MFDS Approves Moderna COVID-19 Variant Vaccine

The Ministry of Food and Drug Safety announced on the 12th that it has approved the COVID-19 vaccine 'Spikevax JN Injection' applied for by Moderna Korea.

Spikevax JN is designed to express the JN.1 variant antigen, similar to the COVID-19 vaccine from Korea Pfizer that was approved domestically on the 30th of last month, and is an mRNA (messenger ribonucleic acid)-based vaccine.

It is administered as a single 0.5 ml intramuscular injection without dilution for the prevention of COVID-19 in individuals aged 12 and older, and if previously vaccinated against COVID-19, it is given at least three months after the prior vaccination.

The Ministry of Food and Drug Safety expects smooth supply as Samsung Biologics receives the active pharmaceutical ingredient from Moderna and produces the finished product through the manufacturing process. It is the only domestically manufactured mRNA COVID-19 vaccine approved in Korea, and it was also approved earlier in Japan and the United Kingdom before Korea.

The Ministry explained, "While strictly reviewing the vaccine's safety and efficacy, we promptly approved the product to ensure there is no disruption to the national vaccination schedule for high-risk groups planned for next month."