Sun Sentinel Palm Beach Edition

Factory error to delay J&J doses

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Workers at a plant making two coronaviru­s vaccines accidental­ly ruined about 15 million doses.

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 country while the Food and Drug Administra­tion investigat­es. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutio­ns’ work to avoid further quality lapses.

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 further shipments of the J&J vaccine — projected to total tens of millions of doses in the next month — were supposed to come from the 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.

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