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January 4, 2024 The Honorable Charles Schumer The Honorable Mike Johnson Majority Leader Speaker United States Senate U.S. House of Representatives Washington, DC 20510 Washington, DC 20515 The Honorable Mitch McConnell The Honorable Hakeem Jeffries Minority Leader Minority Leader United States Senate U.S. House of Representatives Washington, DC 20510 Washington, DC 20515 Dear Speaker Johnson, Majority Leader Schumer, Minority Leader McConnell, and Minority Leader Jeffries: The 850 undersigned organizations—representing the full breadth of diverse programs that support all of America, every day—are extremely alarmed by the possibility for very deep cuts to all of these non-defense programs (often referred to as non-defense discretionary appropriations or simply “NDD”) for fiscal year 24 (FY24) if a full-year continuing resolution were to pass. Such cuts would be disastrous for the capacity of the federal government to serve the public, assist those in need, fuel innovation, and address national and global threats. We strongly urge Congressional leadership to instead finish the FY24 appropriations process and adopt the bipartisan Senate funding framework as a starting point for final negotiations. Vital domestic and international appropriations are a small part of the federal budget—less than one-sixth—yet they fund a wide range of important programs and services that make America run and strengthen our economy. Examples include investments in: scientific and medical research; medical care for veterans; environmental protections; home energy assistance; assistance with housing and child care for low-income families; rural development; K-12 education and skills training; nutrition assistance for young children, families, and older people; financial aid for college students; infrastructure investments in things like transportation choices, sewage treatment, safe drinking water, flood control and navigation improvements; diplomacy, humanitarian aid and development; services for victims of gender-based violence; courts and reentry programs; assistance for small businesses; public safety and other programs for older people; public health; and many more. Republicans and Democrats have historically supported these programs because every state and congressional district in the country benefits from NDD investments. Walking away from these investments would be walking away from the constituents — children, families, seniors, people with disabilities, students, and workers, in rural, suburban and urban communities — Congress has taken an oath to serve. Enacting the FY24 NDD cap of $704 billion included in the Fiscal Responsibility Act by passing a full-year CR for all 12 spending bills would mean reducing NDD spending by as much as 9 percent according to the Center on Budget and Policy Priorities. The cuts would be enacted over the course of nine months or less instead of a full year, making them even more dramatic and painful. The results of these cuts would be catastrophic for the American people and violate the agreement Congress made with the White House in June to lift the debt ceiling. The full terms sheet of the debt ceiling compromise must be honored in the FY24 process. Together we call on Congress to finish the FY24 appropriations process adhering to the agreement reached on behalf of the American people, moving funding packages with the necessary funds and without including dangerous poison pill policy riders. We urge Congressional leadership to adopt the bipartisan appropriations approach the Senate pursued in July as an example of the type of across-the-aisle collaboration the American people expect to ensure the programs they rely on are funded in a manner that allows them to provide the services they need. We also ask that you come to an agreement on funding other urgent spending priorities quickly so we can turn our collective attention to FY25. Sincerely, 350.org A Better Way Services, Inc. A New PATH (Parents for Addiction Treatment & Healing) A Place for Us, Atlantic County Women's Center DBA-AVANZAR A Safe Place Academy of Nutrition and Dietetics Academy of Radiology & Biomedical Imaging Research AcademyHealth ACCESS Family Services, Inc Accessia Health ACT for NIH Act Now: End AIDS (ANEA) Coalition Actors' Equity Association Ad Hoc Group for Medical Research Advance CTE African Methodist Episcopal Church - Social Action Commission AFSCME Council 4 CT Afterschool Alliance Ahimsa House AIDS Foundation Chicago AIDS United Alabama Disabilities Advocacy Program Alchemist CDC All4Ed Allergy & Asthma Network Alliance for Academic Internal Medicine (AAIM) Alternatives Incorporated of Madison County Alzheimer's Association Alzheimer's Impact Movement (AIM) Alzheimer's Los Angeles American Academy of Neurology American Anthropological Association American Association for Dental, Oral, and Craniofacial Research American Association for the Advancement of Science American Association of Colleges for Teacher Education (AACTE) American Association of Colleges of Nursing