NanoFlu Vaccine Description
Novavax, Inc.'s NanoFlu is a vaccine candidate who 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 essential 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, 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,' may be accessed here. Interpretation - qNIV was well tolerated and produced qualitatively and quantitatively enhanced humoral and cellular immune response in older adults compared with IIV4. qNIV might enhance 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.
"Despite high vaccination rates, limitations in the effectiveness of existing influenza vaccines leave significant disease burden unaddressed, particularly in older adults," stated Stanley C. Erck, President, and CEO, Novavax, in a press release issued on September 23, 2021. "These encouraging (study) 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."
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+. 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, in a preclinical challenge study, it was shown 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' 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 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.
NanoFlu Vaccine News
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' 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 the publication of complete results from a pivotal Phase 3 clinical trial of NanoFlu in The Lancet Infectious Diseases. In the complete analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.
September 8, 2021 - Novavax, Inc. announced 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 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 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. 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 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 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 their influenza candidate, NanoFlu, in clinical trials.
ClinicalTrials.gov Identifier: NCT04120194 - Phase 3 clinical trial of NanoFlu - 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.