Other safety alerts
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| Canada: AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of capillary leak syndrome |
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Health Canada announces that very rare cases of capillary leak syndrome (CLS), a life-threatening condition characterized by acute episodes of limb edema, hemoconcentration, hypoalbuminemia and hypotension leading to organ damage, have been reported following vaccination with AstraZeneca COVID-19 Vaccine. The European Medicines Agency reviewed 6 cases in depth, and a history of CLS was noted in 3 of these cases. One of these cases had a fatal outcome. As of 18 Jun 2021, one case of CLS following vaccination with the AstraZeneca COVID-19 Vaccine has been reported in Canada.
AstraZeneca COVID-19 Vaccine and COVISHIELD (the version of the AstraZeneca COVID-19 Vaccine manufactured by the Serum Institute of India) are now contraindicated in individuals who have previously experienced episodes of CLS.
Healthcare professionals should be alert to the signs and symptoms of CLS. CLS is a very rare disorder, which is frequently life threatening, characterised by a dysfunctional inflammatory response, endothelial dysfunction, extravasation of fluid from the vascular space to the interstitial space leading to shock, hemoconcentration, hypoalbuminemia and consequent organ failure. Patients may present with a rapid swelling of the arms and legs, sudden weight gain and have symptoms associated with low blood pressure/shock. Patients with an acute episode of CLS following vaccination require urgent medical attention and treatment. Intensive supportive therapy is usually warranted.
Individuals vaccinated with AstraZeneca COVID-19 Vaccine or COVISHIELD should be instructed to seek immediate medical attention if they develop symptoms such as rapid swelling of the arms and legs, sudden weight gain and feel faint due to low blood pressure.
Health Canada has worked closely with international regulators and reviewed the available data. Health Canada continues to gather Canadian and international information from manufacturers, international regulators and other experts, and will communicate any new information as needed.
Health Canada worked with the manufacturers to update the respective Product Monographs of AstraZeneca COVID-19 Vaccine and COVISHIELD to reflect current knowledge of this safety issue in a timely manner. Further updates will be made or other actions will be taken, if required, based on emerging evidence.
The benefits of the AstraZeneca COVID-19 Vaccine and COVISHIELD in protecting Canadians from COVID-19 continue to outweigh the risks. Canadians are encouraged to get immunized with any of the COVID-19 vaccines that are authorized and available in Canada.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75947a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 10 Apr 2021 and 12 Jun 2021.
Ends/Wednesday, Jun 30, 2021
Issued at HKT 14:00
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