A total of 1,504 South Koreans received expired COVID-19 vaccines between 2021 and 2023 but were never notified, leaving them without required revaccination, according to a government audit released Monday.
The Board of Audit and Inspection disclosed these findings in its "COVID-19 Response Assessment and Analysis" report. The audit revealed that shortages of masks and self-test kits during the pandemic were exacerbated by structural problems in the government's response system.
South Korea established early testing, tracing, and treatment systems when COVID-19 spread globally in early 2020 and implemented aggressive quarantine policies. However, the unprecedented pandemic exposed several areas requiring improvement.
Management blind spots emerged as the country raced to achieve 70% vaccination coverage within eight months of vaccine introduction in October 2021. The Korea Disease Control and Prevention Agency (KDCA) received 1,285 reports of foreign substances in COVID-19 vaccines between March 2021 and October 2024 but notified only manufacturers, not the Ministry of Food and Drug Safety (MFDS).
While most reports involved low-risk rubber stopper fragments (65%), the KDCA failed to suspend vaccinations for 127 cases involving potentially hazardous contaminants such as mold and hair. Consequently, 14.2 million doses from the same manufacturing lots continued to be administered without recall or inspection. Manufacturers eventually provided some internal investigation results, but only after all doses from those lots had been depleted.
The KDCA also failed to notify 2,703 people who received expired vaccines. As a result, 1,504 individuals (55.6%) never received revaccination. Expired vaccine doses do not count toward vaccination records, yet 515 vaccination certificates were issued for such invalid doses.
Additionally, vaccines introduced through "emergency use authorization" bypassed the "national lot release" system, creating another regulatory gap. Between 2021 and 2024, 19.71 million doses of emergency-authorized COVID-19 vaccines skipped national lot release procedures. The KDCA requested quality testing from the MFDS for 18.4 million doses (93.4%), but 1.31 million doses (6.6%) were administered without any quality inspection.
The audit also criticized the deployment of trainee epidemiological investigators who had not completed basic training, attributing this to poor working conditions that made long-term retention difficult.
Coordination failures occurred among multiple agencies, including the KDCA's Central Disease Control Headquarters, the Ministry of Health and Welfare's Central Disaster Management Headquarters, the Central Disaster and Safety Countermeasures Headquarters, local governments, and private sector entities. For instance, the Health Ministry stated cloth masks "can sufficiently prevent infection," while the KDCA maintained that "medical masks are safer due to limitations" of cloth alternatives.
The absence of clear social distancing standards led to inconsistent local enforcement. "Hunting pochas" (bars) were classified as high-risk facilities in Cheonan, South Chungcheong Province, but excluded from that category in Gwangjin District, Seoul. An 82-person cluster infection later emerged at an excluded establishment.
"The 'Crisis Management Standard Manual' assigned crisis communication jointly to the Health Ministry and KDCA without clear role delineation," the Board of Audit stated. "There was no coordination system for pre-aligning public messages between agencies, and no dedicated organization overseeing government-wide crisis communication."
The auditors notified the Health Minister and KDCA Commissioner to establish concrete measures ensuring consistent messaging during infectious disease emergencies.
The government enacted the "Crisis Response Medical Products Act" to enable emergency production and import orders for manufacturers and distributors. However, the lack of practical procedures and criteria for implementation and termination prevented timely market supply of masks and self-test kits.
The Board of Audit said it has notified all relevant agencies to develop improvement measures.