Moderna's 'XBB 1.5' Response Vaccine Granted Emergency Use Authorization... Vaccinations to Begin Next Month

From next month, Moderna's COVID-19 vaccine targeting the Omicron variant XBB 1.5, intended for use in the winter vaccination campaign, has been approved in South Korea.

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The Ministry of Food and Drug Safety (MFDS) announced on the 26th that it has granted emergency use authorization for Moderna's monovalent vaccine 'Spikevax X' (active ingredient Andusomeran) targeting the XBB 1.5 variant.

Emergency use authorization is a system that allows the MFDS to permit manufacturers or importers to produce or import medical products not yet approved domestically in response to requests from relevant central administrative agencies during public health crises such as infectious disease pandemics. The decision on emergency use authorization is made after reviewing clinical and quality data submitted by the company, consulting experts from various fields, and deliberation and resolution by the Public Health Crisis Response Medical Product Safety Management and Supply Committee.

This emergency use authorization was granted following a request from the Korea Disease Control and Prevention Agency (KDCA) in anticipation of the COVID-19 vaccination campaign for the 2023?2024 winter season starting on the 19th of next month. The vaccine is approved for use in adolescents aged 12 and older as well as adults. The vaccine had already been authorized by the U.S. Food and Drug Administration (FDA) on the 11th and the European Medicines Agency (EMA) on the 15th.

Domestic production of the Moderna vaccine is being shipped from Samsung Biologics in Yeonsu-gu, Incheon. Photo by Joint Press Corps

Moderna announced clinical results showing that this vaccine elicited neutralizing antibody responses not only against XBB 1.5 but also against XBB sublineages XBB 1.16 and XBB 2.3.2, as well as variants BA 2.86, EG 5, and FL 1.5.1. In terms of safety, it showed a profile similar to the existing Spikevax vaccine. The most common local adverse reaction was injection site pain, while the most common systemic adverse reactions included headache, fatigue, muscle pain, and chills.

Earlier on the 12th, the MFDS also granted emergency use authorization for Pfizer's monovalent vaccine targeting the COVID-19 XBB 1.5 variant, 'Comirnaty 0.1 mg/mL' (active ingredient Laxtozinameran). Both vaccines are planned to be used during the upcoming winter COVID-19 vaccination period from the 19th of next month through March 31 of next year. The KDCA is recommending simultaneous administration with the influenza (flu) vaccine to improve vaccination convenience.

Son Ji-young, CEO of Moderna Korea, stated, "COVID-19 remains one of the leading causes of death in South Korea and can pose a serious threat to vulnerable populations during the peak of respiratory disease outbreaks." She added, "As the circulating variants continue to evolve, it is important to receive updated COVID-19 vaccinations to protect health." She further urged, "Especially those aged 65 and older, immunocompromised individuals, and people with underlying conditions are strongly recommended to consult with experts regarding COVID-19 vaccination." She concluded by expressing gratitude to government agencies for their cooperation in the swift introduction of the vaccine.

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