J&J says batch of COVID-19 vaccine ingredient fails to meet quality standards

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Johnson & Johnson announced it had found a problem with a batch of drug substance for its COVID-19 vaccine, which did not meet quality standards at Emergent Biosolutions’ production site in Baltimore, Maryland.

The issue was identified and addressed with Emergent and shared with the U.S. Food & Drug Administration, J&J said, adding it was sending more people to supervise manufacturing at the plant.

Workers at the plant manufacturing coronavirus shots for J&J and AstraZeneca accidentally conflated the vaccines’ ingredients several weeks ago, the New York Times earlier reported, adding that Federal officials attributed the mistake to human error.

J&J tapped contract manufacturers Catalent Inc and Emergent to scale up production and meet its global supply targets. Catalent provides the final stage – called fill and finish – while Emergent makes the drug substance.

The company also said it had met its commitment to deliver more than 20 million single-shot vaccines by the end of March in the United States.

Main Photo: Vials of the Janssen (Pharmaceutical Companies of Johnson & Johnson) vaccine against Covid-19. EPA-EFE/ETIENNE LAURENT

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