Kim Kang-lip: "COVID-19 vaccine approvals in Korea and abroad are separate matters"... "Will proceed with Novavax review"

[Asia Economy Reporter Lee Chun-hee] Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety (MFDS), strongly refuted criticisms that domestic vaccine approval procedures are conducted regardless of foreign approvals and that "follow-the-leader" approvals are taking place.

At a press briefing held on the afternoon of the 17th at the MFDS in Osong, Chungbuk, Commissioner Kim clearly drew a line against criticisms that "domestic approval procedures are only conducted after overseas approval." He stated, "It is not true that domestic approval procedures are completed only after foreign approval is granted," emphasizing, "(As the approval authority) the MFDS cannot proceed with the approval process unless companies initiate it."

He acknowledged being aware of such criticisms and said, "(Vaccine developers) employ global strategies, so they strategically choose whether obtaining the first approval from the Korean MFDS would benefit their marketing," stressing that this is entirely the vaccine developers' choice.

Accordingly, he also expressed the intention to proceed with the approval review for Novavax regardless of whether it has received approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Commissioner Kim said, "If the submitted data are thoroughly reviewed and it is determined that there are no safety or efficacy issues and the vaccine meets the standards for approval, it can be approved regardless of foreign approvals. Although we monitor how approvals for the Novavax vaccine are progressing in other countries, these do not directly influence our approval decision," he added.

The Novavax COVID-19 vaccine, contracted for development and manufacturing (CDMO) by SK Bioscience, is exhibited at the Ministry of Food and Drug Safety on the 17th. / Photo by Lee Chunhee

Currently, the Novavax vaccine has only received emergency use authorization in Indonesia. Novavax has applied for emergency use authorization from the World Health Organization (WHO), the European Union (EU), the United Kingdom, Canada, Australia, India, and the Philippines. The day before, SK Bioscience, which is conducting contract development and manufacturing (CDMO) of the Novavax vaccine, submitted an application for product approval of the Novavax vaccine.

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