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F.D.A. Tells Johnson & Johnson That 60 Million Vaccine Doses Cannot Be Used

  • June 13, 2021

The F.D.A.’s move brings to 75 million the total number of doses that Johnson Johnson has had to discard because of the manufacturing lapses. Still to be decided is the fate of more than 100 million other doses of the Johnson Johnson and AstraZeneca vaccines that Emergent has produced.

Regulators are combing through records to determine whether those are safe to release. “The agency will keep the public informed as those reviews are completed,” the F.D.A. said in a statement.

Emergent’s troubles have become a serious problem for the Biden administration, which had been counting on exporting tens of millions of Johnson Johnson and AstraZeneca doses produced at the plant. Federal officials cracked down on Emergent in April, pausing the plant’s operations, stripping Emergent of its responsibility for manufacturing AstraZeneca’s vaccine and instructing Johnson Johnson to take control of manufacturing at the site.

Because of Emergent’s problems, Johnson Johnson has fallen far behind on its promise to deliver 100 million doses to the U.S. government by the end of June. Johnson Johnson also encountered a significant setback in April when federal health officials recommended that states stop using its vaccine temporarily while the F.D.A. and the Centers for Disease Control and Prevention investigated possible ties to a rare blood-clotting disorder.

Although officials reversed that recommendation about 10 days later, the pause appears to have helped sap interest in the Johnson Johnson shot. Dr. Rupali J. Limaye, a Johns Hopkins University researcher who studies vaccine use, said that Emergent’s lapses might further diminish the public’s faith in Johnson Johnson’s shot and might lead to wariness about other coronavirus vaccines.

“It’s a great product — it’s safe, efficacious and allows us to reach people who are more transient,” she said. “But this undermines the confidence in the product more generally.”

President Biden announced in late April that the U.S. would send as many as 60 million doses of AstraZeneca’s vaccine abroad once they had F.D.A. clearance, even though the Emergent plant was already under intense scrutiny from regulators. The agency is continuing to evaluate the safety of at least 70 million AstraZeneca doses produced there, people familiar with the matter said.

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