Quiz: Innovations to outsmart TB

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.

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. Novavax’s COVID-19 vaccine has an overall efficacy of 89.7 percent, with 100 percent efficacy against severe disease, according to final results of its phase 3 trial in the United Kingdom. The results, released Thursday and not yet published in a peer-reviewed journal, showed 96.4 efficacy against the original strain of the COVID-19 virus and 86.3 percent against the B.1.17 variant, first identified in the United Kingdom. The company also announced results from a phase 2b trial in South Africa, which showed 48.6 percent efficacy overall but maintained 100 percent efficacy against severe disease. Phase 3 trials in the United States and Mexico are ongoing. Novavax plans to apply for regulatory approvals around the world, including for use by the global vaccine initiative COVAX, to which Novavax pledged to provide 1.1 billion doses.An antibody cocktail developed by Eli Lilly decreased risk of hospitalization and death due to COVID-19 by 87 percent when compared to a placebo, the company said Wednesday. The antibody duo, a lower-dose combination of bamlanivimab and etesevimab, received emergency use authorization from the US Food and Drug Administration (FDA) in February based on previous trial data indicating a 70 percent reduction in hospitalizations and deaths using higher doses. The treatment showed complete protection against death in both phase 3 cohorts. Eli Lilly has a supply deal with United States for 100,000 doses of the treatment, set to be delivered by the end of the month, and the company has now partnered with Amgen to help produce up to 1 million doses of the cocktail by the end of the year. On Thursday, results from a long-term study in South Africa showed almost all patients who received a new treatment for highly drug-resistant tuberculosis remained clear of the disease two years after the trial. The six-month, all-oral regimen of bedaquiline, pretomanid, and linezolid (BPaL) treats highly drug-resistant strains of tuberculosis and shortens the treatment period from two years, with limited side effects. The new findings come from analysis of the Nix-TB trial, conducted by the TB Alliance of South Africa, which tested the BPaL regimen on 109 patients at three sites in the country. Preliminary trial results showed a 90 percent success rate after six months of treatment and six months of post-treatment follow-up, and according to the new data, only two patients had challenges by two years after the treatment.