Health Canada approves Pfizer-BioNTech COVID-19 vaccine

About 249,000 doses of the two-dose vaccine are expected to be on hand by year's end

Cbc.ca
Dec. 10, 2020
John Paul Tasker

The federal government has given the green light to the Pfizer-BioNTech's COVID-19 vaccine, a key step toward launching the largest inoculation campaign in Canada's history.

Health Canada announced the approval Wednesday after scientists finished a two-month review of the company's clinical trial data.

"The data provided supports favourably the efficacy of Pfizer-BioNTech COVID-19 vaccine as well as its safety," the department said in its report authorizing use of the vaccine in Canada for people over the age of 16.

"The efficacy of the vaccine was established to be approximately 95 per cent. The vaccine was well tolerated by participants and has no important safety concerns. The benefit-to-risk assessment for Pfizer-BioNTech COVID-19 vaccine is considered favourable."

Canada is just the third country in the world to authorize the vaccine, after the United Kingdom and Bahrain. The U.S. Food and Drug Administration will hear tomorrow from an advisory panel on whether the vaccine is safe for use in the United States and authorization is expected in "a matter of days," U.S. Health Secretary Alex Azar said Wednesday.

Dr. Howard Njoo, Canada's deputy chief public health officer, said 249,000 doses of the two-dose Pfizer vaccine will be on hand by year's end -- shots primarily earmarked for long-term care home residents and the staff working there.

Maj.-Gen. Dany Fortin, the military commander leading vaccination logistics at the national operations centre, said 30,000 doses out of the initial run will be shipped from a Pfizer plant in Belgium on Friday.

"We expect vaccines to arrive as early as Monday," Fortin said, adding its "totally possible" some Canadians could get their shots by mid-week.

Njoo said as many as six million doses will arrive in the first three months of 2021. Assuming other promising vaccine candidates from companies like Moderna and AstraZeneca secure regulatory approvals, millions more shots will come online in the months to follow, he said.
The Public Health Agency of Canada (PHAC) said today the country will begin immunizing non-priority populations -- people other than the elderly, health care workers and some adults in Indigenous communities -- in April 2021. The vaccination campaign is expected to end next December.

"At last, we have a reason to feel optimistic and excited about returning to the lives we led pre-COVID," Njoo said. "Things are happening quickly."

Speaking in question period today, Prime Minister Justin Trudeau called the Pfizer-BioNTech approval a "big deal" because it signals that the end of this destructive pandemic is in sight.

"It's a good news day for Canadians but we are not through this yet. We have a tough winter to go through," Trudeau said, urging Canadians to respect public health measures even as shots start to arrive.

Long-term care homes to be among first to get vaccine
The Pfizer trial had more than 43,000 participants -- one of the largest such trials ever conducted -- and regulators found that the vaccine's efficacy was consistent across age, gender, race and ethnicity demographics.

The vaccine is based on groundbreaking messenger RNA technology, or mRNA, which essentially directs cells in the body to make proteins to prevent or fight disease.

The shot was found to be 94.7 per cent effective among clinical trial subjects who were over the age of 65 and who had no prior COVID-19 infection -- a significant finding, given most novel coronavirus-related deaths in Canada have been reported among the elderly.

While the Pfizer vaccine has been given the necessary approvals, regulators conceded that the clinical trial data could not establish the long-term efficacy of the vaccine.

It is not yet known how long the vaccine-induced immunity will last but Health Canada said it will implement a robust "risk management plan" to monitor immunity and gather data on when it begins to wane. The regulator will also track any "adverse events" that follow immunization.

Cole Pinnow, the president of Pfizer Canada, said Health Canada's approval means the country can start to return to a sense of "normalcy," with millions of Canadians set to be vaccinated over the coming months.

"This is historic. We couldn't be more proud that Pfizer and BioNTech were able to bring to Canada the first COVID-19 vaccine. We think this represents a monumental change in the way that we are fighting the pandemic, and hopefully represents the first big step towards normalcy," Pinnow said in an interview with CBC Radio's The Current.

