Health Canada regulators have given the green light to Pfizer’s COVID-19 vaccine, a key step toward launching the biggest inoculation program in Canada’s history.

The department 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 regulator said in its report authorizing use in Canada.

“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.”

Public health and government officials will hold a briefing to discuss details of the vaccine rollout plan at 1 p.m. ET in Ottawa. CBCNews.ca will carry the press conference live.

On Monday, Prime Minister Justin Trudeau announced that several hundred thousand doses of the Pfizer COVID-19 vaccine would be available in Canada before the end of the year — shots primarily earmarked for long-term care home residents and the staff working there.

Maj.-Gen. Dany Fortin, the military commander who is leading vaccine logistics for the Public Health Agency of Canada, has previously said the national operations centre would be ready to deploy vaccines shortly after they are approved in Canada. 

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

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

Trudeau said up to 249,000 doses of the two-dose vaccine will be on hand by year’s end to start the mass inoculation campaign, which is expected to take many months to complete.

The first doses will arrive as some provinces — notably Alberta, Manitoba, Ontario and Quebec — grapple with a sharp increase in COVID-19 caseloads and deaths.

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

The vaccines will be distributed to jurisdictions on a per-capita basis, meaning each province will receive vaccine doses in numbers proportionate to their 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 product will be stored at major hospitals in urban areas

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

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