Canada’s health regulator has approved Pfizer’s Covid-19 vaccine.
Health Canada posted on its website that the vaccine made by US drug manufacturer Pfizer and Germany’s BioNTech has been authorised.
Dr Supriya Sharma, chief medical advisor at Health Canada, said: “This is a critical milestone. Canadians can have confidence in our rigorous review process, and that the vaccine was only authorised only after a thorough assessment of the evidence demonstrated that it met Canada’s strict standards for safety, efficacy and quality.”
Health Canada said terms of the approval require the manufacturer to continue providing information on the safety, efficacy and quality of the vaccine.
Health Canada has authorized Pfizer-BioNTech’s #COVID19 vaccine. After a thorough and independent review of the evidence. Health Canada has determined that the vaccine meets its stringent safety, efficacy and quality requirements. https://t.co/mhFcspCpTi#COVIDvaccines pic.twitter.com/q6xkC27z6i
Advertisement— Health Canada and PHAC (@GovCanHealth) December 9, 2020
Canada is set to receive up to 249,000 doses this month and 4 million doses of the vaccine by March.
The UK began vaccinations with the shot made by Pfizer and BioNTech on Tuesday.
US regulators have also released their first scientific evaluation of Pfizer’s Covid-19 vaccine and confirmed it offers strong protection. Vaccines are emerging from an all-out worldwide race and are reaching the market less than a year after the virus was identified – a remarkable scientific achievement that shaved years off the usual process.
The encouraging developments come as coronavirus continues surging across much of the world. The virus has claimed more than 1.5 million lives.
US Food and Drug Administration scientists are meeting on Thursday, when the agency’s independent advisers will debate if the evidence is strong enough to recommend vaccinating millions of Americans.
Sean Marett, BioNTech’s chief business and chief commercial officer, said: “It is encouraging to see that our mRNA vaccine is now authorised in Canada. Following UK and Bahrain, it is the third country to approve use of our vaccine within a week.”
US FDA scientists reanalysed data and found the Pfizer vaccine appears safe and more than 90% effective across patients of different ages, races and underlying health conditions.
Health Canada said the vaccine is for use in people 16 years of age or older, but noted Pfizer-BioNTech are running further clinical trials on children of all age groups and that could change.
Canada recently amended the contract with Pfizer so that it would deliver up to 249,000 doses this month. That will mean about 124,500 of the highest risk Canadians will get vaccinated at first as two doses are required per person a few weeks apart.
Pfizer and BioNTech said it will supply a minimum of 20 million doses to Canada through 2021 and as many as 76 million.
Canada has contracts with six other vaccine makers as well.
The Canadian government has said 14 distribution centres will be located in large cities initially. There will be at least one in each province and two each in Canada’s four largest provinces.
“This is phenomenal news for all Canadians as we take the next step toward ending this pandemic. As soon as vaccines arrive on Ontario soil, we will be ready to deliver and administer them,” Ontario premier Doug Ford said in a tweet.
