Vaccine Info

NanoFlu Influenza Vaccine

NanoFlu Vaccine Description

Novavax, Inc.'s NanoFlu is a vaccine candidate which is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced in an Sf9 insect cell-baculovirus system. NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type virus HA sequences.

NanoFlu contains Novavax’s patented saponin-based Matrix-M adjuvant, which is potent, well-tolerated, and stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses.

Recombinant seasonal influenza vaccines have an important advantage: once licensed for commercial sale, large quantities of vaccines can potentially be manufactured and in a cost-effective manner, without the use of either the live influenza virus or eggs.

Novavax, Inc. is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

NanoFlu Vaccine Indication

NanoFlu is indicated to prevent serious diseases caused by influenza in older adults. In recent years, it’s estimated that up to 85 percent of seasonal flu-related hospitalizations and deaths have occurred in people 65 years+. It is further estimated that each year, influenza attacks between 5% and 10% of adults and 20% to 30% of children, causing significant levels of illness, hospitalization, and death.

The NanoFlu vaccine demonstrated significantly stronger and broader immune responses against homologous and heterologous influenza strains, including a series of “drift” strains evolved across over more than a decade of influenza seasons. In a preclinical challenge study, we showed that our NanoFlu was protective against both a homologous virus and a ten-year-old drifted strain.

NanoFlu Vaccine Dosage

The NanoFlu vaccine candidate is administered as an intramuscular injection in the clinical trials.

NanoFlu Vaccine Updates

  • November 9, 2020 - Novavax, Inc. announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer. Executive Vice President John Trizzino, who previously served as CFO, will now become the Chief Commercial Officer while continuing in his role as Chief Business Officer.
  • October 13, 2020 - Novavax, Inc. announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company’s influenza vaccine candidate, through global licensure, as well as the exploration of a combined influenza/COVID-19 vaccine that could be used in a post-pandemic setting. Novavax announced the results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intends to seek regulatory approval from the U.S. Food and Drug Administration under the accelerated approval pathway previously granted to the company.
  • January 15, 2020 - Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu.
  • October 15, 2019 - Novavax, Inc announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over. 
  • August 5, 2019 - Novavax Reaches Agreement with the FDA on Pivotal Phase 3 Trial Design for NanoFlu
  • January 03, 2019 - Novavax announced Positive Phase 2 NanoFlu Results in Older Adults.
  • September 2017 - a Phase 1/2 clinical trial of our nanoparticle seasonal influenza vaccine candidate including our proprietary Matrix-M adjuvant (“NanoFlu™”) in older adults.

NanoFlu Vaccine Clinical Trials

Clinical Trial NCT04120194: Phase 3 Pivotal Trial of NanoFlu™ in Older Adults - Last Update Posted: April 17, 2020.

  • A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age.
  • Both vaccines will be formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season.
  • Approximately 2650 subjects (1325 subjects/group) will be enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator.
  • Subjects will be followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera.
  • This trial will be conducted in the United States at approximately 19 clinical sites.

Clinical Trial NCT03293498: Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

  • This is a Phase 1/2, randomized, observer-blinded, active-controlled trial. 
  • The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax’ Matrix-M™ adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.
  • Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below.
  • Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume.
  • On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind.
  • Trial follow-up for each subject will span approximately 1 year from Day 0.

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