AstraZeneca has announced that it has submitted an application to the Food and Drug Administration (FDA) for a supplemental biologics license that would allow eligible individuals in the United States to self-administer their needle-free flu vaccine, FluMist.
The proposed age range for self-administration is 18 through 49, and individuals 18 and older would also be allowed to give the vaccine to eligible children. Currently, FluMist is licensed for use in children and adults aged 2 to 49.
It’s important to note that if approved, this would not lead to over-the-counter sales of FluMist. Instead, the vaccine would be ordered and delivered under appropriate temperature controls after consultation with a medical professional. This program is designed to provide an additional option for busy families to access influenza vaccination.
A “usability study” was conducted to test the likelihood that people could effectively administer the vaccine at home. While the details of the study were not disclosed, AstraZeneca expressed confidence in the feasibility of home administration, citing experiences with at-home Covid-19 tests during the pandemic as a precedent.
If the FDA approves AstraZeneca’s application, the self-administration option could be available for the 2024-25 flu season. The vaccine would come in a pre-filled syringe without a needle and would include detailed instructions for administration.
FluMist is considered an appealing alternative for individuals who are afraid of needles, although some children may still have reservations about the intranasal administration process.
There are potential considerations with home administration, such as the need for refrigeration and ensuring the vaccine is properly administered. Additionally, there may be questions about how data on vaccine effectiveness will be collected, given the history of FluMist’s performance.
FluMist’s history in the U.S. market includes a preferential recommendation for children that was later revoked due to concerns about its effectiveness against certain strains of influenza. The vaccine was later reformulated, and its recommendation was eventually restored.
AstraZeneca anticipates providing 1.5 to 2 million doses of FluMist to the American market this year.