Sanofi has announced that its two combination vaccine candidates, designed to prevent both influenza and Covid-19 infections in people aged 50 years and above, have received fast track designation from the US Food and Drug Administration (FDA).
The candidates merge two existing vaccines that have demonstrated efficacy and favourable tolerability through randomised controlled studies.
The first candidate combines the Fluzone high-dose influenza vaccine and the adjuvanted Novavax Covid-19 vaccine.
The second merges Flublok, an influenza recombinant protein-based vaccine, with the Novavax vaccine.
These influenza vaccines have significantly reduced flu-related hospitalisations in real-world evidence studies.
The Novavax COVID-19 vaccine, when used as a booster dose, has a better tolerability profile than currently available mRNA vaccines and has shown high efficacy in two pivotal Phase III trials.
Sanofi Vaccines executive vice-president Thomas Triomphe stated: “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.”
Two separate Phase I/II trials (NCT06695117 and NCT06695130) to assess the immune response and safety of the combo candidates have been commenced by the company. These randomised, parallel, multi-arm, modified double-blind studies are set to provide further insights into the vaccines' performance.
The two candidates aim to protect against influenza subtypes A and B and coronavirus (SARS-CoV-2) infections.
The use of combination vaccines could simplify immunisation programmes, offering quicker administration, fewer injections, reduced errors and decreased syringe and vial disposal needs.
This announcement follows the European Medicines Agency’s approval in November 2024 of Sanofi/Regeneron's Dupixent for treating eosinophilic esophagitis.
