MFDS Begins Preliminary Review of Moderna's Second COVID-19 Bivalent Vaccine

Moderna's BA.1-based bivalent vaccine, which received domestic approval on September 8.

[Asia Economy Reporter Jo In-kyung] The Ministry of Food and Drug Safety announced on the 28th that it has begun a preliminary review of Moderna's COVID-19 vaccine developed to respond to the Omicron BA.4 and BA.5 variants.

Moderna Korea, the Korean branch of Moderna, submitted an application on the same day for a preliminary review of non-clinical and quality data for 'Spikevax 2-dose (Elasomeran, Davesomeran)'.

This vaccine is a messenger RNA (mRNA) bivalent vaccine developed to express common antigen parts of the original COVID-19 virus and the Omicron BA.4 and BA.5 variant strains, intended for additional vaccination after the primary series of existing vaccines.

It received emergency use authorization in the United States on August 31, and was recommended for conditional approval in Europe on the 19th of this month.

This vaccine is Moderna's second COVID-19 bivalent vaccine. The first bivalent vaccine, developed to express antigens of the original COVID-19 virus and the Omicron BA.1 variant, received marketing authorization on the 8th of last month.

The Ministry of Food and Drug Safety stated, "We will promptly and thoroughly review the submitted data to quickly supply safe and effective vaccines to our people."