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The Global Health Technologies Coalition (GHTC) welcomes yesterday’s G20 Health Ministers’ Declaration, as well as their Declaration on Climate Change, Health and Equity, and on One Health, which elevates the importance of investments in new tools and technologies to fight infectious diseases—work that can be broadly beneficial in confronting a wide range of health threats.It was encouraging to see G20 leaders offer such strong support to the Pandemic Fund, the intergovernmental negotiating body process on a pandemic accord, and the International Health Regulations amendments made earlier this year.   GHTC strongly supports the establishment of a Coalition for Local and Regional Production, Innovation and Equitable Access centered on voluntary cooperation to promote access to vaccines, therapeutics, diagnostics, and other health technologies for neglected and infectious diseases. We are pleased to see that the health ministerial declaration explicitly highlights the need for this coalition to promote synergies with existing and potential future initiatives and to work with a wide range of stakeholders. We appreciate that there are specific callouts supporting the efforts of several of our members and partners, including the Coalition for Epidemic Preparedness Innovations; Gavi, the Vaccine Alliance, and its African Vaccine Manufacturing Accelerator initiative; the Regionalized Vaccine Manufacturing Collaborative; the Pandemic Fund; PATH; Drugs for Neglected Diseases initiative; Stop TB; Global Fund; UNITAID; and Medicines Patent Pool.   While the creation of the coalition is an encouraging step forward, we urge G20 nations to consider additional ways to strengthen local research capacity, including through support for research and development (R&D) hubs, distributed manufacturing, and clinical trial infrastructure in low- and middle-income countries. We also would have liked to see a stronger emphasis on equity throughout the health ministerial declaration—not just in some sections—emphasizing the urgency to address the specific needs of women, children, and other underserved populations.   Beyond placing a strong focus on local production, the Brazilian G20 presidency also elevated the linkages between climate, health, and antimicrobial resistance (AMR) this year. It was encouraging to see the health equity and climate change declaration call on G20 nations to encourage and promote health R&D and stronger, more transparent partnerships between the public and the private sectors, as well as academia, affected communities, and the scientific community.   We also welcome the continued support highlighted in the health equity and climate change declaration for initiatives such as the Global AMR R&D Hub, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, the Global Antibiotic Research and Development Partnership, and the International Centre for Antimicrobial Resistance Solutions. Furthermore, we appreciate the declaration’s continued support for regional organizations that guide research, development, and strategies to accelerate new AMR health technologies and alternatives to the use of antimicrobials, promote equitable access and global stewardship, and maximize public investment returns. We are pleased that the declaration also emphasizes the importance of promoting equitable access to new tools, including through programs like the World Health Organization AWaRe classification of antibiotics.   We applaud G20 leaders for underscoring the linkages between AMR and the ongoing malaria, tuberculosis, and HIV/AIDS epidemics, stressing the need to break down silos. However, it is disappointing to see no commitments or robust support for the financing of AMR, whether through push-pull incentive models or other specific initiatives.   As always, we urge G20 members to work with civil society to push for the successful implementation of these key principles, pledges, and initiatives, and we hope that all relevant stakeholders will work diligently toward increasing access to health technologies.

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. Scientists at the Icahn School of Medicine at Mount Sinai and research partners have developed an innovative antibody platform to tackle viruses like SARS-CoV-2 (the virus that causes COVID-19) that can rapidly evolve and render vaccines and treatments ineffective. The platform uses engineered nanobodies to simultaneously target multiple stable regions of the virus that are less likely to mutate, making it harder for resistance to develop. While most therapeutic antibodies target only a single viral site and can lose effectiveness within a year as viruses evolve, this platform has the potential to offer a more durable, resilient defense against these tricky viruses. It could also be potentially adapted to target other pathogens. In lab tests and experiments in mice, the platform was able to effectively target a range of variants of the SARS-CoV-2 virus and even the closely related SARS-CoV virus. A new research project led by researchers at the Barcelona Institute for Global Health and Columbia University aims to develop a lateral flow test for diagnosing malaria at the point of care that would also enable health care workers to determine the severity of the disease and decide whether a course of treatment is necessary. While some patients with uncomplicated malaria can be treated at home, malaria can also rapidly progress and require more complicated treatment in a health care setting. Lateral flow tests for malaria diagnosis exist, but parasite counting using microscopy is needed to determine severity and that cannot be done at the point of care. The researchers, who hope to have a validated prototype by the fall of 2026, are looking to develop a portable, paper-based assay that uses a smartphone and can deliver results within minutes.   Last Monday, Roche announced that its mpox assay, Cobas MPXV, has been listed under the World Health Organization’s (WHO’s) Emergency Use Listing procedure, a designation that aims to accelerate the availability of and access to the test during the current global mpox emergency. The automated real-time PCR-based test detects DNA from the virus that causes mpox using a dual-target approach and previously received Emergency Use Authorization from the US Food and Drug Administration in 2022. Earlier this month, Abbot’s mpox test was also listed on the Emergency Use Listing procedure following a call by WHO for manufacturers to submit expressions of interest back in August.

