According to a Dec. 9 news release, the national health agency has found that “the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada.”
Still, officials, while confident in the drug’s safety, will be watching closely for any adverse effects, such as allergic reactions.
The much-anticipated news comes just days after Ottawa announced Canada would receive early delivery of 249,000 doses of Pfizer’s vaccine, which is expected to arrive as early as next week.
The vaccine, which will come in a series of shipments, is given in two doses and there will reportedly be enough to inject 124,500 people — starting with those deemed by the National Advisory Committee on Immunization to be the most vulnerable.
According to the release, the “initial indications of the vaccine is for use in people 16 years of age or older.” The safety and effectiveness of the vaccine for those younger than that has not yet been established, it states.
“Pfizer-BioNTech are running further clinical trials on children of all age groups and the indication could be revised in the future to include children if the data from these studies support it,” it goes on to state.
Canada has a deal with Pfizer for 76 million doses.
Health officials have reportedly said they believe there will be enough approved vaccines to treat most Canadians by September.
(Canada also has vaccine contracts with Medicago, AstraZeneca, Sanofi and GlaxoSmithKline, Moderna, Novavax and Johnson & Johnson.)
The news of the Pfizer vaccine’s approval and early arrival comes in the wake of significant spikes in COVID-19 cases in Ontario, Manitoba, Quebec and Alberta.
During a press conference, Health Canada chief medical adviser Dr. Supriya Sharma called the approval of the vaccine a “critical milestone” in the country’s fight against COVID-19 and stressed that it was “authorized only after a thorough assessment” for safety and effectiveness.
In this case, she said, Health Canada’s approval was done via an expedited — yet thorough — process.
“It is a full review in the sense that we looked at the same type of data that we would normally when we look at any vaccine for authorization,” said Sharma. “It was authorized under what we call the interim order pathway, which gives us some flexibility when we do the review, including the ability to do … a rolling review — to accept information as it becomes available, compared to waiting until all of that information is available before starting the review.”
Sharma was asked about possible side effects, such as the reported two cases of allergic reaction in the U.K., which earlier this week became the first western country to begin administering a vaccine.
She said that “with all vaccines, there is a risk of allergic reactions,” even though the risk is low.
“And that is why when people receive the vaccines we ask that they remain in the area that they get the vaccine for a period of time — usually 15 to 20 minutes — to be monitored, and that is because we are introducing something foreign into the body and it is possible to get an allergic reaction, however rare.”
Sharma said people should refer to a list of the vaccine’s ingredients on Health Canada’s website to check if there may be an issue with allergies.
The federal government has set up 14 vaccine distribution sites so far — two in each of Canada’s four largest provinces and one in each of those remaining. (The vaccine will reportedly not be sent to the territories due to a current inability to store it.)
The Pfizer vaccine will have to be stored in temperatures of -80 C, something Prime Minister Justin Trudeau recently called an “incredibly complex” logistical endeavour.
Ottawa has purchased 126 freezers, including 26 for ultra-low temperature storage.
If you have any information, story ideas or news tips for The Lawyer’s Daily, please contact Terry Davidson at t.davidson@lexisnexis.ca or call 905-415-5899.