Janssen COVID-19 Vaccine Shipment Made with Drug Substance from Emergent BioSolutions Fails QA

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 a time when a separate batch of vaccines was contaminated.

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.