Sanofi’s Combo Vaccine for Flu and COVID-19 Gets FDA Fast Track

The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years of age and older. Both candidates combine two already licensed and authorized vaccines.

The first combination vaccine candidate (NCT06695117) consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate (NCT06695130) combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.

Both Fluzone High-Dose and Flublok have been shown to prevent more influenza infections in older adults than standard-dose influenza vaccines in pivotal randomized clinical studies. The Novavax COVID-19 vaccine has been shown to have a better tolerability profile than currently available mRNA COVID-19 vaccines when administered as a booster dose. It has also demonstrated efficacy against COVID-19 as primary vaccination in two phase 3 studies.

Fast Track designation was granted based on the potential for the combination vaccine candidates to address the significant individual and healthcare system burden of two serious illnesses that can result in hospitalization and death, particularly 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.

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