EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application

Biotechnology company, Novavax, has announced in a Nov. 17, 2021 press release that the European Medicines Agency (EMA) has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

NVX-CoV2373 is a protein-based vaccine candidate that has been engineered from the genetic sequence of the first strain of SARS-CoV-2. Confirmation that all data for the regulatory evaluation have been submitted by the company to EMA was announced earlier in November 2021. EMA has also indicated that it will be pursuing the evaluation under an accelerated timeframe, as stated in Novavax’s press release.

“Today's announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe,” said Stanley C. Erck, president and CEO, Novavax, in the press release. “Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program.”

The vaccine, which will be marketed in the European Union under the brand name of Nuvaxovid, has already been granted Emergency Use Authorization in Indonesia and the Philippines. Additionally, Novavax and its manufacturing partner, the Serum Institute of India (SII), have filed for Emergency Use Listing of the vaccine with the World Health Organization (WHO).

Furthermore, the company has filed for regulatory approval of the vaccine in the United Kingdom, Australia, New Zealand, Canada, and with WHO. The company has also announced the submission of a biologics license application, along with SK bioscience, to the South Korean regulatory body. It is expected that the complete package for the vaccine will be submitted to the FDA by the end of 2021.

Source: Novavax