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Novavax COVID-19 vaccine submitted for regulatory approval to Health Canada

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WATCH: Novovax has finished submitting its rolling application to seek regulatory approval of its COVID-19 vaccine to Health Canada, the company said Monday. It is the first protein-based vaccine candidate of its kind and was created using recombinant nanoparticulate technology from the first strain of SARS-Cov-2 – Nov 1, 2021

Correction: This story has been updated to reflect that Novavax announced they have completed their rolling submission to Health Canada. A previous version of this story stated the company had just finished filing for approval

Another COVID-19 vaccine could soon be on the market as Novavax has finished submitting their rolling application to seek regulatory approval of its vaccine to Health Canada, according to a company.

The Novavax COVID-19 vaccine is the first protein-based vaccine candidate of its kind. The vaccine was created using recombinant nanoparticulate technology from the first strain of SARS-Cov-2.

“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,” said Stanley C. Erck, president and chief executive of Novavax in a press release. “We thank the Government of Canada and the European Commission for their ongoing partnership and confidence in our COVID-19 vaccine program.”

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Novavax has released data from vaccine trials conducted in June 2021 in U.S. and Mexico. With 30,000 participants in the trials, the U.S.-based company saw a 100 per cent protection against moderate and severe cases of COVID-19 with an overall efficacy of 90.4 per cent. Earlier trials in the U.K. saw the efficiency of the vaccine at 89.3 per cent.

In June, Novavax wrote that it was prepared to be “on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021,” if it received regulatory approval.

Read more: Novavax seeks WHO approval for emergency listing of COVID-19 vaccine

A spokesperson for the company said the submission to Canadian health authorities comes as Novavax received recent approval for use in Indonesia. It also intends to follow up and do a “completion of data submission in the European Union.” The company has been busy across the globe with another provisional approval application made for the vaccine in Australia on Oct. 30.

The vaccine manufacturer said it plans to deliver COVID-19 vaccines to developing countries and is committed to the COVAX program, a global initiative aimed at increasing global vaccine accessibility.

“The approval and submissions this week — bring us closer to helping fill these important global needs,” wrote a spokesperson in an email.

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Read more: Novavax starts early trials for combined flu and COVID-19 vaccine

On Sept. 23, Novavax filed for an emergency listing with the World Health Organization which would allow the company to ship to middle and low-income counties through the COVAX facility.

— with files from Carolyn Jarvis

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