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.
"Although the FDA does not intend to determine whether to add Catalent as an authorized manufacturing facility for the Moderna COVID-19 Vaccine, Bivalent until the agency’s evaluation of the inspection is complete, in the interim, the FDA can authorize batches of Moderna bivalent drug product produced at this facility provided that FDA has sufficient data and information to conclude these batches are suitable for use.
"On September 16, 2022, Moderna submitted data and information supporting the quality of ten bivalent booster final drug product batches manufactured at the Catalent facility.
"Specifically, Moderna provided the results of its comprehensive batch review, which included, for example, data and analysis covering, environmental monitoring, media fills, and particle characterization.
"CBER’s Office of Vaccine Research and Review (OVRR) has carefully reviewed this information and determined that all applicable specifications were met for these batches. Thus, OVRR does not have safety, effectiveness, or quality concerns with these batches, and has concluded that they are suitable for use."
Catalent addressing issues
Meanwhile, a Catalent spokesperson told us the recent FDA inspection at the Bloomington facility resulted in observations that the CDMO is already addressing, as it seeks "to continuously improve" its operations.
The representative also reported that production at the site "has continued without interruption.”