CAMBRIDGE, UK - The U.S. Food and Drug Administration (FDA) has approved AstraZeneca (NASDAQ:AZN)'s FluMist, a needle-free nasal spray influenza vaccine, for self-administration at home for adults up to 49 years old, and for administration by a caregiver to individuals between 2 to 17 years old. This approval, announced today, makes FluMist the only influenza vaccine in the U.S. that can be self-administered, potentially expanding access to flu vaccination.
The decision by the FDA was based on a comprehensive submission, including results from a usability study, which showed individuals over 18 could effectively self-administer FluMist. Ravi Jhaveri, MD, from Northwestern (NASDAQ:NWE) University School of Medicine, highlighted the significance of this approval, emphasizing the importance of additional tools to increase vaccination access and reduce disparities in healthcare.
Iskra Reic, Executive Vice President at AstraZeneca, pointed out that FluMist, which has been the sole nasal spray flu vaccine licensed in the U.S. for over two decades, is now also the only vaccine that allows for self- and caregiver administration outside of traditional healthcare settings.
Seasonal influenza affects a substantial portion of the population annually, with significant impacts on health systems, school attendance, and employment. Despite the high burden of influenza, vaccination rates in the U.S. have seen a decline. The availability of an at-home vaccination option like FluMist may potentially increase vaccination uptake, especially among adults who do not regularly attend well-care visits.
FluMist Home, an online pharmacy platform, will enable eligible individuals to have the vaccine delivered to their homes after completing a questionnaire reviewed by a pharmacist. FluMist will also continue to be available in offices and pharmacies for administration by healthcare professionals.
The efficacy, immunogenicity, and safety of self-administered FluMist are reported to be similar to those observed with healthcare professional-administered vaccinations. The updated FluMist label includes additional instructions for ordering and administration for eligible self and caregiver use. However, children aged 2-8 with uncertain vaccination history should consult a healthcare provider.
AstraZeneca is a global biopharmaceutical company engaged in developing prescription medicines across various therapy areas. FluMist is among the company's products used by millions of patients worldwide. This information is based on a press release statement from AstraZeneca.
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