The US Food and Drug Administration (FDA) has approved the first self-administered seasonal influenza vaccine – AstraZeneca’s FluMist. FluMist has been available in the US since 2003, but beginning next year, the nasal spray vaccine will also be available for self-administration. This approval increases the accessibility of seasonal influenza vaccines and has the potential to increase vaccine uptake.

FluMist is approved for use in the US in children and adults aged two through 49 years. It is the only seasonal influenza vaccine to be delivered intranasally, which makes it a great option for those who may be needle-phobic.

According to leading data and analytics company GlobalData, the influenza virus was responsible for at least 2.1 million illnesses, 21,000 hospitalisations, and 4,700 deaths during the 2023-24 US influenza season. Vaccination against the influenza virus remains the most important intervention in the prevention of influenza-associated complications, and the US Centers for Disease Control and Prevention (CDC) recommends that everyone six months and older receives a vaccination each influenza season.

FluMist is a live-attenuated influenza vaccine: It is manufactured using a live, weakened version of the influenza virus. This differentiates FluMist from traditional injectable vaccines, which are manufactured using either killed viruses, proteins, or cell-culturing methods. All are effective methods of protection against the seasonal influenza virus.

As part of AstraZeneca’s submission to the FDA, human factors/usability studies were conducted. These studies evaluated whether adults 18 through 49 years of age could properly administer FluMist when given instructions for use. The results of these studies showed that 100% of users were able to administer a full dose. Further, the results of the studies showed that efficacy, immunogenicity, and adverse events associated with self-administration of FluMist were similar to those associated with healthcare provider-based administration. Children two through 17 years of age can receive the vaccination from a parent/caregiver.

FluMist’s approval for self- or caregiver-administration provides patients with increased accessibility to the seasonal influenza vaccine. It also provides patients with increased flexibility to receive the vaccine at their convenience, and in turn, has the potential to increase uptake of the seasonal influenza vaccine.

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To access FluMist for self-administration, AstraZeneca plans to utilise a third-party online pharmacy. Following a screening and eligibility assessment, the online pharmacy will prescribe and ship the vaccine to the patient’s home. AstraZeneca expects this option to be available for the 2025-26 influenza season.

According to GlobalData, the US vaccination rate for seasonal influenza during the 2023-24 season was estimated to be 47%, and this rate is only expected to increase marginally over the coming years. Further, according to GlobalData’s survey of high-prescribing physicians in the US, the percentages of patients vaccinated against seasonal influenza who were administered FluMist during the 2022-23 season were 2.2% of children two to four years of age, 13.4% of children five to 17 years of age, and 3.4% of adults 18-49 years of age. This survey was conducted in June 2023 and included 23 high-prescribing physicians based in the US.

By increasing access to FluMist, there is potential for these percentages to increase. It is possible that we will see an increase in FluMist’s US flu vaccine patient share, given the convenient route of administration and ease of access, as well as an overall increase in seasonal influenza vaccine uptake.