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After the “ room temperature exposure ” influenza (flu) vaccine, this time, a report of “ white particles ” was found in the vaccine and the health authorities began collecting it. Lee Eui-kyung, head of the Ministry of Food and Drug Safety, held a briefing on the 9th and said: “The manufacturer has decided to voluntarily collect 615,000 units from 4 manufacturing units of the Korea Vaccine Co. influenza vaccine. , Ltd. Said.
Size that can be seen with the naked eye.
Manufacturers collect more than 610,000 pieces
Estimated Antigen Protein Aggregate
According to the Ministry of Food and Pharmaceutical Safety, on the 6th a report was received from a public health center in Yeongdeok-gun, Gyeongsangbuk-do, that white particles were found in the product of the influenza vaccine ‘Coboxflu Quadrivalent PF ‘manufactured by a Korean vaccine company. It was enough to be able to confirm it with the naked eye. As a result of emergency collection and inspection by the Ministry of Food and Drug Safety, the white particles were found to be protein (99.7%) and silicone oil (0.3%). As a result of the expert consultation, the Ministry of Food and Pharmaceutical Safety revealed that the white particles are presumed to be aggregates of antigenic proteins.
Choi Won-seok, professor of infectious medicine at Korea University Ansan Hospital, who attended a briefing by the Ministry of Food and Pharmaceutical Safety, said: “This aggregation can occur during the components or the manufacture of the vaccine. It is not very rare because aggregates can appear when stored for a long time.
“As a result of investigating the vaccine distribution process, the cold chain (maintaining the right temperature) was well kept between 2 and 8 degrees, so what I think now is that there may be a problem in the relationship between Vaccine stem and injection machine. Said. Professor Choi said: “If the antigen protein is added, the probability of inflammatory reactions such as pain, redness and swelling at the injection site may increase, but the possibility of adverse reactions occurring throughout the body will not be high. If there is no (even efficacy), it is assumed that there will be no significant effect. “Professor Choi said:” In principle, if the influenza vaccine is visible and there are sediments that do not dissolve with shaking, it is not desirable to use it. , so the experts gathered opinions that it would be better to collect it according to the guidelines for using the vaccine. “Director Lee also said,” We believe there is no problem with the effect and safety of COVEX influenza 4 PF “and said, “The manufacturer has decided to take it back voluntarily for the sake of public safety.” The recovered volume is 615,000. The Food and Drug Administration found that the vaccine was vaccinated to 11,812 people at 3 pm on the 9th. National project to support vaccination (free vaccination) were 7018 and general vaccination pays 11,794. So far only one abnormal case has been reported, which is said to be the degree of local pain.
Previously, the Korean Centers for Disease Control and Prevention decided to collect 480,000 doses (one dose per dose) of the domestically sourced vaccine from Shinsung Pharmaceutical due to exposure to room temperature during vaccine distribution. Here, 615,000 doses of vaccines will be collected from Korean vaccine companies. Altogether, that’s around 1 million people.In a situation where there is concern about the ‘demic twin’, where Corona 19 and the flu are simultaneously an epidemic this year, there is concern that the vaccines may be shortening.
Reporter Baek Minjeong [email protected]
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