Novavax targets approval for the COVID-19 vaccine in the US
Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The aim hints the U.S. could join the U.K. on the list of countries to permit the vaccine in the first half of the year.
The vaccine’s success in a 15,000-subject U.K. phase 3 clinical trial proffers Novavax a clear path to a favorable decision by the Medicines and Healthcare products Regulatory Agency (MHRA). Nevertheless, the lack of data from another phase 3 trial, which only lately finished enrolling 30,000 subjects in the U.S. and Mexico, makes way for an FDA sanction less obvious.
Novavax CEO Stanl...