Health Canada has added a warning about a rare possible side-effect of blood clots from the Oxford-AstraZeneca vaccine but continues to reassure Canadians that the vaccine is safe and effective against COVID-19.

The department’s chief medical adviser Dr. Supriya Sharma says the warning comes on the heels of a similar warning in Europe last week but doesn’t change Health Canada’s analysis that the vaccine’s benefits outweigh its risks.

The European Medicines Agency last week amended its authorization of the vaccine to say there is not an overall increase in the risk of blood clots after getting the vaccine.

“Health Canada has assessed the available data on the reported events and has determined that the AstraZeneca vaccine has not been associated with an increase in the overall risk of blood clots. There have been very rare reports in Europe of blood clots associated with low levels of blood platelets (thrombocytopenia). Blood clots, sometimes fatal, can also be due to COVID-19,” the regulatory body said in a statement affirming the vaccine’s benefits outweigh risks.

“To date in Canada, there has been one report of a stroke that occurred in an individual following vaccination with COVISHIELD (the version of the AstraZeneca vaccine currently being distributed in Canada). This case has been assessed by Health Canada and determined not to be related to the vaccine,” the statement added.

While stating that “minor and temporary adverse events, such as headache, fever, fatigue, or pain at the injection site, are common after all vaccinations”, Health Canada said people should seek medical attention if they experience any new or worsening symptoms. Canadians are also encouraged to report any adverse events after immunization to their healthcare professionals.

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