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SK bioscience Begins Shipment of First Authorized Protein-Based COVID-19 Vaccine

2022. 02. 09

- A vaccine platform with long-term well-understood safety and efficacy is expected to induce more participants to vaccination who are reluctant to. 
- SK started supplying 2 million doses of Nuvaxovid from L-House.
- A total of 40 million doses will be distributed for domestic use in Korea. 




A protein-based COVID-19 vaccine with demonstrated safety and efficacy will be supplied for the first time in South Korea. Experts expect that the protein-based vaccine known as NuvaxovidTM, COVID-19 Vaccine (recombinant, adjuvanted), will contribute to national immunization by inducing a higher vaccination rate.

 

SK bioscience (CEO Jae-Yong Ahn) announced that the first recombinant protein-based COVID-19 vaccine authorized in South Korea and developed by Novavax, Inc., Nuvaxovid,  began to be shipped from SK’s vaccine manufacturing plant, L -House in Andong on the morning of the 9th. The initial volumes to be distributed for domestic use are about 2 million doses.

 

Nuvaxovid is developed by Novavax, a biotechnology company headquartered in the United States that is dedicated to developing and commercializing next-generation vaccines for serious infectious diseases. Novavax and SK bioscience have entered into license and contract manufacturing agreements under which SK bioscience has rights to produce the vaccine for South Korea, Thailand and Vietnam. SK bioscience is the only company in South Korea that can conduct the entire manufacturing process from drug substance to drug product of COVID-19 vaccines. Last year, SK bioscience signed an advance purchase agreement (APA) with the Korean government for 40 million doses of Nuvaxovid and will supply the vaccine sequentially based on the plan of the Korea Centers for Disease Control and Prevention (KDCA).

 

As the first protein-based COVID-19 vaccine approved in South Korea, Nuvaxovid is expected to create a market differentiated from currently commercialized COVID-19 vaccines.

 

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

 

Nuvaxovid has demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile in results from two large global pivotal clinical trials. In addition, laboratory studies have demonstrated a cross-reactive immune response against several variants, including Omicron, in sera from participants in clinical trials of Nuvaxovid.  A recent study conducted by Novavax has demonstrated a cross-reactive immune response of Nuvaxovid to Omicron and other variants. Antibody titers against the Omicron variant were 9.3 times higher against the Omicron variant with a booster dose after 6 months from two initial shots of the same vaccine.

 

Also, unlike the currently commercialized COVID-19 vaccines, Nuvaxovid for domestic use in Korea is made of a pre-filled syringe form for single injection. It can be easily inoculated without dilution at medical institutions. Experts believe that Nuvaxovid will be able to reduce the burden on medical staff who are exhausted from the ongoing pandemic situation.

 

Novavax announced at the JP Morgan Healthcare Conference in January that the company expects to submit additional filings for authorization to expand the vaccination age to adolescents 12 years old and older based on the ongoing research data of the Phase 3 PREVENT-19 clinical trials in this age group. Novavax also expects to conduct a clinical trial for children under 12 years old.

 

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. A booster study is ongoing to evaluate the safety and effectiveness of a third does of the vaccine.

 

SK bioscience has proven its superb manufacturing technology by exclusively producing and supplying two of the five vaccines that have been approved in advanced countries such as the U.S. and Europe. SK bioscience has previously contributed to the early stage of the pandemic prevention by manufacturing and supplying drug substance and drug product of AstraZeneca’s COVID-19 vaccine to global and domestic markets.

 

Jae-Yong Ahn, CEO of SK bioscience said “In order to contribute to the national immunization policy under the ongoing pandemic situation, we have manufactured and distributed various global COVID-19 vaccines. We are also at a last stage of development of our own COVID-19 vaccine. We will try our best to contribute to keep more people safe from the threatening with a proven vaccine platform technology.”