FDA Accepts A Self-Administered Flu Vaccine for Review
27 Oct 2023 • The US FDA is set to review what could be the country’s first self-administered influenza vaccine. The FDA has accepted a supplemental biologics license application for FluMist - a nasal spray influenza vaccine - as a self- or caregiver-administered vaccine based on data from a usability study showing that people aged 18 years or older could follow instructions for the vaccine’s use without additional guidance.
FluMist is already approved for use in the United States for people aged 2 to 49 years, but only as administered by a health care professional. If approved, the vaccine – branded as FluMist Quadrivalent – could become the first self-administered flu vaccine which does not necessitate a healthcare practitioner for administration.
FluMist Quadrivalent is a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention. It was originally approved in the US in 2003. The company said it expects the FDA to decide on the vaccine by the first quarter of 2024, adding that it expects the vaccine to be made available for self-administration in the United States during the 2024-2025 flu season, if approved.
Source: Reuters | Read full story