SK extends the vaccination age of Nuvaxovid to 12 to 17-year-olds

The recombinant protein-based vaccine, Nuvaxovid, has demonstrated high safety and immunogenicity through global adolescent clinical trials

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, announced that the company received a Post Approval Change Application approval for adolescent use of the recombinant protein-based COVID-19 vaccine, Nuvaxovid from the Ministry of Food and Drug Safety(KFDS).

Nuvaxovid, 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, has been manufactured and supplied by SK bioscience in South Korea. The vaccine has been authorized in more than 40 countries to date and received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and emergency use listing (EUL) from the World Health Organization.

Recombinant protein vaccine technology has been used for development of current vaccines including influenza (flu), hepatitis B, and HPV proving long-term safety.

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

The Phase 3 PREVENT-19 trial 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 80% 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.

Further, according to ‘Monitoring Adverse Reactions in The Early Injection of Novavax’ Vaccine report, published by the Korean Disease Control and Prevention Agency(KDCA), the report rate was only 154.8 cases per 100,000 cases, far less number than the other authorized vaccines with the overall average of 309~587 cases.

Stanley C. Erck, President and CEO of Novavax said, “Today’s approval in South Korea is an important step in ensuring broad global access to diversified vaccine options. We are pleased to collaborate with SK bioscience to offer the first protein-based COVID-19 vaccine to adolescents aged 12 through 17 in South Korea.”

Jaeyong Ahn, CEO of SK bioscience said, “We are responding to the reoccurring COVID-19 pandemic by expanding the use of Nuvaxvoid for adolescents and as a booster. With CDMO manufacturing of global COVID-19 vaccines, including Nuvaxovid, joint-developed vaccine ‘SKYCovione,’ which has recently shown the cross-neutralizing activity against Omicron variant BA.1 during a booster trial, and universal and combo vaccines, we will do our best to promote human health in the world.“