With recent polls showing that a sizeable number of Canadians will refuse a vaccine altogether, or will wait some time before lining up for a shot, Pinnow said he wants Canadians to be assured the product is safe.

"I would reassure Canadians that the scientific rigour and regulatory oversight that went into this product is as robust, if not more robust, than any other vaccine that's been brought to market," he said.

Dr. Supriya Sharma, the chief medical adviser at Health Canada, also sought to reassure Canadians that her department conducted a "rigorous" review of all the product's clinical trial and technical information.

She said scientists found "strong evidence" that the vaccine's potential benefits far outweigh any risks.

"Canadians can have confidence ... the vaccine was authorized only after a thorough assessment of the evidence demonstrated it had met Health Canada's strict standards for efficacy, safety and quality," she said.

"It's an exceptional day for Canada. In a year when we haven't had a lot of good news, this is a bit of good news and we should acknowledge that."

British regulators warned Wednesday that people who have a history of serious allergic reactions shouldn't receive the new Pfizer vaccine as they investigate two adverse reactions that occurred on the first day of the country's mass vaccination program.

Asked about those warnings, Sharma said Canada is in constant communication with British authorities.

"We are always on the lookout for more serious adverse events," she said. "It is still a vaccine and there are potential risks even if they are rare. That's why it's important that we still continue to monitor it.

"Because these vaccines will be used in otherwise healthy people ... our tolerance for safety issues is very, very low."

Sharma said Health Canada is recommending individuals with allergies to any of the vaccine's components avoid the shot.

Sharma noted that there were few serious medical incidents reported among the 43,000 clinical trial participants. The most common side effects were soreness at the site of injection, joint pain and fatigue, she said.

Inoculation to take months
Canada is expected to take delivery of vaccines produced in Puurs, a small town in the north of Belgium that will be churning out hundreds of millions of doses of the co-developed Pfizer-BioNTech vaccine for the European Union, Canada, Japan and the United Kingdom over the next 12 months.

Maj.-Gen. Fortin has been leading a series of dry-runs with the provinces and territories to ensure they are prepared to distribute the extremely heat-sensitive Pfizer shot, which must be stored at temperatures between –80 C and –60 C.

Because the Pfizer product is so temperature-sensitive, Pfizer is shipping it directly from its plants to 14 points of use throughout Canada to limit movement and keep the vaccine stable.

Those sites have the necessary cold storage in place and are ready for the "imminent arrival" of the shots, Fortin said.

"We're undertaking a mobilization effort of massive proportions. Never in modern memory have we seen such an unprecedented level of collaboration and cooperation," he said. "It really makes me proud to be a Canadian and proud to serve."

The vaccines will be distributed to jurisdictions on a per-capita basis, meaning each province will receive vaccine doses in numbers proportionate to its share of the population. The vaccine will not be sent to the territories for the time being as they now lack the capacity to safely store the Pfizer product.

While the exact location of each of the 14 distribution centres has not yet been disclosed, some provinces, including Newfoundland & Labrador, have said the Pfizer vaccine will be stored at major hospitals in urban areas.

The national advisory committee on immunization (NACI) said last week the limited initial quantity of doses should be reserved for people who are most at risk of contracting the virus and developing severe symptoms -- elderly residents of long-term care and assisted living facilities, retirement homes and chronic care hospitals, and the staff who care for them.

After long-term care home residents and staff are immunized, NACI said the next priority group should be all Canadians over the age of 80.

It will be up to provincial leaders to decide who gets shots when, but Trudeau said the premiers are in agreement that the NACI guidelines should be followed and the most vulnerable should be first in line.

Trudeau is meeting with premiers virtually Thursday, with vaccine distribution, health care funding and improving long-term care facilities on the agenda.

Health Canada is currently reviewing other promising vaccines from companies like Moderna, AstraZeneca and Johnson & Johnson's pharmaceutical division, Janssen.

In total, Canada has ordered roughly 418 million doses of COVID-19 vaccines from seven different companies -- an insurance policy against the possibility that some of the vaccines in development prove to be ineffective.