Research Roundup: Oral TB treatment shows positive results, AstraZeneca updates vaccine efficacy, and Pfizer launches trial on COVID-19 treatment pill

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. The Pfizer/BioNTech COVID-19 vaccine prevented symptomatic disease and was well-tolerated in a phase 3 trial of adolescents aged 12 to 15, the companies said Wednesday. The trial enrolled 2,260 adolescents, and efficacy was primarily measured through antibody levels in comparison to levels seen in older adolescents and adults. The vaccine prevented symptomatic COVID-19 infection, with no cases of COVID-19 among those who received the vaccine, and was well-tolerated, with participants experiencing symptoms similar to those aged 16 to 25. Pfizer and BioNTech plan to submit the data to the US Food and Drug Administration (FDA) to expand the vaccine’s emergency use authorization, which currently extends to those ages 16 and up. They hope to begin vaccinating adolescents aged 12 to 15 by the beginning of the next school year, according to the press release.Last week, the FDA issued emergency use authorizations to three COVID-19 rapid antigen diagnostic tests, including two tests that will be available over the counter for at-home use. The over-the-counter tests include Quidel’s QuickVue test and multiple versions of Abbott’s BinaxNOW test, which can be used at home and are designed to check an individual twice over two to three days. The FDA also reauthorized a BD hand-held antigen test for point-of-care use without a prescription. The National Institutes of Health (NIH) and Centers for Disease Control and Prevention plan to use the Quidel diagnostic in a community self-testing program, for which they will provide up to 160,000 residents of two counties in North Carolina and Tennessee access to the diagnostic for free in an effort to understand how best to use at-home tests to reduce viral transmission in communities.NIH has begun a clinical trial evaluating a version of Moderna’s COVID-19 vaccine modified to target the B.1.351 variant, first identified in South Africa. The trial will test the modified vaccine, mRNA-1273.351, in 210 adults and is expected to be fully enrolled by the end of April. The modified vaccine will be evaluated in both unvaccinated adults and adults who already received Moderna’s original mRNA-1273 vaccine as part of a clinical trial last year. The vaccinated group will be randomly assigned to receive either a single vaccination of 50 µg of mRNA-1273.351 or a single vaccination containing one 25 µg dose of mRNA-1273 and one 25 µg dose of mRNA-1273.351. A separate clinical trial will assess a booster shot of the original vaccine in the remaining vaccinated participants of the 2020 trial.

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 has launched a phase 2/3 trial of its two-dose, mRNA-based COVID-19 vaccine in children ages 6 months to less than 12 years, the company announced last week. The KidCOVE trial, conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, will enroll about 6,750 children in the United States and Canada. The first stage of the trial will test how participants respond to different dosing levels, followed by an interim analysis to determine appropriate dose levels, and the second stage of the trial will test the selected dose against placebo shots. In a separate, ongoing trial launched in December, Moderna is testing its vaccine in 3,000 children aged 12 to 17.The COVID-19 vaccine developed by AstraZeneca and the University of Oxford reduces mild and serious forms of the disease, according to results from an interim analysis of a phase 3 trial in the United States, Chile, and Peru released Monday. The two-dose vaccine decreased symptomatic disease by 79 percent and severe disease and hospitalization by 100 percent. In its press release, AstraZeneca said the vaccine study identified no new safety concerns, and a specific review found no risk of blood clots—reports of which had led several European countries to halt rollout last week. Last Thursday, the European Medicines Agency announced the vaccine is “safe and effective,” noting its benefits outweigh the risk of potential adverse side effects, which appear to be extremely rare. AstraZeneca plans to request emergency use authorization from the US Food and Drug Administration in the coming weeks.Researchers from Cleveland Clinic's Florida Research and Innovation Center (FRIC) have identified a potential new target for COVID-19 treatments, according to findings published in Nature Microbiology. The research shows that the coronavirus enzyme PLpro blocks the body’s immune response, suggesting that therapeutics inhibiting the enzyme could help treat COVID-19 infection. In a follow-up phase of the study, the FRIC research team will investigate whether blocking PLpro’s enzymatic function, or its interaction with receptor proteins that help govern immune defenses, would strengthen human immune response against the virus. If successful, PLpro could be a new target for future COVID-19 therapeutics.