This information is for health professionals. More information about the program is also available for parents and carers.
To learn more about RSV prevention, symptoms and treatment, read the Respiratory syncytial virus (RSV) fact sheet.
The following guide has been developed to support the implementation of the new NSW Respiratory Syncytial Virus (RSV) Prevention Program commencing 3 February 2025. The guide also contains information about the current NSW Vulnerable Babies Program which will end on 16 March 2025.
The guide is for health professionals administering the maternal RSV vaccine Abrysvo® and the infant immunisation with RSV monoclonal antibody Beyfortus TM (nirsevimab).
Health professionals must administer RSV immunisations in line with this guide and:
The new NSW RSV Prevention Program aims to protect newborn and at-risk infants against RSV and reduce RSV-associated infections and hospitalisations through the transfer of maternal antibodies to the fetus during pregnancy, or provision of passive immunisation to infants not protected by maternal vaccination and eligible at-risk infants.
Under the NSW RSV Vulnerable Babies Program nirsevimab can only be accessed from clinicians in treating hospitals and Aboriginal Medical Services.
From 25 March 2024 to 16 March 2025 nirsevimab should be offered to:
Achieving high vaccination coverage is the overarching aim of the program. All pregnant women should be encouraged to be vaccinated with Abrysvo.
Clinical decision aids are available to assist clinicians to determine an infant's eligibility to receive nirsevimab:
Download below eligibility information as PDF: NSW RSV Prevention Program - Eligibility.
Nirsevimab is recommended for infants who are not protected by maternal RSV vaccination and those who have risk conditions for severe RSV disease who meet the following eligibility criteria:
Eligible infants should receive nirsevimab prior to discharge from hospital.
Eligible children can receive nirsevimab through their local general practitioner (GP), Aboriginal medical service (AMS) or community health service^
Eligible infants can receive nirsevimab through their local GP, AMS or community health service3.
Authorised nurse and midwife immunisers can independently administer Abrysvo® and nirsevimab as detailed in the Authority for Authorised Registered Nurse/Midwife Immunisers to Supply Poisons and Restricted Substances and Vaccination Standards.
Registered nurses, midwives and enrolled nurses can prepare and administer Abrysvo® vaccine and nirsevimab under a medication order from a medical practitioner or nurse practitioner. The medical practitioner or nurse practitioner must be available for supervision or advice if required.
All RSV immunisation products can be ordered through the NSW State Vaccine Centre. Abrysvo® will be available to order from Monday 20 January 2025 and nirsevimab will be available to order from Monday 10 March 2025.
Providers are required to have a vaccine account number (VAN) to order the products. For details on obtaining a VAN please review NSW Heath - Ordering vaccines. In NSW Health facilities this is generally managed by the pharmacy department however individual services in some cases will have their own account.
From Monday 10 March 2025, primary care immunisation providers such as general practitioners, Aboriginal medical services (AMSs) and community health centres can order nirsevimab for eligible infants using the nirsevimab order form on the NSW Vaccine Centre.
One form for each individual must be completed indicating the patient's eligibility to receive nirsevimab.
An adverse event following immunisation (AEFI) is defined in The Australian Immunisation Handbook as “any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine". AEFIs are notifiable conditions under the NSW Public Health Act (Schedule 1) and must be notified to your local public health unit (PHU).
All AEFI notifications are required to be reported to the TGA via your local PHU. To report a suspected AEFI, download the National Adverse Events Following Immunisation (AEFI) Reporting Form and contact your local public health unit on 1300 066 055. Further information regarding AEFIs is available on Adverse events following immunisation (AEFI).
In addition to reporting to the TGA, all AEFIs occurring at the time of immunisation, which occur in NSW Health facilities, e.g. anaphylaxis, must be reported in the NSW Health incident management system IMS+.
Vaccine safety surveillance in Australia aims to monitor vaccine and immunisation program safety and to detect potential serious adverse events that may not be identified in pre-licensure vaccine trials.
Immunisation providers play an important role in vaccine safety surveillance by reporting serious adverse events to the local public health unit (passive surveillance) and participating in active surveillance systems such as AusVaxSafety.
AusVaxSafety is monitoring the safety of RSV immunisations through the AusVaxSafety vaccine safety surveillance system. To review the most recent safety data visit AusVaxSafety - Safety data.
AusVaxSafety uses two software programs Smartvax and Vaxtracker to monitor the safety of vaccines. These programs send an SMS or email to patients or parents following their vaccination at selected general practitioner and immunisation clinics . De- identified information from SmartVax and Vaxtracker are combined and monitored by AusVaxSafety to detect possible vaccine safety signals.
Annual reports on surveillance of AEFIs in NSW are also published at Adverse events following immunisation (AEFI).
Consent can be verbal or written and should be documented in the patient's medical record. Documentation should include details of the consent conversation and information provided to the parent or guardian. If applicable the presence of an accredited interpreter is recommended.
