Novavax says ‘rolling review’ of its COVID-19 vaccine started by Health Canada

Novavax says its COVID-19 vaccine is undergoing a “rolling review” by several health agencies, including Health Canada, to speed up its approval process.

In an announcement Thursday, the company said regulatory agencies now reviewing the vaccine include the European Medicines Agency, the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency, in addition to Health Canada.

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“The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide,” said Gregory M. Glenn, Novavax’s president of research and development, in the statement.

“We appreciate the agencies’ confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination.”

The vaccine is currently undergoing its Phase 3 trials in the United States and the U.K.

Earlier this week, Prime Minister Justin Trudeau announced that Canada had signed a new contract with the Maryland-based company to produce some of its vaccine doses in-country at a new facility in Montreal, though, according to Innovation Minister Francois-Phillippe Champagne, Canada would most likely not see the new vaccines until the fall as the building is expected to be completed in summer and would then have to be certified.

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Canada has since signed a contract to purchase 52 million doses from Novavax, with an option to buy tens of millions more if needed. The company had also announced last week that its vaccine was 89 per cent effective against the virus, according to results from its Phase 3 trials.

The results of that trial, as well as another smaller Phase 2 trial, showed that the vaccine was also effective against the B.1.17 variant first found in the U.K. and the N501Y.V2 variant first found in South Africa.

—With files from the Canadian Press and Reuters