TORONTO — 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.
The department continues to assure Canadians the vaccines are safe and effective in protecting against COVID-19, and that the benefits of being vaccinated far outweigh the risks.
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, about half of whom received the vaccine and half of whom received the placebo.