28 Million Doses of Influenza Vaccines to Receive National Lot Release Approval This Year

MFDS to Supply 14 Types of Influenza Vaccines,
Including Nasal Spray Vaccine

The Ministry of Food and Drug Safety announced on June 12 that approximately 28 million doses of influenza vaccines are expected to receive national lot release approval this year.

National lot release is a system that provides an additional quality check for pharmaceuticals such as vaccines and plasma-derived products by comprehensively evaluating the results of tests and documentation for each manufacturing batch before they are distributed to the market.

This year, unlike last year when only quadrivalent influenza vaccines were supplied, trivalent influenza vaccines (about 27 million doses) will be mainly supplied. This follows the World Health Organization (WHO) recommendation, which takes into account the fact that the B (Yamagata) virus has not been detected in influenza patients since March 2020.

In particular, this year, seven domestically manufactured products and seven imported products will be supplied, including 'FluMist Intranasal Spray' (an influenza vaccine administered via nasal spray), which will be distributed in Korea for the first time.

The Ministry of Food and Drug Safety is holding a briefing session on national lot release for influenza vaccine manufacturers and importers on this day to ensure that influenza vaccines are released without delay in the second half of the year and that the public can receive vaccinations at the appropriate time. The ministry will also provide guidance on how to prepare manufacturing and quality control summaries and information on the 2025 national immunization influenza vaccine supply and procurement plan.