Novavax to File for Emergency Use for COVID-19 Vaccine

Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter.

The submission will be supported by the strong efficacy data from the company’s late-stage trial in which the recombinant DNA-based vaccine proved 100 percent effective in preventing moderate and severe disease, and more than 90 percent effective at preventing symptomatic infections.

The Novavax trial findings, from almost 30,000 patients across 119 sites in the U.S. and Mexico, include results from many participants infected with the SARS-CoV-2 variant first identified in the UK — now known as the Alpha variant — which has become the predominant strain in the U.S.