Health Canada provides update on safety review of AstraZeneca and COVISHIELD COVID-19 vaccines

April 14, 2021 | Ottawa, ON | Health Canada

Health Canada is updating Canadians and healthcare professionals about its ongoing safety review of very rare events of blood clots associated with low levels of blood platelets following immunization with the AstraZeneca and COVISHIELD COVID-19 vaccines.

After a thorough, independent assessment of the currently available scientific data, Health Canada has concluded that these very rare events may be linked to use of the vaccine. This is in line with the findings of other regulators. As a result, the Department has updated warnings in the product information to inform Canadians of the possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following vaccination.

Based on the review of available data from Europe and from the United Kingdom and AstraZeneca, no specific risk factors have been identified. Therefore, Health Canada is not restricting the use of the vaccine in any specific populations at this time.  

Health Canada’s position that the safety of the AstraZeneca vaccine meets its strict safety standards remains valid, and the Department is adjusting the product's labelling to reflect the available scientific evidence. The results of the ongoing safety assessments have been consistent. The potential risk of these events is very rare, and the benefits of the vaccine in protecting against COVID-19 outweigh its potential risks. Health Canada’s findings are based on a sound and thorough review of all evidence available.

In the very rare event that someone experiences unusual blood clots with low platelets, there are treatments available.

The National Advisory Committee on Immunization (NACI) is also reviewing the available information to determine whether to maintain or modify its current recommendation not to use the vaccine in people under 55. 

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.

As the COVID-19 vaccine rollout advances 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.