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Health Canada 7-10 days after decision on antiviral drug Pfizer

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OTTAWA – Health Canada is expected to be ready to make an authorization decision on Pfizer’s Paxlovid antiviral treatment for COVID-19 within a week to 10 days, Chief Medical Advisor Dr. Supriya Sharma said Thursday.

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But it’s still unclear when shipments will start or how much Canada will get early on, as supply issues for the US-made drug have made it incredibly difficult to get even in the US, where it has been cleared. before Christmas.

Canadian health leaders and some prime ministers have publicly pressured Health Canada to give the green light to the drug, which prevents the SARS-CoV-2 virus that causes COVID-19 to reproduce in the body. ‘a patient. Pfizer’s clinical trial showed for high-risk patients it prevented hospitalizations by about 90 percent.

The results were so good that Pfizer ended the trial earlier to start getting the drug approved and distributing it more widely. It applied to the United States Food and Drug Administration on November 22 and to Health Canada on December 1.

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The United States cleared it for use in patients 12 years of age or older three weeks ago. The UK approved it on December 31.

But Sharma told The Canadian Press in an interview Thursday that the Canadian submission was incomplete and that further data arrived the last week of December and again earlier this week.

“So maybe in the week to 10 days, or so, we should have a decision,” she said.

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But Sharma pushes back people who have publicly criticized Health Canada for taking too long.

“It might be a little blunt, but the people making these comments generally have no regulatory experience and either don’t have access to or are unfamiliar with the back and forth we are doing with the company.” , she said. noted.

She added that Canada has also tried to get Pfizer to ship certain courses of the drug before approval by using a regulation that allows drugs approved elsewhere to be used in Canada when there is an urgent health need. .

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“Basically they said they weren’t able to do it, they didn’t have a supply,” she said.

Sharma said that even if Health Canada had obtained all the data it needed three weeks ago, “we probably couldn’t have had any for Canada either.”

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The United States has ordered more than 20 million courses of the drug and was due to obtain four million in January, but US media reports that access to Paxlovid is currently nearly impossible in most of the country.

Canada said last fall it had purchased a million treatment courses.

Pfizer Canada spokeswoman Christina Antoniou said information on Canadian shipments will not be available until Health Canada clears it. She did not specifically confirm that supply issues were preventing Pfizer from making earlier shipments under the Urgent Public Health Needs regulations.

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“During our discussions, we jointly determined that the most effective way to achieve this was through the continuous submission process which is currently underway,” she said.

Kevin Smith, CEO of the University Health Network in Toronto, made Paxlovid’s approval requests public in early January, calling it a “critical addition” to hospital needs.

Although he said he was following Health Canada’s regulatory process, he finds it difficult to understand why the US and UK approved the drugs much faster than Canada.

“My problem is, at the moment, the perception of the clinical community which is struggling, enormously, is that we do not have approval for this drug,” he said in an interview, adding that ” Pfizer chooses not to supply Canada is a different issue and one that I think we would all gladly defend.

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“We would love to help put pressure on Pfizer to make sure we get this drug as soon as possible. “

A second antiviral drug from Merck faces a potentially more turbulent race to approval in Canada. The company filed an application in August for Molnupiravir after initial results suggested it was cutting hospitalizations for high-risk patients by about 50%.

The end results reduced this effectiveness to just 30% and the side effects are also of greater concern, Sharma said.

“It’s a little more complicated,” she said. “So we’re moving forward with that, we’ve requested additional data from the company and we’re basically going to be working on this review. We don’t have a specific timeline for this.

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