Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years.
The vaccine is indicated for active immunisation for the prevention of Covid-19 in people of this age group.
KMFDS granted the approval based on findings from a paediatric expansion of Phase III PREVENT-19 clinical trial underway to analyse the safety, immunogenicity and efficacy of the vaccine.
It enrolled 2,247 adolescents across 73 US sites.
According to the trial findings, the vaccine met the primary immunogenicity endpoint and offered an overall clinical efficacy of 80% when the Delta variant of the SARS-CoV-2 virus was predominant in the country.
Initial safety results showed that Nuvaxovid was generally well-tolerated.
Following the initial two-dose regimen, local and systemic reactogenicity was found to be generally reduced than or in line with adults.
Tenderness/pain at the site of injection, headache, fatigue, myalgia and malaise was seen to be the most common adverse reactions in the trial.
Furthermore, no new safety signal was reported through the trial’s placebo-controlled portion.
In January, the vaccine obtained KMFDS approval for use in adults aged 18 years and above.
SK bioscience and Novavax have a licensing agreement in place in Korea, with the former producing drug substance and drug product of the vaccine for use in the region.
The vaccine is currently authorised for use in 12 to 17-year-old people in the EU, India, Australia, Thailand and Japan and is also being reviewed in various other markets.
Novavax president and CEO Stanley Erck said: “The approval in South Korea is an important step in ensuring broad global access to a protein-based vaccine option.
“We are pleased to collaborate with SK bioscience to offer our vaccine to adolescents aged 12 through 17 in South Korea.”