Europe Begins Reviewing Maryland-Produced COVID-19 Vaccine Candidate

The European Medicines Agency (EMA) announced its human medicines committee had started a rolling review of NVX-CoV2373, a COVID‑19 vaccine developed by Novavax CZ AS, a subsidiary of Maryland-based Novavax, Inc. NVX-CoV2373 is a prefusion protein coronavirus vaccine candidate made using Novavax’s proprietary nanoparticle technology, Matrix-M, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.

A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency.

The Novavax rolling review will continue until enough evidence is available for a formal marketing authorization application. EMA will assess the vaccine’s compliance with the usual standards for effectiveness, safety, and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.