In a shocking turn of events, the legal team at the Informed Consent Action Network (ICAN) has uncovered alarming quality control lapses at a Moderna COVID-19 vaccine manufacturing facility. Following the news of these lapses, ICAN immediately sent Freedom of Information Act (FOIA) requests to the Food and Drug Administration (FDA) to obtain more information about the conditions at the plant. The organization has now obtained the FDA's inspection report, which reveals distressing findings about the facility.
Lead Counsel, Aaron Siri, Esq., provides detailed information about the new findings in a video update. The report obtained by ICAN raises serious concerns about the manufacturing practices at Moderna's Norwood, Massachusetts facility, where the COVID-19 vaccine is produced.
According to a news article published on December 15, 2023, the FDA discovered numerous quality control lapses during its inspection of the Moderna facility in September 2023. ICAN's legal team wasted no time and immediately submitted FOIA requests to gather more details about the inspection's findings. In response, the FDA provided ICAN with a report that contains shocking revelations.
The report highlights several disturbing observations, including the use of expired materials in the manufacturing of the mRNA vaccines and the failure to collect cleaning verification samples. It also reveals that air and temperature alarms were ignored, and equipment used for drug substance manufacturing was not appropriately cleaned prior to use. Furthermore, the report notes that Moderna failed to design and control air handling equipment to minimize potential contamination.
One particularly alarming finding is that more than two thousand expired items were found stored alongside released or in-use materials in the facility's GMP Warehouse and Cold Storage. There was no clear demarcation between these items, posing a significant risk of contamination.
Another concerning issue mentioned in the report is the inadequate design and control of air handling systems in the Grade C cleanroom where the mRNA drug substance is manufactured. The positive pressure in the cleanroom was not consistently maintained, and frequent drops in pressure were observed between January and September 2023. These lapses were not properly assessed for potential impact.
The report also reveals that Moderna failed to respond and follow up on alarm responses within the established timeframe, and cleaning validation studies did not include challenges with actual conditions used in routine manufacturing processes. Furthermore, a required six-month effectiveness check through cleaning verification was not conducted after the implementation of a cleaning procedure update.
Given the significant deficiencies exposed by the report, ICAN's legal team has submitted additional FOIA requests to delve deeper into the matter. The organization is committed to demanding accurate information on COVID-19 vaccines and will keep the public informed of any further developments.
ICAN's work in holding vaccine manufacturers accountable for their practices extends beyond this recent discovery. The organization has been actively involved in demanding accurate information on COVID-19 vaccines. Their efforts to promote transparency and ensure public safety are commendable.
In conclusion, the revelations from the FDA's inspection report on Moderna's vaccine manufacturing facility are deeply troubling. The lapses in quality control and the disregard for proper procedures raise concerns about the safety and efficacy of the COVID-19 vaccines produced at the facility. ICAN's legal team's swift action in obtaining this report and their ongoing efforts to uncover more information are crucial steps towards holding vaccine manufacturers accountable.
