FDA Allows Stalled Emergent Plant to Resume Producing J&J Vaccine
The FDA has given Emergent BioSolutions’ Bayview, Md., facility the green light to restart manufacturing Johnson & Johnson’s (J&J) COVID-19 vaccine — months after new production was put on hold following the discovery of numerous quality issues and cross-contamination with AstraZeneca vaccine doses.
But the FDA has left in place another regulatory hurdle as any vaccine doses produced at the plant still aren’t covered under J&J’s Emergency Use Authorization, which lists authorized manufacturing sites, an Emergent spokesperson explained to FDAnews.
This means, for now, that the agency will need to individually clear any drug batches produced at the Bayview plant individually. And J&J, which is overseeing the facility, saidit will work on securing FDA authorization for drug substance manufactured at the Bayview plant “as quickly as possible.”
The agency most recently authorized a fifth J&J vaccine batch, from among those produced either before the shutdown by the FDA or already in production when the suspension of production occurred. Emergent is also looking to secure clearance for other previously produced J&J and AstraZeneca vaccine batches.
Emergent CEO Robert Kramer issued a statement in response to the FDA’s green light for the plant, calling the resumption of manufacturing “a key milestone” and attributed the lifting of the production hold to weeks of his company implementing a quality action plan and working closely with J&J and the FDA.
Kramer had told lawmakers in a May hearing that he expected his company to resume production “within days,” after it finished addressing inspection observations found during the April inspection (DID, May 20). — Jason Scott
Updated on July 29, 2021 at 3:00 PM.