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It appears to have occurred in the manufacturing stage … One of the vaccinators also complained of pain.
Controversy over silicone oil detection
The free vaccination will resume from the 13th.
Anxiety surrounding the influenza (flu) vaccine is increasing. Some vaccines were out of temperature during distribution last month, and this time, foreign substances were also found in the vaccine. The Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) drew a line saying that there is no problem with vaccine safety, but the situation is spreading because of mistrust about vaccination.
According to the Ministry of Food and Pharmaceutical Safety on the 9th, the Korean vaccine company decided to voluntarily recover 615,140 doses of some 900,000 doses of vaccine manufactured this year. This is because some vaccines that are delivered to medical institutions have white particles.
The government is giving importance to the possibility that the cause of the occurrence of foreign material has occurred at the manufacturing stage. In a briefing on the 9th, the head of the Food and Drug Administration, Lee Eui-kyung, said: “Because all the cold chains were preserved, it is estimated that there may have been a problem between the undiluted solution and the injector at the manufacturing stage. ” Explained.
The Ministry of Food and Pharmaceutical Safety issued the go-ahead without stopping the distribution of the vaccine, which was a problem in the manufacturing process. The route that confirmed the foreign substance this time also started an investigation when the Gyeongbuk Yeongdeok-gun Health Center informed the health authorities that foreign substances were found in the ‘Coboxflu Quadrivalent PF’ vaccine product. Just as the problem of exposure to room temperature in the vaccine last month was reported by other companies, the health authorities were not aware of the problem in advance. The number of people vaccinated with the target vaccine was 11,812 at 9 days. Immediately after the report, the amount was not recovered, and it was three full days from the start of the investigation to the announcement of the government, and the number of inoculations had to increase. One of the inoculators is known to complain of pain at the inoculation site.
As the vaccine collection situation repeats, there is also growing concern about the ‘demic twin’ in which the flu and new coronavirus infection (Corona 19) are simultaneously prevalent. Vaccine The influenza vaccine collected by the Korean Centers for Disease Control and Prevention on day 8 due to exposure to room temperature was 480,360 doses. Part of this amount is known to be included in the 61,15,140 doses that the Korean vaccine company decided to collect. However, the government has not yet confirmed how much the two volumes overlap. If there are not many intersections, up to 1.09 million flu vaccines will be recovered. Considering that the amount of vaccine discarded due to the expiration of the last expiration date was 25.72 TWO last year and 15,957 TWO in 2018, the amount recovered this year is unusually large. Some point out that the flu vaccine supply could be cut off immediately. There is also a controversy over the safety of silicone oil detected as a foreign substance. The Ministry of Food and Drug Safety said that particles with a size of 75 μm or more (one micrometer and 1 μm are 1 millionth of a meter) visible to the naked eye are 99.7% protein and 0.3% oil. of sylicon. The Ministry of Food and Pharmaceutical Safety is a lubricating oil in which silicone oil enters the syringe, and there is no problem because it falls below the standard value. However, Jeong Ki-seok, professor of respiratory medicine at Hallym University Sacred Heart Hospital, said: “Silicone is a synthetic material, so it is not manufactured in nature.”
Quarantine authorities have yet to find alternatives on how to supplement the collected influenza vaccines. The government plans to provide free vaccinations for youth ages 13 to 18, which will resume on the 13th, as well as free vaccinations for those age 70 and over from the 19th and for those ages 62 to 69 from the 26th.
Kang Dong-woong [email protected]· Reporter for Lee So-jung
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