Standard processes for obtaining consent from a parent or guardian for neonatal immunisation should be followed.
Further information about consenting is available on the Australian Immunisation Handbook and NSW Health Consent to Medical and Healthcare Treatment Manual.
The Australian Immunisation Register (AIR) has been updated to accept records of nirsevimab (Beyfortus™ - BFRSV) and Abrysvo® (ABRSV). All vaccination encounters must be reported to the AIR.
It is also important to record a woman's antenatal status on AIR to ensure complete and accurate reporting of maternal vaccine uptake (coverage). This will also enable the monitoring of immunisation coverage as well as the effectiveness and safety of maternal vaccines/vaccination programs including RSV, influenza, and other respiratory vaccines.
Immunisation providers are required to check an individual's vaccination status on the AIR prior to administering any vaccine. Pregnant women should be advised to bring their digital AIR Immunisation History Statement with them to their antenatal appointments to confirm their vaccination history.
Prior to administration of nirsevimab to at-risk infants all immunisation providers must review the AIR history of both the mother and infant.
Some children require administration of 2 x 100mg doses of nirsevimab, therefore two separate injections which may occur in different legs. However, AIR does not record multiple doses.
The AIR does not allow vaccination providers to record the same vaccine brand, administered to the same individual, on the same date (as it's assumed as a reporting error/duplicate data). In addition, the AIR does not record dosage information, only sequential doses numbers (i.e. 1, 2, 3). Services Australia recommends that vaccinations providers report this scenario to the AIR as 1 single dose.
Please see the information sheet developed by Services Australia on how to report infant vaccinations to the AIR, including for infants without a Medicare card.
The following NSW Health facility record management systems are integrated with the AIR to directly transmit immunisation records.
Providers that utilise other record management systems that are not integrated to the AIR will need to ensure that manual processes are in place to meet reporting requirements.
Advice on accessing and uploading AIR records via Health Professional Online Services (HPOS)/PRODA is available from Services Australia - HPOS.
Further information on how to upload records is available from the Services Australia - Manage immunisation records in AIR.
Abrysvo® was approved for use in pregnant women between 24 to 36 weeks gestation for the prevention of RSV in infants by the Therapeutic Goods Administration (TGA) in March 2024. It is a recombinant RSV pre-fusion F protein bivalent vaccine and is a category A drug (safe in pregnancy).
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends administration from 28 to 36 weeks gestation.
Abrysvo® must be protected from light at all times and stored in a purpose-built vaccine refrigerator between +2°C to +8°C at all times and the temperature continuously monitored in accordance with the current edition of the National Vaccine Storage Guidelines: Strive for 5.
The dose of Abrysvo® is 0.5 mL, given by intramuscular injection only, preferably in the deltoid region of the upper arm. Abrysvo® is not to be administered intravascularly, intradermally or subcutaneously.
The vaccine (powder) must be reconstituted only with the diluent provided using the vial adapter to form Abrysvo®. Further detail on use of vial adaptor can be found in instructions for use.
The prepared vaccine is a clear and colourless solution.
For further information, please refer to the product information.
Abrysvo® can be co-administered with other antenatal vaccinations including the pertussis vaccine also given at the 28-week antenatal visit. Abrysvo® can also be co-administered with influenza and COVID-19 vaccines. For further information on co-administration see the Australian Immunisation Handbook - Respiratory syncytial virus (RSV).
In clinical trials4, Abrysvo® vaccine was found to reduce the risk of infant hospitalisation from RSV disease by 60% for up to 6 months. In addition, Abrysvo® vaccine efficacy was 70% in protecting infants from severe medically attended RSV-confirmed LRTI in their first 6 months of life.
A summary of RSV immunisation product efficacy and safety is available at NCIRS - Respiratory syncytial virus (RSV) FAQs.
The most common side effects reported in the Abrysvo® clinical trials were:
The TGA and ATAGI continue to monitor routine pharmacovigilance, including submissions of safety update reports for Abrysvo®.
There was no difference in the rates of serious adverse events during clinical trials in pregnant women who received Abrysvo® or their infant compared with a placebo.
In Abrysvo® clinical trials4,5, there was a trend with no significant association towards preterm birth in vaccinated pregnant women. Early analysis of data from the USA are proving reassuring with no increase in premature birth observed. Nevertheless, preterm births among pregnant women who receive any RSV vaccine are being actively monitored. The TGA and ATAGI evaluated all aspects of Abrysvo® in their approval of and recommendations for the vaccine in Australia, including all known safety concerns raised in clinical trials and submissions.
Abrysvo® is contraindicated in individuals with a history of:
anaphylaxis after a previous dose of the same RSV vaccine
anaphylaxis after any component of an RSV vaccine
Abrysvo® should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these individuals.
There are no data on the use of Abrysvo® in immunocompromised individuals. Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Abrysvo® vaccine.
