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# Sanofi sBLA for Expanded Age Use for Fluzone Quadrivalent
- URL: https://www.fdaweb.com/sanofi-sbla-for-expanded-age-use-for-fluzone-quadrivalent/
- Published: 2018-04-26T12:00:00.000Z
- Updated: 2026-09-15T00:01:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141309

FDA has accepted for review a Sanofi Pasteur supplemental BLA to expand the age indication of its Fluzone Quadrivalent (influenza vaccine) 0.5 mL dose to include children aged six through 35 months. The agency has set a user fee review action target of 1/28/2019\. If approved, physicians will be able to reserve the vaccine for young children for the 2019–2020 flu season, the company says.

The application is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children. Detailed results from the Phase IV, randomized, observer-blinded, controlled, multicenter study will be presented at medical meetings later this year,” the company says.