It has been revealed by the popular press agency Reuters the fact that the US FDA has found control lapses at Moderna. Check out more details below.
Moderna in the spotlight
An FOIA request by Reuters has revealed that Moderna, a biotech company producing mRNA vaccines, experienced production problems and serious quality control lapses at its main production site.
In September, the US FDA inspected Moderna’s facility in Norwood, Massachusetts, and discovered issues with the equipment used to manufacture the drug substance for its COVID-19 vaccine, Spikevax, as well as an experimental mRNA cancer vaccine being developed with Merck & Co.
The FDA report noted five separate observations, including that Moderna had released eight batches of “drug substance” – the active ingredient used to make mRNA vaccines – that was produced with equipment that had failed the company’s cleaning verification tests.
Reuters FOIA request turned up information about Moderna production problems. FDA discovered serious quality control lapses at the mRNA biotech company’s main production site.
“U.S. drug regulators in September found quality control lapses at Moderna’s (MRNA.O) main factory… pic.twitter.com/BHmVKfcK8j
— Dr. Kat Lindley (@KLVeritas) December 17, 2023
The report from FDA did not confirm if the batches concerned were released to the public. However, the report identified that the drug substance involved was for the COVID vaccine. When asked for comment, the agency declined to make a statement.
Moderna released a statement in response to the FDA report, stating that they immediately and comprehensively updated the specific procedures identified in the report. The company said that it is confident that the actions taken will be satisfactory to regulators.
According to Moderna, the inspection was a routine procedure, and the findings do not reflect any product quality or safety concerns.
The company assured that its COVID-19 vaccines are safe and effective. It also confirmed that all products released by the company were tested and meet product specifications and international regulatory requirements.
Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality, who is now a regulatory compliance consultant, has stated that the use of the drug substance in question is a serious issue. However, it is unclear whether the batches containing the substance were released to consumers.
According to the FDA’s report, Moderna did not have the appropriate measures in place to ensure that expired materials were not used to make vaccines and that airborne contaminants did not contaminate any products. Inspectors discovered over 2,000 expired items in Moderna’s warehouse and cold storage that were not kept separately or in a defined location from other materials.
The report also revealed that the materials were used beyond their expiration date.
You can check out more details about the issues at Moderna in the original notes by Reuters.
