Sanofi’s flu-COVID combo vaccines gain FDA Fast Track designation

Clinical studies have begun to evaluate the safety and immune response induced by the combination vaccines 

The US Food and Drug Administration (FDA) has granted Fast Track designation to two Sanofi combination vaccine candidates for the prevention of influenza and COVID-19 in individuals aged 50 and older.

The first combination candidate (NCT06695117) combines the influenza protein-based trivalent vaccine, Fluzone High-Dose, with the adjuvanted recombinant Novavax COVID-19 vaccine.

The second candidate (NCT06695130) consists of Flublok, an influenza recombinant protein-based trivalent vaccine, combined with the Novavax COVID-19 vaccine.

These are already licensed and authorised vaccines with proven efficacy through randomized controlled studies and favorable tolerability profiles.

For example, Fluzone High-Dose and Flublok have been shown to prevent more influenza infections in older adults compared to standard-dose flu vaccines, as demonstrated in pivotal randomised clinical studies.

Additionally, real-world evidence studies have confirmed that both vaccines can significantly and consistently reduce flu-related hospitalizations.

The Novavax COVID-19 vaccine has shown better tolerability than currently available mRNA COVID-19 vaccines when administered as a booster dose. It has also demonstrated high efficacy against COVID-19 in primary vaccination in two pivotal Phase 3 studies.

Thomas Triomphe, executive vice president of vaccines at Sanofi, said: “Building on our immunology expertise and 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.”

The FDA granted Fast Track designation recognising the potential of these combination vaccines to reduce the burden of two serious illnesses that can lead to hospitalization and death, especially among older adults.

Sanofi has initiated two separate phase 1/2 parallel, randomized, modified double-blind, multi-arm studies (NCT06695117 and NCT06695130) to evaluate the safety and immune response induced by the two combination vaccine candidates.