45-Day Deadline for Investigating Vaccine Contamination Reports; QR Codes and Barcodes to Prevent Administration Errors

The Korea Disease Control and Prevention Agency and the Ministry of Food and Drug Safety are overhauling the reporting and investigation system for quality issues involving vaccines used in the National Immunization Program. The measures set a maximum 45-day deadline for manufacturers to investigate reports of foreign matter and aim to prevent administration errors through automatic data entry using QR codes and barcodes.

On the 30th, KDCA and MFDS announced the measures, titled “Measures to Strengthen Quality Control and Safe Administration of National Immunization Program Vaccines.”

The measures follow growing concerns about vaccine safety since the COVID-19 pandemic, as well as a series of issues raised by the Board of Audit and Inspection, the National Assembly and the media regarding the handling of vaccines containing foreign matter and administration before lot release approval.

The government will first unify the system for reporting, receiving and managing vaccine quality issues. The current fragmented process, in which medical institutions report issues individually to manufacturers, will be integrated into the Immunization Registry Information System, enabling KDCA, MFDS and manufacturers to share information in real time.

Medical institutions will register suspected quality issues, including foreign matter, cloudiness or discoloration, damaged containers, labeling problems and temperature excursions, in a standardized form in the system. Vaccines reported to have quality issues must not be used and must be stored separately, with the physical product preserved until the manufacturer collects it.

New deadlines will require manufacturers to submit reports at each stage of investigations into vaccines reported to contain foreign matter. An initial receipt report will be due within 72 hours, a first report within 15 days, a second report within 30 days and a final report within 45 days. The measure takes into account that responses to investigations of COVID-19 vaccines took an average of about 107 days.

Even before an investigation is complete, the government will take precautionary measures if there is a significant safety concern, such as multiple reports of foreign matter within a short period. KDCA may suspend vaccination, while MFDS may halt sales and order a recall.

Distribution management will also be strengthened. To prevent a recurrence of vaccination before lot release approval, manuals will cover system improvements, the use of tamper-evident seals and text message notifications. Specific procedures will also be established for handling temperature excursions at medical institutions.

Starting in March 2027, recipient information will be entered automatically using QR codes to prevent administration errors, and scanning vaccine QR codes or barcodes will help verify the vaccine and check its expiration date. A new course on proper vaccination procedures will also be added to the integrated training program and designated as mandatory.

Adverse event management will expand beyond primarily passive surveillance to include active surveillance. Follow-up investigations will be conducted for newly introduced vaccines and vaccines with changes to their indications or dosage, and National Immunization Program data will be linked with health insurance medical-use data and analyzed monthly to detect adverse events early.

The government plans to revise relevant regulations by the second half of this year and integrate and computerize the quality issue reporting and administration error management systems in the first half of 2027, followed by pilot operation in the second half.