Board of Audit and Inspection [Yonhap News]

It has been confirmed that COVID-19 vaccines with possible foreign matter or expired vaccines were administered due to improper management of COVID-19 vaccines between 2021 and 2024.

The Board of Audit and Inspection (BAI) announced the results of its audit titled 'Diagnosis and Analysis of COVID-19 Response Status' on the 23rd, which included these findings.

According to the BAI, the Korea Disease Control and Prevention Agency (KDCA) received 1,285 reports of foreign matter in COVID-19 vaccines from medical institutions between March 2021 and October 2024.

At the time, the KDCA processed these cases by informing only the manufacturer without notifying the Ministry of Food and Drug Safety, and then receiving the manufacturer's investigation results. In many cases, the investigation results were only received after the vaccination of vaccines from the 'same manufacturing batch' had been completed.

This means that when foreign matter was discovered in a specific vaccine product, vaccinations from vaccines of the same manufacturing batch, which were produced through the same process, should have been temporarily suspended pending investigation, but this was not properly done.

Ultimately, approximately 14.2 million doses of vaccines from the same manufacturing batch continued to be administered even after the foreign matter reports, the BAI pointed out.

The BAI explained that while most of the reported foreign matter was fragments of rubber stoppers caused by improper vaccine usage (835 cases), there were also 127 reports (9.9%) of foreign matter that posed a "risk of harm," such as mold, hair, and silicon dioxide.

The BAI stated that the adverse reaction reporting rate for vaccines from manufacturing batches where concerning foreign matter was actually found was 0.006 to 0.265 percentage points higher than the average for other manufacturing batches.

A BAI official, however, explained, "It is difficult to conclude at this time that there was a causal relationship (between some side effects and foreign matter)."

The BAI also pointed out that the KDCA failed to notify individuals who received expired COVID-19 vaccines of the incorrect vaccination or issued vaccination certificates to them.

As a result, 2,703 people were vaccinated with expired vaccines between 2021 and 2023. 515 certificates were also issued to individuals who received the incorrect vaccines.

The BAI also reported that some vaccines introduced into the country through an emergency use authorization system fell into a management blind spot.

Vaccines that had not undergone national release approval, which verifies quality by manufacturing batch, were used. The BAI stated that the volume of vaccines administered to the public without quality inspection amounted to 1.31 million doses between 2021 and 2024.

The BAI also mentioned that after the upgrade of the Korea Centers for Disease Control and Prevention (KCDC) to the KDCA in 2020, the jurisdiction for negotiation and contract matters with overseas pharmaceutical companies became ambiguous. The BAI pointed out that the Ministry of Health and Welfare and the KDCA both considered the matter to be outside their respective jurisdictions, which effectively halted vaccine contract negotiations and caused delays of over one month.

The BAI identified other issues, including: ▲ omission of flight attendants in charge of the area during contact tracing; ▲ decision-making on vaccine procurement strategies without going through the Central Disaster and Safety Countermeasures Headquarters; ▲ insufficient staffing of legal quarantine investigators; and ▲ inadequate distribution measures for self-testing kits and masks. The BAI has notified the relevant agencies to improve their procedures.

The BAI stated, "Because the roles and responsibilities of each agency were not clearly defined in laws and manuals, and the collaboration system was not specific, confusion and delays occurred in major tasks."