Research Roundup: A promising malaria vaccine candidate, new NIH COVID-19 therapeutics trials, and safety data on COVID-19 vaccines in pregnancy
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 malaria vaccine candidate showed up to 77 percent efficacy in a phase 2b trial among children in Burkina Faso, according to results published by researchers at the University of Oxford’s Jenner Institute. The vaccine is the first to meet the World Health Organization goal of 75 percent efficacy. Developers have begun recruitment for a large-scale phase 3 trial to test the vaccine for safety and efficacy in 4,800 children across four countries. Following final trial results, Oxford would apply for regulatory authorizations, with a best-case scenario of approval by the end of 2022, according to the director of the Jenner Institute. The researchers have made a deal with the Serum Institute of India to manufacture the vaccine at large scale and low cost. It has pledged to deliver 200 million doses a year if the vaccine is licensed.
The National Institutes of Health (NIH) is launching three new clinical trials to evaluate COVID-19 therapeutics, including one trial for severely ill, hospitalized patients; one for a polyclonal antibody treatment; and one to assess repurposed drugs for COVID-19 symptoms. The trial for hospitalized patients will test a combination of NeuroRx’s Zyesami, which is a formulation of aviptadil acetate, and Gilead’s Veklury, which is the antiviral remdesivir. The antibody trial will test SAB Biotherapeutics’ investigative polyclonal antibody in mild to moderate cases of COVID-19, and the study on repurposed drugs will evaluate existing over-the-counter drugs to be used at home. All three trials are part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership.
Preliminary data on Pfizer’s and Moderna’s COVID-19 vaccines bolsters evidence that the mRNA shots are safe during pregnancy, based on reports from more than 35,000 women in the United States who received the doses while pregnant. The new evidence, published in the New England Journal of Medicine last week, showed rates of miscarriage, premature births, and other complications were comparable to those observed in pre-COVID-19 data on pregnancy. The study was led by US Centers for Disease Control and Prevention researchers, who noted continued monitoring and evidence is still needed, including on women who get COVID-19 vaccinations in the early stages of pregnancy.