FDA Asks Emergent Plant To Pause Manufacturing While It Investigates Botched J&J Vaccines


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.

It said the FDA initiated an inspection of the facility on April 12 and asked the company to halt manufacturing four days later, pending completion of the review and remediation. In a filing to the Securities and Exchange Commission, the company also said it quarantined all existing material manufactured at the facility.

In a statement, J&J said it will work with Emergent and FDA “to address any findings at the conclusion of the FDA inspection.”

“Our goal remains ensuring all drug substance for our COVID-19 vaccine meets our high-quality standards and securing Emergency Use Authorization for drug substance manufactured at Emergent Bayview,” the company said. “At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.”

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 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 new materials is the latest setback for J&J. 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.

The women developed the condition known as cerebral venous sinus thrombosis within about two weeks of receiving the shot, an official said. CVST is a rare form of stroke that happens when a blood clot forms in the brain’s venous sinuses. It can eventually leak blood into the brain tissues and cause a hemorrhage.

J&J privately asked Covid-19 vaccine rivals Pfizer and Moderna to join a study looking into the risk of blood clots but the companies declined, The Wall Street Journal reported Friday, citing people familiar with the matter.