Health Canada holding off J&J vaccine over quality issues

Health Canada is holding off using the first batch of 300,000 Johnson & Johnson COVID-19 jabs after learning that a part of the vaccine was made in the same US plant where millions of doses were spoiled.

A statement from Canada’s health agency said it found that a “drug substance” needed to become the final J&J vaccine was made at the Emergent Biosolutions plant in Baltimore, Maryland.

“The drug substance is the active ingredient that undergoes further processing before becoming the final product (i.e., the vaccine). The final Janssen vaccines were manufactured at a different site located outside of the US,” the statement added.

The plant has been in news for several violations, including cleaning and sterilisation as well as the potential for cross-contamination. The US Food and Drug Administration (FDA) has since ordered the facility to stop making more J&J vaccines until it addresses the violations and manufacturing errors, which resulted in 15 millions of those doses being destroyed.

Health Canada stated that it was working with Janssen and the FDA to assess the vaccines and they would only be released once it “is satisfied that they meet the Department’s high standards for quality, safety and efficacy”.

The agency also maintained confidence that the 1.5 million AstraZeneca vaccines also delivered to Canada from that plant in late March were still safe and met “quality specifications”, the report said.

“Since issuing our statement [on AstraZeneca], Health Canada has 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,” read the statement.



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