American Association of Colleges of Osteopathic Medicine American Association of Colleges of Pharmacy American Association of Neuromuscular and Electrodiagnostic Medicine American Association of Service Coordinators American Association of State Colleges and Universities American Association of University Women American Association of Veterinary Medical Colleges American Astronomical Society American Atheists American Brain Coalition American Cancer Society Cancer Action Network (ACS CAN) American Chemical Society American College of Lifestyle Medicine American College of Obstetricians and Gynecologists American College of Physicians American College of Preventive Medicine American Council on Education American Counseling Association American Dental Education Association American Diabetes Association American Educational Research Association American Epilepsy Society American Federation of State, County and Municipal Employees (AFSCME) American Federation of Teachers American Foundation for Suicide Prevention American Foundation for the Blind American Friends Service Committee American Gastroenterological Association American Geophysical Union (AGU) American Geriatrics Society American Heart Association American Indian Higher Education Consortium American Institute of Biological Sciences American Kidney Fund American Liver Foundation American Lung Association American Nurses Association American Physiological Society American Political Science Association American Probation and Parole Association American Psychological Association Services American Public Health Association American Rivers American Society for Biochemistry and Molecular Biology American Society for Gastrointestinal Endoscopy American Society for Investigative Pathology American Society for Microbiology American Society for Nutrition American Society for Pharmacology and Experimental Therapeutics (ASPET) American Society for Reproductive Medicine American Society of Hematology American Society of Nephrology American Society of Neuroradiology American Society of Pediatric Nephrology American Society of Tropical Medicine and Hygiene American Thoracic Society American Urogynecologic Society AMORC Anxiety and Depression Association of America Apiary Ministry Outreach Services Arab American Family Services Arkansas Coalition Against Domestic Violence Artemis Center Arthritis Foundation Asian American Community Services Asian Services in Action, Inc. 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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 phase 3 trial testing a new malaria drug could offer hope for addressing the burden of malaria in babies, which despite being a leading cause of death across Africa, is often underdiagnosed, mistreated, and not studied in this population. There are no malaria treatments for babies weighing under 11 pounds (about three months old or younger), whose cases also often go undiagnosed because malaria presents differently and can easily be mistaken for common childhood illnesses in children this young or they have not even been tested due to resource shortages. Clinical trials, including those for the RTS,S and R21 malaria vaccines, often exclude children under five months because of the assumption that mothers confer immunity. The ongoing trial, which is supported by the PAMAfrica Consortium and co-funded by the European & Developing Countries Clinical Trials Partnership and Medicines for Malaria Venture, is expected to publish results early next year.The Novo Nordisk Foundation has announced a new initiative, developed with the University of Copenhagen, that will invest up to $260 million to create new or improved vaccines for serious respiratory diseases. It is the first global vaccines initiative to solely focus on how to produce immunity in the airway itself as a way to prevent airborne disease infection. The initiative will initially focus on candidates for tuberculosis, the flu, and Group A Streptococcus. The partners hope that the new project can help to address the rise of antimicrobial resistance, which is driven, in part, by the overuse or misuse of antibiotics to treat airway infections, as well as to address the high death toll globally from these diseases.The European Medicines Agency Committee for Medicinal Products for Human Use recently adopted a positive scientific opinion for the investigational drug arpraziquantel for schistosomiasis, a neglected tropical disease that affects more than 240 million people globally, including 50 million preschool-aged children. There is no child-friendly schistosomiasis medication for preschool-aged children, despite safe and effective treatments available for both adults and school-aged children. The Global Health Innovative Technology (GHIT) Fund has supported the Pediatric Praziquantel Consortium’s development of the drug since 2013 and is now working with the consortium’s implementation research program to prepare for the introduction of the drug in endemic African countries to ensure equitable and sustainable access in the countries where it is most needed.

