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Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster

The Novavax BA.1 vaccine candidate met its primary strain-change endpoint allowing for development of variant vaccines, if necessary Novavax' prototype

articleNovavax, Inc.November 8, 20225/company/novavax-inc/news/novavax-phase-3-covid-19-omicron-trial-supports-the-continued-and-future-use-of
Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster

About this update from Novavax, Inc.

[{"type":"text","content":"The Novavax BA.1 vaccine candidate met its primary strain-change endpoint allowing for development of variant vaccines, if necessary Novavax' prototype vaccine induced broad immune response against original Wuhan, BA.1, and BA.5 strains The trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technologyGAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced topline results from its Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1 vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary (see chart 1).\nAdditionally, data show no benefit for the Novavax bivalent vaccine candidate compared to the BA.1 vaccine candidate or prototype vaccine in the overall trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and prototype strains showed similar responses across the three vaccine groups (prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 strain (which is structurally similar to BA.1), pseudoneutralization responses demonstrated that there was no benefit for the BA.1 or bivalent vaccine candidates compared to the prototype vaccine.**\nOverall, the data demonstrated that the prototype vaccine induced a broad immune response against original prototype, BA.1, and BA.5 strains. The prototype vaccine induced robust IgG responses to both BA.1 and the matched prototype strain.* Pseudoneutralization responses against BA.5 for the prototype vaccine were comparable to those induced by the more closely matched BA.1 vaccine and bivalent vaccine candidates.*\n\"Today's results show that use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype ...

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