Paxlovid, Pfizer’s oral COVID-19 pill, approved in Canada – National | Globalnews.ca

Pfizer’s Paxlovid COVID-19 antiviral pill has been approved for use in Canada.

Health Canada announced Monday it has approved Pfizer’s pill for use in the fight against COVID-19. The regulator posted on its website that the drug has received authorization.

Paxlovid has been approved for use in adults 18 and older who are positive for COVID-19 and are experiencing mild or moderate illness, or who are at high risk of becoming more seriously ill, Health Canada said.

The drug is intended for use as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms, Health Canada added. The pill, which has to be prescribed, is the first COVID-19 treatment approved for at-home use in Canada.

Paxlovid should not be used to prevent infection or to treat patients who are already hospitalized due to severe or critical COVID-19, nor should it be taken for longer than five days in a row.

“COVID-19 treatments, along with vaccinations and public health measures, are essential to save lives, reduce illness and lessen the burden on our health care facilities,” said Dr. Theresa Tam, Canada’s chief public health officer.

“Today’s announcement is particularly important as access to easy-to-use treatments could help to reduce the severity of COVID-19 in adults who become newly infected and are at high risk of progressing to serious illness.”

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Last month, the federal government announced it signed a purchase agreement with Pfizer to buy up to one million courses of its treatment, pending regulatory approval. Officials also announced a purchase agreement with Merck, maker of oral treatment Molnupiravir, to buy up to 500,000 courses of its treatment, with an option to add 500,000 more pending approval.

A Pfizer spokesperson told Global News the company is ready to start delivery in Canada immediately. Some supply is already in the country and will be distributed this week, however, it is limited at this time.

Tam said federal officials are working to firm up a delivery schedule. She said provinces and territories will manage distribution.

Until more Paxlovid pills make it into Canada, the Public Health Agency of Canada has offered suggestions about how to best use or triage the current supply. It currently recommends prioritizing the pill for people who are at the highest risk for severe illness and hospitalization, such as the immunocompromised.

The current supply should also be prioritized in rural and remote communities.

“This first treatment that is taken orally and can be taken at home will be in high demand,” Tam said.

“There are mechanisms being set up right now to make sure that individuals in these high-risk groups, for example, clinicians looking after those who are moderately or severely immunocompromised, are getting themselves ready to respond to the needs of that group and those in long-term care and other places as well.”

Pfizer began a rolling submission with Health Canada in December for Paxlovid, which it said is designed to block a key enzyme needed for the COVID-19 virus to multiply.

The full results of Pfizer’s 2,250-person study found the drug reduced combined hospitalizations and deaths by about 89 per cent among high-risk adults when taken shortly after initial COVID-19 symptoms.

Pfizer added on Dec. 14 its COVID-19 pill appeared to be effective against the Omicron variant.

Separate laboratory testing also showed that the drug still works when it faces off against the Omicron variant, according to Pfizer.

The pill has also been approved for use in the United States by the U.S. Food and Drug Administration.

Before Monday’s announcement, the government had approved four COVID-19 treatments. Unlike Pfizer’s pill, all of them have to be given intravenously.

The government hinted in recent weeks that a decision on approving oral COVID-19 treatments would be made in the coming days.

In November, Pfizer announced it signed a deal with a U.N.-backed group to allow other manufacturers to make its COVID-19 pill, potentially making it available to more than half of the global population.

Last month, Merck announced it would be partnering with a pharmaceutical company in Ontario to make its antiviral pill in Canada.

Merck said that Thermo Fisher has been making Molnupiravir for distribution in Canada and the United Kingdom, as well as for European, Asian Pacific and Latin American countries, pending approvals in those regions.

Molnupiravir has shown to be effective at reducing hospitalizations and deaths in high-risk individuals by around 30 per cent. It is still under Health Canada review.

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Merck Canada announces its antiviral COVID-19 treatment will be manufactured in Ontario

Cardiologist and epidemiologist Dr. Christopher Labos previously told Global News that antiviral pills could potentially limit the strain of COVID-19 on Canada’s health-care system by reducing the effects of the virus, but they don’t “prevent the problem.”

“It just treats the problem,” he said. “In terms of preventing outbreaks, vaccines are clearly the better course of action.”

— with files from Eric Stober

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