AstraZeneca’s nasal flu vaccine nears FDA approval

Nasal flu vaccine by AstraZeneca awaits FDA nod | Pharmtales

AstraZeneca’s FluMist, a nasal spray flu vaccine with a two-decade history, is poised to potentially become available for self-administration as early as next year. The FDA has accepted AstraZeneca’s supplemental biologics license application (sBLA) for self-administered FluMist Quadrivalent, with a decision expected in the first quarter of the upcoming year. The company is preparing to launch this innovative product in the 2024-2025 flu season.

This needle-free vaccine, originally endorsed for individuals aged 2 to 49, may soon be self-administered by those between the ages of 18 and 49, with adults also having the capability to administer it to children aged 2 to 17. Currently, healthcare practitioners are the sole authorized administrators of the nasal spray. Remarkably, since its initial FDA approval in 2003, FluMist has remained the singular nasal flu vaccine on the market.

Why is this change happening now, after two decades? AstraZeneca saw an opportune moment in the wake of declining flu vaccine usage during the COVID-19 pandemic. Lisa Glasser, AstraZeneca’s head of US medical affairs for vaccines and immune therapies, noted the chance to attract potential users, emphasizing that the pandemic highlighted people’s ability to take care of their health and administer tests themselves. If approved, FluMist could be accessible through an online pharmacy request system, with vaccines shipped to homes in temperature-controlled packaging.

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Even though the CDC recommends seasonal flu vaccinations for everyone over 6 months old, fewer than half of the US population complies with this guidance, with rural areas seeing even lower vaccination rates.

AstraZeneca anticipates that the self-administered vaccine could entice individuals who currently receive flu shots due to its convenience. Furthermore, the broader hope is that it will introduce new people to flu vaccination, ultimately increasing overall uptake.

Supported by a usability study confirming that individuals aged 18 and above could self-administer the product effectively when provided with instructions, AstraZeneca’s application is bolstered by previous studies showcasing FluMist’s comparable efficacy and safety profiles to other flu vaccines.

AstraZeneca has experienced a rollercoaster ride with FluMist sales. They reached $288 million in 2015 before the CDC recommended against its use in the 2016-17 flu season. Sales hit a low point in 2017 at $78 million due to production challenges following WHO guideline adjustments. However, the pandemic prompted a resurgence, with sales reaching $295 million in 2020. Last year, the company reported $175 million in FluMist revenue, with $151 million coming from Europe. This development could potentially reinvigorate FluMist’s presence in the market and provide a novel solution for flu vaccination.

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