Workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines’ ingredients several weeks ago, ruining about 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.
The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca. Federal officials attributed the mistake to human error.
The mix-up has halted future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions’ work to avoid further quality lapses.
The mistake is a major embarrassment for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program.
It does not affect Johnson & Johnson doses that are currently being delivered and used nationwide. All those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.
But all further shipments of the Johnson & Johnson vaccine — projected to total tens of millions of doses in the next month — were supposed to come from the massive Baltimore plant.
Those shipments are now in question while the quality control issues are sorted out, according to people familiar with the matter.
Federal officials still expect to have enough doses to meet President Joe Biden’s commitment to provide enough vaccine by the end of May to immunize every adult. The two other federally authorized manufacturers, Pfizer-BioNTech and Moderna, are continuing to deliver as expected.
Pfizer is shipping its doses ahead of schedule, and Moderna is on the verge of winning approval to deliver vials of vaccine packed with up to 15 doses instead of 10, further boosting the nation’s stock.
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April 01, 2021 at 05:46AM
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J&J vaccine manufacturing error affects 15 million doses - The Boston Globe
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