Novavax Inc. has said that it has completed its rolling submission to Health Canada to authorize its Covid-19 vaccine candidate.
The company said that it has now completed the submission of every module deemed necessary by Health Canada for the regulatory evaluation of its protein-based NVX-CoV2373 vaccine.
This is the first submission of a protein-based Covid-19 vaccine in Canada.
Novavax said had submitted regulatory filings for its vaccine in the United Kingdom and Australia and plans to complete others in new markets.
The company also revealed that it has completed the submission of all data and modules to the European Medicines Agency for final regulator review.
Novavax said: “The final step to completing the application in the European Union will be an invitation from EMA to file for conditional marketing authorization.”
