NSW RSV Prevention Program - Information for health professionals

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​This information is for health professionals. More information about the program is also available for parents and carers and ​parents and carers of Aboriginal babies. 

To learn more about RSV prevention, symptoms and treatment, read the Respiratory syncytial virus (RSV) fact sheet.

Find out more about RSV

​​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 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:

On this page

  1. NSW RSV Prevention Program​
    1. Eligibility
    2. Initiation and administration of RSV immunisation product
    3. Ordering Abrysvo® and nirsevimab
    4. Reporting adverse events (AEFI)
    5. Consenting
    6. Reporting vaccinations to AIR
  2. Abrysvo® vaccine  (maternal RSV vaccine)
    1. Recommendations and timing
    2. Storage and cold chain management
    3. Dosage, presentation and administration
    4. Efficacy
    5. Safety
    6. Contraindications and precautions
  3. Nirsevimab (brand name Beyfortus™)
    1. Storage and cold chain management
    2. Dosage, presentation and administration
    3. Efficacy
    4. Safety
    5. Contraindications and precautions
  4. More information
    1. Resources
    2. References
    3. About Respiratory Syncytial Virus (RSV)
    4. Burden of RSV in NSW
    5. Infants and young children at risk of severe RSV disease
  5. ​ Contact

NSW RSV Prevention Program

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.

  • Abrysvo® is funded for pregnant women under the National Immunisation Program (NIP) and recommended at 28 to 36 weeks gestation.
  • From 17 March 2025, NSW Health will fund nirsevimab (Beyfortus™) for:
    • infants at birth born on or after 17 March 2025 not protected by​​ maternal RSV vaccination or who have risk conditions for severe RSV disease
    • children up to 24 months of age with risk conditions for severe RSV disease entering their second RSV season and
    • NSW RSV Vulnerable Babies Program​ catch-up for infants born from 1 October 2024 to 16 March 2025 who are not protected by maternal vaccination and did not receive nirsevimab at birth.​
Refer to the  NSW RSV Prevention Program - Eligibility ​for more information and information in the eligibility section below. ​​​

  • ​NSW RSV Prevention Program eligibility

    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.

    Refer to the RSV vaccine and inmmunisation product information sheet to ensure you are administering the right vaccine or immunisation product to your patient.

    National Immunisation Progra​​m: Maternal RSV vaccine Abrysvo®
    A single dose of Abrysvo should be offered year-round to all pregnant women at the 28-week antenatal visit (recommended between 28 to 36 weeks ges​​tation)
    • Free under the National Immunisation Program from 3 February 2025.
    • Abrysvo is the only RSV vaccine available for administration to pregnant women.
    • Abrysvo can be co-administered with other antenatal vaccinations including diphtheria, tetanus and pertussis (dTpa) vaccine and influenza vaccines. For further information on co-administration see the Australian Immunisation Handbook.
    • Abrysvo is not recommended for use from 24 to less than 28 weeks until additional safety and effectiveness data is available.
    • Abrysvo can be given after 36 weeks gestation however infants may not be adequately protected if they are born within 2 weeks of their mother being vaccinated. If delivery occurs within 2 weeks of the mother receiving Abrysvo, the infant is recommended to also receive nirsevimab (see below).
    NSW funded monoclonal antibody: BeyfortusTM (nirsevimab)
    Infants born on or after 17 March 2025 who meet the following eligibility criteria:
    ​
     
    		Born:

    • to mothers who did not receive Abrysvo during pregnancy, or
    • within 2 weeks of the mother receiving Abrysvo during pregnancy, or
    • with risk conditions for severe RSV disease1 regardless of maternal vaccination status, or
    • to mothers with active malignancies or receiving chemotherapy or taking rituximab or other high-dose immunosuppressive therapy as per the Australian Immunisation Handbook, or
    • to mothers who have received Abrysvo in pregnancy but have subsequently undergone a treatment, such as cardiopulmonary bypass or extracorporeal membrane oxygenation, that has led to loss of maternal antibodies.
    Eligible infants should receive nirsevimab prior to discharge from hospital. If an eligible infant is not immunised with nirsevimab before they are discharged from hospital, they can receive nirsevimab up to 6 months of age from their GP, community health centre or Aboriginal medical service2
    Children up to 24 months of age entering their second RSV season who meet the following eligibility criteria:
    • Children with risk conditions for severe RSV disease1.
    • ​A minimum interval of 6 months is recommended between a 1st and 2nd season dose of nirsevimab. 


    Eligible children can receive nirsevimab through their local general practitioner (GP), Aboriginal medical service (AMS) or community health service2.

    NSW RSV Vulnerable Babies Program catch-up for infants born from 1 October 2024 to 16 March 2025 who meet the following eligibility:

     
    • Infants not protected through maternal RSV vaccination, and 
    • did not receive nirsevimab at birth, and
    • Infants who meet one of the following eligibility criteria:
      • premature infants born less than 37 weeks gestation, or
      • Aboriginal and Torres Strait Islander infants, or
      • infants with risk conditions for severe RSV disease1.
    Eligible infants can receive nirsevimab through their local GP, AMS or community health service.2

     

     

    Notes

     

    1. Conditions associated with increased risk of severe RSV disease in infants and young children include:

      • preterm birth <32 weeks gestational age

      • ongoing haemodynamically significant congenital heart disease

      • significant immunosuppression, such as from solid organ transplant, haematopoietic stem cell transplant, or primary immune deficiencies such as severe combined immunodeficiency (SCID) in consultation with a paediatric infectious disease, immunology or immunisation specialist.

