Research Roundup: Moderna vaccine in kids under 6, a supply deal for COVID-19 pill, and 'mosquito-grounding' insecticide

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.

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.