The FDA and AstraZeneca are both touting the agency’s approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to review AstraZeneca’s sBLA for the self-administration change in October 2023. FluMist will still be available for healthcare provider administration but will now also be available for home delivery to people aged 18.
AstraZeneca Executive VP, Vaccines and Immune Therapies, Iskra Reic commented, “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza. For more than 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self- and caregiver administration outside of traditional healthcare settings.”
FDA Center for Biologics Evaluation and Research Director Peter Marks said, “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families. Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”
Read the AstraZeneca press release.
Read the FDA press release.
