Ten batches of the new shots, equivalent to millions of doses, manufactured at the CDMO’s facility in Bloomington are to be released, amid concerns of supply shortages for Moderna’s Omicron-specific booster vaccine in the US.
The Catalent facility was subject to a long FDA inspection in August, and, on Tuesday this week, the watchdog sent the contract development and manufacturing organization (CDMO) a Form 483, citing 12 process violations it had identified as part of its review – the observations were linked to quality control and record keeping issues, among others.
However, according to an emailed statement from the FDA, the agency has determined that there were no issues with Moderna’s updated boosters produced at the facility and it has thus authorized their release.
FDA spokesperson, Michael Felberbaum, said the agency found “numerous batches” of the Moderna booster vaccine manufactured at Catalent’s plant met the criteria for distribution “following a careful review” of information provided by Moderna about their manufacture.
Addressing supply concerns
The spokesperson explained that when the agency gave Moderna’s updated boosters an EUA, it was in the middle of a routine safety inspection of the Catalent facility, and, therefore, did not include the site “as an authorized manufacturing facility for the updated COVID-19 vaccine booster” at that time.
However, in light of concerns about potential supply limitations, Moderna requested that the FDA review and authorize, under the EUA, certain batches of Moderna bivalent final drug product produced at the Catalent facility.