SK Bioscience "Preliminary Review Application for COVID-19 Vaccine 'New Bexovid' Adolescent Vaccination"

Novavax-Developed Recombinant Antigen Vaccine
Confirmed Safety and Efficacy in Clinical Trial with 2,247 US Adolescents

New Bacchus-D.

[Asia Economy Reporter Lee Gwan-joo] A review is underway to expand the vaccination age of the Novavax COVID-19 vaccine, made using a recombinant antigen method, to include adolescents.

SK Bioscience announced on the 23rd that it has applied to the Ministry of Food and Drug Safety for a preliminary review to change the approval to expand the eligible vaccination age of 'Nuvaxovid,' the only recombinant antigen COVID-19 vaccine approved in Korea, to all age groups aged 12 and above.

The preliminary review is a procedure in which data necessary for the review are submitted in advance to expedite the approval change process by the Ministry of Food and Drug Safety. Since Nuvaxovid has already been approved for adults, the company expects that the vaccination age can be expanded through an approval change without a new product approval.

Nuvaxovid is a recombinant antigen COVID-19 vaccine developed by the U.S. company Novavax, and full-scale vaccinations are currently underway in 38 countries worldwide. In Korea, SK Bioscience has a license-in agreement and manufactures the vaccine from bulk substance to finished product. It was first approved for adults aged 18 and over on January and began supply in February.

Through this approval change, SK Bioscience plans to expand the vaccination age of Nuvaxovid to those aged 12 to 17, providing a new alternative for COVID-19 prevention to adolescents and parents who have a high reluctance toward COVID-19 vaccines.

The preventive efficacy and safety of Nuvaxovid in the 12 to 17 age group have been confirmed through clinical trials. According to the Phase 3 clinical trial conducted by Novavax from May to September last year at 73 medical institutions in the U.S. involving 2,247 adolescents aged 12 to 17, the preventive efficacy against COVID-19 virus after two doses of Nuvaxovid was about 79.5%, similar to the level in adults. It showed about 82% efficacy against the Delta variant, and the antibody titers against all variants including Omicron were 2 to 3 times higher than those in adults.

Additionally, a recent study conducted by Novavax on adults confirmed the immune response of Nuvaxovid against Omicron and other variants. After two doses of Nuvaxovid and a booster shot given six months later, the antibody titers responding to the Omicron variant were 9.3 times higher, and for the Delta variant, 11.1 times higher compared to after two doses.

SK Bioscience plans to quickly expand indications domestically once additional clinical data on Nuvaxovid for children, booster shots, and variants such as Omicron are secured. SK Bioscience President Ahn Jae-yong said, “As the proportion of confirmed cases among adolescents is rapidly increasing, we expect the recombinant antigen vaccine to provide a new alternative,” adding, “We will contribute to national quarantine with a vaccine whose safety and efficacy have been verified and further utilize it as a platform to respond to the 'Next Pandemic.'”

The Ministry of Food and Drug Safety has begun reviewing the submitted data. The ministry stated, “We plan to thoroughly review the safety and efficacy based on the submitted clinical trial data.”

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