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Canada’s health regulator approves Pfizer’s COVID-19 vaccine

Dr. Supriya Sharma is Health Canada's chief medical advisor
Health Canada’s chief medical advisor, Dr. Supriya Sharma, right, and Deputy Chief Public Health Officer Dr. Howard Njoo, center, look on as Maj. Gen. Dany Fortin holds up a device used in the transportation of a vaccine during a COVID-19 vaccine-related news conference in Ottawa on Wednesday, Dec. 9, 2020.
(Adrian Wyld / Canadian Press )

Canada’s health regulator approved Pfizer’s COVID-19 vaccine Wednesday, days ahead of possible approval in the United States, and said it hopes to start giving the shots next week.

The vaccine made by U.S. drugmaker Pfizer and Germany’s BioNTech already has been authorized for use by the United Kingdom and Bahrain, and officials have said they expect the U.S. authorization within days.

“This is a momentous occasion,” said Dr. Supriya Sharma, chief medical advisor at Health Canada. “The geek in me is amazed. 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 be authorizing and distributing a vaccine.”

Sharma said Canadians should feel comfortable getting the shot, which was “authorized only after a thorough assessment of the evidence demonstrated that it met Canada’s strict standards for safety, efficacy and quality.”

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Health Canada said the terms of the approval require the manufacturer to continue providing information on the vaccine.

Canada is set to receive up to 249,000 doses this month, and officials expect to start to administer 30,000 doses next week after an initial batch is shipped from Belgium on Friday.

Britain began vaccinations Tuesday.

U.S. regulators on Tuesday 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 about a year after the virus was 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 Thursday, when the agency’s independent advisors will debate whether 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, referring to the new type of messenger RNA vaccine involved.

In the 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 that could change. Pfizer and BioNTech are running further clinical trials on children of all age groups.

Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions shouldn’t receive the vaccine from Pfizer and BioNTech for the time being. Sharma said Health Canada is advising only people with allergies to the ingredients in the vaccine to avoid it, but said the agency will review information out of the U.K. and decide whether to expand that advice.

“The people that had the allergic reaction in the U.K. had histories 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; each person requires two doses that are administered 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 and is reviewing three other vaccines, including one by Moderna that Canadian health officials said could be approved soon.

Dr. Howard Njoo, Canada’s deputy chief public health officer, said officials plan to get initial shipments of the new vaccine to 14 sites across the country by next week.

“We have a reason to feel optimistic and excited about returning to the lives we had pre-COVID,” Njoo said.

“We anticipate having approved vaccines for 3 million Canadians between January and March with supply ramping up the rest of 2021.”

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.


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