"Quality" issue at Baltimore vaccine plant delays some of Johnson & Johnson's vaccine

Employees work in a lab at Emergent Biosolutions which is manufacturing vaccines for Astra Zeneca and Johnson & Johnson on February 8

Workers at Emergent BioSolutions' Baltimore plant accidentally conflated the Janssen vaccines' ingredients several weeks ago, Johnson & Johnson confirmed Wednesday.

In a statement, Johnson & Johnson said a batch of drug substance failed its quality test.

The company also said the batch "was never advanced to the filling and finishing stages of our manufacturing process".

To be clear, the Times report says this "does not affect Johnson & Johnson doses that are now being delivered and used nationwide". In a statement, J&J said it's working with federal authorities to deliver 24 million doses of the vaccine in April.

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J&J has met its goal to ship 20 million doses to the US government by the end of March, the company said in its statement.

"This quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine". He relied on that in moving up his timeline on when the USA would have enough vaccine to cover all adults. Some additional doses may not yet have been recorded as delivered, and federal health officials said Wednesday that another 11 million doses of the vaccine would be available for shipments starting on Thursday. J&J didn't immediately offer an explanation as to why CDC data show just 6.8 million doses having been delivered to states.

The state administration "has not received any notice of delay in shipment of J&J vaccine to the Commonwealth from the federal government, and this week received 383,000 doses as part of the state allocation from the federal government of Moderna, Pfizer and J&J doses", wrote Kate Reilly, the communications director for the state's COVID-19 Response Command Center. Following a December 2017 inspection at an Emergent plant in Canton, Massachusetts, the FDA said the company hadn't corrected "continued low level mold and yeast isolates" found in the facility.

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