EU Authorized Novavax's Vaccine

The European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 in individuals 18 years of age and older. The authorization of the vaccine (also known as NVX-CoV2373) is applicable in all 27 European Union (E.U.) member states. This is the first authorization of a protein-based COVID-19 vaccine for the people of the E.U. and the fifth vaccine recommended in the EU for preventing COVID-19.

Novavax and the EC announced an advance purchase agreement (APA) for up to 200 million doses of Novavax’s COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January.

In two Phase 3 clinical trials [1, 2], NVX-CoV2373 showed an efficacy of around 90 % and an acceptable safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants including Omicron, as the vaccine is distributed. NVX-CoV2373 has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. FDA.

This authorization leverages Novavax’s manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. Novavax and SII recently received emergency use authorization (EUA) in Indonesia and the Philippines, where it will be commercialized by SII under the trade name Covovax™. The companies also received emergency use listing for Covovax from the World Health Organization (WHO). The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing, and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) by the end of the year.

NVX-CoV2373 is a protein-based vaccine developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. Developed using Novavax’s recombinant nanoparticle technology to generate antigens from the Coronavirus Spike (S) protein, NVX-CoV2373 is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant to boost the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The vaccine is packaged as a ready-to-use liquid formulation in a ten-dose vial. The vaccination regime requires two doses of 0.5 mL (5 µg antigen and 50 µg Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored at 2 to 8 °C.

Novavax, Inc., Gaithersburg, Maryland, USA
Full leaflet and adverse reaction reporting instructions
European Medicines Agency on Novavax Vaccine

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico,
Lisa M. Dunkle, Karen L. Kotloff, Cynthia L. Gay, Germán Áñez, Jeffrey M. Adelglass, Alejandro Q. Barrat Hernendez, Wayne L. Harper, Daniel M. Duncanson, Monica A. McArthur, Diana F. Florescu, R. Scott McClelland, Veronica Garcia-Fragoso, Robert A. Riesenberg, David B. Musante, David L. Fried, Beth E. Safirstein, Mark McKenzie, Robert J. Jeanfreau, Jeffrey K. Kingsley, Jeffrey A. Henderson, Dakotah C. Lane, Guillermo M. Ruíz-Palacios, Lawrence Corey, Kathleen M. Neuzil, Robert W. Coombs, Alex L. Greninger, Julia Hutter, Julie A. Ake, Katherine Smith, Wayne Woo, Iksung Cho, Gregory M. Glenn, Filip Dubovsky,
New England Journal of Medicine 2021.
https://doi.org/10.1056/NEJMoa2116185
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine,
Paul T. Heath, Eva P. Galiza, David N. Baxter, Marta Boffito, Duncan Browne, Fiona Burns, David R. Chadwick, Rebecca Clark, Catherine Cosgrove, James Galloway, Anna L. Goodman, Amardeep Heer, Andrew Higham, Shalini Iyengar, Arham Jamal, Christopher Jeanes, Philip A. Kalra, Christina Kyriakidou, Daniel F. McAuley, Agnieszka Meyrick, Angela M. Minassian, Jane Minton, Patrick Moore, Imrozia Munsoor, Helen Nicholls, Orod Osanlou, Jonathan Packham, Carol H. Pretswell, Alberto San Francisco Ramos, Dinesh Saralaya, Ray P. Sheridan, Richard Smith, Roy L. Soiza, Pauline A. Swift, Emma C. Thomson, Jeremy Turner, Marianne E. Viljoen, Gary Albert, Iksung Cho, Filip Dubovsky, Greg Glenn, Joy Rivers, Andreana Robertson, Kathy Smith, Seth Toback,
New England Journal of Medicine 2021, 385, 1172–1183.
https://doi.org/10.1056/NEJMoa2107659