SOUTH KOREA- The Korean Ministry of Food and Drug Safety (KMFDS) has approved SK Bioscience’s Nuvaxovid, COVID-19 vaccine for use in adolescents aged 12 to 17 as an active vaccination against COVID-19.
The biotech company, SK Bioscience in South Korea has produced and distributed Nuvaxovid, a recombinant protein-based COVID-19 vaccine created by Novavax.
In order to assess safety, effectiveness, and efficacy, the Phase 3 PREVENT-19 trial enrolled 2,247 adolescents between the ages of 12 and 17.
The trial was done in 73 locations throughout the United States and mainly focused on ensuring that participants’ racial and ethnic backgrounds were fairly represented.
In comparison to adults, teenage immune responses were roughly two- to three-fold greater against all variations examined.
With no safety signals noticed after the immunization, the vaccine was well accepted.
The total protective effectiveness of Nuvaxovid against COVID-19 is said to be 80% while its effectiveness against the Delta variant is pegged at 82.0%.
Furthermore, the report rate for the vaccine “Monitoring Adverse Reactions in The Early Injection of Novavax” by the Korean Disease Control and Prevention Agency (KDCA) was only 154.8 cases per 100,000 cases.
This was a significantly lower rate than the other authorized vaccines, which had an overall average of 309~587 cases.
We are responding to the reoccurring COVID-19 pandemic by expanding the use of Nuvaxovid for adolescents and as a booster, we will do our best to promote human health in the world
Novavax is a biotechnology company with headquarters in the United States that is committed to creating and marketing next-generation vaccines for critical infectious illnesses.
To date, the vaccine has gained emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and emergency use listing (EUL) from the World Health Organization. It has also been approved in more than 40 countries.
Current vaccinations against the flu, hepatitis B, and HPV were developed using recombinant protein vaccine technology, demonstrating their long-term safety.
Stanley C. Erck, President and CEO of Novavax stated that the approval in South Korea is a crucial step in assuring broad global access to varied vaccine choices.
He added that Novavax is thrilled to work with SK Bioscience to provide South Korean teenagers aged 12 to 17 with the first protein-based COVID-19 vaccination.
Jaeyong Ahn, CEO of SK bioscience said, “We are responding to the reoccurring COVID-19 pandemic by expanding the use of Nuvaxovid for adolescents and as a booster, we will do our best to promote human health in the world.”
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