Abrysvo® has not been studied in pregnant women less than 24 weeks of gestation.
Vaccination with Abrysvo® should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Nirsevimab is a long-acting monoclonal antibody (mAB) and was approved by the TGA in November 2023 for the prevention of RSV lower respiratory tract disease in:
Refer to the NSW RSV Prevention Program eligibility for more information.
Nirsevimab must be stored at +2°C to +8°C and always protected from light. It may be kept at room temperature (below 25°C) for a maximum of 8 hours. After removal from the vaccine fridge, nirsevimab must be used within 8 hours or discarded. Do not shake or expose to heat. For further information, please refer to the TGA Product Information.
Nirsevimab is available in a 50mg 0.5mL prefilled syringe with a purple plunger rod and a 100mg in 1mL prefilled syringe with a light blue plunger rod.
The recommended dosage of nirsevimab in neonates and infants during or entering the RSV season as recommended in Australian Immunisation Handbook is:
Recommended dosage: 200mg by 2 x100mg IM injections given at the same visit.
Nirsevimab is administered intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. If two injections are required, different injection sites should be used.
For further information, please refer to the TGA Product Information.
For general information regarding vaccine administration, please refer to the Australia Immunisation Handbook:
Nirsevimab is a pre-filled syringe and occupational exposure is unlikely. There is no information that suggests nirsevimab has the characteristics of a hazardous medicine. Preclinical studies of nirsevimab have not identified nirsevimab as a special hazard for humans (there are no known or suspected cytotoxic, genetic or reproductive toxicities). Refer to local policies and procedures for safe handling of mABs of this nature.
Nirsevimab is a passive immunisation specific for RSV, so it is not expected to interfere with the active immune response to co-administered vaccines.
Nirsevimab can be given at the same time as routine childhood vaccines. Nirsevimab should not be mixed with any vaccine in the same syringe or vial. When co-administered with vaccines, they should be given with separate syringes and at different injection sites.
There is no information regarding co-administration of nirsevimab with other immunoglobulin products.
In clinical trials a single dose of nirsevimab showed efficacy of 77% against both RSV hospitalisation and very severe medically attended RSV-associated LRTI for up to 150 days after immunisation7.
Early real-world data show that nirsevimab was over 80% effective in preventing infants less than 6 months from being hospitalised with severe RSV8.
The clinical trial data on the efficacy of nirsevimab is available on NCIRS - Respiratory syncytial virus (RSV): Frequently asked questions (FAQs).
Data on the safety of nirsevimab is monitored by the TGA. The clinical trial data on the safety of nirsevimab is available on NCIRS - Respiratory syncytial virus (RSV): Frequently asked questions (FAQs).
Clinical trials have reported the following possible side effects of nirsevimab:
Nirsevimab is contraindicated in individuals with a history of severe hypersensitivity reactions, including anaphylaxis, to any of the active components or to any of the following ingredients:
Recipients should be monitored for at least 15 minutes post administration of nirsevimab. 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 medical treatment.
As with any other intramuscular injections, nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder.
Respiratory syncytial virus (RSV) is a common respiratory virus that can infect people of all ages. RSV usually causes mild, cold-like symptoms but can cause serious illness such as bronchiolitis and pneumonia. Infants and older adults are more likely to develop severe RSV and need hospitalisation. RSV is also an important cause of respiratory disease and hospitalisation in Aboriginal and Torres Strait Islander adults and people with underlying conditions that increase their risk of severe RSV disease.
Early-life RSV lower respiratory tract infection (LRTI) has also been associated with significant long-term respiratory issues, including recurrent LRTI, asthma, and lung function impairment. These effects can persist into adulthood as chronic respiratory disease.
RSV is transmitted through droplets from an infected person’s cough or sneeze.
Almost all children experience at least one RSV infection within the first two years of life. Between 2016 and 2023, there were more than 45,000 hospitalisations with an RSV diagnosis in NSW, of which approximately 47% were in children aged less than one year.
Between 2016 and 2019, the average annual RSV hospitalisation rate for children aged less than one year in NSW was approximately 2,700 per 100,000 population. During the years of the COVID-19 pandemic (2020-2021) when public health restrictions impacted the circulation of many respiratory pathogens including RSV this rate decreased to approximately 1,750 per 100,000 population. In 2022 and 2023, this rate increased to approximately 3,800 per 100,000 population, surpassing pre-COVID levels +.
In NSW, RSV hospitalisations are more common in autumn and winter however they can occur year-round.
+Admitted Patient, Emergency Department Attendance and Deaths Register, NSW Ministry of Health SAPHaRI.
Most infants hospitalised with RSV disease are otherwise healthy. Infants with certain risk factors have an increased risk of severe disease from RSV infection, these include:
If further information regarding immunisation is required, please contact your local public health unit on 1300 066 055.
