Search

Health Canada takes further action to confirm the benefit-risk profile of AstraZeneca vaccine

As part of its continued commitment to transparently communicate all information about COVID-19 vaccines, Health Canada is advising Canadians of new measures it has taken.


Health Canada takes further action to confirm the benefit-risk profile of AstraZeneca COVID vaccine

Health Canada has already issued a statement on its ongoing assessment of very rare adverse events reported in Europe, namely cases of thrombosis (blood clots) associated with thrombocytopenia (low blood platelet count) following administration of the vaccine, AstraZeneca. Product information has recently been updated to include this information.


So far, no case of these events has been reported in Canada. However, thanks to our sustained international collaboration, Health Canada has learned that other cases have been recorded in Europe .


In light of this evolving information, Health Canada will subject the vaccine registrations of AstraZeneca and Verity Pharmaceuticals / Serum Institute of India to additional conditions.


Among other things, manufacturers will need to conduct a thorough assessment of the benefits and risks of the vaccine by age and gender in the Canadian context. This information will facilitate the ongoing assessment of these rare cases of blood clots and allow Health Canada to determine if particular groups may be more susceptible to this problem. Health Canada has had discussions on this evolving issue with AstraZeneca.


The Department will assess the information as soon as it receives it to determine if further regulatory action is necessary. Health Canada will continue to work with its international counterparts to collect and assess the information.


The guidelines provided by Health Canada to healthcare professionals last week remain in effect and inform people who get vaccinated of the signs and symptoms to look out for after vaccination.


Related Links Statement - Health Canada Releases New Label Version and AstraZeneca COVID-19 Vaccine Guidance


SOURCE Health Canada via CISION


CONTACT: Contacts: Media Relations: Health Canada, 613-957-2983, hc.media.sc@canada.ca; COVID-19 Public Inquiries: 1-833-784-4397