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AstraZeneca PLC

FLUMIST (Influenza, Vaccine Live, Intranasal), the nation’s only nasal spray flu vaccine, now available for home delivery

AstraZeneca launches the first FDA-approved influenza vaccine available for self- or caregiver administration, providing a convenient, household-based option for seasonal flu vaccination

WILMINGTON, Del.--(BUSINESS WIRE)--Aug. 15, 2025-- AstraZeneca today launches FluMist Home, the first-of-its-kind, at-home delivery service for FLUMIST®(Influenza Vaccine Live, Intranasal). FLUMISTis the first and only seasonal influenza vaccine approved to be self-administered by adults 18 to 49 years of age or administered by a parent or caregiver to individuals 2-17 years of age.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250815310613/en/

Initially approved by the Food and Drug Administration (FDA) in 2003, this recent approval extends a safe and effective vaccination option for individuals and their families to help protect themselves during flu season with no needles or waiting rooms. Now, for the first time, eligible individuals and their families can help protect themselves during the 2025-26 flu season from the convenience of their own home.2

Individuals 18 and older can visit www.FluMist.com to learn more and click to order, where they will be directed to complete a medical screening questionnaire. A licensed healthcare provider will review each submission to determine eligibility. Once eligibility is confirmed and insurance is verified, FLUMIST will be prescribed and shipped directly to the consumer’s home on the date they had selected, complete with clear administration instructions, storage guidance and how to dispose.1

Joris Silon, US Country President and Senior Vice President, AstraZeneca, said: “The launch of FluMist Home is a transformational moment in the evolution of influenza protection, bringing a simple and accessible option directly into the hands of consumers. FluMist Home reflects the growing importance of direct-to-consumer offerings and underscores our commitment to continuous innovation, making it easier for people to get vaccinated and stay protected.”3

According to the Centers for Disease Control and Prevention, the 2024-2025 influenza season was classified as a high-severity across all age groups in the US–the most severe since the 2009 H1N1 swine flu pandemic, resulting in at least 610,000 hospitalizations and 27,000 deaths.4-6 These trends underscore the importance of increasing influenza vaccination coverage and providing more accessible vaccination options to help improve immunization rates for protection against flu.

Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, US, said: “As influenza vaccination rates decline, especially among younger populations, this first-of-its-kind, at-home, needle-free option offers a critical opportunity to help make protection more accessible, convenient, and better aligned with the realities and current preferences of people’s lives.”7

Michele Slafkosky, Executive Director, Families Fighting Flu, said: “Seasonal influenza can have a serious, even life-altering, impact on individuals and families, especially for those most vulnerable. Providing flexible vaccination options makes it easier for individuals and caregivers to help get protected. This can help to improve protection for individuals and strengthen collective immunity against influenza.”8

Ami Patel, Executive Vice President, Hub Operations, ASPN Pharmacies, LLC, said: “For the first time, consumers can receive and administer an influenza vaccine entirely at home—marking a historic shift in how preventive care is delivered. Through FluMist Home we’re seeing a new model of care that puts consumers in control, offering a seamless, end-to-end experience, from determining eligibility to convenient home-delivery and administration. This milestone not only redefines convenience in vaccine delivery, but also sets the stage for a more accessible, patient-centered future in healthcare.”

Through FluMist Home, all orders will be reviewed by a licensed healthcare provider with ASPN Pharmacies, an independent online specialty pharmacy, and then dispensed and shipped by Polaris Pharmacy Services, a specialty pharmacy, in temperature-controlled packages to maintain cold chain continuity. Consumers can select their preferred delivery date during the ordering process for added convenience. FLUMIST for self- or caregiver-administration is packaged in a consumer-friendly format with clear, at-home specific instructions that support proper handling, administration, and disposal. Once received, the vaccine should be stored in the refrigerator until use. The service also ensures documentation of vaccination in the relevant Immunization Information System.1

For the 2025-26 flu season, FluMist Home will be available in 34 states covering about 80% of the eligible population. There are a number of states where FluMist Home is unavailable due to local pharmacy laws. Our aim is to have this service available in all 48 contiguous states in future seasons. FLUMIST will continue to be available in doctors’ offices and pharmacies for administration by healthcare professionals across the nation. More information on FLUMIST and FluMist Home is available at www.FluMist.com.

