CDMO Catalent has refuted claims that US rollout of the recently approved J&J vaccine has been slowed down by problems at its fill-finish facilities.
Shortly after the US Food and Drug Administration (FDA) approved Johnson & Johnson’s single-shot vaccine making it the third authorized COVID vaccine in the US, the Financial Times reported that Catalent is suffering production problems that “have contributed to the US government being set to receive millions fewer doses than it expected this month.”
The British newspaper said “Catalent had to resort to checking vials by hand for two weeks,” which slowed and affected J&J’s expected vaccine doses.
Catalent is one of numerous third parties contracted by J&J to support commercial production of its COVID-19 vaccine. The contract development and manufacturing organization (CDMO) defended its manufacturing processes and told BioProcess Insider “Using manual inspection is common, and Catalent has been able to use its highly skilled personnel to accomplish all the required steps expeditiously, without risk to vaccine supply or patient safety.”
The spokesperson added “There will be no effect on J&J doses as Catalent is on track to meet all its commitments to J&J.”
J&J echoed Catalent’s statement, telling us “The company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the US. The Company plans to deliver 100 million single-shot vaccines to the US during the first half of 2021.”
No production problems
According to Catalent, it is working on over 80 global COVID-19 vaccines and treatments and no facility has experienced any problems that has hindered its ability to deliver its contracts.
“Catalent has not suffered any issues beyond those commonly experienced during scale up, calibration and validation steps in the installation of two brand new high-speed filling, visual inspection, and packaging lines,” said a spokesperson for Catalent.
They added the firm has “implemented round-the-clock production shifts at the site, which involved the hiring of over 1000 new employees,” to meet its customer commitments.
The Financial Times also reported Catalent’s production for Moderna’s mRNA COVID-19 vaccine has been affected, saying it “suffered a setback in the US when tuning up its automated visual verification line.” Catalent dismissed this and told us it has met “all its commitments to supply Moderna, including delivery of approximately 50 million doses to date, and future commitments are also all on track.”