The Candian government agency found that a "drug substance" needed to become the final
"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 agency was quoted as saying in a statement.
The plant has been in news for several violations, including cleaning and sterilisation as well as the potential for cross-contamination. The
Health Canada stated that it was working with Janssen and the FDA to assess the vaccines and they would only be released once they were deemed to be safe.
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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