Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Rolling Review Submission to European Medicines Agency

Novavax, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada. In addition, the company has completed the submission of all data and modules to the European Medicines Agency (EMA) to support the final regulatory review of its dossier.

"Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the Government of Canada and the European Commission for their ongoing partnership and confidence in our COVID-19 vaccine program."

Novavax has now completed the submission of all modules required by Health Canada and EMA for the regulatory evaluation of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The final step to completing the application in the European Union will be an invitation from EMA to file for Conditional Marketing Authorization.

The submissions also include clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also previously submitted to the regulatory agencies, in which NVX-CoV2373 demonstrated the efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile.