Samsung Bio Production of Moderna Vaccine Officially Approved... 'First Domestic Production of mRNA Vaccine'

On the morning of October 28, the Moderna vaccine, contract-manufactured at the Samsung Biologics vaccine factory in Songdo, Yeonsu-gu, Incheon Metropolitan City, was shipped domestically for the first time. / Photo by Joint Press Corps

[Asia Economy Reporter Chunhee Lee] The Moderna COVID-19 vaccine produced by Samsung Biologics, which has been used domestically under emergency use authorization, has received formal product approval.

On the 13th, the Ministry of Food and Drug Safety announced that on the 8th of last month, it decided to grant manufacturing product approval for the 'Spikevax' produced by Samsung Biologics, as applied for by Moderna Korea.

Spikevax is the same vaccine as the 'Moderna Spikevax' developed by the U.S. company Moderna, which was approved for import on May 21. The vaccine name was changed from 'Moderna COVID-19 Vaccine' at the time of approval in May to its current name on the 1st of last month.

Currently, Samsung Biologics has a contract manufacturing organization (CMO) agreement with Moderna, importing and supplying the active pharmaceutical ingredient (DS), and producing the finished Moderna COVID-19 vaccine (DP) through processes such as filling and labeling.

This vaccine induces an immune response by injecting the antigen gene of the COVID-19 virus in the form of messenger ribonucleic acid (mRNA), which generates antigen proteins inside the body. Notably, it is the first mRNA vaccine produced domestically among COVID-19 vaccines approved in Korea.

Previously, on October 25, the Ministry of Food and Drug Safety completed Good Manufacturing Practice (GMP) certification for Samsung Biologics' vaccine manufacturing facilities and granted emergency use authorization on the same day upon the request of the Korea Disease Control and Prevention Agency. Subsequently, starting with an initial production quantity (PPQ) of 2,435,000 doses of the Moderna COVID-19 vaccine on October 28, domestic supply has been underway.

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