NanoFlu is on the FDA’s Vaccine Fast-Track
A Maryland based biotechnology company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, a recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.
Novavax’s NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system.
NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences.
Additionally, NanoFlu contains Novavax’s patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes.
Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a press release issued on January 15, 2020, “We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness.”
“We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”
The ongoing Phase 3 clinical trial is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone. The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone and to describe its safety profile.
Top-line clinical data from this trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.
Positive top-line results of a Phase 2 clinical trial of NanoFlu in older adults released in January 2019, showed that NanoFlu induced improved immune responses when compared to the best-selling flu vaccine in the older adult market.
In this study, all formulations of NanoFlu were well tolerated and elicited vigorous immune responses to the four strains included in the vaccine.
FDA Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
And, FDA Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. An estimated 1 million deaths globally each year are attributed to influenza, says the World Health Organization.
The Centers for Disease Control and Prevention (CDC) recently issued Health Advisory on January 10, 2020, reminding clinicians that influenza B viruses can cause severe illness in people of all ages.
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Novavax, Inc. is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
Influenza vaccine news is published by Precision Vaccinations.