FDA orders troubled Baltimore J&J contractor to pause manufacturing

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.

“While we await the FDA’s full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine,” Emergent said in an e-mailed statement to The Hill.

“We recognize the confusion these recent events may have caused our customers, our employees, and the public. We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes,” the company said.

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.

In response to that mistake, the Biden administration removed AstraZeneca manufacturing from the plant and installed Johnson & Johnson leadership for complete control of vaccine production.

Johnson & Johnson had been struggling to maintain a consistent supply of vaccine doses to the U.S. Biden administration officials and the company have said it will produce nearly 100 million doses by June.

But it’s unclear if the company will be able to meet that goal. Biden administration officials were counting on the Baltimore facility to produce millions of doses a week by the end of this month, even though the plant has yet to receive FDA authorization.

J&J has not publicly acknowledged a previous goal of delivering 24 million doses by the end of April.

The Biden administration has said it has enough supply of vaccines from Pfizer-BioNTech and Moderna to inoculate the population without J&J, but the one-dose vaccine plays an important role in helping to reach particularly vulnerable communities such as the homeless, homebound and prisoners.

Last week, regulators paused the use of Johnson & Johnson’s vaccine in the U.S. because of the potential risk of rare but serious blood clots. The pause remains in effect, though some officials have said it could be lifted by Friday.