American firm Moderna has announced that the Ministry of Food and Drug Safety of Korea (MFDS) has issued a marketing authorization for Spikevax®, Moderna’s COVID-19 vaccine (mRNA-1273) manufactured by Samsung Biologics, a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services. 

This marketing authorization obtained by Moderna Korea officially allows the Moderna’s COVID-19 vaccine manufactured at Samsung Biologics’ local pharmaceutical production facilities to be distributed within Korea and exported to other countries.

In May 2021, Moderna and Samsung Biologics announced the agreement for fill-finish manufacturing of the Moderna COVID-19 vaccine. Upon execution of the deal, Samsung Biologics successfully reduced the overall timeline by leveraging its technology and capabilities, enabling the first batch of Moderna’s COVID-19 vaccine to be released for domestic supply within five months from the signing of the contract. Moderna Korea applied for a full marketing authorization for Spikevax® with the MFDS in early November, and successfully obtained it within a month’s time. 

The Philippines and Colombia authorized emergency use of the Moderna COVID-19 vaccine manufactured by Samsung Biologics on November 26 and December 2, respectively.