Government: "Swift Approval of Novavax Vaccine in Korea Underway... Technology Transfer Contract Extended" (Comprehensive)

Supply of up to 20 million doses by the third quarter

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The government is initiating a rapid approval process to expedite the domestic supply of Novavax's COVID-19 vaccine.

Currently, the Novavax vaccine has completed Phase 3 clinical trials in the UK and has prioritized approval procedures in the UK and the European Medicines Agency (EMA). Going forward, Korea will proceed with the approval process concurrently with these countries.

Additionally, to prepare for increased demand next year, the government plans to extend the license-in production contract to enable domestic companies to produce and utilize the vaccine.

Kwon Deok-cheol, head of the 'Pan-Government Vaccine Introduction Task Force (TF)' and Minister of Health and Welfare, stated on the 27th that he met with Stanley Erck, CEO of Novavax, who visited Korea, to discuss the early supply of the COVID-19 vaccine.

The government has secured a total of 192 million doses (enough for 99 million people), which is approximately 1.9 times the total population and 2.75 times the vaccination target of 36 million people needed for herd immunity. Among these, the Novavax vaccine accounts for 40 million doses (enough for 20 million people).

The Novavax vaccine is planned to be supplied sequentially by the end of the year, with up to 20 million doses expected to be delivered by the third quarter.

TF head Kwon explained, "The Novavax vaccine is a recombinant protein vaccine, which has already been used in other vaccines such as the cervical cancer vaccine, and is evaluated to be excellent in terms of safety and efficacy. It can be stored at room temperature, making distribution and vaccination easier, and is known to be effective against variant viruses."

According to Novavax, the vaccine showed a preventive efficacy of 96.4% in Phase 3 clinical trials, with 86% efficacy against the UK variant and 55.4% efficacy against the South African variant.

Notably, unlike the existing contract manufacturing method where overseas companies sell vaccines produced by domestic companies, the Novavax vaccine is produced by the domestic company SK Bioscience through technology transfer and sold to the Korean government.

[Image source=Yonhap News]

During the meeting, the government and Novavax agreed to actively pursue the extension of the license-in production contract to ensure that domestic companies can continue producing and utilizing the vaccine next year for stable supply.

Originally, SK Bioscience and Novavax had signed a license-in production contract for vaccine bulk production until the end of this year and for final filling until next year. The government plans to extend the license-in production contract for bulk production to ensure stable mid- to long-term supply of the vaccine.

Furthermore, the government and Novavax will strengthen cooperation on the supply of raw materials necessary for vaccine production and expedite the approval process to enable early domestic vaccination with the Novavax vaccine.

Novavax will submit the required data early to obtain rapid approval in Korea, and the Ministry of Food and Drug Safety will promptly review the vaccine's safety and efficacy by operating a 'Novavax Vaccine Review Team.'

TF head Kwon emphasized, "SK Bioscience's involvement in supply production through technology transfer is very meaningful for Korea. It establishes a foundation for providing vaccines produced in Korea not only domestically but globally, highlighting Korea's significance as a vaccine-producing country."

He added, "Although the government has already secured sufficient doses to achieve herd immunity by November as initially planned, we continue to make multiple efforts to introduce vaccines early and stably so that the public can feel fully reassured. We urge the public to actively participate in vaccination to achieve rapid herd immunity with the secured vaccines."

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