Antivirals could be a game-changer in the event of a pandemic – and they could soon arrive in Canada

As a pandemic-weary country faces another wave of COVID-19 cases with a strained healthcare system, Health Canada is exploring new products that may offer some relief: antivirals.

Two such drugs are making their way through the maze of Health Canada’s approval process: Pfizer’s Paxlovid and Merck’s molnupiravir.

These antiviral treatments, which are prescribed by a doctor and given in pill form, are designed to help the body fight off the SARS-CoV-2 virus, reduce the symptoms of an infection and shorten the duration of illness.

While Merck has questioned the effectiveness of its product – molnupiravir is said to reduce hospitalizations or deaths by 30% – Paxlovid scored particularly high marks in testing.

This undated photo provided by Merck & Co. shows their antiviral drug molnupiravir. (Merck & Co via AP Photo)

After a study lasting several months, Pfizer reported in November that Paxlovid reduced the risk of hospitalization or death by 89% compared to a placebo in non-hospitalized high-risk adults with COVID-19.

Medical professionals here are now scrambling to get their hands on this product to ease the strain on hospitals and save lives.

Although Canada has some of the highest vaccination rates in the world – a development that has significantly reduced cases of serious illness – infections among unvaccinated cases and breakthroughs in those who have received two doses are still testing a system of health which is on the ropes after two years of the pandemic.

An effective and easy-to-self-administer pill at home could relieve some of that pressure and change the trajectory of the pandemic.

Dr. Zain Chagla is an associate professor at McMaster University and an infectious disease specialist who leads a pilot program delivering monoclonal antibodies at St. Joseph’s Healthcare in Hamilton, Ontario.

Chagla said therapeutics – especially ones like Paxlovid that can be given outside of a hospital – are “absolutely” a “game changer”.

“We know vaccines have an incredible role to play, but we need a back-up option,” Chagla told CBC News. “Therapeutics gives those most at risk the chance to stay out of the hospital and have a mild recovery like everyone else.”

Deployed correctly in the most vulnerable populations infected with COVID-19 — the unvaccinated, the immunocompromised, the elderly and people with comorbidities — treatments could reduce hospitalizations by up to 80%, Chagla said.

Fewer hospital admissions would leave more capacity in the healthcare system – which could end lockdowns, he said.

A ‘way’ out of lockdowns

“A lot of the real COVID hospitalizations are groups that you can select on paper and say, ‘If this person gets COVID, they’re going to be most at risk,'” he said.

“If you could tie them to testing, to therapy, if you could mitigate hospitalizations, that’s our way of living with that.”

Some US jurisdictions, such as Florida, have embraced therapeutics. Florida Governor Ron DeSantis has aggressively pushed monoclonal antibodies — which are given intravenously — as a treatment option.

In Canada, monoclonal antibody treatments are not readily available. Chagla, who launched Ontario’s first antibody clinic last fall, said he faced a series of hurdles.

“We are way behind on the implementation and it has been difficult,” he said. “I would have hoped this drug would be in our hands a few weeks ago when we were facing the worst hospitalizations we have ever experienced during the pandemic.

“We are facing a health care overload and the sooner we get it the better.”

Health Canada review ‘progressing rapidly’, minister says

Pfizer submitted data to the United States Food and Drug Administration for Emergency Use Authorization (EUA) on November 16. A month later, the company got the green light to roll out the product nationwide.

US President Joe Biden last week doubled the government’s order for the antiviral drug Pfizer from 10 million to 20 million treatments to be delivered in the coming months – a supply that could saving up to a million American lives, based on initial estimates.

US President Joe Biden listens to Pfizer CEO Albert Bourla talk about the Biden administration’s global COVID-19 vaccination efforts on June 10, 2021. (Patrick Semansky/AP Photo)

Pfizer, the New York-based pharmaceutical giant that has also developed a highly effective COVID-19 vaccine, began sending Paxlovid data to Health Canada regulators on Dec. 1.

Some sort of approval could come soon, Health Minister Jean-Yves Duclos told reporters on Wednesday.

“Health Canada’s approval process is moving quickly in an expedited fashion, as it has been for many other approval processes over the past 22 months,” Duclos said.

The country’s premiers, including Ontario’s Doug Ford, seem to be losing patience with Ottawa’s pace. During a call on Monday, the premiers urged Prime Minister Justin Trudeau to make the supply of antivirals a top priority.

Duclos says the message has been received.

Health Minister Jean-Yves Duclos said Health Canada’s review process is “moving rapidly.” (Adrian Wyld/The Canadian Press)

“I have had several discussions with provincial and territorial health colleagues over the past two weeks, to ensure that when and if this treatment from Pfizer is approved, we will be able to move quickly to clinical use. of this treatment across Canada,” he said. .

In early December, Canada placed an order for an initial quantity of one million treatments. Some of this supply will start arriving after the expected approval from Health Canada – how much remains to be seen.

Christina Antoniou, spokeswoman for Pfizer Canada, told CBC News that the company is “moving as quickly as possible in our efforts to get this treatment into the hands of patients.”

“Details on delivery times and quantity of products to be received will be shared upon approval,” she said.

A spokesman for Procurement Minister Filomena Tassi said the federal government expects deliveries “to begin soon after approval”.

Paxlovid supply could be a problem

One of the biggest sticking points for Canada and the world is manufacturing capacity. Nearly three weeks after FDA approval, products from Paxlovid and Merck are anything but plentiful south of the border.

Some small states received very small shipments. Wyoming has enough supply for less than 100 people.

After the Biden administration refused to enter into advance purchase agreements for antivirals last summer — when COVID-19 appeared to be under control — Pfizer produced just 120,000 treatments last year.

In an interview with CNBC on Thursday, Rick Bright, Biden’s former therapy adviser, acknowledged that the administration should have been much more “aggressive” in procuring the product and helping expand Pfizer’s production capacity.

He said Biden may now want to invoke the Defense Production Act, which gives the president the power to order the production and supply of goods and services.

“It’s an area where I wish I had done more sooner,” Bright said. “I wish we had accelerated the manufacturing of these antiviral drugs as they were in development.”

Now, with global interest in antivirals high as the Omicron variant takes its toll, Pfizer promises to produce 120 million treatments by the end of the year.

The company told investors late last month that it was undertaking a “massive network expansion” across 14 different sites to meet the insatiable demand for the pills.

“We leverage our extensive manufacturing and supply network for the production of Paxlovid. We are currently adding additional capacity and increasing further; as with our vaccine, we plan to use our strong manufacturing capabilities and extensive supplier network to rapidly scale up production,” said Antoniou, the Pfizer spokesperson.

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