SK Bioscience said Wednesday that it has obtained the product license for Nuvaxovid, Novavax's Covid-19 vaccine, from the Ministry of Food and Drug Safety.

Korea regulator has approved Novavax's Covid-19 vaccine, Nuvaxovid.
Korea regulator has approved Novavax's Covid-19 vaccine, Nuvaxovid.

Nuvaxovid is the first Covid-19 vaccine in Korea to receive approval as a synthetic antigen-based vaccine. The company applied for permission on Nov. 15.

SK Bioscience said the approval had proven its world-class technology, independently producing and supplying two of the five types of Covid-19 vaccines licensed in developed countries, such as the U.S., EU, and Korea.

The company recalled that it contributed to the early stage of epidemic prevention by consigning the original solution and finished product of AstraZeneca's Covid-19 vaccine and supplied it to the global and Korean markets.

SK Bioscience added that it is also the only Korean company handling the entire production process, from the stock solution to the finished product for a Covid-19 vaccine.

The company expects to supply Nuvaxovid after receiving national shipping approval quickly. Last year, it signed a pre-purchase contract with the Korea Disease Control and Prevention Agency to provide 40 million doses of Nuvaxovid.

The approval comes after Novavax confirmed the safety and efficacy of the vaccine through a clinical trial in the U.S. and Mexico on about 30,000 people over 18.

Novavax confirmed Nuvaxovid's effectiveness in preventing the Covid-19 virus reached 90 percent. Most of the adverse reactions that occurred after vaccination were mild or moderate.

Novavax is expanding the vaccination age through phase 3 clinical trials in the U.S., targeting 3,000 adolescents aged 12-17.

In separate trials, the company proved that a booster shot of Nuvaxovid six months after receiving the first two doses of Nuvaxovid could increase the antibody titer by 4.6 times and confirm the vaccine's immune response against the Omicron and other variants.

"In a situation where the Delta and Omicron variants threaten the world, we are proud that Novavax's Covid-19 vaccine can contribute to Korea's quarantine efforts," Novavax CEO and President Stanley C. Erck said. "We express our deep appreciation for the efforts and dedication made by SK Bioscience and the Ministry of Food and Drug Safety, and expects our vaccine to be a major option to halt current and future pandemics."

SK Bioscience CEO Ahn Jae-yong said, "Nuvaxovid, which the MFDS has verified for effectiveness and safety, will be a new key to controlling the current pandemic situation."

The company is producing the vaccine with its proven technology and will supply sufficient amounts through consultation with the government, Ahn added.

Nuvaxovid is the first synthetic antigen-based Covid-19 vaccine. SK Bioscience and Novavax expect to create a market differentiated from existing vaccines.

The synthetic antigen-based vaccine platform has been used for a long time in existing vaccines such as influenza, hepatitis B, and cervical cancer, with proven safety and efficacy.

Also, as hospitals can store the vaccine under refrigeration conditions of 2 to 8 degrees Celsius, the government can distribute Nuvaxovid using the existing vaccine distribution network.

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