Health Canada Approves Pfizer COVID-19 Vaccine

CTV— Health Canada has approved the Pfizer-BioNTech COVID-19 vaccine for use in this country.

It’s a critical moment in Canada’s fight against the novel coronavirus, as it is the first vaccine to receive the green light.

The federal health agency has deemed the vaccine effective and safe for use on Canadians, which means that the team responsible for the rollout of vaccines can now begin the process of administering them.

“Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada,” said Health Canada in a statement, alongside a series of documents related to the decision, with the promise of more information about the clinical trial in the weeks ahead.

In an interview with CTV National News Medical Correspondent Avis Favaro, Pfizer Canada’s Vaccines Medical Lead Dr. Jelena Vojicic said she is “very pleased” with Health Canada’s decision.

“This is certainly a historic moment for science, and for Canadians. And this is a result of a tremendous effort, starting with the international scientific community, and then going over the dedicated work of Pfizer and BioNTech employees, the clinical trial sites, the participants in the clinical trials, the volunteers,” Vojicic said.

“And of course, I need to acknowledge the tremendous work by Health Canada in quickly reviewing our file while maintaining really gold standards of review and keeping a vigilant eye on the data.”

The initial doses of the Pfizer vaccine are expected to arrive in Canada next week, and plans are already in place to have the shots ready to be administered at 14 delivery sites in major cities across Canada, within one or two days of shipments arriving.

SHIPPING DOSES ‘IMMINENTLY’

Vojicic said that Pfizer is prepared to ship to Canada and she is expecting that shipment will happen “imminently.” She anticipates most vaccines destined for Canada will be coming out of Belgium.

By the end of December, Canada is set to receive up to 249,000 doses of this vaccine, or enough to vaccinate 124,500 people, given it requires two shots 21 days apart. In total, the federal government has purchased 20 million doses of the vaccine, and has option to buy 56 million more.

From there, Maj.-Gen. Dany Fortin, the top military general leading the rollout from the Public Health Agency of Canada, is expecting a “constant flow” of doses to arrive — up to four million by the end of March 2021.

Prioritized groups will be the first to receive the vaccine, given the limited quantities to begin with. Among the earliest to receive these shots will be staff and residents in long-term care and other congregate senior living facilities and health-care workers with high exposure risks. Each province is able to modify the national recommendations for prioritization based on their regional situation. For example, Ontario has opted to use the first small batch in Toronto and Peel region, where the most severe lockdowns are in place due to weeks of surging case counts.

For now, the vaccine is being recommended for use in people 16 years of age or older, and further clinical trials are being run on children of all age groups, so it’s possible the Health Canada approval could be revised in the future to include children, if the data from these studies support it.

Because the vaccine needs to be stored at temperatures below -70 C, Pfizer will be delivering batches in special thermal shipping boxes it developed that can keep the vaccine stable for days.

“These thermal shippers are also equipped with GPS-enabled data loggers that records the temperature as well as the location of these shippers. So at any point of time, between the manufacturing site and the point of use, we will be able to track those shipments and prevent any unwanted temperature excursions,” said Vojicic, who added she doesn’t think the security of theses shipments will be an issue.

Before being injected, the vaccine is thawed, decanted, and mixed, but can only last a few hours at room temperature, so Pfizer is requesting the first doses be given on-site at these 14 facilities where there are ultra-cold freezers in place, to avoid as much wastage as possible from transporting the vials elsewhere.

CANADA SECOND IN WORLD

Canada is the second country in the world to approve the Pfizer-BioNTech vaccine.

The United Kingdom was first, and began vaccinating its citizens with this vaccine on Tuesday, but the U.K.’s Medical and Healthcare Products Regulatory Agency is now warning that people who have a history of serious allergic reactions should not receive the vaccine as they investigate two instances of adverse reactions that occurred in health workers when they received the vaccine.

The United States Food and Drug Administration is set to give the Pfizer-BioNTech vaccine the green light to roll out to Americans this week.

For weeks, questions had been raised about Canada’s place in line for vaccines in comparison to other nations, given in part our inability to domestically produce initial vaccines. But Pfizer said Wednesday that “you can see from what’s happening today, that we’re definitely not at the back of the line. We’re actually at the front of the line in terms of the approvals of the vaccines, and the rollout of the vaccines.”

“I think we can be very content as to how Canada has done,” Vojicic said.

Typically, the vaccine submission review process can usually take up to a year, but because of an emergency order, Health Canada has been able to expedite the authorization process. The agency began its regulatory review of the Pfizer vaccine in October, and has since been assessing rolling information as it comes in from the pharmaceutical company’s studies, rather than having to wait until the end of its work to begin reviewing the findings.

“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. 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,” said Health Canada on Tuesday. The pharmaceutical giant will also have to routinely provide additional quality, efficacy, and safety information.

Pfizer was one of four vaccine candidates Health Canada has been evaluating, with assessment ongoing for the Moderna, AstraZeneca, and Johnson & Johnson vaccines. In total, Canada has signed contracts guaranteeing access to 194 million doses of potential COVID-19 vaccines with the option to purchase 220 million more, meaning if all trials pan out, we’d have access to 414 million doses.

COVID-19 vaccines will be offered to Canadians free of charge, will not be mandatory, and will eventually be available to all who want to be vaccinated. The government has said its target is to vaccinate the majority of Canadians by September, 2021.

Article By News784

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