Canadian officials say they will continue to monitor for any additional side effects from Pfizer’s coronavirus vaccine after reports of allergic reactions in the United Kingdom.
Health Canada officially gave the green light to the vaccine from the U.S. pharmaceutical company, deeming it safe for use following a thorough review of the clinical data submitted by Pfizer.
“It’s really important to say that as we monitor the vaccines, adverse event reports will come up,” Dr. Supriya Sharma, chief medical advisor with the regulatory branch of Health Canada, said in a press conference on Wednesday.
“We are always looking for any additional side effects. And that’s why we continue to monitor.
“But it is still a drug, still a vaccine, and there are potential risks even if they are rare.”
In updated guidelines on Wednesday, Britain’s medical regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), advised that people who have a history of significant allergic reactions to a vaccine, medicine or food should not receive the Pfizer vaccine.
Canada’s public health officials said they were working closely with the U.K. government to get additional information, but were not changing their recommendations at the time.
According to Health Canada’s current guidelines, people who have previous allergic reactions to any of the listed ingredients in the Pfizer vaccine should not get the vaccine.
Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late-stage trials, which is reflected in the MHRA’s emergency approval protocol.
Sharma said in the clinical trials, there were two cases of severe allergic reactions — one from the group that received the vaccine and the other that got the placebo.
“So it wasn’t a significant finding in the trials. However, we know that with all vaccines there’s a risk of allergic reactions.”
It is not uncommon for a vaccine or any drug to result in side effects.
Other side effects reported during clinical trials included discomfort at the injection site, fatigue and headache, but all the reactions were “relatively mild,” Sharma said.
“In total, when we look at the overall population for the clinical trials, the rate of serious adverse events is quite low.
“So I would say to Canadians, we’ve authorized it. If it is their turn to get the vaccine, they absolutely should feel comfortable getting that.
“But we still do need to continue to monitor it, as we would any product.”
In a statement, Pfizer said the regulator’s approval makes Canada the third country in the world to approve the vaccine and that it can start shipping it as soon as it gets the green light that distribution networks are in place.
Canada has a firm order for 20 million doses of the vaccine, enough to inoculate 10 million people, with options to buy up to 56 million more.
For the most part, provincial and territorial health systems will administer the shot, for free, across the country. They will have final say over how to use scarce early supplies in their jurisdictions.
According to preliminary guidance published by the federal government in early November, vulnerable people and those who look after them are high priority, including long-term care residents and some health-care workers.
— With files from Reuters
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