According to a recent Reuters article, the FDA discovered quality control deficiencies at Moderna's primary manufacturing facility in Norwood, Massachusetts, during a routine inspection back in September. The FDA report outlined five observations, including concerns about equipment used in producing the drug substance for Moderna's COVID-19 vaccine, Spikevax, and an experimental mRNA cancer vaccine developed in collaboration with Merck & Co. The report raised alarms about eight batches of the "drug substance" being released using equipment that had failed the company's cleaning verification tests.
While Moderna has not confirmed whether these batches reached the public, the company asserts that all released products were thoroughly tested and met regulatory requirements. The FDA also highlighted additional issues, such as Moderna's lack of measures to prevent the use of expired materials in vaccine production and to safeguard against airborne contaminants compromising product integrity. Despite the FDA's findings, Moderna maintains the identified issues don’t compromise the quality or safety of their COVID-19 vaccines.
