Canada’s Health Regulator Approves Pfizer’s COVID-19 Vaccine

TORONTO (AP) — Canada’s health regulator on Wednesday approved Pfizer’s COVID-19 vaccine, days ahead of possible approval in the United States.

Health Canada posted on its website that the vaccine made by U.S. drugmaker Pfizer and Germany’s BioNTech is authorized. The vaccine already has been approved by the United Kingdom and Bahrain and officials have said they expect U.S. approval within days.

“This a momentous occasion. I mean the geek in me is amazed,” Dr. Supriya Sharma, chief medical advisor at Health Canada, said. “No one would have thought, even when we looked back at the first discovery of the virus, that less than a year later we would authorizing and distributing a vaccine.”

Sharma called it an exceptional day for Canada.

“Canadians can have confidence in our rigorous review process, and that the vaccine was only authorized only after a thorough assessment of the evidence demonstrated that it met Canada’s strict standards for safety, efficacy, and quality,” she said.

Health Canada said the terms of the approval require the manufacturer to continue providing information on the safety, efficacy, and quality of the vaccine.

Canada is set to receive up to 249,000 doses this month and Canadian officials expect to administer them within days.

Britain on Tuesday began vaccinations with the shot made by Pfizer and BioNTech.

U.S. regulators on Tuesday 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 even identified — a remarkable scientific achievement that shaved years off the usual process.

The encouraging developments come as the coronavirus continues surging across much of the world. The scourge has claimed more than 1.5 million lives, including over 285,000 in the U.S., the highest toll of any country. U.S. 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.

“It is encouraging to see that our mRNA vaccine is now authorized in Canada. Following U.K. and Bahrain, it is the third country to approve use of our vaccine within a week,” said Sean Marett, BioNTech’s chief business and chief commercial officer.

U.S. FDA scientists reanalyzed 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.

Asked how Health Canada beat the U.S. FDA, Sharma smiled and said. “We’re just better,” she joked.

“We’re not in a race with any other regulator.”

Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions shouldn’t receive vaccines from Pfizer and BioNTech. Sharma said Health Canada is only advising people with allergies to the ingredients in the vaccine to avoid it but said they’ll review info out of UK and decide on whether to expand that advice.

“The people that had the allergic reaction in the U.K. had other a history of severe allergic reactions,” she said. “At this point in time, we are not changing our recommendation.”

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 is currently reviewing three other vaccines including one by Moderna that Canadian health officials said could be approved soon.

The government has said 14 distribution centers will be located in large Canadian 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.