RCPCH Webinar: Respiratory syncytial virus (RSV) update 2025 – Changes to monoclonals for preterm infants

In July 2025 it was announced that high efficacy, single dose nirsevimab immunisation will replace the NHS use of monthly palivizumab injections for infants at high risk of severe respiratory syncytial virus (RSV) infection, and that nirsevimab would be introduced for very preterm infants born too early to be protected by antenatal maternal RSV vaccination. This webinar updates health professionals on the evidence behind the JCVI advice and outline the practical steps for implementation.

Speakers

  • Dr Conall Watson
  • Dr Thomas Williams MRCPCH PhD
  • Dr Anoo Jain
  • Nigel Gooding

Date of Recording

August 21, 2025

Available Until

August 20, 2026

Useful links and resources

Q&A questions and responses

The table below contains the questions posted by the audience during the webinar (verbatim) and the written responses from the speaker panel. It may be useful to use ‘Find on page’ (CTRL + F on your keyboard) to search for a specific word or phrase relating to a question you may have.

Question

Panel response`

Is anyone eligible for nirsevimab after 1 year-old/in the second season? After 12mo the named indication is SCID. There is also the clinical discretion indication but this may not be commissioned.
Is nirsevimab a vaccine or an immunisation? This is a crucial distinction. Nirsevimab is an immunisation, a passive immunisation, ready-made antibody. It is not a vaccine. RSV vaccines are currently contraindicated in young children due to the theoretical possibility of enhanced disease when they first encounter RSV. More details are in the Green Book.
In Nigel Gooding’s presentation it was detailed that the SNOMED procedure code for RSV immune globulin 117089007 must be used to avoid erroneously recording vaccination.
Does nirsevimab need to refrigerated? Yes 2-8C, 8h at room temp is acceptable for running clinics. If kept out of the fridge, betwen 20 – 20C and protected from light expiry is reduced to 8 hours max.
What would you advise for cardiac and cardiac surgery patients? Confirmed with NHSE medicines commisioning team that a 2nd dose of nirsevimab will be funded for patients after a bypass IF they are still eligible for use (i.e. their underlying cardiac condition has not be resolved by surgery) and also in the current RSV season. For other CHD indications for patients <12 months of age and coming into the 2nd RSV season nirsevimab is not commissioned (only 1st season is commissioned and funded)
Can high risk patients (long term ventilation and chronic lung disease) receive vaccination in their 2nd year?
Ie will bluteq cover these patients
These are not named indications beyond infancy (first 12 months of age). Note LTV is for respiratory indications
Hi, I’m a Paediatric Cardiac Nurse Specialist at Alder Hey.
The JCVI statement 11/09/23 says that Palivizumab should be replaced by Nirsevimab for the currently eligible cohort – at that time it was CHD patients under the age of 2.
The latest Green Book only refers to under 2s for SCID patients and no age specified for CHD patients – is it still under 2s?
The Green Book recommendations cover infants up to 12 months; the indication for 12-23 months is for SCID.
If babies born < 32 weeks during the last RSV season weren’t eligible for palivizumab, e.g. not ventilated, non-CLD, does that mean they don’t require nirsevimab in their 2nd RSV season? If the infant was born on or after 1st Oct 2024 and not discharged from NICU before 1st March 2025 then they would not qualify for nirsevimab. If they were still on NICU throughout the last RSV season then this will essentially be their 1st RSV season in the community and so they should receive nirsevimab
1. For cardiac patients post bypass that need a repeat dose as per SPC-Nirsevimab is being paid in block…has bypass been considered?
2. CHD under 2yrs were given Palivizumab…not clear with Nirsevimab 2nd season patients comissioned status
Confirmed with NHSE medicines commisioning team that a 2nd dose of nirsevimab will be funded for patients after a bypass IF they are still eligible for use (i.e. their underlying cardiac condition has not be resolved by surgery) and also in the current RSV season. For other CHD indications for patients <12 months of age and coming into the 2nd RSV season nirsevimab is not commissioned (only 1st season is commissioned and funded)
– A few questions please:
– What happens to patients after mid-October as we would have completed most pre-season catch up patients?
– Would we still need to run monthly clinics to capture those patients who require this or would this be in-patient use on NICU or our in-patient wards
– Is it Corrected Gestational Age of 2 years and under?
Thank you
1) there need not be specific mab clinics but it would be reasonable to have arrangements for OPD attendance during RSV season for eligible children who did not get nirsevimab in the mid Sep to mid Oct window
2) ages are chronological ages, i.e. since birth
We will begin administering Nirsevimab in October for all eligible patients. So far, we have compiled a list of those scheduled to receive it during that month.

