FluMist Becomes First At-Home Self-Administered Flu Vaccine Approved by FDA

FluMist Becomes First At-Home Self-Administered Flu Vaccine Approved by FDA

(IN BRIEF) FluMist, a needle-free nasal spray influenza vaccine, has been approved by the FDA for self-administration in the US, making it the first flu vaccine of its kind to be used at home. Adults up to 49 years old can self-administer FluMist, and caregivers can administer it to children aged 2 to 17. This approval is expected to improve access to flu vaccinations and address declining vaccination rates. FluMist will also be available via FluMist Home, an online service that delivers the vaccine directly to eligible individuals’ homes.

(PRESS RELEASE) CAMBRIDGE, 21-Sep-2024 — /EuropaWire/ — FluMist, the needle-free nasal spray influenza vaccine, has been approved by the US Food and Drug Administration (FDA) for self-administration, making it the first influenza vaccine in the US to be administered at home. This approval allows adults up to 49 years of age to self-administer the vaccine, while parents or caregivers can administer it to children between the ages of 2 and 17.

The FDA’s decision was supported by comprehensive data, including a usability study that demonstrated adults could safely and effectively self-administer the vaccine, or administer it to eligible individuals within the 2-49 age group.

Dr. Ravi Jhaveri, an infectious disease expert at Northwestern University, highlighted the significance of this development: “This is the first time families and caregivers can administer a flu vaccine at home, offering a convenient, needle-free option to protect against influenza. Given the annual burden of flu on individuals and healthcare systems, this increased accessibility is critical for boosting vaccination rates and reducing health disparities.”

AstraZeneca’s Executive Vice President, Iskra Reic, emphasized the importance of this milestone in expanding access to vaccines: “For over two decades, FluMist has been the only nasal spray flu vaccine available in the US. Now, with self-administration, we are providing individuals and families with a convenient way to protect themselves outside of traditional healthcare settings.”

Influenza remains a significant public health issue, causing up to 1 billion infections globally each year. The introduction of FluMist for self-administration is expected to help increase vaccination rates, which have seen a decline in the US since 2020. FluMist will also be available through a new online service, FluMist Home, where eligible individuals can order the vaccine for home delivery after completing a questionnaire. It will continue to be offered in doctors’ offices and pharmacies as well.

Notes

Influenza
On average, about 8% of the US population becomes ill from influenza each season, with a range of between 3 percent and 11 percent, depending on the season.7 During the 2022-2023 influenza season, an estimated 31 million people developed illness from influenza, 14 million visited a healthcare provider for influenza, with 360,000 hospitalisations, and 21,000 deaths.8

About FluMist Live Attenuated Influenza Vaccine
FluMist is a live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. FluMist is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended influenza vaccine option. FluMist was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.1

Human Factors Usability Study for FluMist Self Administration
In FDA-required human factors/usability studies, AstraZeneca evaluated if individuals 18 through 49 years of age could appropriately administer FluMist when given instructions for use. The results showed that 100% of intended users administered a full dose. In addition, data show that efficacy, immunogenicity and adverse events with self-administration of FluMist are similar to that seen with HCP-administered vaccination.1,9 The FluMist label has been updated to provide additional instructions for ordering and administration for eligible self and caregiver use. Children 2-8 years of age with an uncertain vaccination history may not be eligible for caregiver use and should consult their healthcare provider for further information.1

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

References

1. FluMist Prescribing Information. March 2024.

2. World Health Organization. Influenza (Seasonal. URL: https://www.who.int/news-room/fact-sheets/detail/influenza(seasonal)#:~:text=There%20are%20around%20a%20billion,infections%20are%20in%20developing%20countries.

3. McLean, HQ, Peterson, SH, King, JP, Meece, JK, and Belongia, EA. School absenteeism among school-aged children with medically attended acute viral respiratory illness during three influenza seasons, 2012-2013 through 2014-2015. Influenza Other Respi Viruses. 2017; 11, 220–229. https://doi.org/10.1111/irv.12440

4. Blanchet Zumofen, MH., Frimpter, J. & Hansen, S.A. Impact of Influenza and Influenza-Like Illness on Work Productivity Outcomes: A Systematic Literature Review. PharmacoEconomics 41, 253–273 (2023). https://doi.org/10.1007/s40273-022-01224-9

5. Centers for Disease Control and Prevention. Flu Vaccination Coverage, United States, 2022–23 Influenza Season. URL: https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm

6. Anderson EL. Recommended solutions to the barriers to immunization in children and adults. Mo Med. 2014 Jul-Aug;111(4):344-8. PMID: 25211867; PMCID: PMC6179470.

7. Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). URL: https://www.cdc.gov/flu/about/keyfacts.htm

8. Centers for Disease Control and Prevention. Preliminary Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths in the United States — 2022–2023 Influenza Season. URL: https://www.cdc.gov/flu/about/burden/2022-2023.htm

9. Burgess, T.H., Murray, C.K., Bavaro, M.F., Landrum, M.L., O’bryan, T., Rosas, J.G., Cammarata, S.M., Martin, N.J., Ewing, D.F., Raviprakash, K., Mor, D., Zell, E.R., Wilkins, K.J., & Millar, E.V. (2015). Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine, 33 32, 3894-9 . DOI:10.1016/j.vaccine.2015.06.061

Adrian Kemp
Company Secretary
AstraZeneca PLC

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SOURCE: AstraZeneca