Adverse events in Europe following immunization with the AstraZeneca COVID-19 vaccine

Starting date:
March 11, 2021
Type of communication:
Advisory
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-75123

Last updated:

Issue

Health Canada is aware of reports of adverse events in Europe following immunization with the AstraZeneca COVID-19 vaccine, and would like to reassure Canadians that the benefits of the vaccine continue to outweigh its risks. Health Canada authorized the vaccine based on a thorough, independent review of the evidence and determined that it meets Canada’s stringent safety, efficacy and quality requirements.

At this time, there is no indication that the vaccine caused these events. To date, no adverse events related to the AstraZeneca COVID-19 vaccine, or the version manufactured by the Serum Institute of India, have been reported to Health Canada or the Public Health Agency of Canada.

Health Canada has been informed by the European Medicines Agency (EMA) that several countries in Europe have either temporarily paused the use of specific batches of the AstraZeneca vaccine or use of the AstraZeneca vaccine altogether as a precautionary measure, pending the outcome of the EMA’s investigation. None of the identified batches under investigation have been shipped to Canada.

The EMA’s safety committee has initiated an investigation into cases of thromboembolic events (blood clots) reported in Europe post-vaccination. This investigation is expected to be completed on an accelerated timeline.

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has confirmed that, following the administration of 11 million doses of the AstraZeneca COVID-19 vaccine in its jurisdiction, reports of blood clots are no greater than expected.

The Government of Canada will continue to work with international regulators, including the EMA, to gather and assess the information available to determine whether there is any need to take action in Canada.

For further information on Health Canada’s authorization of the AstraZeneca COVID-19 vaccine, please visit the COVID-19 Vaccines and Treatments Portal.

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