Janssen seeks Health Canada approval for its COVID-19 vaccine

Janssen seeks Health Canada approval for its COVID-19 vaccine-Milenio Stadium-Canada
A woman receives an injection during Phase 3 testing for the Janssen Pharmaceutical-Johnson & Johnson vaccine in the U.S. The company has begun the Health Canada approval process, Health Minister Patty Hajdu said on Monday. (Johnson & Johnson/The Associated Press)


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

How close are we to a vaccine for COVID-19?

Hajdu called the request for vaccine approval by Janssen Inc., a pharmaceutical subsidiary of U.S.-based multinational Johnson & Johnson, “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.

Janssen’s vaccine is a non-replicating viral vector vaccine — based on viral material that has been genetically engineered so it can’t replicate and cause disease.

Johnson & Johnson began Phase 3 clinical trials in September with a massive study that would test the shot in 60,000 volunteers in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. The trial was put on hold in early October as the company investigated an “unexplained illness” among one of the study’s participants, but was restarted just weeks later after the company reported finding no evidence that the vaccine had caused the volunteer to fall ill.

Health Canada is evaluating three other vaccine candidates as part of what it calls 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.

Canadians anxiously await vaccine approval

The question of 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 discuss 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.

Premiers want answers on vaccine delivery

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. Officials have said an estimated six million doses could arrive in the first three months of 2021.

But officials have provided little detail on exactly when those doses will arrive or how they will be distributed.

On Monday, Ontario Premier Doug Ford said he isn’t satisfied with the lack of information coming from the federal government and called on the prime minister to specify a delivery date for the province’s share of vaccines, adding that “the clock is ticking.”

Ford said he would speak directly to Pfizer on Monday afternoon to ask for details, but expected to be told the information must come from Ottawa.

Conservative Leader Erin O’Toole said the Liberals’ inability to specify a delivery timeline showed an “absence of leadership.”

Prime Minister Justin Trudeau has defended his government’s procurement plan, arguing that Canada has secured access to a wide variety of potential vaccines that provide the country with multiple options.


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