Pfizer’s coronavirus vaccine is officially approved for use in Canada, with health officials hailing the move as a “critical milestone” in the fight to get the pandemic under control.
Health Canada has completed its review of the clinical data submitted by Pfizer and BioNTech and deemed the hotly awaited vaccine safe for use, the regulator announced in a notice on its website on Wednesday.
“The ongoing COVID-19 pandemic has a significant impact on public health. There is no vaccine authorized for the prevention of COVID-19 in Canada,” the regulator noted in its decision authorizing the use of 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.”
“The data provided supports favorably the efficacy of Pfizer-BioNTech COVID-19 Vaccine as well as its safety. The efficacy of the vaccine was established to be approximately 95 per cent, the vaccine was well tolerated by participants and has no important safety concerns.
“The benefit to risk assessment for Pfizer-BioNTech COVID-19 Vaccine is considered favorable.”
Dr. Supriya Sharma, chief medical advisor with the regulatory branch of Health Canada, spoke to reporters on Wednesday following the approval and said she wants to assure Canadians that although the approval process was quick, it was as thorough as approvals for any other drug.
“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.”
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.
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.
In a statement, Pfizer said the regulator’s approval makes Canada the third country in the world to approve the vaccine and that it can start shipping it as soon as it gets the green light that distribution networks are in place.
“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.
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