The Ministry of Food and Drug Safety said Monday that Moderna Korea applied for the approval of Moderna Covid-19 Vaccine Inj. manufactured by Samsung Biologics.

Moderna’s Covid-19 vaccine obtained the regulatory nod as an imported drug with the brand name Moderna Spikevax Inj. on May 21.

The Ministry of Food and Drug Safety is reviewing the authorization of Moderna Covid-19 Vaccine Inj., which will be manufactured by Samsung Biologics for the Korean market.
The Ministry of Food and Drug Safety is reviewing the authorization of Moderna Covid-19 Vaccine Inj., which will be manufactured by Samsung Biologics for the Korean market.

However, to supply Moderna vaccines locally produced by Samsung Biologics in the Korean market, the vaccine needs a separate permit under a different brand name.

As Moderna Korea changed the name of the vaccine from Moderna Spikevax to Moderna Covid-19 Vaccine on Monday last week, Moderna’s Covid-19 vaccine produced in Korea will be sold under the new name if it gets the license.

Moderna’s Covid-19 vaccine is produced by injecting the antigen gene of the Covid-19 virus in the form of mRNA to produce antigen proteins in the body and induce an immune response.

"We will thoroughly assess the product’s quality, non-clinical, and clinical data, and decide whether to authorize the product by confirming its safety and effectiveness,” the MFDS said in a statement. “We will do our best to supply safe and effective vaccines for Korean people swiftly.”

Copyright © KBR Unauthorized reproduction, redistribution prohibited