The Emergent BioSolutions plant, a manufacturing partner of 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 as U.S. regulators investigate its Baltimore plant responsible for ruining millions of Johnson & Johnson shots, say Monday Emerging in a regulatory dossier.
The FDA began an inspection of the facility on April 12 and asked the company to stop manufacturing on April 16, pending completion of overhaul and repair, Emergent said in a file to the Securities and Exchange Commission. The company said it quarantined all existing material manufactured at the facility.
J&J was not immediately available for comment.
Earlier this month, the Biden administration put J&J at the helm 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, was mixing ingredients for both shots. Officials also stopped production of the AstraZeneca vaccine.
The government’s decision to make the facility only make the J&J single-dose vaccine intended to prevent future confusion, the New York Times reported, citing two senior federal health officials.
The production pause for the J&J vaccine is the company’s latest setback. Last week, the Food and Drug Administration and the Centers for Disease Control and Prevention advised states to temporarily stop using the J&J vaccine “with great caution” after six women developed a disorder. of rarely life-threatening blood clotting that left one dead. and one in critical condition.
This is a developing story. Please check for updates again.
–Reuters contributed to this report.