FDA, J&J to announce vaccine contamination problems at Baltimore plant are resolved: report
The Food and Drug Administration (FDA) and Johnson & Johnson expect to announce that COVID-19 vaccine contamination problems at a facility in Baltimore have been resolved, The Wall Street Journal reported.
U.S. officials told the newspaper that emergency use authorization for the Emergent BioSolutions facility to produce J&J’s vaccine could come next week.
One official told the newspaper Emergent’s plant has produced millions of doses but most aren’t finished and are placed in vials, meaning it could take months before all the doses are ready.
As part of the arrangement, The U.S. and J&J tentatively agreed that about 60 million doses of the vaccine substance made at the plant will be cleared for use in either the U.S. or overseas.
The report comes about a week after Emergent CEO Robert Kramer told a House panel that the plant could resume manufacturing the vaccine “within a matter of days.”
Kramer further acknowledged the unsanitary conditions at the factory and that staff were inadequately trained. He said the company had been working with the FDA to resolve the issues.
The FDA ordered Emergent to stop producing vaccine materials for J&J’s vaccine pending an inspection after 15 million doses of the vaccine were contaminated with ingredients from AstraZeneca’s two-dose vaccine. The plant was manufacturing both doses at the time.
The Biden administration made AstraZeneca find a new manufacturing partner, giving J&J complete control over the Emergent plant.
A report released days after the plant stopped production revealed that the plant wasn’t maintained in a “clean and sanitary condition,” and that procedures were not in place to prevent cross-contamination.
Emergent did not have any comment on the Journal’s reporting when reached by The Hill.
The Hill has reached out to J&J and the FDA for comment.
The issues with the plant were revealed at the same time that use of the J&J vaccine was briefly paused due to reports of rare blood clots.