FDA urges Emergent Plant to cease manufacturing whereas investigating botched Covid vaccines

The Emergent BioSolutions facility, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, on April 9, 2021 in Baltimore, Maryland.

Saul Loeb | AFP | Getty Images

The Food and Drug Administration has asked Emergent BioSolutions to temporarily 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, shared Emergent in a registration application filed on Monday.

The FDA initiated an inspection of the facility on April 12, asking the company to stop production four days later until the review and remediation was complete. In a filing with the Securities and Exchange Commission, the company also said it had quarantined all material produced at the facility.

Emergent stocks were down more than 9% on the news.

In a statement to CNBC, J&J said it would work with Emergent and the FDA “to clarify any results after the FDA inspection is complete”.

“Our goal remains to ensure that all drug substances for our COVID-19 vaccine meet our high quality standards and receive emergency use approval for drug substances manufactured in Emergent Bayview,” the company said. “At this point it is premature to speculate about the potential impact this may have on the timing of our vaccine shipments.”

Earlier this month, the Biden administration hired J&J to run the Baltimore facility after US officials learned that Emergent, a contract manufacturer that made vaccines for J&J and AstraZeneca, mixed the ingredients for the two shots would have. Officials also stopped production of the AstraZeneca vaccine.

The government’s move to let the facility manufacture 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 production hiatus for new materials is the most recent setback for J & J. Last week, the Food and Drug Administration and Centers for Disease Control and Prevention advised states to temporarily “cease” use of J & J’s vaccine, after six women developed a rare but potentially life-threatening bleeding disorder in which one died and one was in critical condition.

The women developed the condition known as cerebral sinus thrombosis within about two weeks of receiving the shot, an official said. 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 privately asked Covid-19 vaccine rivals Pfizer and Moderna to participate in a study examining the risk of blood clots. The companies refused, however, the Wall Street Journal reported on Friday, citing people familiar with the matter.

–Reuter contributed to this report.