MFDS: "No Impact on Efficacy or Safety of Flu Vaccine with 'White Particles'"

At the Yeongdeok County Public Health Center in Gyeongsangbuk-do, the Korean vaccine Cobaxflu4aPF flu vaccine was reported to contain 'white particles' [Image source=Yonhap News]

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety announced on the 27th that tests on the influenza (flu) vaccine, which was recalled due to the discovery of white particles, confirmed that the particles do not affect the vaccine's efficacy or safety. The particles were identified as proteins originating from the vaccine's original components. All of the affected vaccines were recalled and disposed of.

Earlier, the Ministry of Food and Drug Safety requested a voluntary recall after reports from some local health centers found white particles in 'Kovax Flu Quadrivalent PF Injection' produced by one of the vaccine manufacturers, Korea Vaccine. Subsequently, the ministry examined whether the vaccine's effectiveness had changed and if it remained safe.

At a briefing, Deputy Director Yang Jin-young of the Ministry stated, "We compared and analyzed the size and distribution patterns of proteins using the vaccine with white particles, the World Health Organization's standard reference material, and normal products from other companies as control groups," adding, "There was no difference from the control groups, and it was confirmed that the white particles are influenza proteins that make up the vaccine."

For the efficacy analysis to verify whether the vaccine provides proper preventive effects, the antigen content of the vaccine containing white particles was tested. The test results met the standards, leading to the conclusion that there is no problem with the vaccine's effectiveness. Safety analysis involved toxicity tests using rabbits, which showed no unusual findings other than typical reactions at the injection site.

The manufacturer reported to the Ministry of Food and Drug Safety that all 615,000 doses of the affected vaccine were collected, and the ministry is verifying whether the recall was properly conducted. Approximately 18,000 people received the vaccine, and adverse reactions are being monitored through the Korea Disease Control and Prevention Agency and others.

Deputy Director Yang said, "We held three expert discussions regarding the white particles and concluded that the vaccine containing these particles is unlikely to have significant safety or efficacy issues," adding, "We will work with related ministries to establish measures to improve the vaccine management system to ensure that safe and effective vaccines are supplied in a timely manner."

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