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Novavax's NanoFlu Influenza Vaccine Phase 3 Trial Meets All Primary Endpoints

Novavax Inc. (NVAX) said that a complete results from a pivotal phase 3 clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant, was published in The Lancet Infectious Diseases. The trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine.

The trial evaluated the immunogenicity and safety of NanoFlu in older adults compared to a leading U.S.-licensed quadrivalent influenza vaccine. In the complete analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.

"These encouraging results reflect NanoFlu's promise, especially as we currently have a combination COVID-19-influenza vaccine under evaluation for protection against two life-threatening diseases simultaneously," said Stanley Erck, President and Chief Executive Officer, Novavax.

Novavax previously announced that NanoFlu achieved the trial's primary endpoints, demonstrating non-inferior immunogenicity to Fluzone Quadrivalent against all four influenza virus strains included in the vaccine. It also showed both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains and six heterologous A/H3N2 strains as compared to Fluzone Quadrivalent.

In addition, NanoFlu showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A/H3N2 and B/Victoria strains, with a 126-189% increase in various post-vaccination cell-mediated immunity markers as compared to Fluzone Quadrivalent.

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