Health Canada holding back 1st batch of J&J COVID-19 vaccines over quality control issues

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Health Canada says it will hold back the first batch of 300,000 Johnson & Johnson COVID-19 vaccines after learning that a part of the vaccine was made in the same U.S. plant where millions of doses meant for the U.S. market were spoiled.

According to the agency, a “drug substance” that would then undergo processing to become the final J&J vaccine was made at the Emergent Biosolutions plant in Baltimore, Maryland. The substance was then shipped to a separate site located outside of the U.S. to be created into the final version of the vaccine.

READ MORE: Johnson & Johnson vaccine is coming to Canada. How do we use it best?

The U.S. Food and Drug Administration (FDA) previously cited the plant for several violations, including cleaning and sterilization as well as the potential for cross-contamination.

The 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.

In a statement Friday, the health agency said 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.”

“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.
READ MORE: U.S. puts Johnson & Johnson in charge of plant that botched batch of COVID-19 vaccines

“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 U.S.”

In a tweet Friday, federal Conservative Health Critic Michelle Rempel Garner called Health Canada’s announcement “inexcusable.”

“Why was this communicated at the eleventh hour before shots went into arms?” she wrote.

“We knew these vaccines were coming for weeks. Major screw up with huge implications.”

Health Canada did not add anything further to its statement after being contacted by Global News.

Source: Global News