Novavax, Inc. announced that European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for its COVID-19 vaccine, which will be marketed in the EU as Nuvaxovid.
"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 Chief Executive Officer, Novavax. "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 company previously announced it had completed the submission of all data and modules required by EMA for regulatory evaluation of NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. EMA has indicated that its assessment will proceed under an accelerated timeline, with an opinion issued potentially within weeks.
The chemistry, manufacturing and controls (CMC) data package submitted to EMA and other global regulatory agencies leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
Other Filings
The Novavax/SII vaccine recently received Emergency Use Authorization (EUA) in Indonesia and the Philippines, and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the UK, Australia, New Zealand, Canada and with the WHO.
Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.