Johnson & Johnson admits batch of COVID-19 vaccine failed ‘quality standards’

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Vaccine hopes boosted by data from Novavax and J&J, but fears over new variants remain


Johnson & Johnson Inc. on Wednesday acknowledged a batch of its COVID-19 vaccine produced by one of its manufacturing partners “did not meet quality standards,” and said it will provide more experts to oversee production.

Earlier, the New York Times reported that 15 million doses of the one-shot vaccine were ruined at a Baltimore production plant run by Emergent BioSolutions
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after workers made a mistake with the vaccine’s ingredients. The Times reported the incident prevented federal regulators from approving the plant’s production lines.

In a statement late Wednesday, Johnson & Johnson
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said the the error was discovered in the quality-control process, and the batch “was never advanced to the filling and finishing stages of our manufacturing process.” The drug maker did not say how many doses were affected.

“Quality and safety continue to be our top priority,” the company said. “Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”

Johnson & Johnson said those steps will keep it on track to deliver an additional 24 million vaccine doses by the end of April, and 100 million doses to be delivered in the U.S. by the end of May.



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