Health Canada taking further action to confirm the benefit-risk profile of the AstraZeneca vaccine
March 29, 2021 | Ottawa, ON | Health Canada
As part of Health Canada’s continuing commitment to openness and transparency on all information relating to COVID-19 vaccines, the Department is updating Canadians on new actions it has taken.
Health Canada has previously communicated on its ongoing assessment of very rare adverse events reported in Europe of thrombosis (blood clots) with thrombocytopenia (low blood platelets) occurring after immunization with the AstraZeneca vaccine. The product information was recently updated to reflect this information.
To date, no cases of these events have been reported in Canada. However, through our ongoing international collaboration, Health Canada has become aware that additional cases of these events have been reported in Europe.
In light of this evolving information, Health Canada will be issuing additional terms and conditions on the authorizations of the AstraZeneca and Verity Pharmaceuticals/Serum Institute of India vaccines. These will include a requirement that the manufacturers conduct a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context. This information will support the ongoing evaluation of these rare blood clotting events, and allow Health Canada to determine if there are specific groups of people who may be at higher risk. Health Canada has been in discussions with AstraZeneca on this evolving issue.
Health Canada will assess this information when it is received and will determine if additional regulatory actions are necessary. Health Canada will continue to work collaboratively with its international counterparts to collect and assess information.
Health Canada’s guidance issued to healthcare practitioners last week still stands, and provides vaccine recipients with information on the signs and symptoms to monitor for following vaccination.
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