Novavax files for COVID-19 Vaccine authorization with Health 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 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 chemistry, manufacturing and controls (CMC) data packages submitted to Health Canada and EMA, as well as other global regulatory agencies, leverage Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest supplier of COVID-19 vaccines. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

The submissions also include clinical data from PREVENT-19, a pivotal Phase III 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 III trial of 15,000 participants in the U.K. were also previously submitted to the regulatory agencies, in which NVX-CoV2373 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. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile.

Novavax recently announced regulatory filings for its vaccine in the United Kingdom and Australia and expects to complete additional regulatory filings shortly in multiple additional markets, along with an additional supplemental filing for its vaccine for Emergency Use Listing (EUL) with the World Health Organization. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.