Korea approves export of Samsung Biologics-made Moderna vaccine

South Korea approved exports of Moderna Inc.’s COVID-19 vaccine produced by Samsung Biologics Co. in a move that will help the country’s largest conglomerate Samsung Group accelerate the development of its biopharmaceutical business, one of its key next growth engines.

The Ministry of Food and Drug Safety issued marketing authorization for Spikevax, Moderna’s messenger ribonucleic acid (mRNA)-based vaccine manufactured by Samsung Biologics in South Korea, the authority said on Dec. 13.

“The approval is expected to contribute to a stable supply of COVID-19 vaccines in South Korea, helping the country leap into its role as a global vaccine hub,” said the ministry in a statement.

The authorization, the country’s first approval on such a vaccine, officially allows its export and local sales, Moderna and Samsung Biologics said. The Philippines and Colombia authorized emergency use of the vaccine on Nov. 26 and Dec. 2, respectively.

EXPORTS WITHOUT EMERGENCY-USE LIMITATIONS

Samsung Biologics, a global contract development and manufacturing organization (CDMO), in May signed a drug product (DP) manufacturing deal with Moderna, a contract that involves putting vaccines into vials or syringes, sealing and packaging for shipping, but not making the drug substance (DS) of the vaccine.

In October, the South Korean company delivered some 2.43 million doses of the vaccine in the country with emergency use authorization, which is valid only during what is deemed a health crisis. The latest official approval allows vaccine use without limitation, provided there are no issues with the product.

“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 US," said Stéphane Bancel, the chief executive officer of Moderna.

Samsung Biologics has been building facilities for the DS of mRNA vaccines in South Korea with a target of production from the second quarter of 2022 to reach full capacity to manufacture such vaccines.

“Samsung Biologics is growing into a production hub for the COVID-19 vaccine in Asia,” said an industry source. “Its exports are expected to gradually increase.”

The company became a core unit within Samsung Group, succeeding the semiconductor division as a future growth engine, fully supported by the group’s de facto leader and Samsung Electronics Co. Vice Chairman Jay Y. Lee, according to industry sources.

In August, Lee discussed vaccine production with Moderna’s top executives through video conferences. Last month, he met with Moderna co-founder Noubar Afeyan in Cambridge, Massachusetts to discuss cooperation on vaccines and further collaborations.

Earlier this year, Samsung Group unveiled plans to invest 240 trillion won ($203 billion) over the next three years in its key businesses such as semiconductors, biopharmaceutical products and displays.

Write to Sin-Young Park at nyusos@hankyung.com
Jongwoo Cheon edited this article.