Pfizer’s COVID-19 vaccine gets positive FDA review
We will have tens of millions of American vaccinated by the end of 2020 Fox News medical contributor Dr. Nicole Saphier tells ‘Fox & Friends.
Canadian health officials on Wednesday granted approval to Pfizer and BioNTech’s two-dose coronavirus vaccine, becoming the second Western country to do so in recent days.
“We are proud to announce that Health Canada has granted Authorization under Interim Order for the emergency use of Pfizer and BioNTech’s COVID-19 vaccine. This is a historic step forward in our efforts to reduce the number of Canadians suffering from this devastating virus,” Pfizer Canada said on Twitter.
The interim order that helped speed along the approval process is similar to emergency use authorizations (EUAs) from the U.S. Food and Drug Administration (FDA).
Health Canada, the country’s federal health agency, said in a statement that approval — what officials called a “critical milestone” in the battle against the virus — was granted following a “thorough, independent review of the evidence” that showed the vaccine “meets the Department's stringent safety, efficacy and quality requirements for use in Canada.”
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The health agency noted that a “number of documents” related to the decision have been made public in an effort to provide transparency.
“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,” health officials said in a statement.
Health Canada noted that the vaccine will be for anyone above the age of 16; children are excluded at this time because more research on the vaccine is needed for those younger than 16.
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Similar to vaccine rollout recommendations in the U.S., the country’s National Advisory Committee on Immunization (NACI) has reportedly recommended that residents and staff of long-term care facilities, front-line health care workers, as well as adults 70 years of age or older and adults in Indigenous communities should receive the initial vaccine doses.
The news out of Canada follows that out of the United Kingdom, which last week became the first country in the West to approve Pfizer and BioNTech’s two-dose jab — though some criticized the swift action.
A 90-year-old woman on Tuesday became the first to receive the COVID-19 vaccine in the U.K.
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In the U.S., the FDA is slated to meet on Thursday regarding the companies’ applications for emergency use authorization; documents posted ahead of the meeting showed that the vaccine candidate meets such requirements from the federal agency.
The documents did not flag any new concerns or safety issues regarding the vaccine after reviewing the submitted data.
Pfizer's vaccine candidate proved more than 90% effective in late-stage clinical trials and the company has previously said it expects to produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021.
Fox News’ Alexandria Hein contributed to this report.