The Korea Food and Drug Administration (KFDA) is gearing up to approve approximately 27.4 million doses of flu vaccine for this year. The agency is also establishing a support system to ensure smooth distribution of the vaccine in the second half of the year and timely vaccinations for the public.
On June 12, the KFDA announced it will hold an information session for manufacturers and importers of the flu vaccine to assist with the national approval process.
National approval is a system that allows the government to conduct a comprehensive evaluation of test results and documentation for each manufacturing lot of vaccines and plasma-derived products before they are distributed to the market. This is considered a crucial step for final verification of safety and efficacy.
The session will cover the national approval procedures and methods, the 2026 flu vaccine approval plan, guidelines for preparing manufacturing and quality control summaries, and the procurement plans for the national vaccination program (managed by the Korea Disease Control and Prevention Agency).
This year, about 27.4 million doses of flu vaccine are expected to receive national approval, including eight domestically manufactured products and six imported products, totaling 14 products.
The primary vaccines to be supplied will be a trivalent flu vaccine, which includes two types of Type A (H1N1, H3N2) and one type of Type B (Victoria), as recommended by the World Health Organization (WHO).
Flu is an acute respiratory illness caused by the influenza virus, typically peaking in the winter months. Common symptoms include fever (38-40 degrees Celsius), headache, muscle aches, fatigue, dry cough, and sore throat.
While most individuals recover within one to two weeks, those in high-risk groups may experience severe complications and should take precautions. High-risk groups include seniors aged 65 and older, infants (6 months to 5 years), individuals with chronic diseases (such as heart, respiratory, kidney, and metabolic disorders), and pregnant women.
On June 12, the KFDA announced it will hold an information session for manufacturers and importers of the flu vaccine to assist with the national approval process.
National approval is a system that allows the government to conduct a comprehensive evaluation of test results and documentation for each manufacturing lot of vaccines and plasma-derived products before they are distributed to the market. This is considered a crucial step for final verification of safety and efficacy.
The session will cover the national approval procedures and methods, the 2026 flu vaccine approval plan, guidelines for preparing manufacturing and quality control summaries, and the procurement plans for the national vaccination program (managed by the Korea Disease Control and Prevention Agency).
This year, about 27.4 million doses of flu vaccine are expected to receive national approval, including eight domestically manufactured products and six imported products, totaling 14 products.
The primary vaccines to be supplied will be a trivalent flu vaccine, which includes two types of Type A (H1N1, H3N2) and one type of Type B (Victoria), as recommended by the World Health Organization (WHO).
Flu is an acute respiratory illness caused by the influenza virus, typically peaking in the winter months. Common symptoms include fever (38-40 degrees Celsius), headache, muscle aches, fatigue, dry cough, and sore throat.
While most individuals recover within one to two weeks, those in high-risk groups may experience severe complications and should take precautions. High-risk groups include seniors aged 65 and older, infants (6 months to 5 years), individuals with chronic diseases (such as heart, respiratory, kidney, and metabolic disorders), and pregnant women.
* This article has been translated by AI.
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