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When the government tested an influenza (flu) vaccine exposed to room temperature during distribution, it was found that the quality was not abnormal. The government collected 12,736 doses of products from eight companies supplied by Shinsung Pharmaceutical, which was in charge of distributing the vaccine in question, and inspected the quality and stability. Although it was confirmed that there was no problem with quality, important problems in the management of vaccine distribution directly related to public safety were revealed, such as the amount of transport of more than 2000 DOS when the storage temperature of the vaccine (2 -8 degrees Celsius) was out of conditions for more than 13 hours for a long time. The government decided to collect around 480,000 doses and it was found that more than 500 people were vaccinated. The free vaccination is scheduled to resume on the 12th, but many citizens are still anxious.
On the 6th, the Korean Centers for Disease Control and Prevention (DDS) and the Ministry of Food and Drug Administration (KFDA) announced the results of a survey and quality assessment of the vaccine distribution process. influenza. As a result of the investigation of a vaccine that was suspected of being exposed to room temperature, it was confirmed that some of the shipments were shipped outside of the appropriate temperature, but there were no quality anomalies. The eight products surveyed were found to have no abnormalities in quality, even when exposed to 25 degrees Celsius for 24 hours. With the condition that the temperature was raised to 37 ° C, the quality was maintained for more than 72 hours for 5 products and 48 hours for 1 product. The two remaining products had a quality change in 12 hours. The Agency for Disease Control and Prevention said: “There were no cases of exposure to the 37 degree environment among the vaccines that were a problem during distribution this time.”
Problems were also identified in the distribution process. Contrary to handling regulations, the amount of vaccine exposed to temperatures below 0 degrees was 27,770 degrees. Flu vaccines can be rendered ineffective if frozen. In the case of loading on the outside floor during loading and unloading, it was also confirmed that the proper storage temperature was outside 800 minutes (13 hours 20 minutes) during delivery. During distribution, the storage temperature is not confirmed and the amount of water also exceeds 30,000 doses. The government decided to charge the confirmed amount for having had a problem in the transportation process. It was confirmed that there was no abnormality as a result of the quality test, but it is due to concern that the vaccine may be a “water vaccine” that is ineffective. Items subject to collection were delivered to 11 regions, including Seoul, Daegu, Incheon, Gwangju, Gyeonggi, Gangwon, Chungnam, Jeonnam, Gyeongbuk, Gyeongnam, and Jeju. The amount subject to collection is 480,360 degrees. Among them, it was confirmed that only 554 people had been vaccinated in 7 regions. The government plans to promote revaccination or reimbursements through Vaccine Review Committee discussions.
The government plans to resume vaccination from day 12, as the results of the quality test of the vaccine exposed to room temperature confirmed that there were no problems. Free immunizations will resume for high school students (16-18 years old) and high school students (13-15 years old), whose vaccination was suspended after the 22nd of last month. Initially, the intensive vaccination period was September 22-29 for high school students and October 5-12 for high school students. Primary school students (7-12 years old) and pregnant women resumed vaccination from the 25th of last month. The government said it would resume vaccination for a good vaccine, but some citizens were still anxious. Shinmo (37, female), who is about to vaccinate her son for the first time in Yangcheon-gu, Seoul, said: “I am concerned that other vaccines, such as baby vaccinations, childcare and paid vaccinations, are fine. because it has been shown that some vaccines are actually exposed to room temperature. Jeong Ki-seok, professor of infectious medicine at Hallym University Sacred Heart Hospital (former director of the Centers for Disease Control), said: “Of the 5.37 million doses delivered by Shinsung Pharmaceutical, only 14,000 samples were analyzed by the Ministry of Food and Drug Safety, so it cannot be considered 100% safe. ” He noted: “Since vaccine management is handled by various institutions, such as the Korea Disease Administration and the Food and Drug Administration, blind spots will inevitably occur.”
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