Health Canada approves Pfizer-BioNTech COVID-19 vaccine

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 Canadaannounced 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 authorizinguse of the vaccinein 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 andauthorizationisexpected in "a matter of days," U.S. Health Secretary Alex Azar said Wednesday.

Dr. Howard Njoo, Canada's deputy chief public health officer, said249,000 doses of the two-dose Pfizer vaccine will be on hand by year's end shots primarily earmarkedfor 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 theinitial runwill be shipped from a Pfizer plant in Belgium on Friday.

"We expectvaccines to arrive as early as Monday," Fortinsaid, adding it's "totally possible" someCanadians could get theirshotsby mid-week.

Njoo said as many as six million doses will arrivein the first three months of 2021. Assuming otherpromising 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 measureseven as shots start to arrive.

Long-term care homes to be among first to get vaccine

The Pfizer trial hadmore 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 isbased ongroundbreakingmessenger 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 clinicaltrial subjects who were over the age of 65 and who had no prior COVID-19 infection a significant finding, given mostnovel coronavirus-related deaths in Canada have been reported among the elderly.

While thePfizer vaccine has been given the necessary approvals, regulators conceded that the clinicaltrial data could not establishthe 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," withmillions of Canadiansset 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'sThe 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.

WATCH: Pfizer addresses vaccine concerns:

Dr. Sharma calls the approval of the Pfizer vaccine a 'critical milestone' in the fight against COVID-19.

4 years ago

Duration 2:19

Health Canada chief medical adviser Dr. Supriya Sharma briefed reporters on the vaccine's approval during a briefing on Wednesday.

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'sclinical trial and technical information.

She saidscientistsfound "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."

WATCH: Health Canada calls Pfizer approval a 'critical milestone' in fight against COVID-19:

Pfizer Canada addresses concerns over Bell's palsy in U.S. vaccine trials

4 years ago

Duration 0:18

Pfizer Canada president Cole Pinnow said the four occurrences of facial paralysis among close to 22,000 subjects in U.S. clinical trials who received the Pfizer-BioNTech COVID-19 vaccine represented a frequency not above what is expected in the general population.

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 thefirst day of the country's mass vaccination program.

Asked about those warnings, Sharma said Canada is inconstant 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."

WATCH: Health Canada discusses allergic reactions to the Pfizer vaccine:

Dr. Sharma discusses allergic reactions to Pfizer's vaccine and how it was approved

4 years ago

Duration 2:38

Health Canada chief medical adviser Dr. Supriya Sharma briefed reporters on the vaccine's approval during a briefing on Wednesday.

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 incidentsreported 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 Belgiumthat will be churning out hundreds of millions of doses of the co-developed Pfizer-BioNTechvaccine for the European Union, Canada, Japan and the United Kingdom over the next 12 months.

Maj.-Gen.Fortinhas 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.

WATCH | Canada approves 1st COVID-19 vaccine for Pfizer-BioNTech:

Canada approves 1st COVID-19 vaccine from Pfizer-BioNTech

4 years ago

Duration 2:35

Health Canada has approved the first COVID-19 vaccine for Canadians. Priority populations could start getting the Pfizer-BioNTech vaccine as early as next week, with rollout for the general population slated tentatively for the spring.

Those siteshave 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. "Itreally 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 provincewill receivevaccine dosesin numbersproportionateto its share of the population.The vaccine will not be senttothe territories for the time beingas they now lackthe 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 limitedinitialquantity 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,retirementhomes 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 leadersto decide who getsshots when, but Trudeau said the premiersare 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 hasordered roughly418 million doses of COVID-19 vaccines from seven different companies an insurance policy against the possibility thatsome of the vaccines in developmentprove to be ineffective.