Government: "Swift Approval Process for Novavax Vaccine in Korea... Extension of Technology Transfer Agreement"

Supply of up to 20 million doses by the third quarter

[Image source=Yonhap News]

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

Currently, the Novavax vaccine has completed Phase 3 clinical trials in the United Kingdom and has prioritized approval procedures with 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 technology transfer production contract to enable domestic companies to produce and utilize the vaccine.

Kwon Deok-cheol, head of the 'Pan-Government Vaccine Introduction Task Force' and Minister of Health and Welfare, announced on the 27th that he met with Stanley Erck, Chairman and 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 about 2.75 times the vaccination target of 36 million people needed to achieve herd immunity. Among these, the Novavax vaccine accounts for a total of 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.

The Novavax vaccine is a recombinant protein-based vaccine that is easy to store and distribute, can be stored for a relatively long period, and is known to have strong efficacy against variant viruses.

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.

During the meeting, the government and Novavax agreed to actively pursue the extension of the technology transfer production contract to allow domestic companies to produce and utilize the vaccine stably next year as well.

Originally, SK Bioscience and Novavax had signed a technology transfer production contract for vaccine bulk production until the end of this year and for final filling until next year. Accordingly, the government plans to extend the technology transfer 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 the early use of the Novavax vaccine in domestic immunization programs.

Novavax will submit the necessary 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.'

Task Force leader Kwon Deok-cheol stated, "Although we have already secured sufficient quantities to achieve herd immunity by November as initially planned, we continue to make multiple efforts to introduce the vaccine early and stably so that the public can feel fully assured." He added, "We urge the public to actively participate in vaccination so that rapid herd immunity can be achieved through the vaccines secured by our government."

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