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A nurse at the Royal Cornwall Hospital in Truro, England, prepares to administer COVID-19 vaccinations. Britain has approved the Pfizer-BioNTech vaccine, as has Canada.

Hugh Hastings/Getty Images

Health Canada has approved its first vaccine for COVID-19, making Canada just the third country to approve a fully tested shot and providing hope in a battle against a virus that has killed more than 1.5 million people during the worst pandemic in a century.

The Canadian regulator announced Wednesday that it has authorized a two-dose vaccine made by U.S.-based Pfizer Inc. and the German company BioNTech, firing the starting pistol on the most ambitious and complex immunization campaign in this country’s history.

“It’s monumental. It really is. A vaccine just has the potential to do so much good for Canada,” said Isaac Bogoch, an infectious-diseases physician at Toronto’s University Health Network and a member of Ontario’s vaccine distribution task force. “I feel like I’m at a loss for words when I think about it.”

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The federal government expects to receive enough vaccines to cover everyone in Canada by September, 2021. Priority groups will begin getting their shots within days and the general population will get access starting in April.

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Still, many challenges lie ahead, including distributing vials to the far corners of a vast country, ensuring recipients return for their second doses, and winning over Canadians who are nervous about taking a vaccine made with new technology.

The approval is a “big deal,” Prime Minister Justin Trudeau said.

“We will see 30,000 vaccines begin to arrive next week with many more on the horizon, but we are not through this yet,” he told the House of Commons on Wednesday. “We’ve got a tough winter to get through and I know we’re going to be able to get through it together.”

The initial doses of the Pfizer-BioNTech vaccine could be injected into the upper arms of Canadians as early as Tuesday, with hospital and nursing-home staff at the front of the line.

Some provinces have already revealed how they will deploy their first shots. The Alberta government will use its early batch of vaccines to inoculate doctors, nurses, respiratory therapists and long-term care workers in Edmonton and Calgary, with the first shots beginning next Wednesday.

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British Columbia plans to start distributing its first delivery of 3,900 doses next week to workers in long-term care and hospitals through two Lower Mainland clinics.

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Saskatchewan intends to launch a pilot program to immunize 1,950 health care workers in Regina beginning Tuesday, while Manitoba plans to start by immunizing 900 staff in the province’s four critical-care units.

Other provinces, including Ontario, have yet to share detailed plans for the first injections.

Quebec hopes to start with residents of the province’s virus-ravaged nursing homes, but that depends on the logistics of transporting a vaccine that has to be stored at -70 C, an ultra-cold temperature usually reserved for freezers at research laboratories. Pfizer has asked provincial governments to begin with recipients who are able to get to 14 “point-of-use” sites across the country, places equipped with ultra-low temperature freezers.

Mr. Trudeau revealed Monday that Pfizer has agreed to ship as many as 249,000 doses of its COVID-19 vaccine to Canada by the end of December, earlier than the federal government’s previously stated goal of January. Massachusetts-based Moderna Inc. – another vaccine-maker whose COVID-19 shot is on track for a December authorization from Health Canada – has also said that it could begin shipping doses this month.

canada’s COVID-19 Immunization Plan

The federal government expects to receive enough

doses to cover all Canadians by September 2021.

Percentage

of Canadian

population

able to be vaccinated

Number

of Canadians

able to be

vaccinated

2020 Q4

125,000

>1%

2021 Q1

3 million

8%

Vaccinations

will start

for general

population

in April 2021

2021 Q2

15-19 million

40-50%

2021 Q3

100%

38 million

Note: Information is based on regulatory approval and

anticipated delivery schedules of vaccine supply.

JOHN SOPINSKI/THE GLOBE AND MAIL,

SOURCE: PUBLIC HEALTH AGENCY of CANADA

canada’s COVID-19 Immunization Plan

The federal government expects to receive enough

doses to cover all Canadians by September 2021.

