Will Moderna Vaccine Produced in Samba Be Introduced Domestically Starting Next Month?

Incheon Songdo Samsung Biologics Plant 3 Exterior (Photo by Samsung Biologics)

[Asia Economy Reporter Lee Chun-hee] There is speculation that the Moderna COVID-19 vaccine, which Samsung Biologics is preparing to manufacture under contract, could be supplied domestically as early as next month.

Kang Ki-yoon, a member of the National Assembly’s Health and Welfare Committee and the chairman of the People Power Party’s COVID-19 Vaccine Task Force, announced on the morning of the 29th that during a visit to Samsung Biologics’ second plant in Incheon with other members of the Health and Welfare Committee and the Vaccine Task Force from the People Power Party, he met with John Rim, CEO of Samsung Biologics, and others to inspect the Moderna vaccine contract manufacturing site and discuss current issues, during which this information was mentioned.

According to industry sources, Samsung Biologics, which has signed a contract to import the bulk substance of the Moderna vaccine and perform finished product manufacturing (DP), is currently conducting pilot production, and it is reported that more than 2 million doses have been produced.

Regarding this, Kang said that they had intensive discussions about the government’s plan to prioritize the domestic supply of 1 million doses of the Moderna vaccine in cooperation with Moderna. According to Kang, "if the Ministry of Food and Drug Safety’s approval for the manufacturing and sale of the Moderna vaccine is swiftly completed, and negotiations between the government and Moderna on domestic vaccine introduction proceed smoothly, it is expected that the Moderna vaccine could be introduced domestically even in October.

Moderna COVID-19 Vaccine
[Image source=Reuters Yonhap News]

Currently, the Moderna vaccine has already been conditionally approved by the Ministry of Food and Drug Safety in May and is being administered domestically. However, since this approval is for imported vaccines, the Moderna vaccine produced by Samsung Biologics domestically must obtain a separate approval.

However, a Ministry of Food and Drug Safety official explained, "Samsung Biologics has not yet submitted an application for approval or even a preliminary review request for the Moderna vaccine it is producing," adding, "It is too early to predict the timing of approval and subsequent supply."

At present, the Ministry of Food and Drug Safety supports COVID-19 vaccine approvals through prior review of each product and expedited review by a dedicated approval team, but the approval process typically takes about 40 days. If Samsung Biologics submits a formal approval application, actual vaccine supply would realistically be possible only by November at the earliest. However, if the Korea Disease Control and Prevention Agency requests emergency use authorization from the Ministry of Food and Drug Safety, the period could be shortened to about 10 days. In that case, supply as mentioned by Kang next month would also be possible.

This content was produced with the assistance of AI translation services.