OTTAWA—As Canada confronts climbing COVID-19 case counts, rising hospitalizations and worker shortages, there’s one measure some experts say could stave off a worsening crisis: emergency approval of Pfizer’s oral antiviral pill.
The drug, known as Paxlovid, was approved in the United States and South Korea for emergency use in late December. Several days later, regulators in the United Kingdom also gave the treatment a green light after completing a “rigorous” review of its effectiveness. Israel recently became one of the first nations to dispense the pills, shortly after giving it the thumbs up.
But in this country, the drug is still awaiting approval.
Health Canada received an application for the antiviral on Dec. 1, but told the Star that while all COVID-19 submissions are processed on an expedited timeline, the regulator is not planning to further accelerate its ongoing review. Regular approval of drugs in Canada can take anywhere from several months to two years.
“Health Canada will only authorize the use of anti-viral treatments if the independent and thorough scientific review of all the data included in the submissions show that the benefits of the treatments outweigh the potential risks,” the statement read.
Paxlovid primarily works by stopping the virus that causes COVID-19 from replicating itself and invading healthy cells. The drug is a combination of the Pfizer antiviral Nirmatrelvir and the antiretroviral Ritonavir, a medication used to treat HIV.
While it’s up to Health Canada, and not politicians, to determine how quickly a treatment is reviewed, Health Minister Jean-Yves Duclos said Friday that a decision could be coming soon.
“I will have more to say about (antiviral drugs) and about Health Canada’s approval process in the coming weeks,” Duclos told reporters at a news conference.
That time frame is simply not fast enough, says Dr. Kevin Smith, president of Toronto’s University Health Network.
“We’re projecting that this wave will peak early in February. We obviously needed access to this drug yesterday,” Smith told the Star.
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“It is just part of the arsenal of addressing Omicron. I don’t want Canada to be disadvantaged relative to our American, British, Korean and other colleagues who are safely using the drug and bending the curve of hospitalization and serious illness.”
An interim analysis of Pfizer clinical trial data for non-hospitalized adults with COVID-19 found that the drug was 89 per cent effective at reducing hospitalizations and deaths compared to patients who received a placebo.
Canada has already inked a deal with the U.S. drugmaker for 1 million courses of the treatment. The federal government has also signed a separate agreement with Merck for up to 500,000 courses of its oral treatment, Molnupiravir, with options for up to 500,000 more courses of the yet-to-be approved drug. The U.S. Food and Drug Administration last month gave emergency approval to Molnupiravir.
Paxlovid works best in people with mild to moderate symptoms in the early stages of COVID infection.
“If you’re vaccinated, and you’re following the public health measures, and you still happen to get this disease — which is easy to do these days — and you at the first sign of symptoms take this drug, the likelihood is you’re going to stay home for five days, take your pills and at the end of that, be fine and be able to rejoin civil society,” Smith said.
He said the drug would get essential workers back on the job more quickly and reduce pressure on the health-care system.
Smith is now calling for greater transparency from the federal government to learn what is causing the delay, given the drug’s approvals in other jurisdictions.
“What is it that you still need that the United Kingdom and the United States didn’t require?” Smith said.
“We’re asking people to leave their normal job positions and go into new job roles that they haven’t done historically, in order to care for all of these patients who are coming in with COVID … that’s about as close to emergency use as I can think of.”
Health Canada did not respond to the Star’s request regarding what data is still required to complete the review.
Raisa Patel is an Ottawa-based reporter covering federal politics for the Star. Follow her on Twitter: @R_SPatel
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