Beyfortus™ (nirsevimab) is a monoclonal antibody for use in infants and young children to protect against severe respiratory syncytial virus (RSV) infection. Beyfortus™ (nirsevimab) is a passive immunisation that provides antibodies directly to the infant so they have immediate protection against RSV.
Beyfortus™ (nirsevimab) is provided as a single dose and directly provides long-acting antibodies to infants and young children. The dose can be given to:
In NSW, Beyfortus™ (nirsevimab) will be available to babies most vulnerable to severe illness from RSV as part of a phased program for the 2024 RSV season. Beyfortus™ (nirsevimab) will only be available through treating hospitals.
Each dose of Beyfortus™ (nirsevimab) provides protection for at least 5 months. Clinical trials have demonstrated that the risk of hospitalisation from RSV infection is reduced by almost 80% in infants who receive Beyfortus™ (nirsevimab).
Only one dose of Beyfortus™ (nirsevimab) is recommended for the 2024 RSV season. Each dose of Beyfortus™ (nirsevimab) provides protection for at least 5 months, and a second dose of Beyfortus™ (nirsevimab) is not recommended to be given within 5 months of the first dose.
Children who are eligible for Beyfortus™ (nirsevimab) under the NSW Health RSV (Respiratory Syncytial Virus) vulnerable babies program include:
**at clinician’s judgement in consultation with specialist paediatric infectious diseases physician, specialist in paediatric immunisation, or designated Beyfortus™ (nirsevimab) program lead at a NSW Health facility. This group includes children with conditions/disorders requiring continuous home oxygen/respiratory support including neurological conditions, congenital malformations of the upper and/or lower airways, chronic suppurative lung diseases including cystic fibrosis with severe respiratory function impairment.
Infants and children less than 24 months old who have already received palivizumab, and who meet the above eligibility criteria, can receive Beyfortus™ (nirsevimab) 28 days later, instead of their next Synagis (palivizumab) dose. Synagis (palivizumab) should then be discontinued.
Infants who have had prior laboratory-confirmed RSV infection in 2024 are excluded.
Do not use Beyfortus™ (nirsevimab) if a child has had an allergic reaction to it, or any of the ingredients listed in the Therapeutic Goods Administration (TGA) approved Product Information. Ask a child's parent or guardian if their child has medical conditions or are taking any other medications.
Infants who have had prior laboratory-confirmed RSV infection in 2024 are excluded from receiving Beyfortus™ (nirsevimab) in 2024 under the NSW Health RSV (Respiratory Syncytial Virus) vulnerable babies program.
The eligible cohorts are listed above.
Beyfortus™ (nirsevimab) should be given as soon as possible according to the eligibility criteria during the RSV season between March 2024 and September 2024.
As per the Australian Immunisation Handbook for infants born during or entering their first RSV season, the recommended dose for Beyfortus™ (nirsevimab) is:
This should be administered as a single dose by intramuscular injection. Do not divide a 100 mg pre-filled syringe into two 50 mg doses.
For children at an increased risk of severe RSV disease in their second season, the recommended dose for Beyfortus™ (nirsevimab) is 200 mg administered as 2 x 100 mg (2 mL total) intramuscular injections in different sites (preferably separate limbs, or else separated by 2.5 cm) at the same visit. This is 4 times more than the dose and volume for a newborn.
Further information about the dosing recommendations is available on the TGA Product Information.
Infants and children less than 24 months old who have had prior laboratory-confirmed RSV infection in 2024 are excluded from eligibility criteria to receive Beyfortus™ (nirsevimab) in 2024.
Yes, co-administration of Beyfortus™ (nirsevimab) with age-appropriate vaccines is recommended. Beyfortus™ (nirsevimab) is not expected to interfere with the immune response to vaccines.
Infants and children less than 24 months old who have already received Synagis (palivizumab) and who meet the eligibility criteria, can receive Beyfortus™ (nirsevimab). Beyfortus™ (nirsevimab) can be administered 28 days after Synagis (palivizumab), instead of their next Synagis (palivizumab) dose. Synagis (palivizumab) should then be discontinued.
Data on the safety of BeyfortusTM (nirsevimab) is monitored by the TGA. The clinical trial data on the safety of BeyfortusTM (nirsevimab) and information about the common side effects after BeyfortusTM (nirsevimab) is available on the National Centre for Immunisation Research and Surveillance (NCIRS).
Report all uncommon, serious or unexpected adverse events following medication administration or any event felt to be significant. To report a suspected adverse event, please download the National Adverse Events Following Immunisation (AEFI) Reporting Form and contact your local Public Health Unit on 1300 066 055.
Synagis (palivizumab) is another monoclonal antibody used to protect against RSV.
Synagis (palivizumab) is only provided to children at the highest risk of severe illness from RSV. It is given as a course of up to five injections at 1-month intervals throughout the RSV season.
