Canada Janssen seeks Health Canada approval for its COVID-19 vaccine

04:30  02 december  2020
04:30  02 december  2020 Source:   cbc.ca

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

Moderna Inc. is seeking emergency approval from the U.S. Food and Drug Administration to distribute their COVID - 19 vaccine .

a person taking a selfie: 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 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.

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

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.

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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 it was restarted just weeks later after the company reported finding no evidence that the vaccine had caused the volunteer to fall ill.

"Janssen is committed to bringing an affordable COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use," the company said in a statement.

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Pfizer Inc and BioNTech's COVID - 19 vaccine could be rolled out in Europe this month, the companies said on Tuesday after they applied for EU emergency approval for the shot. The application to the European Medicines Agency (EMA) comes days after the companies applied for emergency use of

Vaccine sorcery is underway folks, and you if don’t learn how to read vaccine literature right now, you are in for a rude awakening. Let’s face it, there’s a lot we don’t understand about novel Covid - 19 which is why a vaccine will NOT work. This virus is using the whole human body as a host to spread.

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, such as 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.

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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.

The European Medicines Agency — the regulator for the EU — will meet on Dec. 29 to consider data about the safety and efficacy of Pfizer's vaccine, and it could meet as early as Jan. 12 to consider Moderna's product.

At a technical briefing with reporters last week, Health Canada's chief medical adviser said Health Canada is on track to make a decision on timelines similar to those of the U.S. and European regulators.

"Canadians can be sure that whatever Canada approves, in terms of vaccines, will only be done when it's entirely safe to do so," Hajdu told reporters on Tuesday.

Premiers want answers on vaccine delivery

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. By securing doses from a variety of vaccine makers before they are approved, Ottawa says it is increasing the chances it will have priority access to a successful vaccine even if some on the list don't make it through clinical trials.

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Officials have said an estimated six million doses could arrive in the first three months of 2021, but they have provided little detail on exactly when those doses will arrive or how they will be distributed.

Ontario Premier Doug Ford said on Monday that 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 government's 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.

"Everyone wants to know when this is going to be over," Trudeau told CBC Radio's The Current on Tuesday. "What Canadians can know is we have the plan necessary to get through this, to get the vaccines here, to get the vaccines into people's arms, and we're going to do it with the provinces who have a high degree of expertise on this."

Trudeau said Health Canada is working with the same data as regulators in the U.S. but that Canada will make its own decision on when and if to approve a vaccine.

"It is so important that these vaccines be safe for Canadians, and we're not going to cut any corners on making sure that, when Health Canada gives the thumbs up, that this vaccine is safe to go and to release into the population, [that] people can know that it will indeed be safe," Trudeau said.

Last week, the federal government appointed Maj.-Gen. Dany Fortin, the current chief of staff to the Canadian Joint Operations Command and a former commander of the NATO mission in Iraq, to lead the national COVID-19 vaccine distribution effort.

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