• 29 Dec 2020
• Admin
• News Article

Novavax Announces Initiation Of Prevent-19 Pivotal Phase 3 Efficacy Trial Of Covid-19 Vaccine In The United States And Mexico

Novavax, Inc. (Nasdaq: Nvax), A Late-Stage Biotechnology Company Developing Next-Generation Vaccines For Serious Infectious Diseases, Today Announced Initiation Of Prevent-19, Its Pivotal Phase 3 Study In The United States And Mexico To Evaluate The Efficacy, Safety And Immunogenicity Of Nvx-Cov2373, The Company'S Covid-19 Vaccine Candidate. The Trial Builds On Research From Phase 1/2 Studies Demonstrating That The Vaccine Provoked A Robust Immune Response, Generated Highly Neutralizing Antibodies Against The Virus And Was Generally Well-Tolerated."With The Covid-19 Pandemic Raging Around The Globe, This Trial Is A Critical Step In Building The Global Portfolio Of Safe And Effective Vaccines To Protect The World&Rsquo;S Population," Said Stanley C. Erck, President And Chief Executive Officer, Novavax. "We Thank Our Colleagues And Partners Who Continue To Work With Us To Urgently Advance Our Commercial-Scale Manufacturing Processes, And We Are Grateful For The Hard Work And Assistance From Operation Warp Speed, The U.S. Fda And The Government Of Mexico On This Program."Nvx-Cov2373 Contains A Full-Length, Prefusion Spike Protein Made Using Novavax' Recombinant Nanoparticle Technology And The Company'S Proprietary Saponin-Based Matrix-M&Trade; Adjuvant. The Purified Protein Is Encoded By The Genetic Sequence Of The Sars-Cov-2 Spike (S) Protein And Is Produced In Insect Cells. It Can Neither Cause Covid-19 Nor Can It Replicate, Is Stable At 2&Deg;C To 8&Deg;C And Is Shipped In A Ready-To-Use Liquid Formulation That Permits Distribution Using Standard Vaccine Supply Chain Channels.Prevent-19 Is Being Conducted With Support From Operation Warp Speed Partners, Including The Department Of Defense And The National Institute Of Allergy And Infectious Diseases (Niaid), Part Of The National Institutes Of Health (Nih), And The Biomedical Advanced Research And Development Authority (Barda), Part Of The U.S. Department Of Health And Human Services (Hhs) Office Of The Assistant Secretary For Preparedness And Response. Barda Is Also Providing Up To $1.6 Billion Under A Department Of Defense Agreement (Identifier Mcdc Ota Agreement Number W15Qkn-16-9-1002).The Company Is Also Currently Conducting A Large Pivotal Phase 3 Clinical Study In The United Kingdom (U.K.), A Phase 2B Safety And Efficacy Study In South Africa, And An Ongoing Phase1/2 Trial In The U.S. And Australia. Data From These Trials Are Expected As Soon As Early First Quarter 2021, Although Timing Depends On Transmission Rates In The Regions. About The Prevent-19 Phase 3 StudyPrevent-19 (The Pre-Fusion Protein Subunit Vaccine Efficacy Novavax Trial | Covid-19) Is A Randomized, Placebo-Controlled, Observer-Blinded Study To Evaluate The Efficacy, Safety And Immunogenicity Of Nvx-Cov2373 With Matrix-M In Up To 30,000 Subjects 18 Years Of Age And Older Compared With Placebo. The Trial Design Has Been Harmonized To Align With Other Phase 3 Trials Conducted Under The Auspices Of Operation Warp Speed, Including The Use Of A Single External Independent Data And Safety Monitoring Board To Evaluate Safety And Conduct An Unblinded Review When Predetermined Interim Analysis Events Are Reached.The Trial'S Primary Endpoint Is The Prevention Of Pcr-Confirmed, Symptomatic Covid-19. The Key Secondary Endpoint Is The Prevention Of Pcr-Confirmed, Symptomatic Moderate Or Severe Covid-19. Both Endpoints Will Be Assessed At Least Seven Days After The Second Study Vaccination In Volunteers Who Have Not Been Previously Infected With Sars-Cov-2.Two Thirds Of The Participants Will Be Assigned To Randomly Receive Two Intramuscular Injections Of The Vaccine, Administered 21 Days Apart, While One Third Of The Trial Participants Will Receive Placebo. Trial Sites Were Selected In Locations Where Transmission Rates Are Currently High, To Accelerate The Accumulation Of Positive Cases That Could Show Efficacy.The Primary Efficacy Analysis Is Event-Driven, Based On The Number Of Participants With Symptomatic Mild, Moderate Or Severe Covid-19 Disease. Participants Will Be Followed For 24 Months Following The Second Injection.