The US Food and Drug Administration has discovered gaps in quality control at Moderna’s main plant, including the equipment used to manufacture the drug substance for the coronavirus vaccine
The inspection was carried out from September 11 to 21 by the US Food and Drug Administration at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s Spikevax coronavirus vaccine and an experimental RNA-mRNA cancer vaccine, which is being developed together with Merck.
The FDA report noted 5 separate observations, including that Moderna released 8 batches of pharmacological substances, the active ingredient used to make mRNA vaccines that were produced with equipment that failed the company’s cleaning verification tests.
The FDA did not say in the report whether these batches had been released to the public but identified the drug substance in question as intended for the coronavirus vaccine, and the agency declined to comment on the report.
Moderna said in a statement: upon receipt of the results of the FDA, Moderna immediately and comprehensively updated the specific actions identified, and is confident that the actions taken will be satisfactory to the regulators.
