Press Releases

Press Releases

Moderna COVID-19 Vaccine Manufactured in Korea by Samsung Biologics Receives Marketing Authorization from Ministry of Food and Drug Safety of Korea

COMPANY NEWS

COMPANY NEWS

Moderna’s COVID-19 vaccine manufactured by Samsung Biologics obtains drug authorization from Korea's Ministry of Food and Drug Safety



Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today 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. 

“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. (NYSE: CTLT), Baxter BioPharma Solutions and Sanofi (Nasdaq: SNY). Outside of the U.S., this includes Rovi (BME: ROVI) in Spain, Recipharm in France and Samsung Biologics (KRX: 207940.KS) in Korea. 
Moderna_COVID-19_mRNA_vaccine_manufactured_by_Samsung_Biologics_obtains_drug_authorization_from_MFDS.png

Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today 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. 

“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. (NYSE: CTLT), Baxter BioPharma Solutions and Sanofi (Nasdaq: SNY). Outside of the U.S., this includes Rovi (BME: ROVI) in Spain, Recipharm in France and Samsung Biologics (KRX: 207940.KS) in Korea. 

SITE MAP

close
Close

Your download is ready

Click Download.

Close

Subscribe to Our Newsletter

Please fill in your details, select one or more areas of interest, and click the subscribe button to receive our newsletter.

Subscribe to Our Newsletter
  • Privacy Policy to collect the email address that I have provided until I withdraw my consent. The collected information will only be used for the purpose of mailing service. If you do not wish to consent, you will not be able to receive the newsletter. Samsung Biologics respects the privacy of its subscribers.
Close

Please fill out the form
to view the full content

Please sign up to view the post..
* Required
Privacy Policy
close

SECURITY REPORT

Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.

  • This page is created for reporting core technology and management information leakage.
  • The reported contents as well as the identity of the reporter are strictly secured.
THE MANUAL FOR SECURITY NOTIFICATION