FLUMIST approved for self-use in the US

FLUMIST, a needle-free nasal spray, has gained US approval as the only influenza vaccine that can be self-administered. This new option allows adults up to 49 years old to self-administer the vaccine, or for parents and caregivers to administer it to children aged 2-17. The approval from the US Food and Drug Administration (FDA) followed a thorough submission, including a usability study where individuals over 18 demonstrated they could effectively self-administer FLUMIST or administer it to eligible recipients.

Dr. Ravi Jhaveri, a prominent figure in infectious diseases at Northwestern University, emphasized the significance of this development. He noted that for the first time, families and caregivers have the opportunity to protect themselves against influenza conveniently and needle-free at home. He highlighted the importance of increasing access to vaccinations to help reduce the substantial annual burden that influenza places on individuals, society, and healthcare systems.

Iskra Reic, Executive Vice President at AstraZeneca, echoed similar sentiments, stating that the approval of FLUMIST for self-administration marks a crucial step in making vaccines more accessible. She pointed out that FLUMIST has been the only nasal spray flu vaccine licensed in the US for over two decades and now stands alone in offering self- and caregiver-administration outside traditional healthcare settings.

Seasonal influenza remains a significant health concern, causing up to 1 billion infections annually worldwide. Severe outcomes from influenza, such as hospitalizations and deaths, affect millions each year. In the US alone, the 2022-2023 influenza season saw an estimated 31 million cases, resulting in 14 million healthcare visits, 360,000 hospitalizations, and 21,000 deaths. Additionally, influenza negatively impacts school attendance and work productivity, with significant numbers of school days and workdays missed each year.

Vaccination rates for influenza have dropped by 3.3% among US adults since the 2020-2021 season. A US survey indicated that a key reason adults skip vaccinations is their failure to attend regular well-care visits. The availability of at-home vaccination options like FLUMIST could potentially increase vaccination uptake.

In response to these needs, FLUMIST Home will soon be available, allowing individuals 18 and older to receive the vaccine directly at their homes. This service will operate through an online pharmacy where eligible individuals fill out a questionnaire reviewed by a pharmacist before the vaccine is shipped. FLUMIST will also remain available in healthcare offices and pharmacies for professional administration.

FLUMIST is a live attenuated influenza vaccine (LAIV) administered as a nasal spray. It is recommended by the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP). Initially approved in the US in 2003, FLUMIST has seen the distribution of almost 200 million doses globally.

FDA-required human factors and usability studies have confirmed that individuals aged 18-49 can properly self-administer FLUMIST with provided instructions. The updated FLUMIST label includes additional instructions for ordering and administering the vaccine for eligible self and caregiver use. However, children aged 2-8 with uncertain vaccination histories should consult their healthcare provider.

AstraZeneca, the company behind FLUMIST, is a global biopharmaceutical firm focusing on oncology, rare diseases, and biopharmaceuticals, including cardiovascular, renal, metabolism, respiratory, and immunology areas. Operating in over 125 countries, AstraZeneca’s innovative medicines are used by millions worldwide.