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Thank you for the opportunity to provide feedback on agenda items that will be tackled during this year’s World Health Assembly. GHTC urges US policymakers to prioritize the following actions to strengthen research and development (R&D) to address these urgent health challenges: On antimicrobial resistance (AMR), it is vital to bolster investments and incentives for R&D for new antimicrobials and other tools to fight AMR and to improve global surveillance and laboratory capacity. Innovations should be developed with the goal of promoting broad accessibility, including for vulnerable populations and those in low-resource settings. The United States should work with member states to support the resolution tabled under this agenda item and call for the creation of a global AMR laboratory network to strengthen diagnostic capacity. In advance of this year’s United Nations High-Level Meeting on AMR, we also urge the United States to push the relevant United Nations agencies to hold an open, inclusive consultative process to define global AMR priorities. On maternal and child health, we welcome the draft resolution and its proposed language calling for increased R&D of health tools to address the specific medical needs of women and children, which are often neglected. We urge the United States to support the ongoing work of the Global Accelerator for Paediatric Formulations Network, or GAP-f, including prioritizing R&D for priority products on the World Health Organization’s (WHO’s) Paediatric Antiretroviral Drug Optimization list. For pregnant women, we need to speed up and scale up access to preventive tools and treatments and include pregnant and lactating women in research and clinical trials to improve data quality and availability of therapeutic options. On tuberculosis (TB) and neglected tropical diseases (NTDs), we urge the United States to work with member states to substantially increase investments in R&D. To meet the goals of the Global Strategy for Tuberculosis Research and Innovation, member states must increase domestic investments in TB R&D in line with fair share targets and supercharge research efforts to develop novel vaccines, point-of-care diagnostics, and improved therapies while also ensuring tools are appropriate for all populations, including pregnant people and children. In implementing research efforts to support the NTD roadmap, member states and WHO should position impacted countries to lead in R&D priority-setting, promote South-South collaboration models, and consider the growing impact of climate change. For both TB and NTD innovations, the United States should work with WHO’s divisions on Science and Access to Medicines and Health Products, as well as member states to consider ways to better align the prequalification and regulatory approval processes to accelerate access to vaccines, diagnostics, and therapeutics.  

GHTC sent letters to House and Senate appropriations subcommittees: the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS); the Subcommittee on State, Foreign Operations, and Related Programs (SFOPS); and the Subcommittee on Defense, urging these subcommittees to sustain and protect global health research and development funding in the fiscal year 2025 (FY25) budget.

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. As reports of H5N1 bird flu circulating in dairy cow herds across the United States continue, the experts in charge of preparing and responding to pandemics are now considering our ability to quickly develop a vaccine if human transmission were to occur in the future. The world has decades of experience producing, regulating, and updating flu vaccines, as well as the recent memory of the incredibly rapid development of vaccines during the COVID-19 pandemic. However, current global production capacity for flu vaccines would not yield enough doses quickly enough to vaccinate the large portion of the world’s population that would be necessary to quell a bird flu pandemic. Adjuvants—compounds that boosts immune response to the active vaccine antigen —or the introduction of an mRNA vaccine could, respectively, stretch supplies and speed up production, but it is not clear that there is sufficient production capacity for relevant adjuvants, and it is unclear how close producers are to advancing mRNA flu vaccines to market. Additionally, current flu production capacity is highly concentrated in high-income countries with no flu production in Africa, underlining the potential of another highly inequitable pandemic response.Last week Medicines for Malaria Venture (MMV) and Novartis announced positive data from their Phase 2/3 trial in Africa demonstrating the efficacy and safety of a novel formulation of the Coartem® malaria medicine developed for babies weighing less than 5 kilograms. Previously, this population lacked access to an evidence-based treatment option developed specifically for them, with this trial becoming the first evidence-based trial conducted to evaluate a new antimalarial dose and regimen for all infants under 5 kilograms with acute uncomplicated malaria. This population is currently treated with tablets meant for higher-weight children that are simply adjusted for weight, which can lead to overdose and toxicity in smaller kids. The data have been submitted for regulatory review, and if approved, the partners aim to make the treatment available as soon as possible.The Drugs for Neglected Diseases initiative (DNDi) and partners have initiated a Phase 2 clinical trial in Ethiopia testing an innovative, safer, simpler, and patient-friendly medicine to treat visceral leishmaniasis, the world’s deadliest parasitic killer after malaria. Visceral leishmaniasis is currently treated with painful injections that must be given at the hospital daily for 17 days and can cause rare but life-threatening side effects. The hope is that the new drug, which is administered via oral pills, will be efficacious, less toxic, and more accessible than the currently available treatment regimen, ensuring earlier access to treatment. A similar Phase 2 trial is also being conducted in South Asia to test if patients in the two endemic regions respond differently to the treatment.