Though the World Health Organization (WHO) declared an end to the public health emergency of international concern for COVID-19 back in May, rising COVID cases and new innovations continue to make headlines in December—exemplifying this year as one still dominated by the legacy of the pandemic but also marked by exciting advances in global health research and development (R&D). As the year comes to an end, GHTC reflects on a few of the global health innovation stories that shaped 2023. 1. COVID-19 leaves a complicated legacy of scientific achievement but growing political backlash. While we all hoped the experience of COVID-19 would usher in a new era of proactive health preparedness and improved scientific understanding, 2023 has proved that the legacy of the pandemic is complicated, and history is still actively being written. On the positive side, it has been exciting to see groundbreaking research fueled by COVID-19 funding continue to bear fruit. Applying lessons learned from the pandemic response, researchers and funders alike have sought to accelerate innovative solutions to make countermeasures easier and cheaper to produce, deploy, and administer. For example, this past year brought the announcement of the Biden administration’s more than $5 billion successor to Operation Warp Speed—Project NextGen—to deliver next-generation vaccines and treatments, as well as positive clinical results from Moderna and Pfizer/BioNTech trials on combination COVID-19 and flu shots, and promising research results and funding announcements regarding a variety of needle-free vaccine technologies, including those delivered via nasal spray, inhaler, pen applicator device, and oral film. Taken together, this research could fundamentally alter our approach to controlling COVID-19, as well as ultimately help more people access and benefit from vaccines for a range of deadly diseases. Yet, 2023 could also be characterized as a year of COVID-19 political backlash, particularly in the United States. Fueled by lingering anger over COVID-related public health restrictions, misinformation, and concerns over the origins of the pandemic among their supporters, the Republican-led House of Representatives spent the year calling current and former Biden administration health officials before various subcommittees to testify on their actions, putting science and public health agencies under increasing scrutiny. Additionally, the House has proposed a funding bill for fiscal year 2024 that, if enacted, would slash funding for key agencies that were at the center of the COVID-19 response, including the National Institutes of Health and the Centers for Disease Control and Prevention, as well as cut funding to WHO and limit funding to Chinese government-supported research institutions. Only time will tell whether these efforts ultimately prove more bark than bite or whether they will lead to harmful policies and funding cuts. 2. Attention turns to research on other pandemic and epidemic threats. The year brought no rest for the weary when it comes to emerging infectious disease threats. Alongside managing COVID-19 as a here-to-stay threat, in 2023, the world also dealt with a still-smoldering global mpox outbreak, the conclusion of a Sudan Ebola outbreak in Uganda, and outbreaks of Marburg in Tanzania and Equatorial New Guinea. With these threats looming in the backdrop, researchers forged ahead on efforts to boost future preparedness. The Sabin Vaccine Institute and IAVI launched trials for their Marburg and Sudan virus vaccine candidates, respectively. Gavi, the Vaccine Alliance, also announced this year that some remaining funds from COVAX, the COVID-19 vaccine delivery initiative, would be redirected toward further investigational vaccine candidates for those two deadly viruses. Over the summer, Moderna launched a phase 1/2 trial of its mpox vaccine after having begun preclinical work during last year’s major mpox outbreak. Universal influenza shots and combination COVID-19 and flu shots also saw exciting advances this year, with the National Institutes of Health launching a clinical trial testing an mRNA universal flu vaccine and biopharmaceutical company Osivax’s broad-spectrum influenza vaccine candidate showing strong results. 3. mRNA vaccine technology remains an area of growth, particularly for Africa. The success of mRNA-based COVID-19 vaccines has inspired a flurry of efforts to leverage mRNA technology to address other diseases and potential pandemic threats, as well as to remedy the inequity in access to new tools faced by African countries during the pandemic. BioNTech is advancing mRNA vaccine candidates for malaria, tuberculosis, and HIV, among others, and initiated in April a phase 1 clinical trial to test mRNA vaccine candidates against tuberculosis. This year, newly published research also found that a novel mRNA-based malaria vaccine was effective in animals that had already been exposed to malaria. Additionally, the Coalition for Epidemic Preparedness Innovations this year announced support for a variety of mRNA vaccine candidates against virus families that can affect humans, aiming to create a library of prototype vaccines that can be rapidly adapted as new viral threats emerge. 