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 suspend production of materials for Covid-19 vaccines while U.S. regulators investigate their Baltimore plant responsible for the destruction of millions of Johnson & Johnson shots, Emergent said. Said Monday in a regulatory submission.
It is said that the FDA started an inspection of the facility on April 12 and asked the company to stop production four days later, pending the review and repair. In a submission to the Securities and Exchange Commission, the company also said that all existing materials manufactured in the factory are placed in quarantine.
Emergent shares fell more than 9% on the news.
In a statement to CNBC, J&J said they would work with Emergent and the FDA “to address any findings at the end of the FDA inspection.”
“Our goal is to ensure that all medicines for our COVID-19 vaccine meet our high quality standards and ensure the emergency clearance for medicines manufactured in Emergent Bayview.” “At the moment, it is premature to speculate about the possible impact this could have on the timing of our vaccine delivery.”
Earlier this month, the Biden J&J government put the Baltimore plant in charge after U.S. officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, had mixed ingredients for the two shots. Officials also halted production of the AstraZeneca vaccine.
The government’s effort to have only the J&J vaccine made against the institution is intended to avoid future confusion, The New York Times reported, citing two senior federal health officials.
The production break of new materials is the latest setback for J&J. Last week, the Food and Drug Administration and the Centers for Disease Control & Prevention advised against temporarily stopping the use of J & J’s vaccine “out of caution” after six women developed a rare but potentially life-threatening blood clotting disorder that one late death and one in critical condition.
The official said the women developed the condition known as cerebral venous sinus thrombosis, within two weeks of receiving the shot. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.
J& J has asked private Covid-19 competitors against vaccine Pfizer and Moderna to take part in a study examining the risk of blood clots, but the businesses have declined, The Wall Street Journal reported on Friday, referring to people familiar with with the case.
– Reuters contributed to this report.