SK submitted a post-approval change application for Nuvaxovid™, Novavax’ recombinant protein-based COVID-19 vaccine, which has demonstrated safety for 12 through 17-year-olds

Nuvaxovid demonstrated similar efficacy in adolescent and adult clinical trials with no serious adverse events

[7, April, 2022] Sungnam, South Korea-SK bioscience announced that the company has submitted a Post Approval Change Application for the COVID-19 vaccine, Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted), to the Korean Ministry of Food and Drug Safety (KMFDS) to expand the vaccination age to 12 through 17-year-olds. If this application is authorized, adolescents 12 years of age and older can be vaccinated with Nuvaxovid, which has demonstrated safety and efficacy.

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 authorized in 38 countries to date and received emergency use listing from the World Health Organization. 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 has been distributed for domestic use since February.

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

According to the Central Disease Control Headquarters investigation, as of 00:00 on April 5, only 65% of the adolescent group in Korea has received a second dose of a COVID-19 vaccine. Its percentage has increased less than 1% compared to a month ago (64.1%). Experts are emphasizing the need for vaccination in this age group as the number of confirmed cases is rapidly increasing, with two out of 10 confirmed cases in Korea as of April occurring in children under the age of 18.

According to the Korean COVID-19 Vaccination Promotion and Safety Management Team, for four weeks from February 14th, the report rate of adverse reactions in the early injection stage of Nuvaxovid was only 193.9 cases per 100,000 cases, which was only half of the overall average of 386.9 cases.

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.

Recently, Novavax obtained emergency use authorization from the Drug Controller General of India (DCGI) to extend the vaccination age of its COVID-19 vaccine to adolescents. In addition, Novavax applied for conditional marketing authorization from the European Medicines Agency (EMA) to expand the use of Nuvaxovid to adolescents.

Jae-Yong Ahn, CEO of SK bioscience said, “The expansion of indication for use in adolescents is expected to have an important role in preventing the rapidly spreading COVID-19 infection,

especially among those 12 to 17 years old. We will do our best for national immunization by securing additional clinical data and expeditiously expanding indications.”