Important Safety Information

  • You should not get FLUMIST if you have a severe allergy to its components, eggs or other flu vaccines; or are 2 through 17 years old and take aspirin or medicines containing aspirin - children or adolescents should not be given aspirin for 4 weeks after getting FLUMIST unless your healthcare provider tells you otherwise
  • Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST
  • Before getting FLUMIST, tell your healthcare provider about all your medical conditions, including if you: are currently wheezing; have a history of wheezing and are under 5 years of age; have asthma; have had Guillain-Barré syndrome (severe muscle weakness); have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking antiviral drugs for the treatment of influenza
  • FLUMIST may cause rare but serious side effects including allergic reactions. Seek medical help right away if you experience any allergic reactions, including: hives; swelling of the face, lips, eyes, tongue or throat; throat tightness or trouble breathing
  • The most common side effects are runny or stuffy nose, sore throat, and fever over 100 °F

Approved Use

FLUMIST is a vaccine that is sprayed into the nose to help protect against influenza in people ages 2 through 49 years. FLUMIST may not prevent influenza in everyone who gets vaccinated.

Please see full Prescribing Information, including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products .

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.8 During the 2024-2025 influenza season, an estimated 47 – 82 million people developed illness from influenza, 21 – 37 million visited a healthcare provider for influenza, with 610,000–1.3 million hospitalizations, and 27,000–130,000 deaths.4

About FLUMISTLive Attenuated Influenza Vaccine

FLUMIST is a live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza.9 FLUMIST is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP)-recommended influenza vaccine option. 10,11 FLUMIST was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.2,3

FluMist Home State Availability

Pharmacy laws vary state-by-state. For the 2025-2026 flu season, FluMist Home will be available in the following states: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, MA, MD, ME, MI, MT, NC, ND, NE, NH, NJ, NV, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. For the 2025-2026 flu season. FluMist Home will not be available in: AK, AR, DC, DE, HI, IN, KS, KY, LA, MN, MO, MS, NM, NY, OK, RI, and WV. Our aim is to have this service available in all 48 contiguous states in future seasons.

Human Factors Usability Study for FluMist Self-Administration

FLUMIST for self- or caregiver-administration was approved by the FDA in September 2024, following research demonstrating that individuals over 18 years of age can safely and effectively self-administer or administer FLUMIST to eligible individuals. 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 successfully administered a full dose.12 In addition, data show that efficacy, immunogenicity and adverse events with self-administration of FLUMIST are similar to those seen with HCP-administered vaccination.13 The FLUMIST label has been updated to provide additional instructions on self and caregiver administration for eligible patients. Children 2-8 years of age with an uncertain vaccination history may not be eligible for caregiver administration and should consult their healthcare provider for further information.9

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization 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 www.astrazeneca-us.com and follow the Company on social media @AstraZeneca.

References

  1. FLUMIST Home Ordering, processing, and Disposal DoFP. REF-263898.
  2. US Food and Drug Administration (FDA). FDA approves nasal spray influenza vaccine for self- or caregiver administration. Accessed July 28, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration
  3. AstraZeneca. FluMist approved for self-administration in the US. Accessed July 28, 2025. https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html
  4. US Centers for Disease Control and Prevention. Flu Burden. Preliminary estimated flu disease burden 2024-2025 flu season. Accessed July 28, 2025. https://www.cdc.gov/flu-burden/php/data-vis/2024-2025.html
  5. US Centers for Disease Control and Prevention. Influenza (Flu) Past flu season severity assessments. Accessed July 22, 2025. https://www.cdc.gov/flu/php/surveillance/past-seasons.html.
  6. US Centers for Disease Control and Prevention. 2024-2025 United States flu season: preliminary in-season severity assessment. Accessed June 10, 2025. https://www.cdc.gov/flu/php/surveillance/in-season-severity.html.
  7. US Centers for Disease Control and Prevention. FluVaxView Weekly Flu Vaccination Dashboard. Accessed July 31, 2025. https://www.cdc.gov/fluvaxview/dashboard/index.html.
  8. US Centers for Disease Control and Prevention. About Influenza. . Accessed July 28, 2025. https://www.cdc.gov/flu/about/index.html
  9. FLUMIST Prescribing Information.
  10. Grohskopf LA, Ferdinands JM, Blanton LH, Broder KR, Loehr J. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices — United States, 2024–25 influenza season. MMWR Recomm Rep. 2024;73(5):1–25.
  11. Recommendations for Prevention and Control of Influenza in Children, 2025–2026: Policy Statement. Pediatrics (2025) https://doi.org/10.1542/peds.2025-073620
  12. Bandell A, Araj E, Wu J. The role of human factors engineering in the FDA approval process for self-/caregiver-administration of live attenuated influenza vaccine. Presented at: National Immunization Conference, August 12-14, 2024, Atlanta, GA, USA.
  13. Burgess TH, Murray CK, Bavaro MF, et al. Self-administration of intranasal influenza vaccine: immunogenicity and volunteer acceptance. Vaccine. 2015;33(32):3894-3899. doi: 10.1016/j.vaccine.2015.06.061

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Source: AstraZeneca