      • chronic lung disease requiring ongoing oxygen or respiratory support

      • neurological conditions that impair respiratory function

      • cystic fibrosis with severe lung disease or weight for length <10th percentile

      • trisomy 21 or another genetic condition that increases the risk of severe RSV disease

    2. GPs, AMSs and community health centres must use the Nirsevimab Order Form on the NSW State Vaccine Centre to order nirsevimab for eligible children.

  • 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.

    Pharmacist immunisers can administer Abrysvo® under the NSW Pharmacist Vaccination Standards.

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  • All RSV immunisation products can be ordered through the NSW State Vaccine Centre​.

    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.

    Nirsevimab order form for primary care immunisation providers

    Primary care immunisation providers such as general practitioners, Aboriginal medical services (AMSs) and community health centres can order ​nirsevimab for eligible infa​nts​ and children 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+.

    Active vaccine safety surveillance

    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).

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  • 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.

    Recording multiple doses of nirsevimab in the AIR

    Some children require administration of 2 x 100mg doses of nirsevimab, therefore two separate injections which may occur in different limbs. 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.

    Specific advice for NSW Health public facilities

    The following NSW Health facility record management systems are integrated with the AIR to directly transmit immunisation records.

    • Cerner eMR – eMeds
    • eRIC
    • ORION
    • SHIP
    • MedChart
    • MOSAIQ

    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.

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Abrysvo® vaccine (maternal RSV vaccine)

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.

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Important

  • Abrysvo® is the only RSV vaccine approved for use in pregnant women. Abrysvo® is not registered for use in infants and must not be administered to an infant or child.
  • Arexvy®, another RSV vaccine, is registered for use in adults aged 60 years and over and should not be given to pregnant women.
  • Abrysvo® is also registered for use in individuals 60 years of age and above and is only available in the private market for this age group.
    • A single dose of Abrysvo is funded under the National Immunisation Program for all pregnant women and recommended at 28 to 36 weeks gestation. Abrysvo should be offered year-round at the 28-week antenatal appointment to ensure a high level of antibodies are transferred to the baby before birth and maximise protection for babies who are born prematurely.
    • Abrysvo® is registered for use from 24 weeks to 36 weeks however is not recommended by ATAGI for use earlier than 28 weeks gestation until additional safety and efficacy data is available.
    • Abrysvo® can be given beyond 36 weeks gestation however infants may not be adequately protected if they are born within 2 weeks of the mother receiving the vaccine. If delivery occurs within 2 weeks of the mother receiving Abrysvo, the infant is recommended to also receive nirsevimab.
    • Advice about repeat vaccination of Abrysvo®​ in subsequent pregnancies is not available yet and will be provided when more data becomes available.​
    ​

  • 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.

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  • 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.

    Front of Abrysvo recombinant respiratory synctial virus pre-fusion F protein bivalent vaccine box.  

    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.

    Vaccine co-administration

    Abrysvo® can be co-administered with other antenatal vaccinations including the pertussis vaccine usually 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).

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  • 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.

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  • The most common side effects reported in the Abrysvo® clinical trials were:

    • fatigue (46%)
    • vaccination site pain (41%)
    • headache (31%)
    • myalgia (27%)
    • nausea (20%)
    • joint pain (12%)
    • diarrhoea (11%).

    The TGA and ATAGI continue to monitor routine pharmacovigilance, including submissions of safety update reports for Abrysvo®.

    Serious adverse events

    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.

    Preterm births

    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.​

  • Contraindications

    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

    Precautions

    Thrombocytopenia and coagulation disorders

    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.

    Immunocompromised 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.

    Individuals less than 24 weeks of gestation

    Abrysvo® has not been studied in pregnant women less than 24 weeks of gestation.

    Concurrent illness

    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.

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Nirsevimab (brand name Beyfortus™)

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:

  • neonates and infants born during or entering their first RSV season
  • children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

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.

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  • 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.

    Nirsevimab box and 50mg 0.5mL prefilled syringe with a purple plunger rod Nirsevimab box and 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:

    For infants entering their first RSV season

    ​Body weight at time of dosingRecommended dosage
    Less than 5 kg50mg by intramuscular (IM) injection
    5kg and great​er100mg b​y IM injection (2x 50mg of nirsevimab can be used)

    For infants who remain vulnerable to severe RSV disease entering their second RSV season

    Recommended dosage: 200mg by 2 x100mg IM injections given at the same visit.

    Nirsevimab is administered intramuscularly in the injection site recommended by the Australian Immunisation Handbook. 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:

    Handling requirements

    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.

    Co-administration with vaccines and immunoglobulins

    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.

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  • 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:

    • pain, swelling and redness at the injection site
    • fever
    • rash
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  • Contraindications

    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:

    • histidine
    • sucrose
    • histidine hydrocholoride monohydrate
    • polysorbate
    • arginine hydrochloride
    • water for injections.

    Precautions for use

    Hypersensitivity including anaphylaxis

    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.

    Clinically significant bleeding disorders

    As with any other intramuscular injections, nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder.

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More information

Cont​​​act

If further information regarding immunisation is required, please contact your local public health unit on 1300 066 055.

Current as at: Thursday 6 March 2025
Contact page owner: Immunisation