"Emergent BioSolutions has shut down new manufacturing of Johnson & Johnson’s coronavirus vaccine at its Baltimore plant at the request of the Food and Drug Administration after an inspection of the troubled facility last week, Emergent said Monday.
The halt in production is another setback for Johnson & Johnson as it attempts to meet its promise to deliver nearly 100 million doses of vaccine to the U.S. government by the end of May.
Emergent’s brief statement Monday said the FDA began a new inspection of its Bayview facility on April 12. On Friday, at the FDA’s request, “Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings,’’ the company said."
It said it was striving to make unspecified improvements “to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”
"Johnson & Johnson said it’s working to resolve the situation at Emergent.
“We will work with Emergent and FDA to address any findings at the conclusion of the FDA inspection,’’ said company spokesman Jake Sargent in a statement. “At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries. We remain committed to delivering 100 million single-shot doses of our coronavirus vaccine to the U.S. Government and helping to bring an end to this global pandemic.’’
Johnson & Johnson has an agreement with Merck, brokered by the Biden administration, for vaccine manufacturing, but it is not expected to produce raw vaccine substance for months.
A federal official who spoke on the condition of anonymity to discuss ongoing federal reviews said Emergent would be notified later this week on the inspection results.
“We recognize the confusion these recent events may have caused our customers, our employees, and the public,” Emergent said in its statement."