Canada health regulators approve Pfizer-BioNtech's COVID-19 vaccine

On December 8, the health regulators in Canada approved the Pfizer and BioNtech’s COVID-19 vaccines, hailing the decision as a ‘critical milestone’ to stem the coronavirus pandemic. Health Canada reviewed the clinical trial data submitted by Pfizer and BioNTech Manufacturing pharmaceutical firm as it authorised marketing, usage, sales, and distribution of the COVID-19 mRNA vaccine Tozinameran or BNT162b2.

In an official statement, the regulatory body announced that the vaccines were safe, effective, and of good quality to inoculate the population. Health Canada also reviewed the serious and non-serious adverse drug reactions (SAE) in Canada and abroad, after which it approved the shipment of 249,000 doses of the two-dose vaccines by the last week of December. 

Read: From Storage Facility To Stages Of Inoculation: Republic Accesses UP's COVID Vaccine Plan

"The data provided support favourably the efficacy of Pfizer-BioNTech COVID-19 vaccine as well as its safety," the department said in its report authorizing the Pfizer vaccine use in Canada. "The efficacy of the vaccine was established to be approximately 95 percent. 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," it added. 

Read: UK Regulator Chief On Vaccine Allergic Reactions

For nursing home elderly and staff

Canada’s public health and federal government officials are expected to hold a news conference to discuss the government’s roll-out program in detail. Canadian Prime Minister Justin Trudeau announced in a release that the vaccines are intended to reach the high risk and vulnerable population, with shots primarily earmarked for nursing home elderly and the staff. Meanwhile, Health Canada said in an update that the officials will develop a robust "risk management plan" after the vulnerable population is inoculated to monitor the critical mass immunity from the vaccine.

The health regulators are also expected to monitor any "adverse events” from the vaccines. President of Pfizer Canada, Cole Pinnow said in an interview with CBC Radio's The Current that the vaccines coming to Canada imply the government’s first big step towards restoring normalcy and eliminating the pandemic. The head of the vaccine logistics for the Public Health Agency of Canada, Maj.-Gen. said in a statement that the vaccinations will begin at the national operations center that has been leading a series of dry-runs to prepare for the deployment of the extremely heat-sensitive Pfizer shot.

Read: Canada Health Regulator Approves Pfizer's COVID-19 Vaccine

Read: Trump Signs Order To Prioritise Americans For COVID Vaccine, Critics Say 'publicity Stunt'

(With agency inputs; Image Credit: AP)