Novavax COVID-19 Vaccine 'Nuvaxovid' Application for Approval Change to Include Ages 12 and Older

[Asia Economy Reporter Lee Gwan-joo] SK Bioscience announced on the 7th that it has completed the application for a change in product approval to the Ministry of Food and Drug Safety to expand the vaccination age for the COVID-19 vaccine 'Nuvaxovid.'

If this approval change is granted, Nuvaxovid vaccination will be possible for adolescents aged 12 and older. SK Bioscience had previously submitted the necessary data for review on the 23rd of last month to expedite the approval change process with the Ministry of Food and Drug Safety.

Since Nuvaxovid has already been approved for adults, it is expected that the vaccination age can be expanded through a change in approval without a new product approval.

Nuvaxovid, a recombinant protein-based COVID-19 vaccine developed by Novavax, is currently approved and used in 38 countries worldwide. In South Korea, SK Bioscience has a technology transfer agreement and has been manufacturing from bulk to finished products, supplying the vaccine since February.

The recombinant protein platform has been used for a long time in vaccines such as influenza and human papillomavirus (HPV) vaccines, confirming its safety. The company expects that Nuvaxovid, being the only recombinant protein-based vaccine approved domestically, will encourage vaccination among the unvaccinated.

Since the start of domestic vaccination with Nuvaxovid, the frequency of side effects has been relatively low. According to the 'Novavax Vaccine Initial Vaccinee Adverse Reaction Surveillance Status' investigated by the COVID-19 Vaccination Response Promotion Team over four weeks from February 14, the adverse reaction reporting rate for initial Nuvaxovid vaccination was 193.9 cases per 100,000 doses, about half the overall average of 386.9 cases.

Ahn Jae-yong, CEO of SK Bioscience, said, “This expansion of indication for adolescents will play an important role in curbing the rapidly spreading COVID-19 infections mainly among those aged 12 to 17.” He added, “We will secure additional clinical data on children, booster shots, and variants such as Omicron to promptly expand indications and do our best for national quarantine.”

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