The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Saul Loeb | AFP | Getty Images
The Food and Drug Administration has asked Emergent BioSolutions to temporarily stop producing materials for Covid-19 vaccines while U.S. regulators investigate its plant in Baltimore responsible for ruining millions of Johnson & Johnson shots, Emergent said in a regulatory filing Monday.
The FDA initiated an inspection of the facility on April 12 and asked the company to halt manufacturing on April 16, pending completion of the review and remediation, Emergent said in a filing to the Securities and Exchange Commission. The company said it quarantined all existing material manufactured at the facility.
J&J wasn’t immediately available for comment.
Earlier this month, the Biden administration put J&J in charge of the Baltimore plant after U.S. officials learned that Emergent, a contract manufacturer that had been making vaccines for both J&J and AstraZeneca, mixed up ingredients for the two shots. Officials also stopped production of the AstraZeneca vaccine.
The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the New York Times reported, citing two senior federal health officials.
The pause of production of the J&J vaccine is the latest setback for the company. Last week, the Food and Drug Administration and the Centers for Disease Control and Prevention advised states to temporarily stop using J&J’s vaccine “out of an abundance of caution” after six women developed a rare but potentially life-threatening blood clotting disorder that left one dead and one in critical condition.
This is a developing story. Please check back for updates.
–Reuters contributed to this report.