MFDS "Sterility Test Results Coming Soon"... KDCA "Vaccination Plan to Be Announced Based on Results"

[Image source=Yonhap News]

[Image source=Yonhap News]

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[Asia Economy Reporter Seo So-jeong] Health authorities have mostly completed the inspection results for influenza (flu) vaccines suspected of being exposed to room temperature, and with an announcement scheduled for the 6th, free flu vaccinations are expected to resume as early as this week.


On the 5th, the Korea Disease Control and Prevention Agency (KDCA) stated, "We are monitoring the progress of the quality inspection by the Ministry of Food and Drug Safety (MFDS) on the problematic vaccines," adding, "We plan to announce the vaccination plan based on the results once the MFDS completes the quality inspection." An MFDS official said, "The quality inspection takes about 1 to 2 days per item, but the sterility test requires at least 14 days," and added, "Since free flu vaccinations were suspended on the 22nd of last month, the sterility test results are not yet available, but we will submit the related data to the KDCA as soon as the test results come out."


According to the KDCA, as of the 3rd, the number of people vaccinated with flu vaccines suspected of room temperature exposure was 2,295, which is 8 fewer than the previous day. By region, the cases are Seoul 149, Busan 101, Daegu 105, Incheon 214, Gwangju 361, Daejeon 17, Sejong 51, Gyeonggi 673, Chungbuk 1, Chungnam 74, Jeonbuk 326, Jeonnam 40, Gyeongbuk 161, Gyeongnam 14, and Jeju 8. The KDCA explained, "The number decreased by 8 due to corrections made by local governments."


Initially, the KDCA announced on the 22nd of last month, right after suspending vaccine use, that "there are no cases of vaccination with vaccines suspected of room temperature exposure," but since September 25, the numbers have increased as follows: 105 → 224 → 324 → 407 → 873 → 1,362 → 1,910 → 2,290 → 2,303. On the 3rd, the number decreased by 8 due to revisions in Busan Metropolitan City, but the number of people vaccinated with the problematic vaccine is approaching 2,300. Because the investigation and management of vaccines suspected of room temperature exposure rely on local governments, errors have occurred in the data aggregation.


Frontline Hospitals: "Vaccine Cold Chain Distribution Principles Must Be Followed... Concern Over Another Incident if Resumption Is Forced"
Medical Experts: "Comprehensive Cold Chain Management Needed Ahead of Future COVID-19 Vaccine Introduction"

Frontline hospitals have expressed concerns ahead of the resumption of free flu vaccinations. This is because it is the peak flu vaccination season, and this year, a 'twindemic' of COVID-19 and flu could occur simultaneously, causing a surge in flu vaccination demand. An otolaryngologist located in Gangnam-gu, Seoul, said, "Vaccines must follow cold chain distribution principles, but I worry that forced preparations might cause issues during delivery," adding, "There must never again be poor management of vaccine temperatures."


Experts agreed that this vaccine room temperature exposure incident should serve as an opportunity to analyze and improve the overall status of cold chain maintenance for domestic vaccines to prepare for future COVID-19 vaccinations. Vaccines must be stored at 2?8℃ after leaving the manufacturer, but many medical institutions have not complied. According to a report titled "Analysis and Improvement Plan for Cold Chain Maintenance of Domestic Live Vaccines," submitted to the National Assembly Health and Welfare Committee member Shin Hyun-young (Democratic Party) by the KDCA on the 29th of last month, only 26 out of 86 public health centers and private hospitals (30.3%) stored vaccines at the appropriate temperature.



In particular, COVID-19 vaccines currently under development worldwide require storage temperatures ranging from minus 20 to minus 70 degrees Celsius, much lower than flu vaccines, making cold chain maintenance critical. The quarantine authorities also expressed difficulties ahead of the COVID-19 vaccine introduction. Kwon Jun-wook, Deputy Director of the Central Disease Control Headquarters, said, "Vaccines that have entered phase 3 clinical trials vary not only in platform but also in cold chain requirements," adding that the government must consider various factors when procuring vaccines. If the cold chain for vaccine transportation is not properly established, even if COVID-19 vaccines are released, supply may have to be delayed. Professor Lee Jae-gap of the Department of Infectious Diseases at Hallym University Kangnam Sacred Heart Hospital said, "Vaccine storage temperature is one of the criteria for selecting COVID-19 vaccines," adding, "Since cold chain is important for maintaining vaccine efficacy, this opportunity should be used to thoroughly inspect it."


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

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