A Moderna plant that manufactures a substance used in the company's COVID-19 vaccine has been found to have several deficiencies, according to a document released by the U.S. Food and Drug Administration (FDA). The FDA inspectors visited the plant in Norwood, Massachusetts, from September 11 to September 21 and discovered multiple violations of regulations aimed at preventing contamination.
Among the problems identified were improper cleaning of equipment before usage, inadequate simulation of the cleaning process, failure to follow alarm procedures, and a lack of design features to minimize contamination risks. Inspectors also found that Moderna had used materials beyond their expiration date, including over two thousand expired items stored in their warehouse at the time of inspection.
The FDA's lead investigator, Unnee Ranjan, summarized the inspections and highlighted these deficiencies. The Epoch Times obtained the 6-page document through a Freedom of Information Act request after the FDA's media office initially refused to release it.
Under federal law, the FDA has the authority to inspect facilities and report any issues related to unsanitary conditions or contamination risks. The FDA Form 483 is a report that contains observations deemed objectionable by inspectors and is intended to help companies comply with regulations.
The substance in question is used in Moderna's COVID-19 vaccine, mRNA-1273, which is the company's only product available to the public. According to the FDA inspectors, Moderna released eight batches of the substance despite violating manufacturing rules. It remains unclear whether any commercially distributed vaccines contained the problematic substance.
Moderna responded to the findings by stating that they immediately updated the specific procedures identified and expressed confidence that the actions taken would satisfy regulators. The company also assured that all products released meet specifications and international regulatory requirements.
Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality and now a regulatory compliance consultant, acknowledged the seriousness of using the drug substance in question but noted that it is uncertain whether the batches were released to consumers. The FDA has not issued any recalls of Moderna vaccines based on their recalls, market withdrawals, and safety alerts database.
In 2021, Japan suspended the use of 1.63 million doses of Moderna's COVID vaccine due to contaminants found in vials produced by a contract manufacturer in Spain. However, no previous manufacturing issues have been reported in Moderna's own facilities.
Another part of the FDA report highlighted deficiencies in the air handling systems at the Norwood facility, which are crucial for maintaining appropriate air quality in the cleanroom where the mRNA drug substance is manufactured. Inspectors discovered that positive air pressure was not consistently maintained between cleanrooms and airlocks, and there were instances of negative pressure in the cleanroom between January and September.
According to Mr. Lynn, these findings suggest that multiple controls designed to prevent contamination were deficient.
Interestingly, another recently released document from the nonprofit Informed Consent Action Network revealed issues with the manufacture of a substance used in the Pfizer-BioNTech vaccine at a facility in Andover, Massachusetts. Pfizer has stated that it has taken corrective actions in response to these concerns.
The FDA has not issued a recall of any Moderna vaccines based on these findings.
In conclusion, the FDA inspection of Moderna's manufacturing plant has uncovered several violations of regulations aimed at preventing contamination. The deficiencies range from improper cleaning procedures and inadequate simulation of cleaning processes to expired materials and design flaws in the facility.
Moderna has responded by updating procedures and expressing confidence in meeting regulatory requirements. However, it remains unclear whether these violations have resulted in contaminated vaccines reaching the public.
