Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on Feb. 22 that it completed enrollment in the 30,000-subject U.S. and Mexican Phase III PREVENT-19 trial of the adjuvanted, protein-based COVID-19 vaccine.

Novavax also revealed it’s testing a six-month booster shot, on top of the initial prime-boost vaccinations, in its U.S. and Australian Phase I/II trial; and that it plans to begin human studies of variant-specific candidates, as stand-alone or bivalent products, midyear. Other COVID-19 vaccine developers are taking similar steps to address SARS-CoV-2 variants...