Novavax plans FDA filing after NanoFlu trumps Sanofi flu vaccine

Novavax has unveiled new Phase III data showing that its recombinant quadrivalent seasonal influenza vaccine candidate, NanoFlu, met all primary endpoints in adults aged 65 and older against Sanofi’s Fluzone Quadrivalent.

As a results of the successful data, the company has announced plans to submit a filing to the US Food and Drug Administration (FDA) under the agency's accelerated approval pathway.

In the trial, geometric mean titers (GMT) at day 28 for NanoFlu were 24% to 66% higher than for Fluzone Quadrivalent, while the experimental vaccine was associated with 11.4 to 20.4 higher seroconversion rates (SCR) percentage points than the Sanofi drug.

Top-line results showed that NanoFlu achieved the primary endpoints, using both GMT and SCR, for all four strains included in the vaccine, as measured by haemagglutination inhibition (HAI) assays using egg-derived reagents.

According to the company, NanoFlu was also well tolerated in the Phase III study and had a safety profile comparable to Fluzone Quadrivalent, but was associated "with a modest increase in local adverse events."

Last year Novavax announced that its respiratory syncytial virus vaccine ResVax failed to hit its main goal, despite showing efficacy against a secondary objective, preventing RSV LRTI hospitalisations by 44%.

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