The new nationwide immunisation program to protect Australian
babies from severe RSV will include Sanofi’s infant immunisation Beyfortus™ (nirsevimab), which has been used to help reduce RSV- related infant hospital admissions in Queensland and Western Australia this year.
Announced today by Federal Minister for Health and Aged Care Mark Butler, the funded hybrid program will include Beyfortus alongside maternal immunisation to provide eligible infants* with free access to protection against severe RSV during winter when seasonal outbreaks of the virus often occur.
Beyfortus will be made available through hospitals, immunisation clinics and general practitioners to help prevent RSV-related lower respiratory tract disease in newborns and infants entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.1
RSV is a seasonal virus which can cause lower respiratory tract infections such as bronchiolitisand pneumonia in infants, leading to potentially life-threatening breathing difficulties.2,3
As a leading cause of infant hospitalisation, severe RSV is responsible for around 12,000 hospital admissions among Australian babies aged 12 months and younger each year.4 Up to 80 per cent of infants and children who are admitted to hospital with RSV are otherwise healthy children, with no predisposing conditions.4
As part of the new nationwide immunisation program that has united the Federal, State and Territory governments in offering infants protection against RSV, a single injection of Beyfortus will be administered to eligible* infants prior to or during the RSV season, depending on their birth date.1
Dr Desiree Anthony, RSV Medical Lead, Sanofi Australia and New Zealand
“We applaud Minister Butler and his state and territory counterparts for the leadership shown in ensuring all babies in all postcodes are offered RSV protection next winter. This preventative health milestone will allow parents to help protect their baby against severe RSV when they need it most.”
Sanofi will work alongside federal, state and territory governments, healthcare professionals and immunisation advocates to ensure a smooth rollout of the 2025 infant
RSV immunisation program.
In 2024, there have been nearly 80,000 confirmed cases of RSV in Australian children under five years of age, comprising around 50 per cent of all reported cases of the virus.5
This year, Queensland and Western Australia joined governments in the United States, France, Spain, Luxemburg and Chile in providing all-infant access to Beyfortus during their most recent RSV seasons.
Beyfortus is a long-acting antibody which attaches to a protein on the surface of the RSV virus, blocking it from entering the body’s cells (especially cells in the lungs) if the child becomes infected with the virus. A single, intramuscular injection is administered to the infant prior to or during the RSV winter season, depending on their birth date.1
Beyfortus has been extensively studied, including in a Phase III clinical trial published in The New England Journal of Medicine in which 1,490 healthy late-preterm and term infants were randomly assigned Beyfortus or placebo, in a 2:1 ratio, before an RSV season.1,6
A single, fixed dose of Beyfortus reduced medically attended RSV-associated lower respiratory tract infection (including hospitalisation) by 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001 by Poisson regression) through 150 days after the injection.1,6
The most common side effects in children receiving Beyfortus include rash and injection site reactions such as swelling, and an elevated body temperature.1
Beyfortus is designed for use in either primary or secondary care settings, with pre- filled
syringe doses indicated for use based on an infant’s weight (<5kg – 50mg nirsevimab; 5kg or above – 100mg nirsevimab).1
Minimum Product Information: Beyfortus (nirsevimab)
Indication: Beyfortus is indicated for the prevention of RSV LRTD in neonates and infants entering or during their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus should be used in accordance with official recommendations. Dosage and administration: For infants entering their first RSV season, Beyfortus is administered as a single 50 mg (for infants under 5 kg) or (for infants 5 kg and above) 100 mg prefilled syringe via intramuscular (IM) injection from birth for infants born during the RSV season and ideally prior to the RSV season for those born outside of the season. For infants entering their second RSV season, BEYFORTUS is given as a single 200 mg dose administered as two IM injections (2 x 100 mg) at the same visit. For dosage in infants undergoing cardiopulmonary surgery, consult the full PI. Contraindication: Beyfortus is contraindicated in individuals with a history of severe hypersensitivity reactions, including anaphylaxis, to the active substances or to any of the excipients. Warnings and Precautions: Hypersensitivity including
anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal
products and/or supportive therapy. Clinically significant bleeding disorders: nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder. The safety and efficacy of nirsevimab in children aged 2 to 18 years have not been established. Interactions:
Palivizumab should not be administered to infants who have already received BEYFORTUS in the same season.
Adverse Effects: Uncommon (≥0.1% – <1%): rash, injection site reaction and pyrexia.
Please refer to full Beyfortus Product Information before prescribing. Beyfortus Product
Information is available at: https://qr.medsinfo.com.au/files/swpbeyfo.pdf
1. Sanofi Australia. Beyfortus Approved Product Information, November 2023.
2. Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev.
2014;35:519-53.
3. Li, Y., et al. Global, regional, and national disease burden estimates of acute lower
respiratory infections due to respiratory syncytial virus in young children in 2019: a systematic
analysis. The Lancet, 399(10340), 2047 2064. https://doi.org/10.1016/S0140-6736(22)00478-0
4. Evohealth. Time to Act – Protecting our children from RSV. 2023. Available at:
https://www.evohealth.com.au/insights/time-to-act-protecting-our-children-from-rsv/
5. Department of Health and Age Care. National Notifiable Disease Surveillance System. 8 October
2024. Available at https://nindss.health.gov.au/pbi-dashboard/
6. Hammitt LL, Dagan R, Yuan T, et al. Nirsevimab for prevention of RSV in healthy late-preterm
and term infants. MELODY study. N Engl J Med 2022; 386:837-46. DOI: 10.1056/MEJMoa2110275Available
at: https://www.nejm.org/doi/full/10.1056/NEJMoa2110275
© Sanofi Australia and New Zealand. Talavera Corporate Centre, Building D, 12-24 Talavera Road,
Macquarie Park, NSW 2113 MAT-AU-2402067 v1.0 First issued November 2024.
PBS / NIP Information:
Beyfortus is funded by State and Territory governments for eligible infants as restrictions apply.
Contact your local state or territory health department for
further details. Beyfortus is not listed on the PBS or NIP.
