FluMist Takes Flu Protection Home: FDA Approves Self-Administration

FluMist, a needle-free nasal spray, has been approved by the US Food and Drug Administration (FDA), making it the first and only influenza vaccine in the US that can be self-administered at home. Adults up to 49 years of age can now self-administer the vaccine, while caregivers can administer it to children aged two to 17. This new approval expands access to flu protection, offering a convenient option for those who may not regularly attend healthcare appointments.

Now available with two administration options, FluMist can be administered either by a healthcare professional in a clinical setting or by the vaccine recipient or caregiver at home. However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine.

The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations. These studies confirmed that 100 percent of users aged 18 and older could successfully self-administer a full dose of FluMist. The efficacy and safety profiles of self-administered doses were comparable to those administered by healthcare professionals. Given the steady decline in flu vaccination coverage among US adults (18 years and older) in the 2022 to 2023 season — at 46.9 percent, down by 2.5 percent from the prior season — this at-home option may help reverse that trend.

Influenza remains a significant public health concern, leading to three to five million severe cases globally. In the US, the flu contributes to missed workdays and school absences, affecting productivity across all sectors. According to AstraZeneca’s news release, some studies have suggested that a barrier to vaccination is the lack of regular healthcare visits.

The introduction of FluMist Home, an online pharmacy service, is expected to streamline access even further. Eligible individuals can complete an online questionnaire reviewed by a pharmacist before receiving the vaccine directly at home.

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Beyond FluMist, research into other routes of vaccine administration is ongoing. A National Institutes of Health (NIH)-sponsored Phase I trial is underway to evaluate an investigational nasal COVID-19 vaccine designed to offer broader protection against new SARS-CoV-2 variants. The candidate, MPV/S-2P, uses a murine pneumonia virus to deliver the stabilized spike protein, aiming to activate immunity both in the blood and in the respiratory tract’s mucosal tissues — where many respiratory viruses take hold.

Vaccines which could be inhaled as dry powder formulations are also being studied for their ability to induce strong local immune responses in the respiratory system.

Although still in clinical trials, these alternatives not only open up the possibilities of improved stability and room temperature storage, making them ideal for at-home use, but also highlight the growing focus on non-invasive vaccine technologies​.