Canada is pausing distribution of the recent shipment of the Johnson & Johnson COVID-19 vaccine after Health Canada learned part of them were manufactured at a Maryland facility that messed up the ingredients in 15 million doses bound for the U.S. market.
The Emergent Biosolutions facility in Baltimore was recently cited by the U.S. Food and Drug Administration for violations including cleaning and sterilization failures, the potential for cross-contamination and failure to follow required protocols.
The FDA ordered the facility to stop making more J&J vaccine until the problems are corrected and the earlier mistake on the doses resulted in all 15 million being destroyed.
Health Canada had already cleared 1.5 million doses of the Oxford-AstraZeneca vaccine made at the facility, but did not think the Canadian J&J doses had any connection to that plant.
Now Health Canada says the drug substance that makes up part of the J&J vaccine was actually produced there and then shipped elsewhere for the vaccines to be finished.
Health Canada says it is seeking information from the FDA and J&J’s pharmaceutical arm, Janssen, to determine if the 300,000 doses shipped to Canada meet required safety standards.
In a statement, Health Canada says those doses will only be released when “once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”
A spokesperson for Health Minister Patty Hajdu said the government was made aware of the information late Friday – the same day that Health Canada decided to communicate it with Canadians.
The J&J vaccine has not been used in Canada so far, and the National Advisory Committee on Immunization hasn’t yet provided guidance on how they think it should be used.