Efficacy similar to adults 18 years and older with robust cross-reactive immune responses against Omicron variant

The vaccine is expected to induce more adolescents to get vaccinated based on the vaccine’s recombinant protein-based platform with demonstrated safety and efficacy

[23 March, 2022] Sungnam, South Korea--SK bioscience (CEO Jae-Yong Ahn) has submitted an application for rolling review of the only protein-based COVID-19 vaccine approved in South Korea, Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted), to the Korea Ministry of Food and Drug Safety (KMFDS) to expand the vaccination age to over 12 years old. Since Nuvaxovid, which is developed by Novavax, Inc., has already been approved for adults in Korea, the vaccination age may potentially be extended without the submission of an entirely new biologics license application (BLA).

Nuvaxovid, which has been authorized in 38 countries to date, is a recombinant protein-based COVID-19 vaccine 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. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substance and drug product of Nuvaxovid for domestic use. The vaccine received BLA approval from the KMFDS in January and has been distributed for domestic use since February. According to statistics released by the Korea Centers for Disease Control and Prevention (KDCA) on the 17th of March, 86% of eligible aged 18 years and older in Korea who had been shot the first dose of COVID-19 vaccines in the preceding weeks, had received Nuvaxovid.

Through this regulatory, SK bioscience plans to extend the vaccination age of Nuvaxovid to those over 12 years of age and provide a new alternative adolescents and parents, including those who may be reluctant to be immunized with the COVID-19 vaccines currently authorized for this group.

The efficacy and safety of Nuvaxovid for 12 through 17-year-olds were confirmed through clinical trials.

The study enrolled 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S. to evaluate safety, effectiveness (immunogenicity), and efficacy, with an emphasis on ensuring well balanced racial and ethnic representation among participants. Nuvaxovid demonstrated overall protective efficacy of 79.5% against COVID-19. The vaccine efficacy against the Delta variant was 82.0%. Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied. The vaccine was well-tolerated with no safety signals identified.

Also, a recent study of adults 18 years and older conducted by Novavax demonstrated cross-reactive immune responses of Nuvaxovid against 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 6 months after a primary two-dose regimen.

SK bioscience plans to file to expand indications in Korea as soon as additional Nuvaxovid clinical data of variants, boosters, and younger age groups is secured.

Jae-Yong Ahn, CEO of SK bioscience said, “As the proportion of infections in the adolescent age group is rapidly increasing, we expect that Nuvaxovid will provide a new alternative for immunization. We will support national immunization efforts with the protein-based COVID-19 vaccine with demonstrated safety and efficacy and further utilize it as a platform to respond to the next pandemic.”