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FDA Grants Fast Track Designation to Flu Vaccine for Older Adults

January 16, 2020

Novavax’s recombinant quadrivalent flu vaccine candidate (NanoFlu) is being evaluated in an ongoing phase 3 clinical study for use in older adults.

Officials with the FDA have granted Fast Track Designation to Novavax's recombinant quadrivalent seasonal influenza vaccine candidate (NanoFlu), adjuvanted with Matrix-M, in adults aged 65 years and older.1

NanoFlu uses hemagglutinin (HA) amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences.1

The designation is based on an ongoing phase 3 clinical study evaluating the immunogenicity and safety of NanoFlu compared with the quadrivalent formulation of Fluzone. The study aims to demonstrate non-inferior immunogenicity as measured by HA inhibition titers of vaccine homologous influenza strains compared with Fluzone. NanoFlu’s safety profile is also being studied.1

Data from the phase 2 study evaluating NanoFlu in older adults were released in January 2019. The study included 1375 healthy adults 65 years of age and older.

Related: US Adults Forgoing Flu Shot

According to the results:2

  • All formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the 4 strains included in the vaccine.

  • Matrix-M adjuvant resulted in significant enhancement of immune responses when compared with the unadjuvanted formulation.

  • NanoFlu is a differentiated flu vaccine, as evidenced by significantly superior HA inhibition antibody responses against wild-type A (H3N2) viruses, including drifted strains, when compared with Fluzone High-Dose.
  • 45% increase against vaccine-homologous virus, A/Singapore (p<0.001)

  • 22% increase against a historic drifted virus, A/Switzerland (p=0.014)

  • 42% increase against a forward drifted virus, A/Wisconsin (p<0.001)

According to Novavax, topline results from the phase 3 trial are expected by the end of the first quarter of 2020.1

Sanofi’s Fluzone High-Dose Quadrivalent Influenza Vaccine was approved by the FDA in November 2019 for the prevention of influenza caused by Influenza A subtype viruses and type B viruses in adults 65 years of age and older.

References:

1. Novavax Granted Fast Track Designation for NanoFlu in Older Adults [news release]. Novavax’s website. http://ir.novavax.com/news-releases/news-release-details/novavax-granted-fast-track-designation-nanoflu-older-adults. Accessed January 16, 2020.

2. Novavax Announces Positive Phase 2 NanoFlu Results in Older Adults [news release]. Novavax’s website. http://ir.novavax.com/news-releases/news-release-details/novavax-announces-positive-phase-2-nanoflu-results-older-adults. Accessed January