Q1) My question is regarding patients who are referred externally after October. How can we ensure that they also receive Nirsevimab if they miss the October clinic? AS we were told it was only for inpatient use.

Q2) If a child is unable to attend the clinic due to poor health, can they be offered another appointment for Nirsevimab, or would they miss the opportunity to receive it altogether?

There need not be specific mab clinics but it would be reasonable to have arrangements for OPD attendance during RSV season for eligible children who did not get nirsevimab in the mid Sep to mid Oct window, including if they missed their initial appointment due to ill health
Has any trust been able to procure nirsevimab yet? if so, where from? Beyfortus® (nirsevimab) can be ordered from Phoenix Healthcare Distribution
What is everyone doing with their left over stock of Palivizumab? Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
what date is considered “the start of RSV season”? thankyou 1-Oct
What is eligibility criteria for 2nd year nirsevimab? SCID
Is the Information leaflet available in different languages? Not currently, it was only finalised in English this week.
high risk babies that are entering their second season (who will have had palivizumab last year) will they qualify this year for nirsevimab ? Only if they meet a Green Book criteria e.g. infant (<12m) on LTV
Who will provide the red book inserts? Use the lines that allow for other immunisations
We (Bliss) are writing additional information for parents to let them know about the new immunisation. Who do we suggest that parents go to for questions particularly if they haven’t received and invitation to clinic.

Also is there more detail on eligibility for babies born / discharged earlier in 2025?

