FDA Grants Fast Track Designation to Flu Vaccine for 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