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The Ministry of Food and Pharmaceutical Safety concluded that “there is no effect on efficacy and safety” regarding the Korean vaccine flu vaccine, which was recently discovered and recovered by white particles in the syringe.
“No problem, but to alleviate anxiety the harvest product is discarded”
The Ministry of Food and Pharmaceutical Safety announced on the 27th that it had confirmed this through characterization, antigen content testing and animal testing of the ‘Korean vaccine PF tetravalent Coboxflu strain’.
Flu vaccine from a Korean vaccine company. Photo provided by KFDA
Based on the test results, the white particles formed in the vaccine syringe were identified as proteins of the original components of the vaccine. The Ministry of Food and Drug Safety explained: “As a result of comparing and analyzing the size and distribution patterns of proteins, there was no difference in the products producing white particles from the standards of the World Health Organization (WHO ) and the normal products of other companies. ”
There were no efficacy or safety issues. To confirm the effect, the Ministry of Food and Drug Safety carried out an antigen content test between the WHO standard product and the normal product and the white particle vaccine from another company and found that it was suitable for the standard. .
The white particle vaccine did not show any toxicity that could cause side effects. To confirm this, the Ministry of Food and Pharmaceutical Safety observed the product with white particles in the rabbit for 3 days after intramuscular injection, and performed autopsy and histopathology.
The Ministry of Food and Drug Safety said: “There were no specific findings other than the general reaction at the injection site due to the administration of the vaccine, such as redness of the skin at the injection site.” He added: “We have had three expert discussions on the white particles in the flu vaccine and decided that there would be no major issues with the safety and efficacy of this vaccine that contains white particles.” He added: “I am sorry to have caused anxiety and concern to the public.” Revealed.
On the afternoon of the 13th, citizens of the Gyeonggi branch of the Korean Health Management Association in Jangan-gu, Suwon-si, Gyeonggi-do, wait at a distance to receive flu shots. News 1
However, the cause of the white particles has not been identified. Yang Jin-young, deputy director of the Ministry of Food and Drug Safety, in a briefing on the afternoon of 27, “We are conducting experiments on various conditions that affect the formation of white particles through expert meetings or literature studies, and the direct cause has not yet been clearly identified. ” He said. The Ministry of Food and Drug Safety plans to make additional announcements as soon as the cause is revealed.
No problem, but the recovered vaccine is discarded.
Deputy CEO Yang Jin-young said: “It was confirmed that there were no special safety and effectiveness issues, but in order to eliminate public anxiety, the company voluntarily recovered, and voluntarily recovered volume is discarded if there are no specific issues.” . On the 6th, the Ministry of Food and Drug Safety ordered the manufacturer to voluntarily collect 615,000 after collecting the product after receiving a report from the public health center in Yeongdeok-gun, Gyeongsangbuk-do.
Reporter Hwang Soo-yeon [email protected]
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