Moderna's Latest Variant-Targeting Vaccine Approved in Korea

Spikevax LP.8.1 to be Offered Free to High-Risk Groups

 LP.8.1 Variant-Targeting COVID-19 Vaccine 'Spikevax LP.8.1' [Provided by Moderna Korea]

Moderna Korea announced on the 1st that its COVID-19 vaccine targeting the LP.8.1 variant, 'Spikevax LP.8.1', has received approval from the Ministry of Food and Drug Safety.

Spikevax LP.8.1 is a vaccine confirmed to induce broad cross-immune responses against the latest circulating variants, including the LP.8.1 strain of COVID-19, and can be used in adolescents and adults aged 12 and older.

Moderna plans to supply the newly approved vaccine to Korea in time for the government's 2025-2026 season vaccination program, which is set to begin in October.

According to the National Immunization Program guidelines, Spikevax LP.8.1 will be provided free of charge to high-risk groups, including individuals aged 65 and older and those hospitalized or residing in facilities for vulnerable populations.

The LP.8.1 series vaccines to be supplied to Korea this season have been recommended for use by the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA). In response, the Korea Disease Control and Prevention Agency (KDCA) decided to adopt the LP.8.1 series vaccine, which has shown a higher neutralizing antibody response compared to the JN.1 series used last year, following deliberation by the Advisory Committee on Immunization Practices.

Moderna stated that its COVID-19 vaccine has demonstrated excellent immunogenicity and safety through large-scale Phase 3 clinical trials and extensive Real-World Evidence (RWE), noting that it is characterized by similar immune effects in individuals aged 65 and older compared to younger age groups.

Moderna manufactures and supplies the only mRNA COVID-19 vaccine in Korea in collaboration with Samsung Biologics [207940], and maintains a stable vaccine supply system through continuous cooperation with Boryung Biopharma.

Kim Sang-pyo, CEO of Moderna Korea, said, "The number of COVID-19 hospitalizations has been increasing for seven consecutive weeks, posing an ongoing threat to high-risk groups. We will do our best to supply the updated COVID-19 vaccine capable of responding to the latest circulating variants in a timely manner and ensure that the public can receive vaccinations safely."