Health Canada is updating the product information for the Pfizer-BioNTech COVID-19 vaccine to acknowledge very rare reports of Bell’s Palsy following vaccination.
In an advisory issued on Friday, the agency said it decided to update the labelling after a small number of people in Canada and internationally reported temporary weakness or paralysis on one side of the face shortly after receiving the vaccine.
A report released by the U.S. Food and Drug Administration on Pfizer’s clinical trial of the vaccine shows that cases of Bell’s Palsy occurred in only four participants out of approximately 43,000, all of whom received the vaccine and not the placebo.The Moderna vaccine label already reflects extremely rare reports of Bell’s Palsy, and Health Canada stated it will continue to assess the issue for all COVID-19 vaccines approved in Canada.
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