FDA Approves Self-Administered AstraZeneca FluMist Vaccine

The US Food and Drug Administration (FDA) has given the nod to FluMist, a needle-free nasal spray influenza vaccine developed by AstraZeneca, for self-administration. This milestone approval positions FluMist as the sole influenza vaccine in the United States that can be self-administered by adults up to 49 years or administered by a caregiver to individuals aged two to 17 years.

FluMist, a live attenuated influenza vaccine, has garnered recommendations from both the Advisory Committee on Immunization Practices and the American Academy of Pediatrics. Since its introduction to the US market in 2003, FluMist has seen the distribution of 200 million doses worldwide.

The newly approved self-administration option will enable individuals aged 18 and older to have FluMist delivered directly to their homes via the FluMist Home service. This service will function through an online pharmacy, requiring eligible recipients to complete a questionnaire reviewed by a pharmacist before the vaccine is shipped. Despite this new option, FluMist will continue to be available at medical offices and pharmacies where it can be administered by healthcare professionals.

The FDA’s approval was backed by a thorough submission that included a usability study. This study demonstrated that individuals over 18 years could effectively self-administer FluMist and administer it to eligible persons aged two to 49 years. Remarkably, the study found that 100% of participants were able to successfully administer a full dose. Data from the study also indicated that the efficacy, immunogenicity, and adverse events associated with self-administration are comparable to those observed when vaccinations are administered by healthcare professionals.

AstraZeneca has updated the FluMist label to incorporate additional instructions for both self and caregiver administration. However, it is advised that children aged two to eight years with an uncertain vaccination history consult a healthcare provider, as they may not qualify for caregiver administration.

Iskra Reic, AstraZeneca's executive vice-president for vaccines and immune therapies, remarked on the significance of this approval: “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. Now, it is also the only vaccine that facilitates convenient access to influenza vaccination through self and caregiver administration outside of traditional healthcare settings.”

This development is expected to play a vital role in increasing the accessibility of influenza vaccines, potentially improving vaccination rates and helping to mitigate the annual impact of influenza on public health.