The last few years have highlighted more than ever the incredible power of vaccines—from the millions of lives saved by the unprecedented rapid development of COVID-19 vaccines to the approvals and early-stage rollout of the first-ever vaccines for malaria and chikungunya.  We are now fortunate to have vaccines to prevent more than 20 life-threatening diseases, and immunization currently prevents 3.5 to 5 million deaths every year. While it is vital that countries continue to strengthen routine immunization programs to reach the 20 million children who missed out on one or more of their vaccines in 2022, it is also important that countries sustain strong investments in research and development to deliver the next generation of breakthrough vaccines.In recognition of World Immunization Week 2024, GHTC is highlighting five vaccines in development that could be game changers for some of world’s most threatening diseases, reminding us not only of the tremendous impact vaccines have already had but also of the great promise of innovative vaccines to save even more lives in the future.1. TBIn 2022, 1.3 million people worldwide died from tuberculosis (TB), which is the second leading infectious disease killer after COVID-19. Currently, the only approved vaccine for TB is the bacille Calmette-Guérin, or BCG, vaccine, which was developed more than 100 years ago. Though effective at preventing some types of TB in infants, it offers inconsistent protection in adults and adolescents against pulmonary TB, which is why new vaccine options are urgently needed.Last month, the Bill & Melinda Gates Medical Research Institute announced the launch of a pivotal Phase 3 trial evaluating a novel vaccine for TB, which researchers hope could become the second licensed vaccine for TB. The adjuvanted subunit vaccine M72/AS01E vaccine was originally developed by GSK, along with Aeras and IAVI. The trial, which is supported by the Bill & Melinda Gates Foundation and the Wellcome Trust, is testing the vaccine’s ability to prevent latent TB from progressing to active pulmonary TB in adults and adolescents. While it is expected that the trial could take at least five years, if successful, it could lead to an urgently needed new tool with the potential to transform TB control globally.2. ZikaZika is a mosquito-borne virus that can cause congenital malformations in infants born to individuals infected during pregnancy, as well as preterm birth and miscarriage. There are currently no vaccines available to prevent or treat Zika, nor are there specific treatments.There have been numerous outbreaks of Zika around the world, with a widespread outbreak in the Americas just under a decade ago sparking the World Health Organization (WHO) to declare a Public Health Emergency of International Concern in 2016.Last month, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year. Additionally, Moderna is advancing an mRNA-based Zika vaccine, mRNA-1893, which is currently in a Phase 2 trial in the United States and Puerto Rico; the trial is expected to end in July 2024.3. Lassa feverLassa fever is an acute viral hemorrhagic illness that is endemic primarily in parts of the West African region. Annually, there are around 5,000 deaths from Lassa fever and an estimated 100,000 to 300,000 cases. There are currently no approved vaccines that protect against Lassa fever.This month, the first participants were vaccinated in a Phase 2 clinical trial of a vaccine candidate for Lassa fever virus, which is being led by an international collaboration between IAVI, the Coalition for Epidemic Preparedness Innovations (CEPI), and in-country partners in Nigeria. The hope is that this trial, which is the most advanced Lassa vaccine trial to date, will lead to the availability of a vaccine candidate for evaluation and use in future Lassa outbreaks and, eventually, an approved vaccine for routine immunization.  4. Nipah virusNipah virus is a zoonotic virus that can cause a wide range of illnesses, from asymptomatic infection to severe respiratory illness and, sometimes, fatal brain inflammation. Nipah has an estimated case fatality rate of 40 to 75 percent, with South Asia facing the greatest burden of outbreaks. There are currently no specific drugs or vaccines for Nipah virus infection.The first human trial of a new vaccine against the deadly Nipah virus began in January of this year after the work, which started in 2017, was paused during the COVID-19 pandemic. The new vaccine, ChAdOx1 NipahB, which was developed using the same viral vector vaccine technology as the University of Oxford and AstraZeneca’s COVID-19 vaccine, will be evaluated over the next 18 months in a Phase 1 trial led by the Oxford Vaccine Group and funded by CEPI.5. ETECEnterotoxigenic Escherichia coli (ETEC) is one of the leading causes of moderate and severe diarrhea in children worldwide. It is estimated that ETEC causes about 220 million diarrhea episodes globally each year, resulting in an estimated 42,000 child deaths. There are currently no approved vaccines for ETEC, and bacterial resistance to the antibiotics often used to treat it is growing globally, underscoring the need for a preventative vaccine.ETVAC is an oral vaccine candidate for ETEC developed by Scandinavian BioPharma, which is being advanced in two different formulations, one for travel use, adults, and older children and a second “self-contained” solution requiring no mixing, which is designed for ease of administration in children under five in low- and middle-income countries. The vaccine has shown promising results in both populations in Phase 1 and 2 trials, which received partial funding from PATH through the Bill & Melinda Gates Foundation, and a Phase 2b trial was implemented among nearly 5,000 children in The Gambia, with efficacy results expected later this year, alongside the potential launch of a planned Phase 3 study in Zambia. If successfully advanced and approved, an ETEC vaccine could be a powerful new tool in our arsenal to reduce suffering and death from diarrheal disease and slow the emergence of antimicrobial resistance.  Breakthrough technologies like these vaccine candidates are possible because of long-term, consistent investment throughout the R&D process, from early-stage product development to implementation and rollout. With these promising technologies and more on the horizon, it is critical that we sustain investment in R&D to push these exciting new tools over the finish line and ensure everyone everywhere can access them. Learn more about global efforts for World Immunization Week to recognize the lifesaving power of vaccines here.