Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial

• Trial also achieves statistical significance in key secondary endpoints
• Novavax to submit a U.S. BLA under FDA’s accelerated approval pathway
• Company to host investor conference call today at 8:30 a.m. EDT

GAITHERSBURG, Md., March 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

NanoFlu Phase 3 Primary Objectives

The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents.

• NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine.
   
• NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).

“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”