FDA to Review AstraZeneca's Self-Administered Flu Vaccine

The FDA has accepted AstraZeneca's supplemental biologics license application (sBLA) for FluMist Quadrivalent, a self-administered flu vaccine, for review. If approved, FluMist will be the first self-administered flu vaccine available.

The need for more accessible flu vaccine solutions is evidenced by the low vaccination rates in the 2022-2023 flu season, particularly among children and adults under 50.

A usability study conducted by Astra Zeneca has confirmed that individuals aged 18 and above can adequately self-administer FluMist or administer it to other eligible patients aged 2 to 49 when the caregiver is provided with instructions.

“FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities,” said Iskra Reic, Executive Vice President of Vaccines and Immune Therapies, in a press release from AstraZeneca.

The FDA's regulatory decision on the sBLA for FluMist is expected in the first quarter of 2024. If approved, FluMist will be available for self-administration during the 2024/2025 flu season in the US. The availability of a self-administered flu vaccine would offer convenience for individuals and families, providing an additional option for influenza vaccination.

Influenza is a contagious respiratory illness caused by the influenza virus, and it can lead to serious complications in high-risk individuals. Each season, about 8% of the US population gets sick from the flu, with children aged 5 to 17 accounting for a significant portion of flu-related medical visits, Centers for Disease Control and Prevention.

Influenza also affects school attendance and work, resulting in missed school days and working caregivers taking time off to care for household members. For instance, a study assessing missed school days among children aged 5-17 found that viral illnesses caused about 75% of missed school days. Influenza was a major cause of school absenteeism, with an average of more than one missed day per illness and over 40% missing more than two days.

FluMist Quadrivalent is a live attenuated influenza vaccine that is administered as a nasal spray to help protect against influenza. FluMist has demonstrated comparable effectiveness to other flu vaccines. However, certain people should not receive live vaccines, including those with compromised immune systems.