NanoFlu™ Vaccine Description
Novavax, Inc.'s NanoFlu™ is a vaccine candidate that 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 high-quality and durable antibody responses and multifunctional CD4 and CD8 T-cell responses. Recombinant seasonal influenza vaccines have an essential advantage over other flu shots: once licensed for commercial sale, large quantities of vaccines can be manufactured cost-effectively without using the live influenza virus or eggs, says Novavax.
The Lancet published on September 23, 2021: '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 randomized controlled trial.'. 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. Interpretation - qNIV was well tolerated and produced qualitatively and quantitatively enhanced humoral and cellular immune response in older adults compared with IIV4. qNIV might improve the effectiveness of seasonal influenza vaccination, and future studies to show clinical efficacy are planned. The manuscript was previously posted to the medRxiv preprint server in August 2020.
Maryland-based Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing 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 and older. It is further estimated that influenza attacks between 5% and 10% of adults and 20% to 30% of children each year, 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 that evolved over a decade of influenza seasons. In addition, a preclinical challenge study showed that 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.
COVID-NanoFlu™ Combination Vaccine
Novavax's COVID-NanoFlu™ Combination Vaccine combines the company's recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccine candidates with Matrix-M™ adjuvant in a single formulation. Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. In addition, in preclinical studies, the COVID-NanoFlu Combination Vaccine showed robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein with Matrix-M adjuvant playing a key role.
NanoFlu Vaccine News
November 1, 2021 - NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax's' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
September 23, 2021 - "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."
October 15, 2021 - Novavax, Inc. announced that Vivek Shinde, M.D., Vice President, Clinical Development, will deliver a presentation during the World Vaccine Congress Europe 2021. A topic of discussion will be Novavax's COVID-NanoFlu™ Combination Vaccine, which combines the company's recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccine candidates with Matrix-M™ adjuvant in a single formulation.
September 23, 2021 - Novavax, Inc. announced complete results from a pivotal Phase 3 clinical trial of NanoFlu in The Lancet Infectious Diseases. In the thorough analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.
September 8, 2021 - Novavax, Inc. announced the enrollment of participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax's NanoFlu seasonal influenza and COVID-19 vaccines. Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. In preclinical studies, the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role.
May 10, 2021 - Novavax, Inc. announced positive preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate. The preclinical study found that the combination of NanoFlu/NVX-CoV2373 (qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in ferrets.
March 1, 2021 - Novavax, Inc. announced that they continue to advance the NanoFlu program, including exploring a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting.
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 become the Chief Commercial Officer while continuing 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. In addition, Novavax announced the results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intended 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) had granted Fast Track Designation for NanoFlu.
October 15, 2019 - Novavax, Inc. announced initiating 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 U.S. FDA on Pivotal Phase 3 Trial Design for NanoFlu.
January 03, 2019 - Novavax announced Positive Phase 2 NanoFlu Results in Older Adults.
September 19, 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
Novavax continues to test its influenza candidate, NanoFlu, in clinical trials.