Janssen seeks Health Canada approval for its COVID-19 vaccine

A fourth company has submitted its COVID-19 vaccine candidate for Health Canada approval, Health Minister Patty Hajdu said Monday.

Janssen Inc., a pharmaceutical subsidiary of U.S.-based multinational Johnson & Johnson, put forward its vaccine in what Hajdu called “a promising development for Canadians.”

Ottawa announced a deal with Janssen on Aug. 31 to secure up to 38 million doses of the vaccine — which requires only one dose to provide immunity instead of two.

Health Canada is currently evaluating three other vaccine candidates as part of a “rolling review process” that allows companies to submit data from clinical trials even as those trials are still underway. 

The regulator must approve a vaccine as safe and effective before it can be administered to Canadians. Health Canada is currently evaluating vaccine candidates from U.S. pharmaceutical giant Pfizer and its German partner BioNTech, from U.S. biotechnology company Moderna, and from British pharmaceutical firm AstraZeneca. 

When a vaccine will be approved and distributed has become the subject of intense speculation and debate in Canada as other countries like the U.S., U.K. and Germany have announced plans to begin distributing their vaccines in December.

Opposition politicians, some premiers and public health experts have criticized the Liberal government for falling behind other countries when it comes to approving vaccines and planning for their distribution.

Despite the criticism, none of those countries has granted final approval for a vaccine as of yet.

The U.S. Food and Drug Administration has scheduled a meeting for Dec. 10, during which independent public health experts will debate whether to grant emergency-use approval to Pfizer’s vaccine. Moderna’s vaccine will be considered at a similar meeting one week after that.

At a technical briefing with reporters last week, Health Canada’s chief medical adviser said approval of the first COVID-19 vaccine in Canada could come within weeks.

In total, the federal government has secured agreements with seven companies for up to 429 million doses —  the most per capita of any country in the world, according to research from Duke University’s Global Health Institute.

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