Emergent BioSolutions Factory, a production partner for the Johnson & Johnson Covid-19 vaccine in Baltimore, Maryland, on April 9, 2021.
Saul Loeb | AFP | Getty Images
The Food and Drug Administration has called on Emergent BioSolutions to temporarily halt production of Covid-19 vaccine materials as U.S. regulators investigate the Baltimore plant responsible for destroying millions of Johnson & Johnson photos, Emergent said Monday. a regulatory file.
He said the FDA initiated an inspection of the facility on April 12 and asked the company to stop manufacturing four days later until the review and remediation was completed. In a filing with the Securities and Exchange Commission, the company also said it had quarantined all existing material manufactured at the unit.
Emergent shares fell more than 9% on the news.
In a statement to CNBC, J&J said it would work with Emergent and the FDA “to address any findings at the conclusion of the FDA inspection.”
“Our goal remains to secure all COVID-19 vaccine-compliant medicinal products and to authorize the emergency use of the Emergent Bayview-manufactured drug,” 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 makes vaccines for J&J and AstraZeneca, had mixed ingredients for the two photos. Officials also stopped production of the AstraZeneca vaccine.
The government’s move to make the facility only the J&J single-dose vaccine is meant to avoid future confusion, The New York Times reported, citing two senior federal health officials.
The break in the production of new materials is the latest obstacle for J&J. 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 “out of an abundance of precaution,” after six women developed a rare but rare blood clotting disorder. with life potential, which left one dead and one in critical condition.
The women developed the condition known as cerebral venous sinus thrombosis in about two weeks after 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. Eventually it can leak into the brain tissue and cause bleeding.
J& J privately urged rivals Pfizer and Moderna to join a study on the risk of blood clots, but the companies refused, The Wall Street Journal reported Friday, citing people familiar with the matter.
– Reuters contributed to this report.