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Novavax's Prototype Vaccine Shows Broad Immune Responses Incl. Against Omicron And Other Variants

Novavax Inc.'s (NVAX) prototype vaccine (NVX-CoV2373) demonstrated broad immune responses including against Omicron and other circulating variants. Pre-clinical data demonstrated that boosting with the company's Omicron or prototype vaccine induced immune response against Omicron variants, including BA.4/5, the company said in a statement.

The company said it participated in the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee's or 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.

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, showed cross-reactivity with all variants tested, particularly following booster doses.

According to the company, preclinical trial data showed 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.

A clinical trial is ongoing with results anticipated in September and product availability expected in fourth quarter.

Novavax submitted a request to the FDA for Emergency Use Authorization in January 2022. The VRBPAC Committee voted 21 to 0 with one abstention on June 7, 2022, to recommend that the FDA grant Emergency Use Authorization for NVX-CoV2373 for individuals aged 18 years and over.

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