Health Canada has approved Paxlovid, Pfizer’s oral antiviral treatment for COVID-19 that has been touted as a way to ease pressure on health-care systems overburdened by rising case counts.
OTTAWA—Health Canada’s approval of Pfizer’s oral treatment for COVID-19 was hailed as “good news” by federal officials Monday, despite caveats that the drugs won’t blunt an Omicron-fuelled surge in cases due to limited initial supply.
Canada has so far received more than 30,000 courses of the treatment, called Paxlovid, with a further 120,000 courses expected to arrive by the end of March.
“Until now, the medications for treating COVID-19 we have authorized have to be given intravenously or by injection in a hospital or health-care setting. This is the first COVID-19 therapy that can be taken by patients at home, which is an important distinction,” Health Canada’s chief medical adviser, Dr. Supriya Sharma, told a news conference Monday.
The treatment, which must be prescribed, has been approved for adults with mild to moderate forms of the illness who are at high risk of developing more severe outcomes.
It can only be taken within five days of symptom onset for those who have received a positive test result confirmed by a health-care provider, meaning it cannot be used as a preventative measure before or after exposure to COVID-19. It also can’t be used as a starting point for treatment for those requiring hospitalization for severe COVID-19 cases.
Because safety and efficacy data was not submitted to Health Canada on the use of the drug in younger age groups, Paxlovid has not been approved for those under 18.
The treatment works by stopping the virus that causes COVID-19 from replicating itself and invading healthy cells. It’s a combination of the Pfizer antiviral nirmatrelvir and the antiretroviral ritonavir, a medication used to treat HIV.
Those receiving the treatment will need to take three tablets — two nirmatrelvir pills and one ritonavir pill — twice a day for five days.
Health Canada completed an accelerated review of the antiviral after first receiving an application for approval on Dec. 1. Most recently, the regulator has received clinical trial data from Pfizer conducted in unvaccinated, symptomatic, high-risk adults with COVID-19.
“The study showed that treatment with Paxlovid compared with no treatment reduces the risk of hospitalization and death caused by COVID-19 by 89 per cent when the medications were started within three days of the beginning of symptoms, and by 85 per cent when started within five days,” Sharma said.
Some health-care professionals have touted the medication as a way to ease pressure on hospitals and workers overburdened by soaring case counts.
But because people must start the treatment soon after exhibiting symptoms, it’s imperative that provinces and territories ramp up testing capacity, says Dr. Kevin Smith, president of Toronto’s University Health Network.
“It will be really important to kind of have a fast track between testing results and dispensing where appropriate,” Smith told the Star.
Conservative health critic Luc Berthold called on the government to “rectify the lack of available testing that is impacting provinces, communities, schools and workplaces’ ability to access the tools they need to manage COVID-19.”
Dr. Theresa Tam, Canada’s chief public health officer, acknowledged that meeting the necessary criteria to obtain the treatment would be “challenging.”
“Pay attention to the provinces when they announce who they’re going to be supporting initially,” Tam said, “and then follow the instructions that are provided, because each community is going to be a little different in terms of how they’re going to roll this out.”
While recent data confirms that Paxlovid is effective against the Omicron variant, Tam cautioned that due to limited supply, the treatment won’t immediately affect the virus’s trajectory in Canada.
“It will not be a key contributor to the current wave, so it is very much another layer, another tool as we progress over the next month,” Tam said.
Short supply of the medication has led to the government prioritizing who will first get the treatment when it is dispensed in Canada.
That includes some immunocompromised people who can’t mount an effective response to COVID-19 — regardless of vaccination status — and those over age 80 whose vaccinations are not up to date.
Those ages 60 and up who live in rural and remote communities, long-term-care settings or Indigenous communities whose vaccinations are not up to date will also be among the first to receive the treatment.
When asked about the decision to prioritize those without vaccinations, Tam said those populations were most at risk of developing serious illness and winding up in hospital.
“I think as health-care providers you don’t pick and choose which patients you have coming into the hospital or getting treated,” she said.
“We have to be careful when we talk about people who are unvaccinated,” Health Minister Jean-Yves Duclos said in French at a news conference.
“Some would like to be vaccinated but can’t find the time to go. Others would like to be vaccinated but would still like to … have more information. Other people are getting their information from misleading sources and other people are against vaccination as a whole.”
The federal government is currently hashing out its delivery schedule with the U.S. drugmaker, and is working with provinces and territories to dispense the treatment on a per-capita basis.
At Queen’s Park, Health Minister Christine Elliott’s office said the 10,000 courses of Paxlovid treatment earmarked for Ontario will go to 15 hospital systems across the province once delivery dates are confirmed.
About 6,000 courses have been set aside for Quebec, Duclos said.
The federal government has already signed a deal with Pfizer for one million courses of the treatment. A separate agreement was also inked 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.
Article From: The Star
Author: Raisa Patel
