By Adriano Marchese
Novavax Inc. said Monday that it has completed its rolling submission to Canada’s health regulator to authorize its Covid-19 vaccine candidate.
The clinical stage biotechnology company said that it has now completed the submission of all modules necessary by Health Canada for the regulatory evaluation of the protein-based NVX-CoV2373 vaccine.
This is the first filing of a protein-based Covid-19 vaccine in the country.
Novavax has submitted regulatory filings for its vaccine in the U.K. and Australia and expects to complete others in a number of new markets, it said.
Additionally, it said that it has also completed submission of all data and modules to the European Medicines Agency for final regulator review.
“The final step to completing the application in the European Union will be an invitation from EMA to file for conditional marketing authorization,” it said.
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