June 11, 2021 | Ottawa, ON | Health Canada
Further to Health Canada’s statement on April 30, 2021, Health Canada has completed its quality review of the shipment of Janssen vaccines that are currently in quarantine. To protect the health and safety of Canadians in response to concerns regarding a drug substance produced at the Emergent BioSolutions facility in Baltimore Maryland, Health Canada will not be releasing the shipment.
The drug substance produced at the Emergent BioSolutions facility was used in the manufacturing of this shipment of Janssen vaccines. The drug substance was manufactured at the time a separate batch of vaccines was contaminated by the components of a different vaccine. Health Canada was unable to determine that this shipment of Janssen vaccines meets the Department’s rigorous quality standards.
To ensure the safety of any future vaccine supply from this facility, Health Canada is planning an onsite inspection, expected to take place this summer. Until this inspection has been completed, Canada will not be accepting any product or ingredients made at this site.
Canadians can be assured that any vaccines will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.