Future shipments of the Johnson & Johnson COVID-19 vaccine have been halted while the Food and Drug Administration investigates after human error at a manufacturing plant ruined 15 million doses, The New York Times reported Wednesday.
The plant in Baltimore is run by Emergent Biosolutions, and workers mixed up the ingredients in the vaccine, the Times reported.
The error does not affect doses of the Johnson & Johnson vaccine that have already been distributed, as they were made in the Netherlands, but it impacts future shipments of the vaccine, according to the Times.
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The Johnson & Johnson vaccine is one of three being used in the United States.
The Pfizer and Moderna vaccines were already the bulk of the U.S. supply, and those are proceeding as planned. But the error could limit the ability of Johnson & Johnson to add considerably to the U.S. supply in the coming weeks.
The Johnson & Johnson vaccine is the only one of the three that requires just one shot to be effective. The others require two shots spaced apart.
In response to the Times report, Johnson & Johnson acknowledged in a statement that the “quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions,” noting that the doses never advanced to the packaging stage.
“The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration [FDA],” the company added.
The company said it is sending additional experts to the facility to oversee manufacturing.
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“In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April,” Johnson & Johnson said.
An FDA spokesperson said, “FDA is aware of the situation, but we are unable to comment further. Questions about a firm’s manufacturing facilities should be directed to that firm.”
Johnson & Johnson said it still has a goal of delivering 100 million doses to the U.S. by the end of June.