OTTAWA – Canada’s health minister said regulators are working hard to review data on a treatment for COVID-19 already in use in the United States and preparing in advance to get the pills to patients.
Several provincial premiers have called on the government to approve Paxlovid, a treatment for COVID-19 developed by Pfizer which has been shown to significantly reduce the risk of hospitalization for people provided they receive the drug within five days of their first symptoms.
A full treatment course of the drug runs for five days, with two pills taken each day.
Drug maker Merck has a similar drug called molnupiravir, which has also been shown to reduce hospitalizations, though not as significantly as Pfizer’s pill. Both companies stress their drug is not a substitute for vaccination, but say it can reduce the likelihood that someone who gets the virus will end up in hospital.
Health Minister Jean-Yves Duclos said the government’s regulators are reviewing all the information on the treatments and hope to have news soon.
“The Health Canada approval process is proceeding swiftly in an accelerated manner as has been the case for many other approval processes in the last 22 months,” he said.
The government has signed orders for one million courses of Pfizer’s pill and 500,000 of Merck’s with options in both cases for more pills. Duclos said he has been in touch with provincial health ministers about the pill to ensure they will be ready to use the pills to treat Canadians.
“I’ve had several discussions with provincial and territorial health colleagues within the last two weeks, making sure that when and if this treatment from Pfizer is approved, we are able to move swiftly to clinical use of that treatment across Canada.”
Dr. Supriya Sharma, Chief Medical Advisor at Health Canada, said the review on Pfizer’s drug is the closest to approval.
“We’re in the final stages of that review. I can’t commit to a specific time, but in the next week to 10 days is likely when we’ll have a decision on that one,” she said.
U.S. regulators approved Pfizer’s drug in late December. Sharma said Pfizer submitted information to Canadian regulators after it had given the information to American regulators and they are working as quickly as possible.
She said because the drug is brand new she doesn’t believe it would be available today even if an approval had been issued last month.
“Up until this point, even if we had had an authorization, it’s unlikely that we would have had a product that would have been able to be supplied to us anyway.”
Sharma said Merck’s drug, molnupiravir, could take longer to approve because of new information that has come forward on the drug.
“We got some initial data in and then follow up data from the clinical trials that didn’t show as high an effectiveness and then there’s also some safety issues that we’re still working through,” she said.
The government added more resources to Health Canada to review COVID vaccines and treatments and allowed companies to do rolling reviews of their products rather than submitting final data all at once.
Sharma said Health Canada still has more staff on hand to review new treatments and vaccines and to review the expansion of some existing vaccines for boosters or as pediatric doses.
“Those resources are all still in place and they’re still working flat out,” she said.
Conservative MP Luc Berthold, the party’s health critic, charged the Liberals are not doing enough to sure these drugs can be approved more quickly.
“It is crucial that the Liberal government uses all of the scientifically supported tools to fight the latest surge and protect our health care system,” he said in a statement. “For weeks, Canada’s Conservatives have been calling on the Liberal government to rapidly but effectively review these game-changing therapeutic treatments, obtain them, and promptly distribute them to Canadians.”
Two more vaccines are also pending approval with Health Canada, including one from Novavax and another from Canadian firm Medicago.
Novavax submitted all of their clinical trial information in November. Sharma said Health Canada has reviewed that information and is now working with the company on how the vaccine will be manufactured.
“It’s really primarily now working through some issues on the manufacturing and the quality measures that are in place to make sure that all of the vaccines that are manufactured are of high quality and meet the standards.”