SK Bioscience "Synthetic Antigen COVID-19 Vaccine 'New Bexovid' Approved for Domestic Adolescent Vaccination"

Synthetic antigen-based COVID-19 vaccine, Nuvaxovid.

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience announced on the 12th that it has received approval from the Ministry of Food and Drug Safety for the vaccination of adolescents aged 12 to 17 with the synthetic antigen-based COVID-19 vaccine 'Nuvaxovid.'

Nuvaxovid is a COVID-19 vaccine developed by Novavax and produced and supplied domestically and globally by SK Bioscience through a technology transfer agreement.

According to the results of a Phase 3 clinical trial conducted by Novavax last year involving 1,799 adolescents aged 12 to 17 at 73 medical institutions in the United States, the preventive efficacy of Nuvaxovid against COVID-19 in adolescents was approximately 79.5%, similar to the efficacy observed in adults. The antibody levels against variant viruses, including Omicron, were about 2 to 3 times higher than those in adults, and no severe adverse events related to vaccination were reported.

This approval is significant as it allows the administration of a synthetic antigen-based vaccine with proven safety to adolescents amid an increase in new COVID-19 cases in this age group during the resurgence phase. The Korean Pediatric Society and the Korean Society of Pediatric Infectious Diseases recently pointed out that one in five new confirmed cases are children and adolescents, emphasizing the need to review the medical response system to ensure their safety against the highly transmissible COVID-19 pandemic.

Additionally, according to health authorities, as of the 30th of last month, there have been a cumulative total of 142,732 reinfections since the onset of COVID-19 in Korea, with 40.7% of these cases occurring in children and adolescents aged 17 and under. The authorities have urged detailed adherence to preventive measures and COVID-19 vaccination among the adolescent age group.

Stanley Erck, CEO of Novavax, said, "We are pleased to provide the synthetic antigen-based COVID-19 vaccine to Korean adolescents in partnership with SK Bioscience," adding, "This adolescent vaccination approval in Korea will be an important milestone in improving global vaccine accessibility by expanding vaccine options."

Ahn Jae-yong, President of SK Bioscience, stated, "We are fully committed to responding to the domestic COVID-19 pandemic through the expansion of the vaccination age for Nuvaxovid and the recent pre-review application for booster shot approval," and added, "We will do our best to protect human health through our self-developed vaccine 'Skycovione,' which has recently confirmed effectiveness against Omicron (BA.1) in booster shots, as well as through newly developing universal and combo vaccines.”