Canada approves Pfizer/BioNTech COVID-19 vaccine, first shots expected next week

OTTAWA/TORONTO: Canada on Wednesday approved its first COVID-19 vaccine, clearing the way for doses of the Pfizer Inc shots to be delivered and administered across the country as soon as next week.

Canada is the third country after Britain and Bahrain to give the green light to the Pfizer vaccine, developed with Germany's BioNTech SE.

"The approval of the vaccine is supported by evidence that it is safe, effective and of good quality," regulator Health Canada said in a statement. It has initially been authorized for use in people 16 years of age or older.

The vaccine was approved under an interim, accelerated drug review system very similar to the US Food and Drug Administration's emergency use authorizations, and comes a day before a panel of advisers to the FDA is set to review and recommend whether the US agency should authorize use of the Pfizer vaccine.

On Tuesday, British citizens became the first in the world to get the shots outside of clinical trials following last week's UK approval.

In a large, late-stage trial, the vaccine was shown to be 95% effective at preventing illness, far better than originally anticipated.

However on Wednesday, Britain's medicine regulator advised that people with a history of significant allergies not get Pfizer's vaccine after two people reported adverse reactions on the first day of its rollout.

Responding to questions on the allergic reactions, Health Canada officials said that is always a risk with vaccines, but they are recommending that people who have previously had adverse reactions to any of the ingredients in the vaccine not to take it for now.

Officials said they would monitor developments in Britain to see if there were further implications for Canada.

Canada will receive an early shipment of up to 249,000 doses of Pfizer's vaccine by the end of the month, Prime Minister Justin Trudeau said on Monday.

Canada released a detailed plan for its vaccination rollout on Wednesday, saying that the nation is now "well-positioned to immunize 100% of the population in 2021." General inoculations for all Canadians would begin in April after priority populations have been vaccinated, it said.

The province of Saskatchewan said on Wednesday it expected to receive enough doses for 1,950 people by Tuesday intended first for healthcare workers in direct contact with COVID-19 patients.

Quebec expects to have received 55,000 doses of the vaccine by Jan. 4, the premier of the predominantly French-speaking province, Francois Legault, said.

'HISTORIC MOMENT'

"Today's decision from Health Canada is a historic moment in our collective fight against the COVID-19 pandemic and is a major step towards returning to normalcy in Canada," Cole Pinnow, president of Pfizer Canada, said in a statement.

Canada is in the midst of a virulent second wave of the pandemic, with Quebec's Legault saying he is weighing new restrictions and stepping up enforcement of current ones.

As of Tuesday, Canada had reported 429,035 total cases, an increase of 5,981 on the day before, and 12,867 deaths.

"We still need to reduce the pressure on our hospitals," Legault said.

Pfizer will be responsible for shipping its vaccine, which requires ultra-cold storage, to warehouses across Canada.

Canada has a firm order for 20 million doses of the vaccine, enough to inoculate 10 million people, with options to buy up to 56 million more.

For the most part, provincial and territorial health systems will administer the shots, for free. They will have final say over how to use scarce early supplies in their jurisdictions.

According to guidance published by the federal government, vulnerable people and those who look after them are high priority, including long-term care residents and some healthcare workers.

Regulators have received rolling applications for three other experimental vaccines, from Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

The Moderna vaccine is farthest along, having completed pivotal trials showing it to be 94.1% effective at preventing illness and 100% at preventing severe COVID-19.

Officials have said they expect to receive six million doses of Pfizer and Moderna vaccines before the end of March. Each vaccine requires two doses given about three weeks apart.

FedEx Corp and Innomar Strategies, a Canada-based unit of US drug distributor AmerisourceBergen Corp, have been hired to provide logistical support on vaccine delivery.