ongoing mpox emergency. The study, which currently has sites in the Democratic Republic of Congo and plans to include sites in Uganda as well, is investigating the safety and immunogenicity of the vaccine in children compared to adults. Last month, the World Health Organization prequalified the vaccine for adolescents between 12 and 17 years old, following the European Medicines Agency’s approval for this age group. Results from the new trial could support an extension of the current approval.Researchers have identified a novel class of antimicrobial agents known as encrypted peptides that play a key role in the immune system’s response to bacterial infections, opening up new possibilities for combating drug-resistant infections as antimicrobial resistance continues to grow as a global health threat. The immune system is traditionally thought to rely primarily on proteins explicitly linked to immune functions, but this new research reveals that other structural proteins contribute to antimicrobial defenses. Leveraging the immune system’s natural defenses through these non-immune proteins could allow researchers to develop effective antibiotic therapies less prone to resistance.