Novavax files for COVID-19 vaccine approval in Canada – CBC

Vaccine received emergency-use authorization in Indonesia Monday — its first approval in the world

Nov 01, 2021

Novavax announced Monday in a news release that it had completed a rolling submission to Health Canada for authorization of its two-dose COVID-19 vaccine, a long-awaited development for the Maryland company, which has struggled to bring its doses for use in the global inoculation campaign.

Shares of Novavax rose about 11 per cent before the opening bell after the company also said it had filed an application for emergency use for the vaccine to Canada as well as the European Medicines Agency.

“Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world,” Stanley C. Erck, Novavax’s president and chief executive officer, said in a statement.

Meanwhile, Novavax got its first approval anywhere in the world on Monday, when the company and partner Serum received emergency-use authorization for their COVID-19 vaccine in Indonesia

Read more: https://www.cbc.ca/news/health/novavax-covid-vaccine-1.6232507