MFDS "Voluntary Recall of 610,000 Flu Vaccines Due to White Particles Found"
[Asia Economy Reporter Seulgina Jo] On the 9th, the Ministry of Food and Drug Safety announced that the manufacturer, Korea Vaccine, plans to voluntarily recall a total of 615,000 units from 4 production batches of the influenza vaccine 'Kovax Flu Quadrivalent PF Injection.'
This decision follows a report from the Yeongdeok County Public Health Center in Gyeongsangbuk-do, which found white particles inside the vaccine product. After receiving the report, the Ministry conducted an urgent on-site investigation and additional testing, confirming the presence of the white particles.
The Ministry explained that the white particles are believed to be antigen protein aggregates, and experts have opined that aside from local reactions such as injection site pain and inflammation, there are low safety concerns.
Accordingly, it was judged that there are no issues with the vaccine's efficacy and safety, but the manufacturer decided to proceed with a voluntary recall.
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The Ministry of Food and Drug Safety, in cooperation with the Korea Disease Control and Prevention Agency, urged medical institutions to stop using the product and to cooperate with the recall process.
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