2023 saw the official launch of the mRNA vaccine technology hub in South Africa, which will pursue vaccines for COVID-19 and other poverty-related diseases to be produced for the African continent. Gavi also announced the African Vaccine Manufacturing Accelerator, which will invest up to $1 billion in boosting African manufacturing, while BioNTech opened an mRNA vaccine factory in Rwanda, which is expected to become part of a decentralized and robust end-to-end mRNA vaccine manufacturing network in Africa. The hope is that these efforts will boost the capacity of African innovators to design, develop, and produce at scale exciting new technologies to tackle diseases with a high burden on the continent and mitigate the equity challenges exposed during the COVID-19 pandemic.  4. Two vaccines for malaria are now recommended. In October, WHO recommended the R21/Matrix-M malaria vaccine, developed by the University of Oxford—two years after recommending RTS,S, the first malaria vaccine—adding another important tool to the world’s arsenal of malaria control interventions. Additionally, results reported in late 2023 about the pilot rollout of RTS,S showed positive findings about the lives it has already saved, making the case for a broader rollout of RTS,S and the potential of integrating R21 into multipronged efforts to fight malaria, as well as hopefully encouraging further innovation in the space. While right now supply of both malaria vaccines remains constrained, manufacturers of both vaccines have agreed to scale up production to meet global demand. 5. Two major firsts for NTDs. 2023 saw two major firsts for innovation against neglected tropical diseases (NTDs), which hopefully will inspire further investment to fill the growing funding shortfalls in NTD R&D. In November, the US Food and Drug Administration announced its approval of the world’s first vaccine against chikungunya, a chronic and debilitating disease that has no specific treatment, which has become an increasing global threat due to climate change. The single-dose shot was developed by Valneva. A month prior, Johnson & Johnson presented new data showing that its pill for dengue fever appeared to protect against a form of the virus in a small human challenge trial done with the Johns Hopkins School of Public Health, providing hope for the first-ever specific treatment for dengue, a serious disease that currently threatens about half of the world’s population, which is similarly a growing threat around the world due to climate change.  6. Setbacks and hope in HIV innovation. Last month brought disappointing news for the global health community as researchers from the PrEPVacc trial that was testing two different HIV vaccine regimens in Africa announced that the study had been shut down after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy. This leaves no efficacy trials underway globally for HIV vaccines.  While this vaccine outcome is certainly discouraging, in more welcome news, 2023 saw exciting developments in efforts to expand affordability and access to long-acting pre-exposure prophylaxis (PrEP) options. In May, Indian drug company Cipla announced that a generic version of cabotegravir long-acting (CAB-LA)—the first long-acting injectable PrEP option—will be manufactured at its plants in South Africa for the first time, which could potentially offer millions of people at risk of HIV infection in Africa access to this drug. In December, GHTC had the privilege of honoring the partners, led by ViiV Healthcare, that developed and are accelerating access to CAB-LA for PrEP for their efforts to advance this groundbreaking new product that could transform global HIV prevention efforts.  2023 also saw Population Council announce that South African company Kiara Health will start producing vaginal rings for HIV prevention in the next few years, which could make the innovative tool cheaper and more readily available to women in Africa. The dapivirine ring, which has been approved by nearly a dozen countries and WHO offers women an alternative long-acting HIV prevention method that can be used discretely without a sexual partner’s knowledge or consent.  