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Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial
PREVENT-19 trial participants aged 12 through 17 receive third dose of NVX-CoV2373Continuation of pediatric expansion in adolescents of PREVENT-19 Phase 3
About this update from Novavax, Inc.
[{"type":"text","content":"PREVENT-19 trial participants aged 12 through 17 receive third dose of NVX-CoV2373Continuation of pediatric expansion in adolescents of PREVENT-19 Phase 3 trial will evaluate safety and immunogenicity of a booster doseGAITHERSBURG, Md., April 22, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17.\n\"We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19,\" said Gregory M. Glenn, M.D., President, Research and Development, Novavax. \"The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population.\"\nAll PREVENT-19 trial participants aged 12 through 17 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 five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.\nFindings from the pediatric expansion of the PREVENT-19 pivotal Phase 3 trial were announced in February.\nAuthorization in the U.S.\nNVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. Food and Drug Administration.\nAbout NVX-CoV2373 \nNVX-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 t...