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Monday, April 12, 2021

US: Factory mix-up ruins up to 15 million Johnson & Johnson vaccine doses

A manufacturing subcontractor in Baltimore mixed ingredients from the coronavirus vaccines of Johnson & Johnson and AstraZeneca, setting back US production of the “one-and-done” shot

By: New York Times |
April 1, 2021 8:41:33 am
This Dec. 2, 2020 photo provided by Johnson & Johnson shows vials of the COVID-19 vaccine in the United States. (Johnson & Johnson via AP)

Written by Sharon LaFraniere and Noah Weiland

Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, contaminating as many as 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.

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.

The problems arose in a new plant that the federal government enlisted last year to produce both Johnson & Johnson’s and AstraZeneca’s vaccines. Both use similar technology in which genes unique to the coronavirus are shuttled into human cells, where they cause the immune system to produce antibodies.

In less than a year, Emergent hired and trained hundreds of new workers to produce millions of doses of both vaccines that were supposed to be ready by the time that clinical trials showed whether they actually worked. In late February, one or more workers somehow confused a key ingredient for AstraZeneca’s vaccine with Johnson & Johnson’s, raising questions about training and supervision.

Vaccine production is a notoriously fickle science, and errors are often expected to occur and ruin batches. But Emergent’s mistake went undiscovered for days until Johnson & Johnson’s quality control checks uncovered it, according to people familiar with the situation. By then, up to 15 million doses had been contaminated.

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