7. Urgency and awareness of AMR continues to rise. Over the summer, WHO published its first global research agenda for antimicrobial resistance (AMR), outlining topics and needed tools that researchers should focus on to address its rise. The summer of 2023 also saw the largest ever investment from a country in global AMR surveillance—£210 million from the United Kingdom to support the Fleming Fund’s activities in strengthening surveillance and workforce capacity in countries where the threat of AMR is the highest, including investing in new genome sequencing technologies. This year also saw some exciting announcements about ongoing and upcoming research to address AMR. The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) received renewed support from G7 governments and launched three funding rounds, which elicited more than 200 applications from around the world. The Global Antibiotic Research & Development Partnership (GARDP) announced positive results from an unprecedented global phase 3 clinical trial testing a first-in-class oral antibiotic to treat uncomplicated gonorrhea, which if approved, will be the first new antibiotic for treating the bacterial infection in decades. Beyond therapeutics, innovation in diagnostics is also essential to addressing AMR. This year, a new study found that a combination of fluorescence microscopy and artificial intelligence was shown to be effective in detecting AMR across multiple antibiotics, a tool that could help health care providers better treat patients with antibiotics and ultimately stall the rise of AMR. 8. Exciting policy developments in the United States and at WHO could boost global health innovation. At the 76th World Health Assembly held in May, member states adopted a historic resolution on strengthening global diagnostic capacity. The resolution, which GHTC advocated for alongside partners like FIND, recognizes the need for countries to prioritize access to appropriate diagnostic tests and calls upon countries to put in place national strategies to expand diagnostic testing and utilize diagnostic data in health decision-making. In November, GHTC also welcomed the introduction in the US House of Representatives of the Supporting Innovative Global Health Technologies (SIGHT) Act, legislation championed by GHTC to empower the US Agency for International Development to boost its health R&D capabilities. The bipartisan bill would create a distinct disease-agnostic program area and budget line for health R&D within the agency’s Global Health Bureau and establish a Chief Innovation Officer for Health position. For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2023 and beyond, sign up now to receive GHTC’s R&D News Roundup newsletter. Image credits from top to bottom: US Department of State, US Food and Drug Administration, USAID in Africa, USAID in Africa/RTI International/Patrick Adams, USAID in Africa, PATH/Georgina Goodwin, PATH/ Patrick McKern, WHO/Pierre Albouy.

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 study from scientists at the National Institute of Allergy and Infectious Diseases that builds on decades of research offers promising findings about the immune response to HIV, which could help guide further research into HIV vaccine design and development. The researchers compared the immune system activity of past HIV vaccine study participants to people with HIV who naturally keep the virus from replicating even without antiretroviral therapy, finding that future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to continue to stimulate the immune system to deliver the proteins necessary to destroy HIV-infected cells. The research is especially encouraging given the recently halted HIV vaccine trial and hopefully can lead to further advances in the field.Last week, the Global Health Innovative Technology (GHIT) Fund announced that it will invest approximately $8.8 million to accelerate the further development and commercialization of a triple artemisinin combination drug against malaria. Specifically, the investment will support a global, multicenter phase 3 clinical trial project in Africa and Southeast Asia led by Fosum Pharma. The project also includes the development of a co-formulated child-friendly version of the drug, given the high proportion of malaria deaths that occur in children under five. The new drug could also play a role in addressing the rising threat of malaria drug resistance. Recent findings suggest that an inhaled vaccine for COVID-19 delivered directly to the respiratory tract where the virus infects the body could improve protection against infection. The researchers tested COVID-19 vaccine boosters delivered via nasal spray, inhaler, and a shot in the arm in adult rhesus macaques, finding that the inhaled vaccine provided greater mucosal immunity than the other two methods. The promising findings will hopefully further research toward more effective vaccines against COVID-19 and other respiratory viral infections.