India — Canada health authorities have halted the distribution of the single-dose Johnson & Johnson Covid-19 vaccine in the country after it emerged that an active ingredient was made at an American facility that has been flagged by the US’ Food and Drugs Administration.
Canada received 300,000 doses of the vaccine manufactured by Janssen on April 28. However, 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”.
However, the AZ vaccines have already been distributed in Canada and administered across the country. Health Canada asserted that it “remains confident that the 1.5 million doses of AstraZeneca vaccine imported into Canada from this facility meet quality specifications.”
On April 25, Health Canada had stated that the Janssen vaccines anticipated to come into the country this week did not originate from the Emergent facility. The information about the active ingredient came to the department since that statement was issued.