2020 Q4

2021 Q1

2021 Q2

2021 Q3

Number

of Canadians

able to be

vaccinated

15-19 million

125,000

3 million

38 million

Percentage

of Canadian

population

able to be

vaccinated

100%

>1%

8%

40-50%

Vaccinations will start for general population in April 2021

Note: Information is based on regulatory approval and anticipated delivery schedules of vaccine supply.

JOHN SOPINSKI/THE GLOBE AND MAIL,

SOURCE: PUBLIC HEALTH AGENCY of CANADA

canada’s COVID-19 Immunization Plan

The federal government expects to receive enough doses

to cover all Canadians by September 2021.

2020 Q4

2021 Q1

2021 Q2

2021 Q3

Number

of Canadians

able to be

vaccinated

125,000

3 million

15-19 million

38 million

Percentage

of Canadian

population

able to be

vaccinated

>1%

8%

40-50%

100%

Vaccinations will start for general population in April 2021

Note: Information is based on regulatory approval and anticipated delivery schedules of vaccine supply.

JOHN SOPINSKI/THE GLOBE AND MAIL, SOURCE: PUBLIC HEALTH AGENCY of CANADA

The vaccines will arrive at a bleak time in Canada’s fight against SARS-CoV-2, the virus that causes COVID-19.

National case count records are being smashed daily, as the number of infected individuals admitted to hospitals and intensive-care units approaches levels not seen since the height of the first wave. An average of 94 Canadians died of COVID-19 every day in the past week, according to the Public Health Agency of Canada. More than 12,800 Canadians have died of COVID-19 since the pandemic began.

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Pfizer and BioNTech reported in mid-November that their vaccine candidate was 95 per cent efficacious in a late-stage clinical trial involving about 43,000 people. There were 170 confirmed cases of COVID-19 in the trial, 162 in participants who received a placebo and eight in people who received the vaccine.

Science reporter Ivan Semeniuk outlines how Canada benefited from researchers working in parallel and accelerated the approval process to have a safe COVID-19 vaccine ready so quickly.

No serious safety issues emerged during the trial, but many of the vaccine recipients experienced a day or two of pain at the injection site, headaches, fevers, chills and fatigue, the companies said.

Canada is the third country after Bahrain and Britain to approve Pfizer’s vaccine.

Cole Pinnow, the president of Pfizer Canada, said the drugmaker’s chairman and chief executive officer, Albert Bourla, reached out to Mr. Trudeau in a letter in March laying out how the company hoped to help tame the pandemic, including by pursuing a vaccine.

“We had a call with Health Canada two days later,” Mr. Pinnow said.

Margaret Keenan, 90, is applauded by staff as she returns to her ward after becoming the first person in Britain to receive the Pfizer/BioNTech COVID-19 vaccine at University Hospital.

POOL/Reuters

The pursuit of Canadian approval picked up speed in September, when Health Minister Patty Hajdu issued an interim order allowing for rolling reviews of vaccines and treatments for COVID-19.

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The new mechanism allowed Pfizer and other pharmaceutical companies to submit clinical trial data to the Canadian regulator as it poured in, rather than sending Health Canada a single tome when the trial ended. Pfizer and BioNTech announced the start of a rolling submission to Health Canada on Oct. 9.

“They absolutely did not cut any corners,” Mr. Pinnow said. “We can vouch for that, given the level of detailed questions and the amount of back-and-forth that’s occurred between Health Canada and Pfizer Canada.”

The first vaccines won’t give Canadians their old lives back right away. Public-health officials have stressed that people need to keep wearing masks and staying apart for the foreseeable future, especially over the holidays and through the winter.

Still, the development and approval of a safe and effective vaccine for a deadly coronavirus discovered less than a year ago offers hope, said Supriya Sharma, Health Canada’s chief medical adviser.

“This is a momentous occasion,” she said. “The geek in me is amazed.”

With reports from Marieke Walsh, Laura Stone and James Keller

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