Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete for EMA.
Novavax today announced the completion of its rolling submission to Health Canada for authorisation of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada.
In addition, the company has completed the submission of all data and modules to the EMA to support the final regulatory review of its dossier.
