Canada pauses J&J rollout after mistake in Maryland lab

Canada is pausing the rollout of hundreds of thousands of doses of the Johnson & Johnson coronavirus vaccine after learning that they were manufactured in part from materials from the embattled Emergent BioSolutions plant in Baltimore.

Health Canada said in a statement that it had “learned that a drug substance produced at the Emergent site was used in the manufacturing of the initial Janssen vaccines received on April 28 and intended for use in Canada,” referencing Johnson & Johnson’s pharmaceutical arm. 

“As with all vaccines imported into Canada, the Janssen 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. Health Canada is currently working with Janssen and the FDA to obtain all of the information it needs to complete this assessment, prior to releasing the Janssen vaccines for distribution,” it said. 

Health Canada had already greenlighted 1.5 million doses of the Oxford-AstraZeneca vaccine that had been made at the facility, and said it was “confident” the shots “meet quality specifications.”

“Health Canada has rigorous processes in place to continually monitor the quality of vaccines that are administered to Canadians. 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,” the agency said in the statement. 

The Johnson & Johnson shot has not yet been used in Canada.

The announcement is the latest setback for the Emergent plant. 

Johnson & Johnson contracted with Emergent to help manufacture vaccines early in the pandemic, but the company came under a firestorm of criticism after 15 million doses of the vaccine were ruined last month from being contaminated by ingredients from AstraZeneca’s vaccine. 

Compounding the plant’s troubles, the Biden administration removed AstraZeneca manufacturing from the site and ordered Johnson & Johnson to completely oversee vaccine production there.

Federal regulators last week ultimately ordered the plant to halt production of new Johnson & Johnson vaccine material as it conducts an inspection.