[2020 National Audit] Lee Ui-kyung, MFDS Commissioner, "Apologies for White Particles in Vaccine... Doing Our Best to Complete Vaccination"

[Asia Economy Reporter Cho Hyun-ui] Lee Ui-kyung, Commissioner of the Ministry of Food and Drug Safety, expressed regret on the 13th regarding the discovery of white particles in the influenza (flu) vaccine, saying, "We sincerely apologize to the public."

At the National Assembly Health and Welfare Committee's audit on the same day, Commissioner Lee stated, "Recently, during the distribution process of the flu vaccine, there was an issue where storage temperatures were not properly maintained, and white particles were found, causing concern among the public."

Earlier, white particles, suspected to be antigen protein aggregates, were found in some lots of Korea Vaccine's Covax Flu 4gPF injection. The Ministry of Food and Drug Safety conducted additional tests and confirmed that among six manufacturing lots of the product, four lots filled in syringes from a specific manufacturer had a higher number of fine particles. Consequently, on the 9th, the manufacturer voluntarily recalled a total of 615,000 units of the product.

In response to a question from Assemblywoman Shin Hyun-young of the Democratic Party regarding the cause of the white particle formation, Commissioner Lee explained, "We plan to conduct a detailed cause analysis." When asked whether the entire batch of a specific syringe was problematic, he clarified, "The syringe in question is a product approved as a medical device," adding, "The issue is not with the syringe itself but with the interaction between the raw material and the syringe."

Commissioner Lee promised, "We will thoroughly manage vaccine quality to prevent public anxiety and cooperate with the Korea Disease Control and Prevention Agency to ensure the vaccination process is successfully completed." He also stated, "We will actively work with related ministries to establish countermeasures and improve systems to prevent such issues from recurring in the future."

This content was produced with the assistance of AI translation services.