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SK bioscience Submits Biologics License Application to the KMFDS for Novavax Covid-19 Vaccine Candidate

2021. 11. 15

The first submission of a protein-based COVID-19 vaccine candidate in Korea
High expectations of the platform which has demonstrated efficacy and a favorable safety profile

Plan to supply forty million doses in Korea under the contract with KCDC once approved

The COVID-19 vaccine candidate developed with a recombinant technology platform, of which 40 million doses will be distributed in Korea alone, has entered the final review stage for authorization.

 

SK bioscience (CEO Jae-yong Ahn) announced on November 15th that the company has completed a biologics license application (BLA) submission process to the Ministry of Food and Drug Safety (KMFDS) in Korea for approval of Novavax’ COVID-19 vaccine candidate, NVX-CoV2373. SK bioscience has a license to manufacture and commercialize NVX-CoV2373.

 

NVX-CoV2373 is the first protein-based COVID-19 vaccine candidate submitted for BLA approval in Korea. NVX-CoV2373 includes saponin-based Matrix-M™ adjuvant, which strengthens the immune response and induces a high level of neutralizing antibodies.

 

NVX-CoV2373, whose vaccination regimen calls for two 0.5 ml given intramuscularly 21 days apart, is expected to be authorized after being examined for efficacy and safety by the expert advisory board and the final inspection committee under the KMFDS.

 

SK bioscience has completed technology transfer of the protein-based recombinant nanoparticle manufacturing and production technology from Novavax after signing an agreement including both drug product and drug substance in February 2021, following completion of a CDMO contract in August 2020. SK bioscience expects that the domestic supply of NVX-CoV2373 will begin soon after the product is approved.

 

SK bioscience has previously signed a domestic supply contract for 40 million doses of NVX-CoV2373 with the Korea Centers for Disease Control and Prevention (KCDC) (one dose means one-time injection).

 

NVX-CoV2373 was developed using a proven, well-understood adjuvanted recombinant nanoparticle platform, which has been used for development of current influenza (flu), hepatitis B, and cervical cancer vaccines, for example. The vaccine is stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it can be distributed through the current vaccine supply network without thawing at inoculation stage.

 

NVX-CoV2372 also demonstrated high efficacy in Novavax’ pivotal Phase 3 PREVENT-19 trial.

 

Novavax announced in June that NVX-CoV2373 demonstrated 90.4% efficacy overall and 100% protection against moderate and severe disease in its Phase 3 PREVENT-19 trial, which was conducted in the U.S. and Mexico with nearly 30,000 participants over the age of 18. In addition, Novavax confirmed NVX-CoV2373 demonstrated 89.7% efficacy overall, and 96.4% efficacy against the original virus strain in a Phase 3 trial conducted in the U.K., which included more than 15,000 participants between the ages of 18 to 84.

 

In terms of safety, most of the adverse reactions that occurred after injection were mild or moderate.

 

Novavax has recently obtained emergency use authorization (EUA) in Indonesia based on the significant results of the Phase 3 clinical trials and submitted applications for emergency use listing (EUL) to the World Health Organization (WHO) and for authorization to regulatory agencies in E.U., U.K., India, Canada, Australia, New Zealand and the Philippines.

 

Stanley Erck, President and CEO of Novavax, said, “I am grateful to SK bioscience for their partnership in helping to increase equitable access of our COVID-19 vaccine for the world, including Korea. This submission marks another important milestone in Novavax´ transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic.”

 

Jae-Yong Ahn, CEO of SK bioscience, said, “Novavax’ protein-based vaccine, which has proven its effectiveness, safety, and even distribution convenience, will be a new cornerstone in overcoming the global COVID-19 pandemic situation. We will cooperate closely with the Korean government to supply sufficient quantities of Novavax’ vaccine in Korea since we were able to establish an independent production plan based on our technology transfer agreement with Novavax.”