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, scientists in Rwanda and partners from the World Health Organization launched the world’s first clinical trial testing a treatment for the deadly Marburg virus amid the ongoing outbreak in the country. There are currently no approved treatments or vaccines against Marburg virus, although a clinical trial of Sabin Vaccine Institute’s investigational vaccine is currently underway in Rwanda. The new trial will investigate the safety and efficacy of remdesivir and the monoclonal antibody MBP091, developed by Mapp Biopharmaceutical with support from the Biomedical Advanced Research and Development Authority.  At the recent G7 Joint Finance and Health Ministers’ Meeting, the Italian government announced a $21 million commitment over the next three years to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to accelerate the development of innovative products to prevent, diagnose, and treat drug-resistant bacterial infections. AMR is a growing public health crisis, particularly in low- and middle-income countries, and there is an urgent need for international collaboration and investment to revitalize an inadequate clinical pipeline and ensure new antimicrobials, antimicrobial alternatives, and diagnostics are available for patients worldwide.Valneva and LimmaTech announced last week that their Shigella4V (S4V) vaccine has been awarded Fast Track designation by the US Food and Drug Administration. There are no approved vaccines for the Shigella bacteria, which causes shigellosis, the second leading cause of fatal diarrheal disease globally, particularly among children in low- and middle-income countries. S4V is the world’s most clinically advanced tetravalent bioconjugate vaccine for shigellosis. This designation will enable accelerated clinical development and review of the vaccine, which will be investigated in two Phase 2 trials that are expected to begin before the end of 2024.

October 16, 2024 The Honorable Tammy Baldwin Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Robert Aderholt Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 The Honorable Shelley Capito Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Rosa DeLauro Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 Dear Chairs Baldwin and Aderholt and Ranking Members Capito and DeLauro: As you work toward finalizing Fiscal Year 2025 spending, we, the undersigned, urge you to adopt the Senate’s proposal for funding the National Institute of Allergy and Infectious Diseases (NIAID). This funding is critical to ensuring that the nation can respond to public health challenges of today and disease threats of tomorrow. NIAID plays an essential role in addressing long-standing domestic and global health challenges like influenza, asthma, cancer, HIV/AIDS, Sepsis, valley fever, deadly allergic reactions, long COVID, autoimmune diseases, tuberculosis, malaria, neglected diseases, and so much more. With a unique mandate to better understand, treat, and prevent infectious, immunologic, and allergic diseases, NIAID is forging paths to discovery to improve health and save lives. NIAID’s cutting-edge research and network of scientists are eliminating some of the world’s most serious health threats, as well as addressing risks to national security and public health, including antimicrobial resistance (AMR). Because of this work, NIAID is the world’s leader in the global health research and development ecosystem. NIH and NIAID contributed to four-fifths of all U.S. government-supported global health technologies currently in the final stages of the R&D pipeline before they can reach the market and save lives. Thanks to longterm and sustained support from Congress for NIAID over the years, the U.S. has made groundbreaking progress in the fight against diseases at home and abroad. These achievements include but are not limited to: NIAID-funded research spurred the development of the first vaccine for respiratory syncytial virus (RSV). The vaccine will help to prevent an estimated 160,000 hospitalizations and 10,000 deaths of older adults in the United States and is projected to save up to $4 billion in healthcare costs. Decades of NIAID investment helped facilitate public-private partnerships that led to the transformative development of Teplizumab, the first FDA-approved drug for delaying Type 1 diabetes (T1D) onset. The drug can help delay the onset of T1D by two years following a single treatment, which could benefit nearly 200,000 U.S. children. NIAID-funded research led to the development of antiretroviral agents that suppress HIV to undetectable levels in the body—keeping people with HIV healthy and preventing HIV transmission. Further, Protease inhibitors used in HIV treatment contributed to the development of direct-acting antivirals that cure hepatitis C. NIAID-funded research enabled development of mRNA vaccines in the first 100 days of the COVID-19 pandemic, which saved millions of lives worldwide and allowed the global economy to recover. NIAID scientists developed new technologies to identify geographic hot spots for Aedes mosquitoes—a type of mosquito that can spread diseases such as dengue, Zika, and chikungunya. The tool is poised to deliver targeted interventions to fight dengue and other diseases in the U.S. and communities across the globe. Asthma affects one in 13 Americans, including 20 million adults and over 5 million children. A clinical trial funded through NIAID found that the monoclonal antibody mepolizumab reduced asthma attacks by 27% in children and adolescents with severe asthma. An estimated 50 million Americans suffer from one or more autoimmune diseases, including 1.3 million adults with rheumatoid arthritis (RA). NIAID researchers discovered a new species of bacteria in the gut that may trigger RA, offering new avenues for treatment and prevention. Tuberculosis (TB), particularly in its drug-resistant forms, is not only a lethal threat globally (killing 410,000 per year), but remains a threat to the American people. NIAID has provided significant funding for noncommercial translational research – ranging from early discovery-based efforts to late-stage preclinical development – to develop novel anti-TB medicines. This is of fundamental importance, as research in potentially promising compounds has often been challenged by the inability to attract predictable, long-term funding that NIAID has been able to provide. These investments have led to continued breakthroughs in developing new TB treatments. NIAID-supported research is a bridge from the bench to the bedside, bringing together the full spectrum of the biomedical research and healthcare communities in addressing antimicrobial resistance. Each year, drug-resistant infections impact more than 3 million Americans, killing at least 50,000 people in the U.S. It is projected that AMR could become the leading cause of death globally by 2050 and cost the global economy $100 trillion. NIAID is instrumental in the development and training of the next generation of biomedical researchers and sustaining the current biomedical workforce. Further investments in biomedical workforce development at NIAID will yield far-reaching dividends for global health, global health security, and scientific diplomacy. We urge you and your colleagues to work towards finalizing FY 2025 funding bills to avoid longterm continuing resolutions or a government shutdown and to ensure strong funding for the life-saving work of NIAID so that American ingenuity can continue to forge a healthier, safer, and more equitable world for all. Sincerely, American Society for Microbiology American Society for Virology American Society of Tropical Medicine and Hygiene AVAC Drugs for Neglected Diseases initiative Elizabeth Glaser Pediatric AIDS Foundation Global Health Council Global Health Technologies Coalition HIV Medicine Association HIV+Hepatitis Policy Institute IAVI Immune Deficiency Foundation Infectious Diseases Society of America Research!America TB Alliance Texas Biomedical Research Institute Treatment Action Group