The U.S. Food and Drug Administration (FDA) identified several quality control issues at the primary manufacturing facility of Moderna Inc. MRNA during a September inspection.
This revelation comes from a report obtained through a Freedom of Information Act request, highlighting concerns at the Norwood, Mass., plant, according to a news report by Reuters.
The report said that the facility is crucial in the production of Moderna's COVID-19 vaccine, Spikevax, and an experimental mRNA cancer vaccine in collaboration with Merck & Co MRK.
Inspection Findings
The FDA's findings revealed lapses in equipment cleaning verification and the use of expired materials, raising concerns about the manufacturing process.
The agency's report noted that eight batches of the "drug substance," the active ingredient in mRNA vaccines, were produced using equipment that failed cleaning tests.
While it's unclear if these batches reached the public, they were identified as being for the COVID-19 vaccine.
The inspection also revealed over 2,000 expired items in storage areas and inadequate measures to prevent contamination.
Moderna's Response
Moderna has since responded to the FDA's findings, stating that immediate actions were taken to update the specified procedures.
"Upon receipt of the FDA's findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators," Moderna said in a statement to Reuters.
Also See: Texas Attorney General Alleges Pfizer Misled Public on COVID-19 Vaccine Efficacy
Steven Lynn, a former FDA official and current regulatory compliance consultant, emphasized the seriousness of using questionable drug substances. However, he noted that there's no evidence of these issues causing harm to vaccine recipients or clinical trial participants.
No Recalls Issued
Despite these findings, the FDA has not issued any recalls for Moderna's vaccines, as per their database on recalls, market withdrawals, and safety alerts.
Moderna, which is facing declining demand for its COVID-19 vaccine, is in discussions to downsize production and increase in-house manufacturing. The company anticipates added capacity from new mRNA manufacturing facilities that are set to open in various countries by 2025.
Price Action: MRNA shares closed higher by 0.16% to $86.01 on Friday. Shares were down by 0.3% to $85.75 after hours.
This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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