The government is comprehensively overhauling its infectious disease response system to address institutional shortcomings exposed during the COVID-19 pandemic. The move follows the Board of Audit and Inspection's identification of gaps in vaccine management and inter-agency coordination.
The Ministry of Health and Welfare, Korea Disease Control and Prevention Agency (KDCA), and Ministry of Food and Drug Safety announced on the 23rd that they officially accept the BAI's audit findings on "COVID-19 Response Assessment and Analysis." They will incorporate the identified issues into their existing "Infectious Disease Crisis Management System Enhancement Plan" to pursue institutional improvements.
According to the BAI, the KDCA received 1,285 reports of foreign substances in COVID-19 vaccines from March 2021 to October 2024. In some cases, the agency waited for manufacturer investigation results rather than immediately suspending vaccinations from the same lot numbers. During this period, approximately 14.2 million doses from the same lot numbers were administered even after foreign substance reports were filed. Between 2021 and 2023, expired vaccines were administered to 2,703 people, with some receiving vaccination certificates. The audit also noted that 1.31 million vaccine doses were administered without national lot release approval.
At a briefing held that day, the KDCA acknowledged, "COVID-19 was a large-scale infectious disease we had never experienced before, and there were inadequacies in information processing and coordination systems at the time." However, regarding the causal relationship between foreign substances and adverse reactions, the agency explained, "It is difficult to make definitive conclusions at this stage."
The government will first restructure its crisis communication and coordination systems. The KDCA has established a Digital and Crisis Communication Task Force to deliver unified public messages during infectious disease emergencies. The agency plans to establish a "Public Health and Social Response Manual" in the first half of the year to integrate response standards between quarantine authorities and local governments. Criteria and procedures for social distancing and cohort isolation measures will also be specified in greater detail. The KDCA stated, "While it is difficult to present mechanical tier criteria based solely on confirmed case numbers, we will enhance predictability by subdividing the procedures for escalating or easing restrictions."
Quarantine and medical infrastructure will also be strengthened. In response to criticisms about inadequate epidemiological investigation information sharing among public health centers, the agency is improving its integrated quarantine information system, with completion targeted for the third quarter of this year. Regulatory revisions to secure more epidemiological investigators and expanded incentive measures are also being pursued. Construction of regional infectious disease specialized hospitals will be accelerated.
The vaccine safety management system will be significantly strengthened. A quality verification system for vaccines introduced under emergency use authorization will be implemented by May, with manuals established to ensure vaccinations proceed only after confirming national lot release approval. Specific procedures for reporting quality issues to the Ministry of Food and Drug Safety and requesting quality investigations will be established. Guidelines and computer systems have been updated to ensure recipients are notified when vaccination errors occur.
Additionally, following the BAI's criticism that jurisdictional confusion arose between ministries during vaccine procurement, the government has established operating regulations for the "Government-wide Vaccine Procurement Council" to clarify each ministry's role. The government has indicated it will use these audit findings as an opportunity to structurally reorganize its infectious disease response system. A KDCA official stated, "We will incorporate the BAI's findings into our Infectious Disease Crisis Management System Enhancement Plan to respond more preemptively and systematically to future novel infectious disease outbreaks."