Sanofi has received fast track designation from the US Food and Drug Administration (FDA) for two combination vaccine candidates for the prevention of influenza and Covid-19.
These vaccines candidates aim to prevent flu and Covid-19 in people aged 50 and older.
Both combine two already licensed and authorised vaccines with proven efficacy. The candidates have shown favourable tolerability in randomised, controlled clinical studies.
The first combination vaccine candidate combines Fluzone High-Dose, a protein-based trivalent flu vaccine, with the Novavax Covid-19 vaccine.
The second candidate pairs the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax vaccine.
Sanofi said that both Fluzone High-Dose and Flublok have been shown to prevent more flu infections in older adults compared to standard-dose vaccines in clinical studies.
Additionally, real-world data supports their efficacy in reducing flu-related hospitalisations.
The Novavax Covid-19 vaccine, according to Sanofi, offers better tolerability than current mRNA vaccines as a booster. It has shown high efficacy in preventing Covid-19 in two Phase 3 studies.
Sanofi vaccines executive vice president Thomas Triomphe said: “Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes.
“Our goal is to develop a combined flu and Covid-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry leading levels of efficacy, safety and tolerability of the standalone vaccines included in our combination vaccine.”
Fast track designation was granted due to the potential of the combination vaccines to reduce the serious burden of flu and Covid-19, which can lead to hospitalisation and death, especially in older adults.
In addition, the French drugmaker has launched two Phase 1/2 randomised studies to assess the safety and immune response of these combination vaccine candidates.
NCT06695117 combines TIV-HD (FLUZONE High-Dose) with NVXC19 (Novavax Covid-19 vaccine) to prevent influenza subtypes A and B, as well as Covid-19, in individuals aged 50 and older.
NCT06695130 combines RIV3 (FLUBLOK) with NVXC19 (Novavax Covid-19 vaccine) to prevent influenza subtypes A and B, along with Covid-19, in individuals aged 50 and older.
Recently, Sanofi unveiled its plans to invest approximately €1bn to establish a new insulin production facility in Beijing, China.
