Novavax Files For COVID-19 Vaccine Authorization In Canada; Submits For Rolling Review To EMA

Biotechnology company Novavax, Inc. (NVAX) announced Monday the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate NVX-CoV2373. In addition, the company has completed the submission of all data and modules to the European Medicines Agency or EMA to support the final regulatory review of its dossier.

NVX-CoV2373 is the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

According to the company, it is the first filing of a protein-based COVID-19 vaccine to regulatory authorities in Canada.

Novavax noted that it has now completed the submission of all modules required by Health Canada and EMA for the regulatory evaluation of NVX-CoV2373. The final step to completing the application in the European Union will be an invitation from EMA to file for Conditional Marketing Authorization.

The company noted that the chemistry, manufacturing and controls or CMC data packages submitted to Health Canada and EMA, as well as other global regulatory agencies, leverage its manufacturing partnership with the Serum Institute of India Pvt. Ltd. Or SII, the world's largest supplier of COVID-19 vaccines.

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