Janssen COVID-19 Vaccine Authorization Health Canada has authorized the sale of Janssen COVID-19 Vaccine under an Interim Order (IO). The Janssen COVID-19 Vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The Janssen COVID-19 Vaccine must be injected intramuscularly only. The use of Janssen COVID-19 Vaccine is permitted under an interim authorization delivered in accordance with section 5 of the COVID-19 IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the Market Authorization Holder to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada’s IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected reports of adverse events following immunization. Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events Following Immunization (AEFI) Form or call: