Health Canada issues label change and guidance on the AstraZeneca COVID-19 vaccine


March 24, 2021 | Ottawa, ON | Health Canada

Today, Health Canada updated the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19 vaccines to provide information on very rare reports of blood clots associated with low levels of blood platelets (i.e., thrombocytopenia) following immunization with the AstraZeneca vaccine. Following reports of these very rare adverse events in Europe, Health Canada has worked closely with European regulators to review the evidence and has updated the product monograph. The Department has also issued guidance for healthcare professionals and vaccine recipients on the potential symptoms to monitor.

Health Canada reassures Canadians that the AstraZeneca COVID-19 vaccine continues to be safe and effective at protecting them against COVID-19 and encourages people to get immunized with any of the COVID-19 vaccines that are authorized in Canada.

Health Canada has a robust monitoring system in place for vaccines. In Canada, the provinces are administering the COVISHIELD version of the AstraZeneca vaccine and Health Canada has not received any reports of these very rare events to date.

Health Canada is aware that researchers in Europe have indicated that they have identified a possible cause for these very rare events observed in AstraZeneca COVID-19 vaccine recipients; however, little information is available about this emerging research. Health Canada will be reviewing this evidence when available. Health Canada is consulting with scientific experts in Canada and internationally to discuss the very rare events, and continues to be in regular contact with international regulators and the manufacturer of the AstraZeneca vaccine to review all evidence as it becomes available.

Minor and temporary adverse events, such as headache, fever, fatigue or pain at the injection site are common after all vaccinations. 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.

As the COVID-19 vaccine rollout continues in Canada, Health Canada will continue to monitor the use of all COVID-19 vaccines closely and examine and assess any new safety concerns. Should any safety issue be confirmed, the Department will take appropriate action.

For further information on COVID-19 vaccines authorized by Health Canada, including post-market updates, please visit Health Canada’s COVID-19 vaccines and treatments portal.

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