Updated information on AstraZeneca/COVISHIELD COVID-19 vaccines

On June 29, 2021, Health Canada issued a Health Product Risk Communication regarding the AstraZeneca/COVISHIELD COVID-19 vaccine: https://healthycanadians.gc.ca/recall-alert-rappel- avis/hc-sc/2021/75389a-eng.php

Health Canada has updated the product monograph for the AstraZeneca and COVISHIELD COVID-19 vaccines to add capillary leak syndrome as a potential side effect following vaccination. Patients with a history of capillary leak syndrome should not get the AstraZeneca or COVISHIELD COVID-19 vaccine. Patients are advised to seek immediate medical attention if they experience symptoms of capillary leak syndrome which would include rapid swelling of the arms and legs and sudden weight gain, which can be accompanied by feeling faint.

Changes to the product monograph were initiated after reviewing international reports of this very rare side effect, first identified as a potential safety concern by the European Medicines Agency in April 2021. Of the 78 million doses of the vaccine given in Europe and the United Kingdom, six cases of capillary leak syndrome have been reported following immunization. One case of capillary leak syndrome following AstraZeneca/COVISHIELD vaccine has been reported in Canada.

The AstraZeneca/COVISHIELD monographs have also been updated with information about very rare events of blood clots associated with low levels of platelets following immunization.

The updated product monographs for AstraZeneca and COVISHIELD can be accessed here:

https://covid- vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-pm-en.pdf