F.D.A. Gives Approval for Emergent Vaccine Plant in Baltimore to Reopen

Federal regulators have approved the reopening of a troubled Baltimore vaccine-making plant that has been closed for more than three months over contamination concerns that delayed the delivery of about 170 million doses of coronavirus vaccine.

The turnabout came after a two-day inspection at the plant this week by the Food and Drug Administration and weeks of effort by Johnson & Johnson and its subcontractor, Emergent BioSolutions, to bring the site up to standard.

The F.D.A. had halted production at the factory in late March after it was discovered that workers had accidentally contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used in AstraZeneca’s, then made at the same site.

The federal government also stripped Emergent of the responsibility to manufacture AstraZeneca’s vaccine and instructed Johnson & Johnson to assert greater control over Emergent’s operation.

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Robert Kramer, the chief executive of Emergent, said in a statement on Thursday.

“We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone, and we are grateful for the opportunity to help bring this global pandemic to an end,” he added.

The development, reported earlier by The Wall Street Journal, is welcome news for Johnson & Johnson. Because of Emergent’s failures to meet manufacturing standards, Johnson & Johnson has fallen behind on its contractual pledges to deliver vaccine to the United States government and to Europe.

The F.D.A.’s decision that the Baltimore plant can resume operation does not mean that the agency has broadly authorized Johnson & Johnson to distribute doses made by Emergent on an emergency basis. In a statement, Johnson & Johnson said it is continuing to work toward that F.D.A. authorization.

Without it, Johnson & Johnson has been unable to distribute Emergent-produced doses without specific, batch-by-batch clearance by regulators. The equivalent of up to 75 million doses have been cleared since production was halted, but tens of millions of doses still remain in limbo.

It remains unclear whether the federal government would deploy additional Johnson & Johnson doses at home, export them or both. So far, the vast bulk of the nation’s vaccine stock has came from Pfizer-BioNTech and Moderna, the two other vaccine developers. The federal government has purchased huge quantities of those vaccines for the future.

Before it halted operations, Emergent said that the plant had the capacity to produce about a billion doses of vaccine a year. Production will need to gear up in stages, officials said.

In a conference call with investors later on Thursday, company officials disclosed a $41.5 million loss from having to discard batches of vaccine that regulators deemed unusable. The company spent another $12.4 million to correct problems at the Baltimore facility, executives said.

Also during the call, Mr. Kramer announced that Sean Kirk, a longtime Emergent executive overseeing manufacturing who went on personal leave earlier this year after regulators found a host of problems at the Baltimore site, would be leaving the company.

Chris Hamby contributed reporting.


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