F.D.A. Tells J.&J. to Throw Out 60 Million Doses Made at Troubled Plant

F.D.A. Tells J.&J. to Throw Out 60 Million Doses Made at Troubled Plant

2021-06-11 15:24:27

WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used due to potential contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow approximately 10 million doses to be distributed in the United States or shipped to other countries, but with the caveat that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant , followed good manufacturing practices.

The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months due to regulatory concerns, people said.

The doses of Johnson & Johnson administered in the United States to date have been manufactured at the company's facility in the Netherlands, not by Emergent. For weeks, the F.D.A. has been trying to figure out what to do with at least 170 million doses of vaccine that remained in limbo after the discovery of a major manufacturing accident involving two vaccines manufactured at the Baltimore plant.

More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were suspended after Emergent discovered in March that its employees had contaminated a batch of Johnson & Johnson vaccine with a key ingredient used to manufacture AstraZeneca's. Federal officials then ordered the plant to suspend production, stripped Emergent of its responsibility to produce AstraZeneca's vaccine, and instructed Johnson & Johnson to exercise direct control over the production of its vaccine there.

Johnson & Johnson's vaccine was once considered a potential game-changer in the country's vaccine supply, as it required only one injection and was especially helpful in vulnerable communities. But the federal government now has a large stock of the vaccines from Pfizer-BioNTech and Moderna, the two other federally authorized vaccine developers, and no longer needs Johnson & Johnson's stock.

Still, the loss of 60 million Johnson & Johnson doses puts a dent in the Biden administration's plan to distribute vaccines to other countries still gripped by the pandemic. The government had been counting on sharing doses from both Johnson & Johnson and AstraZeneca, but had to postpone its plan while the F.D.A. completed an assessment of the facility.

After arriving in Britain this week for the Group of 7 summit, President Biden announced that he had found another source for donations. Pfizer-BioNTech has now agreed to sell its administration of 500 million doses at cost for donation to low- and lower-middle-income countries over the next year. The World Health Organization estimates that 11 billion doses are needed worldwide to eradicate the epidemic.

The FDA's move is disappointing news for Emergent and Johnson & Johnson, who hired the company as a subcontractor. Inspectors are still investigating the factory and are not expected to decide until later this month whether the company can reopen the factory, according to people familiar with the situation. Regulators also continue to cast doubt on whether the company, which has received hundreds of millions of dollars from the federal government to manufacture coronavirus vaccines, adhered to manufacturing standards.

The agency's plan to allow 10 million doses in the United States or abroad with a warning is somewhat unusual for an emergency-approved product, experts say. Regulators have the freedom to take that action if the drugs are desperately needed and in short supply, they said.

In a statement, the F.D.A. said that before making its decision, it "carried out a thorough review of the facility records and the results of quality tests performed by the manufacturer." It also took into account the ongoing public health emergency. The agency said it continued to "work through problems" at the Baltimore plant with Johnson & Johnson and Emergent.

dr. Peter Marks, the FDA's chief vaccine regulator, said in the statement that the agency has conducted a comprehensive review of batches of vaccine produced at the plant "as Emergent BioSolutions prepares to resume manufacturing operations with corrective action to ensure compliance with the current FDA Good Manufacturing Practice requirements.”

Representatives from Johnson & Johnson and Emergent declined to comment on the agency's decision.


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