Canada’s drug regulator on Friday said that it is halting the release of the country’s first shipment of the Johnson and Johnson vaccine to verify its safety and quality.
In a statement released on Friday, Health Canada said these were being withheld and “will only be released for distribution” once it “is satisfied that they meet the department’s high standards for quality, safety and efficacy”.
This move came after Health Canada learnt that a drug substance was produced at the Emergent BioSolutions facility in Baltimore, Maryland, which has been inspected by the FDA with the agency noting multiple areas of concerns there.
Health Canada noted the substance is the “active ingredient that undergoes further processing before becoming the final product”, the vaccine. “The final Janssen vaccines were manufactured at a different site located outside of the US,” it said.
It added, “We will continue to ensure that products coming from the Emergent facility, or any other facility, will only be imported and distributed in Canada if they are of high quality and safe for use.”
It said the department is currently working with Janssen and the FDA to obtain all of the information it needs to complete its “assessment, prior to releasing the Janssen vaccines for distribution.”
Canada has also received 1.5 million doses of the AstraZeneca vaccine made at the same facility and Health Canada said it is also working with them “to ensure the facility meets manufacturing standards, and that all vaccine supplies for Canada are of high quality”.