Canada has become just the second country in the world to approve Pfizer Inc’s coronavirus vaccine, and may start immunizing residents as early as next week.
On Wednesday, the country’s health regulator, Health Canada, posted on its website that it had authorized the jab after a two-month independent review on safety and efficacy.
‘Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,’ a government department statement read.
‘Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.’
Canada is set to receive up to 249,000 doses this month and four million doses by March 2021.
It comes one day after the UK began administering Pfizer’s jab and one day before the US FDA advisory committee is set to meet to decide whether or not to authorize it.
In the UK, regulators are recommending that anyone with ‘significant’ food or medicine allergies not receive the vaccine after two healthcare workers went into anaphylactic shock.
On Wednesday, Health Canada approved the coronavirus vaccine made by Pfizer Inc and its German partner BioNTech SE. Pictured: The first patient enrolled in Pfizer’s COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4
On Wednesday, Health Canada approved the coronavirus vaccine made by Pfizer Inc and its German partner BioNTech SE. Pictured: Pfizer headquarters in New York City
In total, the Canadian government has purchased 20 million doses of Pfizer’s vaccine, developed with its German partner BioNTech SE. with the option to purchase an additional 56 million.
Prime Minister Justin Trudeau said the first vials will arrive at 14 distribution centers across the country next week.
Because two jabs are required for full protection, the 249,000 doses will be enough to vaccinate 124,500 people by year’s end.
Currently, only Canadians above age 16 are allowed to receive the vaccine. Once Pfizer releases more data from its ongoing clinical trials, it may be approved for use in children.
Pfizer submitted it application to Health Canada on October 9, meaning the vaccine was approved exactly two months later.
According to CTV News, frontline healthcare workers and long-term care residents and staff members will be the first to receive it.
However, each of the 10 provinces is allowed to make modifications to how it will distribute the vaccine based on the local situation.
For example, the province of Ontario will administer its first vaccines in two cities, Toronto and Peel, where cases are rising the most quickly, CTV News reported.
The news comes just one day after Great Britain began administering the inoculation to senior citizens in the city of Coventry.
Unlike Canada, the UK did not conduct an independent review and largely relied on Pfizer’s own data before authorizing the shot.
CASES: Canada is currently reporting a seven-day rolling average of nearly 7,000 coronavirus infections per day
DEATHS: Health officials are recording a seven-day rolling average of about 100 deaths due to COVID-19 in Canada
WHY THE FDA IS TAKING SO LONG TO APPROVE PFIZER VACCINE
FDA Commissioner Steve Hahn said on Wednesday that scientists needed more time to review the raw data from the Pfizer vaccine trial before they’d make a decision.
Before December 10, when the will all meet to discuss it, this is what happens;
Multiple teams examine different data sets
Hahn said that ordinarily, 150 scientists would look at an application. It’s unclear if more have been added for the Pfizer application or the Moderna application given the urgency of the situation
They will separately look at data for different components of the vaccine including;
All the different groups will then come together on the 10th to discuss their findings and if, collaboratively, they can recommend approval
The FDA scientists make a recommendation to the advisory council
The advisory council has already started meeting to discuss who would get the vaccine first if it is approved.
They also have to decide, ultimately, if it is safe for approval.
If they do that, the doses will start being shipped out on December 15.
America’s top infectious disease expert, Dr Anthony Fauci criticized the decision and said he believed the UK should have spent more time thoroughly vetting Pfizer’s vaccine before approving it.
He later apologized for the harsh remarks.
However, the UK Medical and Healthcare Products Regulatory Agency is now warning anyone with a history of serious allergic reactions to not receive the vaccine after two healthcare workers went into anaphylactic shock on Tuesday.
The two workers both carry EpiPens but no other information has been given. They are now both said to be recovering well.
In Pfizer’s study, 137 participants who were given the vaccine had allergic reactions, but so did 111 people who received the placebo.
Because of the statistic insignificance between the two figures, researchers determined the jab was not a potential hazard.
In the US, this could apply to as many as 200,000 Americans with allergies.
Four people in Pfizer’s study were also diagnosed with Bell’s Palsy, a type of facial paralysis, after receiving the vaccine.
However, the trial scientists said it was not necessarily the immunization that caused the condition and was on par with the rate of Bell’s Palsy in the general population.
British scientists have assured the public the vaccine is safe and have urged the public not to panic, but there is still a great deal of skepticism.
It also raises the question of whether or not the the US was right to take longer in approving the vaccine.
On Thursday, the advisory committee of the US Food and Drug Administration (FDA) is set to meet tomorrow on whether or not to recommend authorizing the jab.
Pfizer’s continuing late-stage Phase III trial is being held in several countries including the US, Germany, Turkey, Germany, Argentina, Brazil and South Africa.
In more than 43,000 participants, the vaccine was found to be 95 percent effective at preventing COVID-19 after the second dose.
Among those aged 65 years and total, the inoculation was found to be 94.7 percent effective.