Janssen seeks Health Canada approval for its COVID-19 vaccine

Janssen seeks Health Canada approval for its COVID-19 vaccine

A fourth firm has submitted its COVID-19 vaccine candidate for Well being Canada approval, Well being Minister Patty Hajdu mentioned Monday.

Hajdu known as the request for vaccine approval by Janssen Inc., a pharmaceutical subsidiary of U.S.-based multinational Johnson & Johnson, “a promising growth for Canadians.”

Ottawa introduced a deal with Janssen on Aug. 31 to safe as much as 38 million doses of the vaccine — which requires just one dose to supply immunity as an alternative of two.

Janssen’s vaccine is a non-replicating viral vector vaccine — primarily based on viral materials that has been genetically engineered so it cannot replicate and trigger illness.

Johnson & Johnson started Section three medical trials in September, with an enormous examine that will take a look at the shot in 60,000 volunteers in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.

The trial was placed on maintain in early October as the corporate investigated an “unexplained sickness” amongst one of many examine’s contributors, however it was restarted simply weeks later after the corporate reported discovering no proof that the vaccine had triggered the volunteer to fall sick.

“Janssen is dedicated to bringing an reasonably priced COVID-19 vaccine to the general public on a not-for-profit foundation for emergency pandemic use,” the corporate mentioned in an announcement. 

Well being Canada is evaluating three different vaccine candidates as a part of what it calls a “rolling evaluate course of” that enables corporations to submit knowledge from medical trials at the same time as these trials are nonetheless underway.

The regulator should approve a vaccine as protected and efficient earlier than it may be administered to Canadians. Well being Canada is at present evaluating vaccine candidates from U.S. pharmaceutical big Pfizer and its German associate BioNTech, from U.S. biotechnology firm Moderna and from British pharmaceutical agency AstraZeneca. 

Canadians anxiously await vaccine approval

The query of when a vaccine shall be permitted and distributed has change into the topic of intense speculation and debate in Canada, as different international locations, akin to the U.S., U.Okay. and Germany, have introduced plans to start distributing their vaccines in December.

Opposition politicians, some premiers and public well being specialists have criticized the Liberal authorities for falling behind different international locations in terms of approving vaccines and planning for his or her distribution.

Regardless of the criticism, none of these international locations has granted remaining approval for a vaccine as of but.

WATCH | Prime minister is requested about Johnson & Johnson’s new vaccine candidate:

Prime Minister Justin Trudeau spoke with the CBC’s Tom Parry on Tuesday. 2:10

The U.S. Meals and Drug Administration has scheduled a gathering for Dec. 10, throughout which unbiased public well being specialists will talk about whether or not to grant emergency-use approval to Pfizer’s vaccine. Moderna’s vaccine shall be thought of at an identical assembly one week after that.

The European Medicines Company — the regulator for the EU — will meet on Dec. 29 to contemplate knowledge concerning the security and efficacy of Pfizer’s vaccine, and it may meet as early as Jan. 12 to contemplate Moderna’s product.

At a technical briefing with reporters final week, Well being Canada’s chief medical adviser mentioned Well being Canada is on monitor to decide on timelines much like these of the U.S. and European regulators.

“Canadians can make certain that no matter Canada approves, when it comes to vaccines, will solely be carried out when it is fully protected to take action,” Hajdu informed reporters on Tuesday.

Premiers need solutions on vaccine supply 

The federal authorities has secured agreements with seven corporations for as much as 429 million doses — probably the most per capita of any nation on the planet, based on research from Duke University’s Global Health Institute. By securing doses from a wide range of vaccine makers earlier than they’re permitted, Ottawa says it’s growing the probabilities it can have precedence entry to a profitable vaccine even when some on the listing do not make it by way of medical trials.

Officers have mentioned an estimated six million doses could arrive in the first three months of 2021, however they’ve supplied little element on precisely when these doses will arrive or how they are going to be distributed.

Ontario Premier Doug Ford mentioned on Monday that he is not glad with the lack of awareness coming from the federal authorities and known as on the prime minister to specify a supply date for the province’s share of vaccines, including that “the clock is ticking.”

Ford mentioned he would converse on to Pfizer on Monday afternoon to ask for particulars however anticipated to be informed the data should come from Ottawa.

Conservative Chief Erin O’Toole mentioned the federal government’s incapability to specify a supply timeline confirmed an “absence of management.”

Prime Minister Justin Trudeau has defended his government’s procurement plan, arguing that Canada has secured entry to all kinds of potential vaccines that present the nation with a number of choices.

LISTEN | Trudeau speaks to Matt Galloway on CBC Radio’s The Present:

The Present13:17Justin Trudeau on the price of combating the pandemic

After yesterday’s fiscal replace, Prime Minister Justin Trudeau joins Matt Galloway to debate the price of combating COVID-19, and the way his authorities plans to roll out the vaccines that might lastly subdue the pandemic. 13:17

“Everybody needs to know when that is going to be over,” Trudeau informed CBC Radio’s The Current on Tuesday. “What Canadians can know is now we have the plan essential to get by way of this, to get the vaccines right here, to get the vaccines into individuals’s arms, and we will do it with the provinces who’ve a excessive diploma of experience on this.”

Trudeau mentioned Well being Canada is working with the identical knowledge as regulators within the U.S. however that Canada will make its personal choice on when and if to approve a vaccine.

“It’s so essential that these vaccines be protected for Canadians, and we’re not going to chop any corners on ensuring that, when Well being Canada offers the thumbs up, that this vaccine is protected to go and to launch into the inhabitants, [that] individuals can know that it’s going to certainly be protected,” Trudeau mentioned.

Final week, the federal authorities appointed Maj.-Gen. Dany Fortin, the present chief of workers to the Canadian Joint Operations Command and a former commander of the NATO mission in Iraq, to steer the nationwide COVID-19 vaccine distribution effort.

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