Research Roundup: COVAX releases allocation plans through May, Merck to assist J&J's vaccine manufacturing, and study finds large group of HIV 'elite controllers'

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.

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 US Food and Drug Administration (FDA) on Saturday authorized Johnson & Johnson’s (J&J) COVID-19 vaccine for emergency use in adults over the age of 18, making it the third vaccine to be approved for use in the United States. The authorization follows a recommendation from an independent advisory panel to the FDA, which convened Friday to review the data and subsequently voted to endorse the vaccine. Phase 3 trial data released in late January showed 66 percent efficacy overall in preventing moderate to severe disease 28 days after vaccination, 72 percent efficacy among participants in the United States, and complete protection against hospitalization and death due to COVID-19, which was reinforced by FDA analysis released in advance of the independent panel meeting last week. The shot—made by J&J’s vaccine division, Janssen—requires only one dose and can be shipped and stored using standard refrigeration. The United States has purchased 100 million doses of the vaccine, and distribution is expected to begin this week.On Wednesday, 600,000 doses of the AstraZeneca/University of Oxford COVID-19 vaccine produced by the Serum Institute of India landed in Accra, Ghana, marking the COVAX Facility’s first delivery to the African continent. Ghana will begin its rollout of the doses early this week, prioritizing frontline health workers and others at high risk. The shipment, a first step toward COVAX’s goal of ensuring equitable access to COVID-19 vaccines around the world, was followed by a delivery to Cote d’Ivoire on Friday, and more shipments are expected in the coming days and months. COVAX intends to deliver nearly 2 billion vaccine doses this year, anticipated to cover up to 20 percent of participating countries’ populations.Last week, Moderna reported it had developed a new version of its COVID-19 vaccine designed to specifically work against the B.1.351 COVID-19 variant, first identified in South Africa. The new vaccine has been sent to the National Institutes of Health, which will test to determine if using it as a booster shot would stimulate a strong immune response. Also last week, Pfizer and BioNTech announced they had initiated a study on the safety and immunogenicity of a third dose of their vaccine to evaluate the effect of a booster on immunity against currently circulating variants, as well as any potential new variants. Both the Moderna and Pfizer/BioNTech vaccines are mRNA based, allowing them to be updated relatively quickly by creating a modified mRNA sequence.