Health Canada approves Pfizer antiviral COVID-19 pill

Health Canada has approved Pfizer’s antiviral pill treatment for COVID-19.

The authorization posted to the Health Canada website Monday morning says the treatment is greenlighted for adult patients with mild or moderate COVID-19 who are also at high risk of becoming more seriously ill.

But limited supplies mean the Public Health Agency of Canada is asking provinces and territories to prioritize the treatment for people at most risk of serious illness, including severely immune-compromised patients and some unvaccinated people over the age of 60.

“Canadians should be very happy today to hear that the oral antivirals are beginning to become available in Canada,” chief public health officer Dr. Theresa Tam said at a virtual briefing Monday.

Health Canada did not authorize it for use on teenagers or patients who are already hospitalized because of COVID-19.

The pill will be available by prescription only and has shown 89% effectiveness in preventing hospitalization and death.
The approval has been posted to the Health Canada website #cdnpoli https://t.co/BNRunqtHMo

— Cormac Mac Sweeney (@cmaconthehill) January 17, 2022

The medication is the first oral COVID-19 treatment that can be taken at home but Tam admitted there may be some logistical challenges getting the drug to the right people quickly enough.

It must be given within five days of infection and involves taking three pills of two different drugs, twice a day, for five days.

Paxlovid is a treatment that uses a combination of drugs to prevent the virus that causes COVID-19 from replicating once it has infected a person.

Separate laboratory testing has also shown the drug retains its potency against the Omicron variant, the company added.

Clinical trials showed the treatment, which helps prevent the SARS-CoV-2 virus from reproducing in an infected patient, was almost 90 per cent effective at reducing hospitalization and death in high-risk patients if given within three days of infection, and 85 per cent if given within five days.

Health Canada chief medical adviser Dr. Supriya Sharma said no medications come with zero risk but that Paxlovid meets the “safety, efficacy and quality data standards” set by Health Canada.

“The authorization today provides a new tool in the tool kit against COVID-19 at a crucial time in the pandemic as we’re faced with new variants,” Sharma said. 

Doctors in Canada have been anxious to get access to Paxlovid as the Omicron wave is proving to be the most infectious one in the COVID-19 pandemic to date. But the authorization is likely the easy part of the puzzle.

Supply issues will constrain its use for weeks, if not months to come. The company expects to produce 120 million courses of Paxlovid by the end of this year, including 30 million by the end of June. But supply constraints are limiting its use everywhere, including in the United States where it was approved almost four weeks ago.

Canada has purchased one million courses for delivery in 2022.

Pfizer spokeswoman Christina Antoniou told The Canadian Press there were doses shipped already which can be distributed immediately.

That pre-approval shipment included 30,400 courses. Procurement Minister Filomena Tassi said another 120,000 will be shipped by the end of March.

The federal government has preemptively placed an order for one million courses of the oral antiviral treatment. Pfizer submitted a rolling submission for authorization to Health Canada in December.

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Alexandra Hilkene, a spokeswoman for Ontario Health Minister Christine Elliott, said in a written statement that Ontario expects to receive 10,000 doses this month, and will make them available at 15 sites across the province.

“Ontario welcomes the news that Health Canada has approved Pfizer’s antiviral, Paxlovid,” Hilkene said in an email. “We expect to receive approximately 10,000 courses of treatment from the federal government in January with details on the timing of shipments to be confirmed.”

Canada has also placed an order for a similar pill from pharmaceutical company Merck, though that drug has not yet been approved for use.

Trials for Merck’s COVID-19 drug late last year showed that treatment is able to reduce hospitalizations and deaths by 30 per cent in high-risk adults. Merck announced in December it had signed a deal to make its drug in Canada.

Shortly before that announcement was made, the U.S. Food and Drug Administration came out with its analysis of Merck’s experimental pill, saying it is effective against the coronavirus responsible for COVID-19, but that some questions remained about its safety.

New pills to fight COVID-19 may be a game-changer in the pandemic and could ease pressure on the healthcare system, which has once again seen immense strain due to the latest wave.

It’s unclear when exactly Canadians will have access to Paxlovid.

With files from Cormac Mac Sweeney of CityNews