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, and say it hopes to start giving the shots next week.

Health Canada said the vaccine made by US drugmaker Pfizer and Germany’s BioNTech has received authorisation. The vaccine already has been authorised for use by the United Kingdom and Bahrain and officials have said they expect the US authorisation within days.

“This a momentous occasion,” Dr Supriya Sharma, chief medical advisor at Health Canada, said. “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 authorising and distributing a vaccine.”

Sharma said Canadians should feel comfortable getting the shot.

“The vaccine was authorised 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 officials expect to administer them next week after they are shipped from Belgium via UPS on Friday.

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

US 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 US, the highest toll of any country. US Food and Drug Administration scientists are meeting on today, 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 authorised in Canada. Following UK 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.

Vaccine Appears Safe

US FDA scientists reanalysed data and found the Pfizer vaccine appears safe and more than 90 per cent 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.

Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions for the time being shouldn’t receive vaccine 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 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 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.

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 three million Canadians between January and March with supply ramping up the rest of 2021.”