On Thursday the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend emergency use authorization (EUA) for a vaccine for COVID-19 prevention submitted by ModernaTX Inc. Based on the VRBPAC green light, the FDA is expected to authorize the Moderna vaccine as early as Friday, providing a second authorized inoculation against SARS-CoV-2 after Pfizer’s vaccine was approved on Dec 11.
“Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the US CDC and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Read the FDA’s briefing document on the Moderna vaccination at the FDA website.
