Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom
Oct 27, 2021
Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization
All modules required for regulatory review, including CMC data, are now complete
Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants
Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon
ir.novavax.com
"Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year." |
