The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.
Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.
It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.
“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified,” Emergent BioSolutions said in prepared remarks.
J&J released a statement explaining that it would increase oversight of the Emergent plant, and incorporate “additional controls and personnel to ensure that the plant complies with FDA standards. J&J is also working “closely with the U.S. government, including the FDA, concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday, April 20, 2021.”
Johnson & Johnson will manufacture COVID-19 vaccine in 10 facilities across the world.
The FDA warning letter also identified problems relating to cross-contamination of viral vaccine drug substances.
The 12-page FDA Form 483 document also reported that the Emergent Facility was “not maintained in a clean and sanitary condition.” FDA inspectors discovered loose debris and peeling paint in the facility with brown and black residue on the walls.
The agency also concluded that the building used for viral vaccine manufacturing was “not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations.”
Additionally, FDA said workers in the facility did not follow proper process control procedures to prevent cross-contamination and lacked sufficient training related to their job function. They also did not handle manufacturing waste properly, FDA inspectors concluded.
The report also revealed that employees moved between manufacturing zones without documenting required disinfection measures.
In all, the 483 document cited nine core problem types supported by specific examples of violations.
FDA is working with Emergent to resolve the issues. “While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable, and we will take swift action to remedy them,” Emergent said in a statement.
Emergent has released a statement explaining that it continues to “manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements.”
The company has also announced a television and digital ad campaign highlighting its role in fighting the COVID-19 pandemic.
FDA hadn’t yet authorized the plant from Emergent BioSolutions to produce COVID-19 vaccines.
In related news, the House Committee on Oversight and Reform has launched an investigation of the Emergent BioSolutions. “Specifically, we are investigating reports that Emergent received multi-million-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues,” wrote Carolyn Maloney, chair of the House Committee on Oversight and Reform and James Clyburn, chair of the Select Subcommittee on the Coronavirus Crisis.
The company’s stock has lost roughly half its value since mid-February, falling from $125.19 on Feb. 12 to $65.43 in mid-day trading today.