A vial of the Pfizer-BioNTech COVID-19 vaccine at the Louisa Jordan Hospital in Glasgow, Scotland, Tuesday Dec. 8, 2020. THE CANADIAN PRESS/AP-POOL, Jeff J Mitchell

A vial of the Pfizer-BioNTech COVID-19 vaccine at the Louisa Jordan Hospital in Glasgow, Scotland, Tuesday Dec. 8, 2020. THE CANADIAN PRESS/AP-POOL, Jeff J Mitchell

Health Canada approves Pfizer’s COVID-19 vaccine

OTTAWA — Health Canada has approved the COVID-19 vaccine from Pfizer and BioNTech, paving the way for vaccinations to begin countrywide next week.

Dr. Supriya Sharma, the chief medical adviser at Health Canada who oversaw the review process, said it is “a critical milestone in our fight against COVID-19.”

“This is a momentous occasion,” she said, unable to hold back a big smile. “The geek in me is amazed. No one would have thought as we looked back at the first discovery of the virus that less than a year later we’d be authorizing and then distributing the vaccine.”

Prime Minister Justin Trudeau said Monday Canada’s updated contract with the U.S. drugmaker and its German partner should see 249,000 doses shipped to Canada by the end of the month. But that was always pending the vaccine being deemed safe by Health Canada.

The regulatory team issued that determination at 9 a.m. eastern time Wednesday, and it was announced to the public two hours later. Sharma said Canadians should feel comfortable getting the vaccine when they are eligible to do so.

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

Sharma said while there is never zero risk in taking any kind of pharmaceutical, Health Canada is confident the benefits of the vaccine in protecting people against COVID-19 outweigh any dangers.

Adverse reactions to the vaccine have mainly been pain at the injection site, followed by fatigue and headaches.

Ontario Premier Doug Ford, whose province recorded 1,890 new COVID-19 cases this morning and added 28 people to the death toll, called it “phenomenal news.”

“As soon as vaccines arrive on Ontario soil, we will be ready to deliver and administer them,” he said in a statement. “Friends, the light at the end of the tunnel grows brighter.”

Canada is the third country in the world to greenlight the Pfizer/BioNTech vaccine.

The United Kingdom began inoculating people Tuesday after last week becoming the first to approve its use. The kingdom of Bahrain approved it last Friday.

The Food and Drug Administration in the United States said Tuesday it believed the vaccine was safe and effective. Regulators there are set to meet Thursday to decide whether to authorize it for emergency use.

The U.K. warned that two people had severe allergic reactions on the first day of vaccinations. The reactions are being investigated and the U.K. has asked people who are prone to severe allergic reactions to not get the vaccine for now. The two patients are recovering well, according to British authorities.

One of the two received the vaccine; the other was in the group that received the placebo.

Sharma said Canada has requested more information on those reactions but noted that the two people had previous histories of allergic reactions. She said Health Canada will continue to investigate the situation but that at the moment it has not changed the authorization.

The approval requires Pfizer and BioNTech to continue providing Health Canada with data on safety and effectiveness of the vaccine for at least two years, including measurements of any adverse reactions and data on how long the immunity provided lasts.

Pfizer’s initial trials concluded the vaccine was effective at preventing COVID-19 in 95 per cent of patients.

Canada is set to receive four million doses of the Pfizer vaccine by March and 20 million in 2021. It has the chance to buy 56 million more doses but has not yet exercised that option.

The vaccine must be given in two doses, 21 days apart, and provinces are developing tracking systems to guide the process. Ottawa is also working on systems to track who got the vaccine and whether any problems arise.

The authorization requires Pfizer and BioNTech to continue providing data to Health Canada about the vaccine. The initial authorization is only for use on people over the age of 16.

Pfizer’s initial trials did not include children under 16.

Pfizer needs to store its vaccine at ultracold temperatures — below -70 C — and so the company is planning to ship the doses directly to provinces.

There are 14 sites in the 10 provinces that are now set up to receive the vaccines. Priority is to be given in most provinces to residents and workers in long-term care, front-line health workers, adults in Indigenous communities where an outbreak could be hard to manage, and seniors over the age of 80.

Because of the temperature requirements, the initial doses will be given at the 14 delivery sites, which in most cases are hospitals.

Health Canada is reviewing three other vaccine candidates, including one from Moderna, which is set to deliver two million doses to Canada in the first quarter of 2021.

The National Advisory Committee on Immunization recommends that provinces and territories give their first doses to residents and staff of long-term care homes and adults 80 years of age or older.