According to multiple reports, U.S. Food and Drug Administration (FDA) inspectors discovered quality control problems at a Moderna plant with equipment used to manufacture a substance for its COVID-19 shot.
Earlier this month, Reuters obtained the report via a Freedom of Information Act request.
“The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax and an experimental mRNA cancer vaccine being developed with Merck & Co,” Reuters exclusively reported.
The document said Moderna failed to meet multiple requirements, including rules to minimize contamination potential.
1- “Moderna failed to meet multiple requirements, including rules aimed at minimizing the potential for contamination, according to the document.”
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The FDA did not say in the report if those batches were released to the public but identified the drug substance involved as being for the COVID vaccine. The agency declined to comment on the report.Advertisement
Moderna in a statement said: “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.”
The company described the inspection as routine and said the findings do not reflect any product quality or safety concerns, adding that its COVID-19 vaccines are safe and effective.
It said all product released by the company was tested and meets 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, said using the drug substance in question was a serious matter but that it was unclear whether the batches were released to consumers.
The FDA also found in its report that Moderna did not have the right measures at its facility to ensure expired materials were not used to make vaccines and that airborne contaminates did not make it into any products.
The list of problems identified in the report adds to the mountain of evidence that the experimental shots should be pulled from the market.
Moderna’s methods to care for its equipment should ring alarms.
FDA inspectors found the company did not properly clean the equipment before usage, used materials beyond their expiration date, and did not follow written alarm procedures.
FDA inspectors noted quality control red flags throughout Moderna's Spikevax facility.https://t.co/O0bgXahNmq
— Texans for Vaccine Choice (@TXforVaxChoice) December 27, 2023
The Epoch Times reports:
The FDA has not issued a recall of any Moderna vaccines, according to its recalls, market withdrawals, and safety alerts database.
In 2021, Japan suspended the use of 1.63 million doses of Moderna’s COVID vaccine after contaminates were found in some vials produced by Rovi, a contract manufacturer based in Spain. No manufacturing problems have previously been reported in any of Moderna’s own facilities.
Another part of the FDA report, dated Sept. 21, described how the Norwood facility did not have adequately designed air handling systems to “assure appropriate air quality in the … cleanroom in which the mRNA drug substance is manufactured.”
Inspectors also said they found positive air pressure was not “consistently maintained” between cleanrooms and airlocks and that monitoring data showed the cleanroom pressure turned negative between January and September. That development was “not assessed for potential impact,” they said.
“At face value, it appears multiple controls designed to prevent contamination were deficient,” Mr. Lynn said.
Another recently released document, produced by the nonprofit Informed Consent Action Network on orders from a federal judge, showed the FDA detected in Andover, Massachusetts, issues with the manufacture of a substance used in the Pfizer-BioNTech vaccine. Pfizer said in response it had taken actions to correct the issues.
Read the FDA form HERE.