FDA orders troubled Baltimore J&J contractor to pause manufacturing

In addition to a pause on the use of the Johnson & Johnson vaccine because of concerns about very rare blood clots, there is now also a manufacturing pause at a Baltimore plant making the vaccine.

Federal regulators ordered the embattled Emergent BioSolutions plant in Baltimore to stop producing new Johnson & Johnson vaccine material pending a completed inspection, the company said Monday.

In a regulatory filing with the Securities and Exchanges Commission released Monday, Emergent said it “agreed not to initiate the manufacturing of any new material” for Johnson & Johnson’s vaccine “and to quarantine existing material” until the Food and Drug Administration (FDA) finishes its inspection.

The FDA began its inspection April 12, the company said.

Background: The disclosure from Emergent is the latest blow to Johnson & Johnson’s ramping up of domestic production for its coronavirus vaccine.

J&J contracted with Emergent to help manufacture vaccines early in the pandemic, but the company has come under fire from regulators after 15 million doses of the vaccine were ruined last month after being contaminated by ingredients from AstraZeneca’s vaccine.