Health Canada confirms that the benefits of the AstraZeneca COVID-19 vaccine in protecting Canadians from COVID-19 continue to outweigh the risks, and encourages Canadians to get immunized with any of the COVID-19 vaccines that are authorized in Canada.
There have been recent reports in Europe of blood clots following vaccination with the AstraZeneca COVID-19 vaccine. Health Canada communicated on March 11, 2021 that it was assessing these events, in collaboration with international regulatory partners, particularly the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Today, both the EMA and the MHRA communicated that the benefits of the use of the AstraZeneca vaccine continue to outweigh any risks.
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. Health Canada will continue to work with international regulators and review data and evidence as it becomes available, including as it pertains to these rare events. The Department is also working with AstraZeneca to ensure that healthcare professionals and Canadians have the safety information they need.
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.
While 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 vaccine roll out continues in Canada, Health Canada will continue to monitor the use of all COVID-19 vaccines closely. Health Canada will examine and assess any new safety concerns, and should a safety signal be confirmed, the Department will take appropriate action.
On February 26, 2021, Health Canada authorized the AstraZeneca COVID-19 vaccine and the Serum Institute of India’s (SII) version of the AstraZeneca vaccine, sponsored in Canada by Verity Pharmaceuticals Inc. To date, only the SII version of the AstraZeneca vaccine has been received and used in Canada.
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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