Moderna Covid-19 Vaccine Production Quality Issues

Source: Exclusive: US FDA finds control lapses at Moderna manufacturing plant (December 15, 2023)

In December 2023 Reuters reported that the FDA found multiple quality control violations at a Modern Covid-19 vaccine production facility.

On March 4 2023 the following specifics of the FDA findings were reported by the Informed Consent Action Network (ICAN):

• Air and temperature alarms that were ignored, use of expired materials in the mRNA vaccines, failure to collect cleaning verification samples, and failure to design and control air handling equipment to reduce potential for contamination.
• The report notes that Moderna “does not ensure that the equipment used for drug substance manufacturing are appropriately cleaned prior to the manufacturing of mRNA-1273 drug substance” and then proceeds to list the drug substance batch numbers that were manufactured using equipment utilized “without confirming the cleaning verifications test results for bioburden and endotoxin prior to the usage for subsequent batch manufacturing.”  
• “Expired materials were found utilized beyond their expiration date and restricted materials were utilized in mRNA drug substance production. There are more than two thousand expired items stored in your GMP Warehouse and Cold Storage at time of inspection. These materials are currently stored at the same location with released or in-used materials. There was no clear demarcation between these items in the GMP Warehouse and cold storage.”
• “Equipment and Facilities are not designed to minimize potential for contamination. Specifically, the air handling systems were not adequately designed and controlled to assure appropriate air quality in the Grade C cleanroom in which mRNA drug substance is manufactured. The positive pressure was not consistently maintained between the grade C cleanrooms and grade D Airlocks. Monitoring data from [redacted] system showed frequent drops of Grade C Cleanroom pressure to negative values between January 2023 and September 2023. The negative DPs (differential pressure) were not assessed for potential impact.”
• “Your firm [Moderna] failed to respond and follow up on the alarm responses within the timeframe established per SOP-0416.”
• “Cleaning Validation studies of non-dedicated manufacturing equipment did not include challenges with actual conditions used in routine manufacturing processes.”
• “A cleaning procedure update was implemented based on the change control and a six-month effectiveness check through cleaning verification after each equipment usage (due date: 14Mar2023) was required after the implementation of change actions to review cleaning verification data to ensure automated method change was effective. However, the cleaning verification samples were not collected after 06Feb2023.”

The ICAN story is available here.

ICAN obtained this information from a number of FOIA (Freedom of Information Act) requests. The report documents release by the FDA (via the FOIA request) are available here.