Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates

Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates

Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food and Drug Administration (FDA) for its combination vaccine candidates aimed at preventing influenza and COVID-19 infections in individuals aged 50 and older.

Details of the Combination Vaccine Candidates
One of the combination vaccine candidates (NCT06695117) pairs the influenza protein-based trivalent vaccine Fluzone High-Dose with the adjuvanted recombinant Novavax (NASDAQ: NVAX) COVID-19 vaccine. The other candidate (NCT06695130) combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine. Both Fluzone High-Dose and Flublok have demonstrated their effectiveness in preventing more influenza infections in older adults compared to standard-dose influenza vaccines in pivotal randomized clinical studies.

Real-World Evidence and Vaccine Efficacy
Moreover, in real-world evidence studies, Fluzone High-Dose and Flublok have shown significant and consistent reductions in flu-related hospitalizations. This data supports the potential of these combination vaccine candidates to provide enhanced protection against both influenza and COVID-19, particularly for the older adult population who are at higher risk for severe outcomes from these infections.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry