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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. Last week, advisers to the US Food and Drug Administration convened to assess the country’s COVID-19 vaccine policy, including guidance on updated vaccines to offer increased protection against variants. Some health officials believe revised vaccines will be needed by the fall, when the virus could resurge in force. Researchers developing modified vaccines would need to settle on a formula as early as June to have a vaccine ready for use this fall, according to the panel, though several trials are just now getting underway—including a National Institutes of Health study analyzing a Moderna vaccine revised to target three different variants, for which results are expected this summer. Once regulators decide on a reconfigured vaccine, manufacturers would need several months to produce doses, according to one expert, and several others underscored the uncertainty and difficulty of the highly compressed timeline.Moderna and IAVI will collaborate to develop vaccines and antibodies for HIV/AIDS, tuberculosis, antimicrobial-resistant enteric infections, and COVID-19 using mRNA technology, the organizations announced Thursday. The partnership aims to accelerate the research and development process, as Moderna’s mRNA platform can help develop material for clinical testing more quickly than traditional recombinant protein synthesis or cell systems can. If candidates are successful, they can also be manufactured quickly and at large scale, according to Moderna. The first candidate the partnership will work on is HIV vaccine antigens delivered by mRNA, for which a phase 1 trial was initiated in January. Preclinical efforts in the collaboration include candidates for tuberculosis, COVID-19, and HIV.The world needs to invest $15 billion this year, and $10 billion annually in future years, to establish and maintain an adequate toolkit to respond to COVID-19 and future pandemic threats, according to a working paper released by the International Monetary Fund last week. The paper, published in partnership with the Coalition for Epidemic Preparedness Innovations, the Global Fund, and Wellcome Trust, outlines the funding estimate while asserting that ending the pandemic everywhere remains an urgent economic, health, and moral priority for the world. Countries need vaccines, tests, treatments, and an improved health infrastructure to tackle COVID-19 and other deadly diseases, as well as investments in global surveillance, research and development, manufacturing, and health systems, global leaders said.

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.On Thursday, the World Health Organization launched a new global initiative to combat arboviruses—fast-growing and poorly understood viral diseases carried by insects that have future pandemic potential. The Global Arbovirus Initiative aims to tackle diseases like dengue, yellow fever, chikungunya, and Zika, which currently have limited effective treatments and vaccines. The initiative will better link the various research, surveillance, and vector control efforts around the world in a more formal network of collaboration. Research innovation and partnerships are also key to the new strategy, which is the culmination of a series of consultations among a broad network of partners to enable efficient and successful collaboration across a range of pathogens and disciplines and ensure a more integrated approach to this family of viruses.The US Food and Drug Administration on Tuesday approved HIV treatment Cabenuva for adolescents, the first long-acting injectable regimen for the age group. The treatment, which includes shots of cabotegravir and rilpivirine, was approved for adults last year as a monthly regimen and more recently as a bimonthly regimen, meaning it can be administered as few as six times per year. Both timing options will now be available to virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable antiretroviral therapy regimen, and have no history of treatment failure or resistance to either drug. The approval for adolescents is supported by evidence from studies conducted among adults as well as from interim analysis of an ongoing trial among adolescents.Ahead of a World Health Assembly (WHA) meeting in May, the United Kingdom is circulating a resolution to improve the quality of clinical trials by boosting funding, adding more trial sites, and fully reporting study results. The proposal, which comes amid increased concerns about meeting global health needs in the wake of COVID-19, promotes steps to generate “high-quality research” that can help develop medical products to provide routine care, especially in lower- and middle-income countries, for any global health priority. These steps include coordinating research, ensuring funding, and creating mechanisms to register trials and report results. If the resolution proceeds after member state debate, revisions are expected between now and the WHA session in early May.

The fiscal year 2023 (FY23) budget request released yesterday by the White House includes some much needed and welcome increases to several global health and research and development (R&D) priority accounts but does not meet the moment in terms of putting forth a comprehensive commitment to growing resources across all these essential programs. The Global Health Technologies Coalition (GHTC) is disappointed to see FY23 requests for some critical accounts fall below FY22 enacted levels. The administration has proposed incredibly ambitious multi-year, multi-agency mandatory—or automatic—funding to bolster pandemic preparedness but must lay out a path forward marrying these new visionary commitments with increases to discretionary—or annually determined—global health and R&D spending.Unprecedented global challenges demand unprecedented American leadership—including unprecedented investments in global health and R&D programs, both those newly proposed to respond to emerging challenges and those with decades of proven impact. These investments are not just numbers on a page: they directly translate into lives saved from the enduring epidemics of HIV/AIDS, tuberculosis, and malaria; ground gained against the COVID-19 pandemic still smoldering as 40 percent of the world’s population awaits a first vaccine dose and we live under constant threat of new variants; strengthened health systems worldwide to detect, prevent, and respond to the next health threat; and new and improved health tools designed for impact everywhere in the world they are needed. The International Affairs Division of the FY23 budget request released today includes some hopeful steps in that direction, including a significantly increased US contribution to the Global Fund for AIDS, Tuberculosis and Malaria; new global health security commitments, including the establishment of a financial intermediary fund for pandemic preparedness; and increases to malaria, neglected tropical diseases, and international family planning programming at the US Agency for International Development (USAID) and State Department. Other critical global health accounts, however, are flat funded or even cut relative to FY22 enacted levels in the request. GHTC is disappointed that the budget request does not include comprehensive funding increases across the entire State Department and USAID Global Health Programs account. This sends a mixed message from the White House and does not reflect the administration’s stated commitment to global leadership on a broad range of health challenges. Flat funding or cutting global health programs under more budgetary strain than ever due to the continued impact of COVID-19 does not meet the moment. The $6.5 billion in five-year funding requested for the State Department and USAID through a new mandatory funding pathway, which includes a strong US commitment to the Coalition for Epidemic Preparedness Innovations, is an exciting proposal. The White House must now work with congressional appropriators to ensure this and other mandatory spending for pandemic preparedness proposed in the budget request is realized alongside increases to discretionary spending accounts. Reaching our global health goals in the months and years to come requires robust investments in R&D today, and GHTC welcomes the increases proposed in the budget framework for the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention’s Center for Global Health and National Center for Emerging and Zoonotic Infectious Diseases, and the transformative level of new mandatory spending proposed for pandemic preparedness through these and other agencies within the Department of Health and Human Services. However, of the $4.3 billion increase requested for the National Institutes of Health (NIH), $4 billion would be used to boost the new Advanced Research Projects Agency for Health, leaving very little room for increases to other NIH institutes and centers. GHTC welcomes the increase proposed for the Fogarty International Center but is disappointed that the FY23 request for other NIH institutes and centers vital to global health R&D, including the National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences, and National Institute of Child Health and Human Development, fall below FY22 enacted levels. There are some bright spots and visionary proposals included in the White House’s FY23 budget request, and the proposed mandatory spending for pandemic preparedness across the US government would be transformative—if enacted by Congress. However, the administration missed a crucial opportunity to lay out a comprehensive approach to boosting our global health and R&D capabilities through increases to discretionary spending in this request. At this moment of intersecting global health crises—layered on top of so many other pressing international challenges—maintaining hard-won gains against enduring global health threats and preparing for new threats to come will require even bolder investments. GHTC looks forward to working with champions in Congress to ensure that the final FY23 budget rejects any cuts relative to FY22 and sustains a pathway toward funding commensurate with unprecedented global needs.