Healthcare professionals including infectious disease physicians, family physicians, emergency room physicians, hematologists, neurologists, pharmacists, public health officials, nurses and nurse practitioners, and healthcare professionals at identified points of use.
Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with AstraZeneca COVID-19 Vaccine. A history of CLS was noted in some of the cases. A fatal outcome has been reported.
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.
CLS is characterised by acute episodes of limb edema, hemoconcentration, hypoalbuminemia and hypotension leading to organ damage. Patients with an acute episode of CLS following vaccination require an urgent medical assessment. Intensive supportive therapy is usually warranted for this life-threatening condition.
Health Canada worked with the manufacturers of AstraZeneca COVID-19 Vaccineand COVISHIELD to update the Product Monographs for these products to include this new safety information, as well as other updates including additional guidance for healthcare professionals regarding thrombosis with thrombocytopenia syndrome.
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.
The AstraZeneca COVID-19 Vaccine and COVISHIELD were authorized for use in Canada on February 26, 2021, in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Since the time of authorization, there have been very rare reports of capillary leak syndrome (CLS) following administration of the AstraZeneca COVID-19 Vaccine. Health Canada is working with international regulators and public health authorities to review data and evidence as it becomes available on these very rare events.
AstraZeneca COVID-19 Vaccine, COVID-19 Vaccine (ChAdOx1-S [recombinant])
5 mL solution for intramuscular injection, multiple dose vials.
Each vial contains 10 doses (each dose is 0.5 mL).
DIN: 02510847
4 mL solution for intramuscular injection, multiple dose vials.
Each vial contains 8 doses (each dose is 0.5 mL).
DIN: 02511444
Manufacturer: AstraZeneca Canada Inc.
Canadian Importer and Distributor: AstraZeneca Canada Inc.
COVISHIELD, COVID-19 Vaccine (ChAdOx1-S [recombinant])
5 mL solution for intramuscular injection, multiple dose vials.
Each vial contains 10 doses (each dose is 0.5 mL).
DIN: 02512947
Manufacturer: Serum Institute of India Pvt. Ltd.
Canadian Importer and Distributor: Verity Pharmaceuticals Inc.
The AstraZeneca COVID-19 Vaccine and COVISHIELD are indicated for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 (COVID-19).
Very rare cases of 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 June 18, 2021, one case of CLS following vaccination with the AstraZeneca COVID-19 Vaccine has been reported in Canada.
AstraZeneca COVID-19 Vaccine and COVISHIELD are now contraindicated in individuals who have previously experienced episodes of CLS.
Health Canada contin...
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