OTTAWA, Canada (AP) – Plans to distribute the first 300,000 doses of Johnson & Johnson’s COVID-19 vaccine to reach Canada in the coming days are on hold after Health Canada learned that part of them were manufactured in a Maryland plant that improperly mixed ingredients in 15 million doses destined for the US market.
The doses arrived in Canada on Wednesday, but those J&J vaccines have not been applied in the North American country until now.
The US Food and Drug Administration (FDA) recently cited the Emergent Biosolutions factory in Baltimore for violations including cleaning and sterilization failures, the potential for cross-contamination, and failure to adhere to required protocols.
The FDA ordered the plant to stop producing more J&J vaccines until the problems were corrected. Previous errors caused the destruction of 15 million doses.
The national health agency, Health Canada, had already authorized 1.5 million doses of the Oxford-AstraZeneca vaccine produced at that factory, but did not believe that the doses from J&J for the Canadian market had any connection to that plant. Now Health Canada says that the drug substance that is part of the J&J vaccine was produced there and then shipped elsewhere to finish producing the vaccines.
Health Canada reported that it is seeking information from the FDA and J & J’s pharmaceutical arm, Janssen, to determine whether the 300,000 doses shipped to Canada meet the required hygiene and safety standards.
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