Biotech firm Novavax submits COVID-19 vaccine for approval by Health Canada

GAITHERSBURG, Md. — Biotechnology company Novavax Inc. says it has submitted its COVID-19 vaccine for approval in Canada.

The U.S. company says it has now completed the submission of all modules required by Health Canada for the regulatory evaluation of its protein-based COVID-19 vaccine.

The submission includes clinical data from a trial of 30,000 participants in the U.S. and Mexico.

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The company says the trial found 100 per cent protection against moderate and severe disease and 90.4 per cent efficacy overall. 

Novavax also recently announced regulatory filings for its vaccine in the United Kingdom and Australia and expects to complete additional regulatory filings shortly in several additional markets.

It expects to submit the complete package to the U.S. FDA by the end of the year.

This report by The Canadian Press was first published Nov. 1, 2021.

The Canadian Press