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


One other COVID-19 vaccine may quickly be available on the market as Novavax has formally filed for regulatory approval of its vaccine to Well being Canada.

The Novavax COVID-19 vaccine is the primary protein-based vaccine candidate of its type. The vaccine was created utilizing recombinant nanoparticulate expertise from the primary pressure of SARS-Cov-2.

“Novavax continues to ship regulatory filings that we count on will convey the primary protein-based COVID-19 vaccine based mostly on Part 3 information to the world,” stated Stanley C. Erck, president and chief govt of Novavax in a press launch. “We thank the Authorities of Canada and the European Fee for his or her ongoing partnership and confidence in our COVID-19 vaccine program.”

Novavax has launched information from vaccine trials performed in June 2021 in U.S. and Mexico. With 30,000 individuals within the trials, the U.S.-based firm noticed a 100 per cent safety in opposition to average and extreme circumstances of COVID-19 with an general efficacy of 90.4 per cent. Earlier trials within the U.Ok. noticed the effectivity of the vaccine at 89.3 per cent.

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In June, Novavax wrote that it was ready to be “on observe to achieve manufacturing capability of 100 million doses monthly by the top of the third quarter and 150 million doses monthly by the top of the fourth quarter of 2021,” if it obtained regulatory approval.

Learn extra:
Novavax seeks WHO approval for emergency itemizing of COVID-19 vaccine

A spokesperson for the corporate stated the submission to Canadian well being authorities comes as Novavax obtained latest approval to be used in Indonesia. It additionally intends to observe up and do a “completion of knowledge submission within the European Union.” The corporate has been busy throughout the globe with one other provisional approval utility made for the vaccine in Australia on Oct. 30.

The vaccine producer stated it plans to ship COVID-19 vaccines to creating nations and is dedicated to the COVAX program, a worldwide initiative aimed toward growing international vaccine accessibility.

“The approval and submissions this week — convey us nearer to serving to fill these vital international wants,” wrote a spokesperson in an e-mail.

Learn extra:
Novavax begins early trials for mixed flu and COVID-19 vaccine

On Sept. 23, Novavax filed for an emergency itemizing with the World Well being Group which might permit the corporate to ship to center and low-income counties by means of the COVAX facility.

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— with information from Carolyn Jarvis

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