MFDS: "White particles found in flu vaccines... 615,000 doses recalled" (Update)

"Low Safety Concerns Beyond Local Effects"... Only 1 Reported Adverse Case

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety announced on the 9th that Korean Vaccine will voluntarily recall a total of 615,000 units from four manufacturing lots (PC200701, PC200702, PC200801, PC200802) of its influenza (flu) vaccine, 'Kovaxflu Quadrivalent PF Injection.'

On the 6th, the Ministry received a report from the Yeongdeok-gun Public Health Center in Gyeongbuk that white particles were found in the 'Kovaxflu Quadrivalent PF Injection (lot number: PC200701)' product. An urgent recall and inspection were conducted. Additionally, on-site investigations of the manufacturer, cold chain (refrigerated distribution) analysis, expert consultations, and additional product recalls and inspections were carried out, and the manufacturer was required to submit the results of its own investigation.

Analysis·Inspection results showed that particles larger than 75㎛ consisted of 99.7% protein and 0.3% silicone oil. According to expert consultations, the white particles are believed to be vaccine components, and differences in container (syringe) manufacturing methods may cause variations in adsorption and aggregation patterns. It was also understood that physical influences during distribution could cause the particles to grow larger over time.

A Ministry official stated, "The white particles are considered antigen protein aggregates, and experts believe there is a low safety concern beyond local reactions such as injection site pain and inflammation," adding, "It is not uncommon for antigen proteins in vaccines to aggregate and form particles."

The Ministry explained that, based on recall inspections, manufacturer site checks, and expert opinions, there is no issue with the efficacy and safety of 'Kovaxflu Quadrivalent PF Injection.' However, to reassure the public, the manufacturer decided to voluntarily recall vaccines in which white particles were confirmed.

According to the integrated vaccination management system of the Korea Disease Control and Prevention Agency, as of 3 p.m. on the 9th, 17,812 people (7,018 eligible for the national immunization program and 10,794 general paid recipients) had been vaccinated with the four manufacturing lots of Kovaxflu Quadrivalent PF Injection. So far, one adverse event (local pain) has been reported.

The Ministry of Food and Drug Safety is cooperating with the Korea Disease Control and Prevention Agency to promptly inform medical institutions supplied with the affected lots about the recall and urges medical institutions to suspend use of the product and actively cooperate with the manufacturer's recall.

A Ministry official advised, "Before using the influenza vaccine, it should be shaken sufficiently, and if discoloration or sedimentation is observed visually, it should not be used." They added, "We will establish improvement measures such as strengthening verification of related test items at the national lot release approval stage to prevent recurrence of such issues."

This content was produced with the assistance of AI translation services.