The approval comes as Canada grapples with an Omicron-fueled surge of COVID-19 cases, with over 360,000 cases of the variant confirmed across the country so far, though that’s considered to be an underestimate.
As Canada stares down an expected jump in hospitalizations, the newly-approved pills could play “an important role” in the fight against the disease, said Chief Public Health Officer Dr. Teresa Tam.
“It will…potentially blunt the severity of the illness, which is the key goal.”
In clinical trial data submitted to Health Canada, the drug was found to reduce risk of hospitalization and death by 89 per cent, according to Dr. Supriya Sharma, the chief medical adviser.
Here’s what you need to know about the new medication.
How do you actually get the treatment?
To access this treatment, you have to be 18 or older and have tested positive for COVID-19. However, that’s easier said than done in some provinces these days, as testing capacity has been reduced due to Omicron.
Because the COVID-19 infection “must be confirmed” to start treatment — and treatment has to start within five days of your first symptoms — Tam said that “rapid antigen tests may be used” in the cases where PCR testing can’t be done in time.
Once your COVID-19 infection is confirmed, you will have to determine whether you’re eligible for the treatment. Due to a “limited global supply” of Paxlovid, according to Tam, health officials have prioritized certain at-risk groups to get the first shipment of the medication.
- Those who are moderately to severely immunocompromised and “not expected to mount an adequate response” to COVID infection “regardless of vaccine status.”
- Individuals over 80 years old “whose vaccinations are not up to date.”
- Individuals over 60 years old who live in “underserved rural or remote communities” in a “long-term care setting” or those living in or from First Nations or Metis communities “whose vaccinations are not up to date”
“We know that the unvaccinated are at higher risk of getting severe outcomes and getting hospitalized and ending up in the ICU. So this is the evidence, and we’re following that evidence,” she told reporters on Monday.
“As health care providers, you don’t pick and choose which patients you have coming into the hospital and getting treated. And so I think this approach ensures that we are prioritizing treatments for those most in need.”
The criteria are based on “a scientific and rational use” of the drug in conjunction with current supply levels, said Tam.
In December, the government signed a deal with Pfizer for one million treatment courses of Paxlovid. Tam said they are “are working to firm up a delivery schedule” and aim to get the drug into Canada “as quickly as possible.”
Canada has already received an initial shipment of 30,400 treatment courses, Procurement Minister Filomena Tassi said on Monday, and 120,000 more are expected to be delivered between now and the end of March.
What does the treatment look like?
Paxlovid is comprised of two antiviral medicines which are packaged together, according to the government’s website. Those two drugs are nirmatrelvir and ritonavir, and taken together, the website says they “stop the virus from multiplying.”
“This can help your body to overcome the virus infection and may help you get better faster,” Health Canada said.
A single pink tablet of nirmatrelvir is 150mg, while one white table of ritonavir is 100 mg. Each carton of the treatment contains five cards, each containing six tablets — four of the pink ones, and two of the white ones.
An adult will generally take two of the pink nirmatrelvir tablets and one white ritonavir tablet at the same time, twice per day — once in the morning and again in the evening. You’ll have to repeat this daily for five days in total, says Health Canada.
You have to take the tablets whole, without crushing or chewing them, the website said, and must talk to your healthcare professional if you want to stop taking them before the five-day course is finished, or if you don’t feel any better after five days.
What are the side effects and risks?
Like any other medication, Health Canada’s Dr. Sharma said, Paxlovid carries “some risks.”
“Paxlovid is a prescription medication. It has the potential to interact with a number of other commonly used drugs in ways that can decrease drug effectiveness or in some cases, cause potentially serious effects,” she said.
“As with any prescription medication, patients need to discuss the risks and benefits of treatment with the health care provider who is aware of their health conditions.”
Health Canada’s webpage explicitly highlights the risks for patients with kidney problems, liver problems, HIV, or hepatitis. They should tell their healthcare professional about their condition before taking Paxlovid. The page also details a list of medications that “interact” with the treatment.”
Pregnant women “should not take Paxlovid” without their healthcare professional’s permission, it added, and the treatment “may affect how birth control pills, patches and vaginal rings work.”
As for side effects, Health Canada warns that they might include, but are not limited to an altered sense of taste, diarrhea, muscle pain, vomiting, high blood pressure, and headache.
“Paxlovid is still being studied, so it is possible that all the side effects are not known at this time,” Health Canada added.
What does this mean for the fight against COVID-19?
Overall, the announcement of Paxlovid’s approval is being heralded as good news.
“In addition to vaccines, these treatments can save lives,” said Tassi, calling the approval of Paxlovid “welcome news.”
“It marks another important milestone in Canada’s fight against COVID-19.”
Dr. Brian Conway, medical director of the Vancouver Infectious Diseases Centre, told Global News Paxlovid can help reduce COVID-19 hospitalizations.
“It really is aimed at those who are not being hospitalized but have a significant risk of being hospitalized because of certain issues in themselves or in their disease,” he said.
Dr. Isaac Bogoch, an infectious disease specialist at Toronto General Hospital, agrees.
“Obviously, we’re going to have a limited supply upfront because there’s limited global supply,” he said.
“But I think we can really prioritize those who are at greatest risk with this medication, and it will do a lot of good.”
— with files from Global News’ Aaron D’Andrea