The facility is run by Somerset, N.J.-based Catalent, a pharmaceutical services company that Moderna chose in 2020 to help finish-and-fill production of its COVID-19 vaccine. In a recent inspection, the FDA listed 12 issues with the facility, including the failure to follow sterilization procedures and laboratory controls.
Moderna then asked the FDA to OK some batches of the omicron booster supply made at the Indiana plant. In response, the agency added a few lots to the emergency use authorization it granted the drugmaker to begin distributing the modified vaccine product in early September.
The decision doesn’t apply to the whole facility, though, the FDA said Sept. 26: “This concurrence does not add any other Moderna COVID-19 Vaccine, Bilavent batches manufactured at this facility to the EUA at this time and does not add the facility itself (for manufacture of Moderna COVID-19 Vaccine, Bivalent) to the EUA at this time.”
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