The US Food and Drug Administration (FDA) has approved AstraZeneca‘s FluMist, a needle-free nasal spray influenza vaccine for self-administration.
The approval makes FluMist the only ‘flu vaccine in the US that can be self-administered by adults up to 49 years or given by a caregiver to people aged two to 17 years.
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A live attenuated influenza vaccine, FluMist has been recommended by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics.
Since its initial US approval in 2003, 200 million doses of FluMist have been distributed globally.
The new self-administration option will soon allow individuals aged 18 years and above to have FluMist delivered to their homes through the FluMist Home service.
The service will operate via an online pharmacy where eligible people must complete a questionnaire reviewed by a pharmacist before the vaccine is shipped.
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By GlobalDataFluMist will also remain available at medical offices and pharmacies for administration by healthcare professionals.
The FDA’s decision was informed by a comprehensive submission, including a usability study that confirmed individuals over 18 years could correctly self-administer FluMist, as well as administer it to eligible persons aged two to 49 years.
The study found that 100% of the intended users successfully administered a full dose.
Data indicated that the efficacy, immunogenicity and adverse events associated with self-administration of FluMist are comparable to those observed with healthcare professional-administered vaccinations.
The FluMist label has been updated to include additional instructions for ordering and self or caregiver administration.
However, children aged two to eight years with an uncertain vaccination history may not qualify for caregiver administration and are advised to consult a healthcare provider.
AstraZeneca vaccines and immune therapies executive vice-president Iskra Reic stated: “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza.
“For more than 20 years, FluMist has been the only nasal spray ‘flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self and caregiver administration outside of traditional healthcare settings.”
