South Korea's Board of Audit and Inspection (BAI) has identified multiple gaps in the country's COVID-19 vaccine management system during the pandemic response from 2021 to 2024, including cases where vaccines potentially contaminated with foreign substances or past their expiration dates were administered to the public.
The BAI released its audit findings on the "COVID-19 Response Assessment and Analysis" on Friday, calling for improvements across vaccine safety management, procurement contracts, and inter-agency coordination for disease control.
According to the audit, the Korea Disease Control and Prevention Agency (KDCA) received 1,285 reports of foreign matter found in COVID-19 vaccines from medical institutions between March 2021 and October 2024. However, the KDCA only notified manufacturers and awaited their investigation results without reporting the cases to the Ministry of Food and Drug Safety.
The audit found multiple instances where vaccinations continued with vaccines from the same lot number even after foreign substances were discovered, rather than temporarily suspending their use pending investigation. The BAI stated that approximately 14.2 million doses from the same lot numbers were administered after the foreign matter reports were filed.
Of the reported cases, 835 involved particles such as rubber stopper fragments likely generated during the administration process. However, 127 cases (9.9%) involved potentially harmful substances including mold, hair, and silicon dioxide. Adverse reaction reporting rates for vaccines from the affected lot numbers were 0.006 to 0.265 percentage points higher than the average for other lots. The BAI noted, however, that "it is difficult to establish a causal relationship between the foreign matter and adverse reactions at this stage."
The audit also confirmed cases of expired vaccine administration. Between 2021 and 2023, 2,703 people received vaccines past their expiration dates, and 515 vaccination certificates were issued to some of these recipients. The BAI noted that the KDCA failed to properly notify some recipients of these administration errors.
Some vaccines introduced under emergency use authorization were used without undergoing national lot release testing to verify quality by lot number. Between 2021 and 2024, approximately 1.31 million doses were administered without such quality verification.
The audit also revealed inter-agency confusion during the vaccine procurement process. Following the elevation of the Korea Centers for Disease Control and Prevention to agency status as the KDCA in 2020, unclear delineation of responsibilities between the Ministry of Health and Welfare and the KDCA for negotiations and contracts with overseas pharmaceutical companies caused delays of more than one month in some cases.
Additional issues identified by the BAI included: omission of flight crew members in aircraft contact tracing; vaccine procurement strategy decisions made without going through the Central Disaster and Safety Countermeasures Headquarters; insufficient staffing of legally mandated epidemiological investigators; and inadequate distribution management procedures for self-test kits and masks.
The BAI stated, "Confusion and delays occurred because the roles and responsibilities of each agency were not clearly defined in laws and manuals, and the collaborative framework was not sufficiently detailed."