Research Roundup: Moderna seeks vaccine EUA, COVID-19 drug trial launches, and equitable vaccine distribution efforts around the world
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This morning, Moderna announced 94 percent efficacy of its mRNA-based COVID-19 vaccine candidate in the main analysis of its late-stage trial, and the company is now seeking emergency use regulatory clearances in the United States and Europe. The updated results from Moderna’s 30,000-volunteer phase 3 study show a total of 196 symptomatic cases of COVID-19, of which 185 received a placebo injection and 11 received the vaccine. The news follows similarly strong results from Pfizer and BioNTech’s vaccine candidate, which the companies submitted for US Food and Drug Administration (FDA) emergency use authorization on November 20. The FDA committee will convene December 10 to review Pfizer’s vaccine candidate and December 17 to review Moderna’s candidate.
Thirteen African countries and an international network of research institutions are launching a multi-country clinical trial of COVID-19 treatments in patients with mild to moderate illness. Led by the Drugs for Neglected Diseases initiative, the ANTICOV trial aims to identify drugs that can be used for early treatment of COVID-19. The ANTICOV consortium will carry out the trial at 19 sites across 13 countries and will begin by examining repurposed drugs that have previously been used for HIV, malaria, and other infectious diseases before expanding to additional treatments and adapting over time. The trial is part of the Access to COVID-19 Tools (ACT) Accelerator therapeutics pillar, launched in April to ensure equitable global access to COVID-19 innovations.
As several COVID-19 vaccine candidates await regulatory clearance by health authorities around the world, the question of global distribution efforts is becoming more relevant. While the United States and European countries have signed direct agreements with vaccine developers to secure enough doses to cover their populations if the vaccine candidates are approved, many low- and middle-income countries (LMICs) will be reliant on the ACT Accelerator’s vaccines pillar, a mechanism aiming to accelerate development and equitable distribution of COVID-19 vaccines. The effort plans to distribute 1 billion vaccine doses to LMICs based on a “fair allocation program” by the end of 2021, which will cover about 20 percent of their populations, but it will likely face distribution and storage challenges due to funding gaps, manufacturing facility locations, and cold-storage requirements.