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 manufacturing materials for Covid-19 vaccines, while US regulators are investigating the Baltimore plant responsible for ruining millions of Johnson & Johnson shots, Emergent said Monday in a regulatory application.
The FDA initiated an inspection of the facility on April 12, asking the company to halt production on April 16, pending the completion of the review and recovery, Emergent said in a filing with the Securities and Exchange Commission. The company said it had quarantined all existing material manufactured in the facility.
J&J was not immediately available for comment.
Earlier this month, the government of Biden put J&J in charge of the Baltimore plant after US officials learned that Emergent, a contract manufacturer that made vaccines for both J&J and AstraZeneca, had mixed the ingredients for the two injections. Officials also stopped production of the AstraZeneca vaccine.
The government’s decision to allow the facility to make only the J&J single-dose vaccine is intended to avoid future confusion, the New York Times reported, citing two senior federal health officials.
The interruption in 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 in which one died. and one in critical condition.
This is a story in progress. Please check again for updates.
–Reuters contributed to this report.