The FDA has asked Emergent BioSolutions to temporarily stop making COVID-19 vaccine materials while the agency investigates its Baltimore plant, where 15 million Johnson & Johnson vaccine doses were ruined, according to a Securities and Exchange Commission filing released April 19.
Emergent said in the filing it agreed with the FDA's request and has also quarantined all material manufactured at the facility.
Johnson & Johnson told CNBC it is working with Emergent and the FDA to "address any findings at the conclusion of the FDA inspection."
"Our goal remains ensuring all drug substances for our COVID-19 vaccine meets our high quality standards and securing emergency use authorization for drug substances manufactured at Emergent Bayview. At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries," the company told CNBC.
Emergent BioSolutions said in a statement to Politico: "While we await the FDA's full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes."
It's not clear how long the manufacturing pause could last.
Last month, the FDA put Johnson & Johnson in charge of vaccine manufacturing at the plant after ingredients for its COVID-19 vaccine and AstraZeneca's COVID-19 vaccine were mixed up, leading to 15 million doses being ruined.
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