After a two-day inspection, the F.D.A. said operations could start again at the Emergent BioSolutions site where Johnson & Johnson doses were contaminated. …
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.
