Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, 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.
Also Read: Slingshot Biosciences, Inc. Partners With Almog Diagnostic to Distribute Synthetic Cells Throughout
“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.”
Prototype Vaccine Shows Broad Cross-Neutralizing Antibodies
During 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.
New Pre-Clinical Data Show Broad Immune Responses When Boosting with Prototype or Omicron-Based Vaccine
Novavax 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 prototype covers all strains, providing an Omicron booster enhances immunity to related Omicron sub-variants. Boosting with a bivalent vaccine containing prototype and Omicron BA.1 showed no advantages in any of the responses compared to boosting with BA.1 alone.
Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) in January 2022. The VRBPAC Committee voted 21 to 0 with one abstention on June 7, 2022, to recommend that the FDA grant EUA for NVX-CoV2373 for individuals aged 18 years and over.