Pfizer’s coronavirus vaccine is officially approved for use in Canada, with limited rollout set to begin to priority groups “within days” and vaccination of the general population anticipated to start in April.
Dr. Supriya Sharma, chief medical advisor with the regulatory branch of Health Canada, spoke with reporters in a press conference on Wednesday and said the approval marked a “momentous occasion.”
“It’s an exceptional day for Canada,” Sharma said.
“In a year where we haven’t had a lot of good news, this is a bit of good news. And I think we should take a moment to acknowledge that — and then we’re all going to get back to work.”
She stressed that while the approval process was quick, it has been as thorough as the approvals for any other drug seeking the green light for use in Canada.
“I would say to Canadians, we’ve authorized it. If it is their turn to get the vaccine, they absolutely should feel comfortable getting that,” she said, noting reactions observed so far have been “mild.”
“But we still do need to continue to monitor it, as we would any product.”
Health Canada announced its approval of the vaccine Wednesday after reviewing clinical trial data submitted by Pfizer and BioNTech, issuing the decision in a notice on its website.
The regulator emphasized there have been no serious safety concerns from the vaccine.
“The availability of a safe and effective vaccine will reduce the spread and severity of COVID-19 disease and reduce its social and economic consequences,” said Health Canada, adding the data confirms the vaccine is roughly 95 per cent effective, and was “well tolerated” with no serious safety concerns.
“The benefit to risk assessment for Pfizer-BioNTech COVID-19 Vaccine is considered favorable.”
Some of those side effects noted in the approval included pain at the injection site, body chills, a fever or feeling sluggish, and Sharma added Canadian officials are monitoring two allergic reactions reported in the U.K. in patients who have previously had allergic reactions to other things.
Sharma emphasized Pfizer will be required to carefully monitor any adverse reactions to its vaccine as it begins being rolled out in Canada, and to inform regulators of any such reactions.
Right now, she said the only people who should not get the vaccine are individuals who have had previous allergic reactions to any of the listed ingredients in the Pfizer vaccine.
Two individuals in the U.K. with previous histories of significant allergic reactions did experience allergic reactions to the vaccine as part of that country’s early rollout, which began earlier in the week.
Both are recovering.
Those under the age of 16 are also not yet approved to get the vaccine.
Government officials said on Wednesday that more study is needed on the efficacy of the vaccine in children under the age of 16 before the vaccine can be approved for use by them.
Clinical trial data has focused largely on measuring the vaccine’s efficacy in adults.
The approval comes as coronavirus cases surge across the country, and as officials prepare to roll out the first doses to roughly 124,500 Canadians working in front-line health care and long-term care.
The first vaccinations could begin as soon as next week.
Maj.-Gen. Dany Fortin, who is leading Canada’s vaccine distribution plans, said he expects Pfizer will ship the vaccines from Belgium on Friday and the doses could begin arriving on Monday or Tuesday.
“We expect vaccines to be shipped very soon – by the end of the week,” he said, noting those final details will become clearer over the next 36 hours as the shipping process gets underway.
Public health officials also said the goal is to shift from vaccinating priority populations to the general population beginning in April 2021, and to have that vaccination program wrapped by the end of 2021.
“We are running a marathon but now we can see the finish line,” said Dr. Howard Njoo, deputy chief public health officer in a press conference that outlined plans to start priority vaccinations “within days.”
In a statement, Pfizer said the regulator’s approval makes Canada the third country in the world to approve the vaccine, after the U.K. and Bahrain.
“Today’s decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada,” said Cole Pinnow, president of Pfizer Canada.
“We commend Health Canada for its careful and thorough assessment of our COVID-19 vaccine and timely action to help protect Canadians.”
Coronavirus infections are surging across the country, with many regions imposing new lockdown measures in a frantic bid to prevent hospitals from being overwhelmed.
Nearly 13,000 Canadians have died from the virus, which is highly contagious and whose vast range of symptoms are leaving some survivors with serious lasting effects that continue to puzzle scientists.
Health officials across Canada reported 5,977 new cases of the virus on Tuesday, as the national total of infections soars to more than 430,565.
More to come.