Novavax’s COVID-19 Vaccine Gets Rolling Review From EMA
The European Medicines Agency (EMA) has begun a rolling review of Novavax’s COVID-19 vaccine, NVX-CoV2373.
The agency is looking at preliminary results from nonclinical and early clinical studies indicating the vaccine induced an immune response against the coronavirus.
Novavax released interim results last week from a phase 3 UK trial, demonstrating its vaccine showed 89.3 percent efficacy against both the SARS-CoV-2 virus and a variant first identified in the UK.
The company plans to finalize enrollment of 30,000 participants by mid-February for a phase 3 study in the U.S. and Mexico.