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SK bioscience Obtained Biologics License Application Approval of Novavax’ COVID-19 Vaccine in Korea

2022. 01. 12

The first approval of a recombinant protein nanoparticle COVID-19 vaccine with proven efficacy and safety in South Korea
SK plans to supply 40 million doses the vaccine in South Korea based on an advanced purchase agreement (APA) with the KCDC

 

A recombinant protein nanoparticle COVID-19 vaccine, which has proven high safety and efficacy, will be introduced for the first time in South Korea. Market expectations for SK bioscience, which will exclusively produce and supply the product, have also increased as a new COVID-19 vaccine will provide broader choice of vaccination

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SK bioscience (CEO Jae-Yong Ahn) announced on the 12th that the company has obtained a biologics license application approval of the COVID-19 vaccine, ‘Nuvaxovid™ (NVX-CoV2373)´, which was submitted to the Korean Ministry of Food and Drug Safety (KMFDS) on November 15th. This is the first authorization of a recombinant protein nanoparticle COVID-19 vaccine in South Korea.

 

With this authorization, SK bioscience has proven its technology by manufacturing and supplying internally two of five COVID-19 vaccines approved in advanced countries such as the US and EU. SK bioscience previously contributed to the early stage of the COVID-19 pandemic prevention by manufacturing drug substance and drug product of the AstraZeneca’s COVID-19 vaccine and supplying it worldwide.

 

SK bioscience is the only South Korean company that conducts the entire manufacturing process from drug substance to drug product of COVID-19 vaccines.

 

SK bioscience expects to supply Nuvaxovid quickly once passing the national lot release procedure in South Korea. In February, SK bioscience announced an advance purchase agreement (APA) with Korea Centers for Disease Control and Prevention (KCDC) to supply 40 million doses of Nuvaxovid for South Korea.


Nuvaxovid is the first COVID-19 vaccine developed and commercialized using a recombinant protein nanoparticle technology and is expected to create a market differentiated from existing vaccines.

 

Recombinant protein vaccine technology utilized for Nuvaxovid has been also used for development of current vaccine including influenza (flu), hepatitis B, and HPV. 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.

 

Novavax announced that Nuvaxovid demonstrated 90% efficacy overall 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 terms of safety, most of the adverse reactions that occurred after injection were mild or moderate. Novavax is conducting an extension of its Phase 3 PREVENT-19 trial for up to 3,000 adolescents between the ages of 12 to 17 in the U.S. to extend the vaccination age.

 

Also, Novavax showed the data that antibody titers with a booster dose of Nuvaxovid after 6 months from two initial shots of the same vaccine, were increased by 4.6 times. In addition, a recent study conducted by Novavax has confirmed the immune response of Nuvaxovid to Omicron and other variants. Antibody titers against the Omicron variant were 9.3 times higher and 11.1 times higher against the Delta variant with a booster dose after 6 months from two initial shots of the same vaccine.

 

Stanley Erck, CEO of Novavax said, “Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold in the nation. We thank our partners at SK bioscience for their commitment and the MFDS for its thorough assessment and we look forward to helping address major obstacles to controlling the pandemic with our protein-based COVID-19 vaccine option.”

 

Jae-Yong Ahn, CEO of SK bioscience said, “Nuvaxovid, which has confirmed its efficacy and safety through a thorough review under the Korean Ministry of Food and Drug Safety, will be a new key to controlling the current pandemic situation. We will supply a sufficient amount of the vaccine, which is manufactured under the SK´s proven technology, in South Korea through consultation with the government.