Results from Novavax NanoFlu Influenza Vaccine Phase 3 Clinical Trial Published in The Lancet Infectious Diseases

- Pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine

- NanoFlu vaccine candidate induced significantly enhanced cell-mediated immune responses

- NanoFlu was well-tolerated with a comparable safety profile

GAITHERSBURG, Md., Sept. 24, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant, in The Lancet Infectious Diseases (Lancet ID).

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.

"Despite high vaccination rates, limitations in the effectiveness of existing influenza vaccines leave significant disease burden unaddressed, particularly in older adults," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "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."

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, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous strains (22-66% increased) and six heterologous A/H3N2 strains (34-46% increased) as compared to Fluzone Quadrivalent.

Additionally, 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.

The paper, 'Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial,' may be accessed here. The manuscript was previously posted to the medRxiv preprint server in August 2020.