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NEW YORK (Reuters) – Johnson & Johnson said on Wednesday it discovered a problem with a batch of drug substance for its COVID-19 vaccine, which did not meet quality standards at the Emerging Biosolutions production site in Baltimore, Maryland.
The issue was identified and addressed with Emergent and shared with the US Food & Drug Administration, J&J said, adding that it was sending more people to oversee manufacturing at the plant.
Workers at the coronavirus vaccine manufacturing plant for J&J and AstraZeneca accidentally confused vaccine ingredients several weeks ago, The New York Times reported earlier, adding that federal officials attributed the error to a human error. The Times said about 15 million doses of the single-shot vaccine were destroyed by the confusion. The CDC reports that there are currently 54.6 million fully vaccinated people in the United States, so 15 million doses would be a significant loss.
J&J called on contract manufacturers Catalent and Emergent to increase production and meet its global sourcing goals. Catalent provides the final step – called fill and finish – while Emergent makes the drug substance.
The company also said it has met its commitment to deliver more than 20 million single-injection vaccines by the end of March to the United States.
(Reporting by Dania Nadeem in Bengaluru; Editing by Anil D’Silva)
© Copyright Thomson Reuters 2021
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