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.

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com. 

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: Moderna's development of its vaccine against COVID-19 (mRNA-1273); the future supply of mRNA-1273 through fill-finish services from Samsung Biologics; and the impact of approvals from the MFDS on Moderna's ability to supply mRNA-1273 globally. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Samsung Biologics Forward-Looking Statements

This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics' objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.

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Source: Moderna; Samsung Biologics