• 17 Aug 2022
• Admin
• News Article

Novavax Partner Sk Bioscience Gets South Korean Approval For Nuvaxovid Covid-19 Vaccine For Use In Adolescents Aged 12 Through 17

Novavax, Inc., A Biotechnology Company Dedicated To Developing And Commercializing Next-Generation Vaccines For Serious Infectious Diseases, Announced That Partner, Sk Bioscience, Has Received A Post Approval Change Application Approval From The Korean Ministry Of Food And Drug Safety (Kmfds) For Nuvaxovid (Nvx-Cov2373) Covid-19 Vaccine For Active Immunization To Prevent Coronavirus Disease 2019 (Covid-19) Caused By The Severe Acute Respiratory Syndrome Coronavirus 2 (Sars-Cov-2) In Adolescents Aged 12 Through 17."Today'S Approval In South Korea Is An Important Step In Ensuring Broad Global Access To A Protein-Based Vaccine Option," Said Stanley C. Erck, President And Chief Executive Officer, Novavax. "We Are Pleased To Collaborate With Sk Bioscience To Offer Our Vaccine To Adolescents Aged 12 Through 17 In South Korea."Jaeyong Ahn, Ceo Of Sk Bioscience Said, "We Are Responding To The Ongoing Covid-19 Pandemic By Expanding The Use Of Nuvaxovid For Adolescents And As A Booster. With Cdmo Manufacturing Of Global Covid-19 Vaccines, Including Nuvaxovid, We Will Do Our Best To Promote Human Health In The World."The Approval Was Based On Data From The Ongoing Pediatric Expansion Of The Phase 3 Prevent-19 Trial Of 2,247 Adolescents Aged 12 Through 17 Years Across 73 Sites In The Us, To Evaluate The Safety, Effectiveness (Immunogenicity), And Efficacy Of Nuvaxovid. In The Trial, Nuvaxovid Achieved Its Primary Effectiveness Endpoint And Demonstrated 80% Clinical Efficacy Overall At A Time When The Delta Variant Was The Predominant Circulating Sars-Cov-2 Strain In The Us.Preliminary Safety Data From The Trial Showed The Vaccine To Be Generally Well-Tolerated. Serious And Severe Adverse Events Were Low In Number And Balanced Between Vaccine And Placebo Groups, And Not Considered Related To The Vaccine. Local And Systemic Reactogenicity Was Generally Lower Than Or Similar To Adults, After The First And Second Dose. The Most Common Adverse Reactions Observed Were Injection Site Tenderness/Pain, Headache, Myalgia, Fatigue, And Malaise. There Was No Increase In Reactogenicity In Younger (12 To 30%. A Secondary Endpoint Was The Prevention Of Pcr-Confirmed, Symptomatic Moderate Or Severe Covid-19. Both Endpoints Were Assessed At Least Seven Days After The Second Study Vaccination In Volunteers Who Had Not Been Previously Infected With Sars-Cov-2. In The Trial, The Novavax Covid-19 Vaccine Achieved 90.4% Efficacy Overall. It Was Generally Well-Tolerated And Elicited A Robust Antibody Response After The Second Dose In Both Studies. Full Results Of The Trial Were Published In The New England Journal Of Medicine (Nejm).The Paediatric Expansion Of Prevent-19 Is A 2:1 Randomized, Placebo-Controlled, Observer-Blinded Trial To Evaluate The Safety, Effectiveness, And Efficacy Of The Novavax Covid-19 Vaccine With Matrix-M Adjuvant In 2,247 Adolescent Participants 12 To 17 Years Of Age In 73 Locations In The United States, Compared With Placebo. In The Paediatric Trial, The Vaccine Achieved Its Primary Effectiveness Endpoint (Non-Inferiority Of The Neutralizing Antibody Response Compared To Young Adult Participants 18 Through 25 Years Of Age From Prevent-19) And Demonstrated 80% Efficacy Overall At A Time When The Delta Variant Of Concern Was The Predominant Circulating Strain In The Us. Additionally, Immune Responses Were About Two-To-Three-Fold Higher In Adolescents Than In Adults Against All Variants Studied.Additionally, A Trial Conducted In The Uk With 14,039 Participants Aged 18 Years And Older Was Designed As A Randomized, Placebo-Controlled, Observer-Blinded Study And Achieved Overall Efficacy Of 89.7%. The Primary Endpoint Was Based On The First Occurrence Of Pcr-Confirmed Symptomatic (Mild, Moderate Or Severe) Covid-19 With Onset At Least Seven Days After The Second Study Vaccination In Serologically Negative (To Sars-Cov-2) Adult Participants At Baseline. Full Results Of The Trial Were Published In Nejm.Novavax' Patented Saponin-Based Matrix-M Adjuvant Has Demonstrated A Potent And Well-Tolerated Effect By Stimulating The Entry Of Antigen-Presenting Cells Into The Injection Site And Enhancing Antigen Presentation In Local Lymph Nodes, Boosting Immune Response.Novavax, Inc Is A Biotechnology Company That Promotes Improved Health Globally Through The Discovery, Development, And Commercialization Of Innovative Vaccines To Prevent Serious Infectious Diseases.