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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. Moderna plans to ask the US Food and Drug Administration to authorize its COVID-19 vaccine for emergency use in children aged 6 months to 6 years, the company announced Wednesday. Interim data from two clinical trials among children under 6 showed the vaccine generated similar immune responses to those seen in adults aged 18 to 25 who received two doses of Moderna’s adult formulation. The two-dose vaccine was, however, less effective at preventing symptomatic infection in the young children than seen in previous trials for older age groups. The decreased efficacy was on par with what would be expected of a vaccine in adults against the omicron variant, which predominated during the trial, according to Moderna. There were no severe cases, hospitalizations, or deaths in the studies.Pfizer will supply nearly 4 million courses of its oral COVID-19 treatment, Paxlovid, to UNICEF for use in 95 low- and middle-income countries. The two-drug treatment, which has emergency use authorization in the United States and is currently under assessment by the World Health Organization, will be allocated among the target countries depending on demand, clinical recommendation, and necessary approvals. Paxlovid was shown to be 89 percent effective at reducing the risk of hospitalization or death due to COVID-19 in clinical trials, and early studies indicate the treatment has some efficacy against the newer BA.2 variant that has caused cases to increase across Europe and Asia. Pfizer expects to be able to begin supplying orders to UNICEF in April and continue throughout 2022.A new “mosquito-grounding” insecticide that causes mosquitos’ wings to spasm and wither could bolster the fight against malaria, according to trial results published in The Lancet last week. In a two-year trial in Tanzania, lacing bednets with a combination of the new substance—chlorfenapyr—and a widely used insecticide—pyrethroid—significantly reduced malaria prevalence, including in regions where insecticide resistance is widespread. Insecticide-treated bednets have been central in efforts to reduce the spread of malaria, but rising insecticide resistance among mosquitos has hampered progress. Chlorfenapyr is the first new insecticide to be deemed safe and effective in about 40 years, and an ongoing study in Benin will continue to evaluate whether the substance reduces malaria transmission.

As the G20 Health Working Group kicks off with its initial meeting next week under the Indonesian presidency, health officials from the world’s top economies will be discussing commitments and systemic changes to better prepare for future health threats and improve health equity.As G20 leaders consider broader reforms to reimagine our global health architecture, GHTC urges them to prioritize the following actions to bolster health research and development (R&D).Build sustainable financing structures to mobilize new resources for R&D to address both emerging and enduring global health challenges. G20 nations should fully fund existing multilateral R&D mechanisms for pandemic preparedness and response including the Access to COVID-19 Tools Accelerator—which faces an immediate need of US$840 million to close upstream R&D gaps for vaccines, diagnostics, and therapeutics—and the Coalition for Epidemic Preparedness Innovations—which received just over $1.5 billion of its $3.5 billion replenishment ask to fulfill its next five-year strategy to ramp up vaccine R&D for potentially epidemic threats. G20 countries should also increase assessed contributions to the World Health Organization to at least 50 percent of the base budget by 2029 to enable stronger core funding for its Science Division and programs to facilitate product access, as well as create a new pandemic preparedness fund that could be tapped to bolster regional and national R&D capacity. Beyond addressing epidemic threats, G20 nations should increase investments in R&D for poverty-related and neglected diseases and antimicrobial resistance (AMR), including supporting the Global AMR R&D Hub, to close key gaps in our arsenal of tools.Improve coordination and alignment of R&D actors, while centering the needs of vulnerable populations. G20 nations must support reforms to better integrate R&D into existing health preparedness governance frameworks. The G20 should push for targeted amendments to the International Health Regulations to facilitate R&D coordination and information sharing and modify the Joint External Evaluation process to add a new indicator to better assess national R&D readiness. As pandemic framework negotiations advance, new norms and standards must also be set to govern pathogen and data sharing, research and regulatory coordination, and procurement to facilitate more equitable access to resulting medical countermeasures. Research funders should also prioritize targeted investments in R&D to address the unique needs of pediatric populations, pregnant and lactating people, and other vulnerable populations who are too often neglected in R&D efforts.Scale up manufacturing capacity for vaccines, treatments, and other health technologies in low- and middle-income countries (LMICs). G20 nations should bolster local and regional manufacturing capacity in LMICs through investments and technical support. These investments in manufacturing capacity strengthening must also be coupled with regulatory improvements and commitments by private companies and governments to step up support for technology transfer and workforce development so new innovations can be produced safely and rapidly at scale.It is GHTC’s hope that G20 nations will use this inaugural meeting to chart a new path toward building a more resilient, fit-for-purpose, and equitable R&D ecosystem of the future. For a more detailed look at GHTC recommendations to G20 health leaders, view this document. 

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 clinical trial is underway to evaluate experimental HIV vaccines using the mRNA technology also employed for highly effective COVID-19 vaccines. The phase 1 trial, sponsored by the National Institute for Allergy and Infectious Diseases and conducted by the HIV Vaccine Trials Network at the Fred Hutchinson Cancer Research Center, will enroll up to 108 HIV-negative adults at 11 sites across the United States. The three vaccine candidates—which use mRNA sequences designed by researchers at the Scripps Consortium for HIV/AIDS Vaccine Development and the IAVI Neutralizing Antibody Center at Scripps in collaboration with Moderna—will be assessed for safety and ability to induce an immune response. Knowledge gained from the study will help guide future development of a protective HIV vaccine regimen and expand on knowledge of mRNA vaccines, according to researchers.New studies are enlisting survivors of Nipah virus, a disease with known pandemic potential and a fatality rate as high as 75 percent, to evaluate how the body responds to infection and guide the development of tests, treatments, and vaccines. More than 50 people who have recovered from Nipah in Bangladesh will participate in the effort to research the immune response to the virus, which will be led by the International Centre for Diarrheal Disease Research, Bangladesh and funded by the Coalition for Epidemic Preparedness Innovations. There are currently no vaccines or drugs to fight Nipah infection, though several groups are working to develop vaccines, including a team at the University of Texas that unveiled data last week showing their candidate provided rapid, strong protection in animal studies. Australian regulators last week approved a simple drug combination as an effective cure for children ages 2 to 16 with Plasmodium vivax malaria, adding a new tool in the battle against the disease and opening the door to approval in other countries. The drug—tafenoquine, developed by GlaxoSmithKline and the Medicines for Malaria Venture—is a single-dose treatment administered alongside traditional chloroquine treatment. In 2018, the US Food and Drug Administration and other regulators approved a 300-mg dose of tafenoquine for the radical cure of P. vivax malaria in adults and adolescents 16 and older. The new formulation for children is a 50-mg tablet dispersed in water, making it much easier for children to take than the 7- or 14-day course of pills developed for adults. Further regulatory submissions of the pediatric formulation are planned for malaria-endemic countries as well as the World Health Organization.