US-based Novavax has published top-line Phase III data for its seasonal influenza vaccine Nanoflu in adults aged 65 and over.
Nanoflu is a recombinant quadrivalent vaccine, which means it is designed against four strains of influenza – two influenza A subtypes and two influenza B subtypes.
The study evaluated the immunogenicity and safety of Nanoflu compared to Sanofi’s US Food and Drug Administration (FDA)-approved Fluzone Quadrivalent. Novavax’s candidate met its primary endpoint of non-inferiority to Fluzone Quadrivalent in terms of immunogenicity across all four stains included in the vaccine.
This endpoint was measured using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR); these parameters were measured by haemagglutination inhibition (HAI) assays using egg-derived reagents.
The company’s CEO and president Stanley Erck said: “With this data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine.
“These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults.
“We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
Novavax also investigated Nanoflu with HAI-based on wild-type reagents in order to accurately assess the vaccine’s efficacy against circulating wild-type viruses, compared to Fluzone Quadrivalent. Nanoflu also demonstrated non-inferiority to Sanofi’s vaccine in all four strains, as well as in four drifted H3N2 strains circulating this year.
The company’s president of research and development Gregory Glenn added: “This data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift.”
Nanoflu includes a Matrix-M adjuvant, which provide good immunostimulatory to improve the duration of the vaccine’s effect. Produced using Novavax’s proprietary technology, Matrix-M adjuvants can activate all classes and subclasses of antibodies, as well as cause potent cellular responses.
Navovax is leveraging its proprietary platform to create a drug against the Covid-19 novel coronavirus currently causing a pandemic.