Moderna Spikevax Receives Marketing Authorization in Korea

Moderna received marketing authorization from the Ministry of Food and Drug Safety of Korea (MFDS) for Spikevax, Moderna’s COVID-19 vaccine (mRNA-1273) manufactured by Samsung Biologics, a global CDMO providing integrated contract development and manufacturing services. 
 
This marketing authorization allows the Moderna 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.
 
The Philippines and Colombia authorized emergency use of the Moderna COVID-19 vaccine manufactured by Samsung Biologics on November 26 and December 2, respectively. 
 
“We thank the Ministry of Food and Drug Safety of Korea for their decision to approve this marketing authorization. Our partnership with Samsung Biologics for fill-and-finish manufacturing of the Moderna COVID-19 vaccine is helping us continue to scale up our manufacturing capacity outside of the U.S.,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Along with our manufacturing partners, we remain committed to defeating the COVID-19 pandemic.”
 
“This is truly a significant milestone as we were able to accelerate the approval process in close and prompt collaboration with the Korean government and Moderna, especially under the MFDS’s rigorous screening for the first fill-finish manufacturing of mRNA vaccines in Korea,” said John Rim, CEO of Samsung Biologics. “We were also proud to demonstrate our commitment to providing both quality and agility throughout our processes, and will continue to work closely with our client to stably supply the products especially in light of the increasing importance and demand for vaccines in the battle against the COVID-19 pandemic.”
 
Moderna has multiple strategic partners for fill-finish manufacturing. In the U.S., this includes Catalent, Inc., Baxter BioPharma Solutions and Sanofi. Outside of the U.S., this includes Rovi in Spain, Recipharm in France and Samsung Biologics in Korea.