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Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study
- PREVENT-19 trial participants receive heterologous or homologous third dose of NVX-CoV2373 - Continuation of Phase 3 trial will evaluate safety and efficacy
About this update from Novavax, Inc.
[{"type":"text","content":"- PREVENT-19 trial participants receive heterologous or homologous third dose of NVX-CoV2373\n - Continuation of Phase 3 trial will evaluate safety and efficacy\n\n\nGAITHERSBURG, Md., Dec. 21, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the first booster doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant, have been administered in an extension of the company's PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373. \nAll PREVENT-19 trial participants are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant Spike protein plus 50 micrograms of Matrix-M™ adjuvant) and may be administered at least six months after receipt of active vaccine. The primary endpoint is the first occurrence of polymerase chain reaction (PCR)-confirmed mild, moderate or severe COVID-19 with onset at least seven days after the third (booster) vaccine dose. \nTwo additional groups will be evaluated in this portion of the trial. Trial participants who initially received placebo and subsequently received a different COVID-19 vaccine are also eligible for a booster dose of NVX-CoV2373. Participants who were unblinded after initially receiving active vaccine and did not subsequently receive another vaccine will also be eligible to be boosted with NVX-CoV2373. \nAbout NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.\nNovavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vi...