AstraZeneca: FDA agrees to FluMist sBLA
(CercleFinance.com) - AstraZeneca announces that the FDA has agreed to review its supplemental Biologics License Application (sBLA) for a self-administered or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray.
If approved, FluMist would be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option for flu vaccination.
FluMist, which is sprayed into the nose, has extensive data demonstrating comparable efficacy and acceptable safety compared with other flu vaccines, the Anglo-Swedish company said.
The FDA's decision is expected in Q1 2024. If approved at that time, FluMist should be available for self-administration in the US for the 2024/2025 flu season.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
If approved, FluMist would be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option for flu vaccination.
FluMist, which is sprayed into the nose, has extensive data demonstrating comparable efficacy and acceptable safety compared with other flu vaccines, the Anglo-Swedish company said.
The FDA's decision is expected in Q1 2024. If approved at that time, FluMist should be available for self-administration in the US for the 2024/2025 flu season.
Copyright (c) 2023 CercleFinance.com. All rights reserved.