The Therapeutic Goods Administration (TGA) has registered FluMist® (influenza virus vaccine), a live attenuated influenza virus vaccine, administered via nasal spray, for the prevention of influenza in children and adolescents from 24 months to less than 18 years of age.1
This trivalent formulation provides influenza prevention for Australians aged 2 to less than 18 years of age, offering coverage against three influenza virus strains as recommended by the World Health Organization. FluMist® has been available in the northern hemisphere for over 20 years.2
Influenza is a viral respiratory illness that can result in high rates of illness within the community.3 Vaccination remains the most effective public health measure for reducing the incidence and severity of influenza infections.4
FluMist® will be available on the private market in Australia in early 2026.
Governments in New South Wales, Queensland, South Australia, and Western Australia have recently announced government initiatives to provide FluMist® as a needle-free vaccination option for young children ahead of the 2026 influenza season.
New South Wales, Queensland and South Australia will provide FluMist® for children aged 2 to up to 5 years old,5,6,7 whilst Western Australia will provide FluMist® for children aged 2 to up to 11 years old.8 These programs aim to improve influenza vaccination uptake, particularly amongst young children, and are part of larger public health efforts to reduce influenza-related hospitalisations and illness rates.5,6,7,8
AstraZeneca welcomes these collaborative efforts between the Australian and state governments and remains committed to supporting public health efforts aimed at increasing influenza vaccination rates and reducing the impact of seasonal influenza across Australia.
Benjamin McDonald, Country President, AstraZeneca Australia and New Zealand said: “AstraZeneca welcomes the TGA’s registration of FluMist® for Australian children and adolescents from 24 months to less than 18 years of age, broadening the choices available for influenza prevention.
“We are pleased to support national and state public health programs in their efforts to increase uptake of influenza vaccination, especially where needle-free options may address barriers for families and young children.
“The coordinated rollout of FluMist® in several states demonstrates the strong commitment of government and healthcare professionals to protect vulnerable individuals from influenza-related illness.
“AstraZeneca is committed to partnering with government, clinicians, and the wider healthcare community to strengthen our collective response to seasonal influenza.
“We encourage anyone seeking advice about vaccination to speak with their healthcare professional to ensure the best option for themselves and their families.”
Paul Griffin, Professor of Medicine at University of Queensland and Director of Infectious Diseases at Mater Hospital Brisbane said: “Influenza continues to cause substantial illness and hospitalisations each year. Expanding the options available for prevention is an important step in safeguarding public health, especially during the peak flu season.
“International evidence indicates that providing needle-free options can increase vaccine uptake for young children. This approach may contribute to improved influenza vaccine coverage in Australia.”
Dr Mike Freelander MP, Federal Member for Macarthur said: “I welcome the TGA registration of FluMist® in Australia. With another option available for next year’s flu season, vaccination will be more accessible for families in my region and across Australia.
“Each winter, influenza puts real pressure on hospitals like Campbelltown Hospital and our local GPs. Increasing influenza vaccination coverage will help ease demand on busy emergency and paediatric services.
“I encourage parents to speak with their GP or pharmacist about influenza vaccination and to make a plan before the winter months.
“I’m proud to support practical measures that deliver more choice for families in our community.”
ABOUT FluMist®
Indication: FluMist® is indicated for the prevention of influenza in children and adolescents from 24 months to less than 18 years of age.
FluMist® is contraindicated in persons who have had a severe allergic reaction to the active substances, any of the excipients, gentamicin, eggs or egg proteins; children and adolescents with clinical immunodeficiency due to conditions or immunosuppressive therapy; children and adolescents <18 years of age receiving salicylate therapy because of the association of Reye’s syndrome with salicylates and wild-type influenza infection.
Special warnings and precautions for use include severe asthma or active wheezing.
Interactions: Patients should inform their doctor if they are taking aspirin or influenza antiviral agents. FluMist® may be given at the same time as other vaccines.
Side effects may include runny or stuffy nose, loss of appetite, generally feeling unwell, headache, fever, chills, cough, sore throat, muscle tenderness or weakness/aches not caused by exercise and nose bleeds.
FluMist® is not available on the National Immunisation Program.
More information can be found in the FluMist® Consumer Medicine Information.
- ENDS -
Professor Paul Griffin has been involved in clinical trials sponsored by AstraZeneca and serves on advisory boards for which compensation is received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor Griffin, and the opinions expressed are their own. Professor Griffin has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
FluMist® is a registered trademark of AstraZeneca. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the trea®ent of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com.au
References
1. Australian Product Information FluMist® (influenza virus vaccine) nasal spray https://medsinfo.com.au/product-information/document/FluMist_PI?drug_id=19493&documenttype=pi
2. US Food and Drug Administration Approval Letter – Influenza Virus Vaccine Live, Intranasal, 17 June 2003, available at https://wayback.archive-it.org/7993/20170723030839/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm123753.h® accessed November 2025
3. Australian Centre for Disease Control, Seasonal flu (seasonal influenza), available at https://www.cdc.gov.au/topics/seasonal-flu, accessed November 2025
4. Trombetta, CM et al, 2022 Influenza Viruses and Vaccines: The Role of Vaccine Effectiveness Studies for Evaluation of the Benefits of Influenza Vaccines, Vaccines 10(5) May 2022, https://pmc.ncbi.nlm.nih.gov/articles/PMC9143275/#:~:text=Abstract,subject's%20history%20of%20previous%20vaccination accessed November 2025
5. NSW Ministerial Media Release, Free nasal spray influenza vaccine for children under five, 16 September 2025, https://www.nsw.gov.au/ministerial-releases/free-nasal-spray-influenza-vaccine-for-children-under-five accessed November 2025
6. QLD Ministerial Media Release, Queensland secures needle-free kids vax in Australian first, 16 September 2025, https://statements.qld.gov.au/statements/103536 accessed November 2025
7. SA Ministerial Media Release, Needle-free flu vaccine for SA children, 22 Septemer 2025, https://www.premier.sa.gov.au/media-releases/news-items/needle-free-flu-vaccine-for-sa-children accessed November 2025
8. WA Ministerial Media Release, Cook Government secures 130,000 doses of needle-free flu vaccine for WA kids, 1 October 2025, https://www.wa.gov.au/government/media-statements/Cook%20Labor%20Government/Cook-Government-secures-130%2C000-doses-of-needle-free-flu-vaccine-for-WA-kids-20251001 accessed November 2025
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-24091 December 2025