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Factory Mix-Up Ruins 15 Million Vaccine Doses from Johnson & Johnson

https://www.nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html

A manufacturing subcontractor in Baltimore mixed ingredients from the coronavirus vaccines of Johnson & Johnson and AstraZeneca, delaying U.S. shipments of the “one-and-done” shot.

By Sharon LaFraniere and Noah Weiland

March 31, 2021

WASHINGTON — Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, contaminating up to 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, the British-Swedish company whose vaccine has yet to be authorized for use in the United States. Federal officials attributed the mistake to human error.

The mix-up has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates what occurred. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions’ work to avoid additional quality lapses.

The mistake is a major embarrassment both for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program, and for Emergent, its subcontractor, which has faced fierce criticism for its heavy lobbying for federal contracts, especially for the government’s emergency health stockpile.

The error does not affect any Johnson & Johnson doses that are currently being delivered and used nationwide, including the shipments that states are counting on next week. All those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.

Further shipments of the Johnson & Johnson vaccine — expected to total 24 million doses in the next month - were supposed to come from the giant plant in Baltimore. Those deliveries are now in question while the quality control issues are sorted out, according to people familiar with the matter.

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