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Factory mix ruins up to 15 million doses of Johnson & Johnson vaccines

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WASHINGTON – Workers at a Baltimore plant making two coronavirus vaccines accidentally mixed up the ingredients several weeks ago, contaminating up to 15 million doses of Johnson & Johnson vaccine and forcing regulators to delay approval of factory production lines.

The plant is managed by Emergent BioSolutions, a manufacturing partner of Johnson & Johnson and AstraZeneca, the Anglo-Swedish company whose use of the vaccine has not yet been authorized in the United States. Federal officials attributed the error to human error.

The confusion has delayed future shipments of Johnson & Johnson doses to the United States while the Food and Drug Administration investigates what happened. Johnson & Johnson has decided to strengthen its control over the work of Emerging BioSolutions in order to avoid further quality failures.

The mistake is a major embarrassment both for Johnson & Johnson, whose single-dose vaccine has been credited with speeding up the national immunization program, and for Emergent, its subcontractor, which has faced strong criticism. for his intense lobbying for federal contracts, in particular the government’s emergency health stock.

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

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Other shipments of the Johnson & Johnson vaccine – which are expected to total tens of millions of doses next month – were due to come from the giant Baltimore plant. These deliveries are now being called into question as quality control issues are addressed, according to people familiar with the matter.

Federal officials still expect to have enough doses from the three approved coronavirus vaccine makers to meet President Biden’s pledge to provide enough vaccine to immunize every adult by the end of May. . The other two federally approved manufacturers, Pfizer-BioNTech and Moderna, continue to deliver as planned.

Pfizer is shipping its doses ahead of schedule, and Moderna is close to getting approval to deliver vaccine vials of up to 15 doses instead of 10, further bolstering the country’s stockpile.

The problems arose at a new plant that the federal government enlisted last year to produce the Johnson & Johnson and AstraZeneca vaccines. Both use similar technology in which genes unique to the coronavirus are transferred 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 the two vaccines that were supposed to be ready by the time clinical trials showed whether they actually worked. In late February, one or more workers somehow confused a key ingredient in AstraZeneca’s vaccine with that of Johnson & Johnson, raising questions about training and supervision.

Vaccine production is a notoriously fickle science, and mistakes are often expected to happen and ruin batches. But Emerg’s mistake was not discovered for days until Johnson & Johnson’s quality checks discovered it, according to people familiar with the situation. By that time, up to 15 million doses had been contaminated, people said.

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None of the doses ever left the factory and the batch was quarantined. There is no indication that production of the AstraZeneca vaccine, which has not yet been cleared for emergency use by the Food and Drug Administration, has been affected.

Johnson & Johnson reported the accident to federal regulators, who then launched an investigation that delayed the approval of the plant’s production lines. The company has increased the number of its own staff who oversee Emerg’s work and instituted a variety of new controls designed to guard against future failures.

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Johnson & Johnson has already faced a manufacturing delay that caused the company to fall behind on its commitments to the federal government, but it seemed on track to catch up. It delivered 20 million doses at the end of March and has pledged to deliver around 75 million more doses by the end of May.

White House officials covered their projections in a phone call with governors on Tuesday, predicting some deliveries from Pfizer and Moderna, but warning that Johnson & Johnson shipments would fluctuate.

In a statement Wednesday evening, the company said it expected the steps it is now taking with Emergent to deliver 24 million doses by the end of April, or whatever the federal government expects. . But that depends on whether Johnson & Johnson satisfies the Food and Drug Administration regulators.

Last week, the agency cleared a bottling facility Johnson & Johnson uses in Indiana, allowing the release of more doses made in the Netherlands. But this facility cannot send the doses produced in the Emergent factory until the Food and Drug Administration authorizes it.

Nearly seven million doses of the vaccine have been delivered to date, and about half of those have been administered, according to the Centers for Disease Control and Prevention.

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