French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for two combination vaccine candidates designed to prevent both influenza and COVID-19 infection in individuals aged 50 and older.
These combination vaccines, which combine two already-licensed vaccines, are the first non-mRNA candidates of their kind.
The first combination vaccine candidate consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.
Sanofi is currently conducting two Phase 1/2 clinical trials to evaluate the safety and immune response of these vaccine candidates.
The FDA's Fast Track Designation recognises the potential of these combination vaccines to address the significant public health burden of both influenza and COVID-19, particularly among older adults.
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Sanofi's combination vaccine candidates for flu and COVID-19 get Fast Track Designation