OTTAWA, Ontario – Plans to distribute the first 300,000 doses of Johnson & Johnson COVID-19 vaccine in Canada next week have been delayed after Health Canada learned that some of them were manufactured at a facility in Maryland, confusing ingredients in 15 million doses related to the US market.
The Baltimore Emergency Biosolution Facility was recently cited by the U.S. Food and Drug Administration for violations, including cleaning and sterilization failures, potential for cross-contamination, and failure to comply with required protocols.
The FDA has ordered the facility to stop producing more J&J vaccines until the problems are corrected and an earlier dose error resulted in the destruction of all 15 million.
Health Canada has already cleared 1
Health Canada now says the drug, which is part of the J&J vaccine, was actually produced there and then transported elsewhere to complete the vaccines.
Health Canada says it is seeking information from the FDA’s pharmaceutical division and J&J Janssen to determine whether the 300,000 doses sent to Canada meet safety requirements.
The J&J vaccine is not currently used in Canada.
The doses arrived in Canada on Wednesday.
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