USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates

Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and Drug Administration announced 18 April. Instead, the emergency use authorizations (EUAs) for their bivalent vaccines have been amended so they can be updated more easily in the future.

The move includes authorizing the currently available bivalent vaccines for all doses administered to people 6 months of age and older.

« At this stage, the data shows that most of the US population 5 years of age and older have antibodies to SARS-CoV-2, the virus that causes COVID-19, as a result of either vaccination or having been infected with the virus,” Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said at a press conference. “These data support simplifying the use of the authorized bivalent mRNA COVID-19 vaccines and the agency believes this approach will help us achieve higher vaccination coverage throughout the country.”…