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Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific Variants

Novavax prototype vaccine (NVX-CoV2373) demonstrates broad immune responses including against Omicron and other circulating variantsPre-clinical data

articleNovavax, Inc.June 28, 20224/company/novavax-inc/news/novavax-covid-19-data-presented-at-fda-vrbpac-meeting-demonstrates-broad-antibody
Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific Variants

About this update from Novavax, Inc.

[{"type":"text","content":"Novavax prototype vaccine (NVX-CoV2373) demonstrates broad immune responses including against Omicron and other circulating variantsPre-clinical data demonstrated that boosting with Novavax' Omicron or prototype vaccine induces immune response against Omicron variants, including BA.4/5Novavax will be ready to supply Omicron-based vaccine this fall in accordance with FDA Advisory Committee recommendationGAITHERSBURG, Md., June 28, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today participated in the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting which resulted in a 19-2 vote to recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning this fall.\n\"We are confident that our prototype COVID-19 vaccine generates broad levels of antibodies as a primary series, and that boosting with this prototype vaccine increases the magnitude of the breadth of response,\" said Gregory M. Glenn, M.D., President of Research and Development, Novavax. \"While we believe in the strength of our prototype vaccine data, we are prepared to supply an Omicron-based vaccine this fall in accordance with health authority recommendations.\"\nPrototype Vaccine Shows Broad Cross-Neutralizing Antibodies \nDuring the meeting, Novavax highlighted data showing that the structural features of Novavax' protein-based COVID-19 vaccine, enhanced by the Matrix-M™ adjuvant, displayed epitopes across both the original strain and emerging variants, contributing to the generation of broadly cross-reacting antibodies. Additional data from Phase 2 and Phase 3 trials, as well as in vitro data on neutralizing antibodies and receptor inhibition from trial participants, show cross-reactivity with all variants tested, particularly following booster doses.\nNew Pre-Clinical Data Show Broad Immune Responses When Boosting with Prototype or Omicron-Based Vaccine\nNovavax presented preclinical trial data showing that boosting with either the prototype (NVX-CoV2373), Omicron BA.1 (NVX-CoV2515), or bivalent vaccine generated antibody levels that were consistent with dosing regimens in the Phase 3 clinical trials. While boosting with the proto...

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