Contact the child’s paediatric team. Please refer to the presentations and other Q&A for eligibility
Can the Blueteq forms contain very clear criteria about what ages can receive treatment?  It’s currently not clear and could lead to too old patients being given treatment. The prior approval (Blueteq) forms align with Green Book guidance. If Green book guidance is updated to clarify definition of infant as <12 months age, then Blueteq forms will also be updated to specifically state the age, rather than ‘infant’.
Do you consider verbal consent adequate or should written consent be obtained? Verbal
Would an prem 25 wk gestation now 2 yr old  be eligible as high risk? The child had Palivzumab in 1st yr and none in 2nd year. Had RSV Bronchiolitis requiring HDU care. Mum is pressing for Nirsevimib in this season (3rd year of life). As guideline or as clinician decision? Not eligible under standard criteria, if the clinical team considered them at equivalent risk to other high risk indications then it could be considered but there is unlikely to be a commissioned indication for this. Older children have much lower risk of RSV admission given (primarily) larger airways and (also) development of immunity
What, if any, observations and required prior to giving Nirsevimab? We used to document saturations etc when giving Palivizumab, thankyou Consider nirsevimab to be like other immunisations rather than requring different monitoring
Is it PBr excluded and funded from NHSE via BueTeq? Yes; reimbursement is within the fixed block allocation
It was mentioned this is a immunisation for < 1year old for first season exposure but later said anyone still eligible in second season would still only receive 100mg in 2nd season in the UK. Which patients are still eligible above the age of 12 months? Please see other Q&A. In the webinar it was clarified that there are infants (ie under 12m) reaching their second RSV season as they were born during the previous RSV season.
Does that mean the light colour and dark colour in the chart have different indications ? Yes, please see the Green Book, the full extended area is for CLD and the narrow area CHD.
Do babies need to be in oxygen at 36 weeks to be eligible? Commissioned criteria are as per Green Book. Pre-term infants who have moderate or severe CLD. Moderate or severe CLD is defined as ‘preterm infants with compatible x-ray changes who continue to receive supplemental oxygen or respiratory support at 36 weeks post-menstrual age’. Children who fall into the light and dark red shaded area of Table in Green Book should be offered prophylaxis. Other commissioned criteria are as per the Green Book.
Would an prem 25 wk gestation now 2 yr old be eligible as high risk? The child had Palivzumab in 1st yr and none in 2nd year. Had RSV Bronchiolitis requiring HDU care. Mum is pressing for Nirsevimib in this season (3rd year of life). As guideline or as clinician decision?
To add had CLD and the RSV bronchiolitis occured in 2nd yr of life
Not eligible under standard criteria, if the clinical team considered them at equivalent risk to other high risk indications then it could be considered but there is unlikely to be a commissioned indication for this. Older children have much lower risk of RSV admission given (primarily) larger airways and (also) development of immunity
do infants need to be monitored for a period of time post administration ? Immediate reactions only
If the mother received RSV immunization in her 28th week and delivers in her 32nd week, what would be advice for that infant. That infant is likely to be well protected by maternal immunisation. The new nirsevimab preterm programme is only very/extremely preterm ie less than 32wk.
Apologies if I’ve missed this – is there a confirmed cost of the nirsevimab already? Thanks. The NHS indicative price is £1683 per pre-filled syringe. Cost is the same for 50mg and 100mg syringes
How can we access the information leaflet for parents ? https://www.gov.uk/government/publications/why-is-my-baby-being-offered-an-rsv-immunisation
it was mentioned earlier that babies born last season who received at least one dose of palivizumab do not need to catch up this year as mother would have been vaccinated against RSV. How do we know that the mother received RSV vaccination and what if they didn’t receive RSV vaccination? They wouldnt be eligible under any preterm indications (the tables or <32wk) but may be under SCID, LTV or CHD if they currently meet criteria
can we get the copy of the presentations please? Yes
Is there any information about giving it to coagulation disorders/anticoagulation and how should it be given Please see the Green Book RSV chapter re intramuscular considerations
Can Nirsevimab be given sub-cut to those patients receiving anti-coagulation therapy eg Warfarin, LMWH. Currently we give Palivizumab sub-cut in these patients It is only licensed for intramuscular use. Would suggest in that scenario to contact the manufacturer for advice
Patients who received either a full or partial palivizumab course in winter 2024/2025, and who’s mother did NOT receive maternal immunisation. Will they be elligible for nirsevimab this winter? If discharged from hospital after the RSV season else see other indications
Can I please clarify that we should be identifying babies born in 2024 as well ? If discharged from hospital after the RSV season then some from 1 Oct 2024 births onwards may be eligible under v prem or other infant indications
For any leftover palivizumab, will this be commissioned if we hope to use this up? Thanks. Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
is there a recommended observation period post dose in OP clinics? Immediate reactions only
Can I please confirm which Blueteq should be completed if a baby falls into 2 or more categories? Just choose 1 of the forms to register if they fit into BPD or CHD. <32 week form should only be used if they do not fall into BPD, CHD or SCID indication.
we have a large stock of paluvizimab – should we continue to use this in place of nirsevimab or should we discard this and go with the new programme? Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
Post immunisation at an out-patient clinic do babies require a short period of observation prior going home. No specific requirement, there is almost always some transit time in leaving the hospital in which they could rapidly return to an OPD HCP, and reactions to immunisations are typically rapid onset
What consent forms do we use with parents and is there a place to document the dose given in the child health record – red book once completed ? Verbal is usually adequate and the existing lines for other imms in the red book can be used
Previously, there was an option for considered high clinical risk. Is this available? It remains a green book criteria but may not be commissioned
is palivizumab still funded for this year if using up old stock trusts may hold?  Can we still order palivzumab to complete if course started with it or is there guidance if patients have part course of palivizumab can they then have nirsevimab?  If so what is the interval from last palivizumab administration to nirsevimab.

thanks

Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
Do you consider verbal consent is adequate or should written consent be obtained? Verbal
What is the commission stance for CHD high risk patient who have had cardiac bypass – The SPC states if this occurs within in 90 days of the vaccine dose to repeat a dose when stable. Would this be the case? Confirmed with NHSE medicines commisioning team that a 2nd dose of nirsevimab will be funded for patients after a bypass IF they are still eligible for use (i.e. their underlying cardiac condition has not be resolved by surgery) and also in the current RSV season. For other CHD indications for patients <12 months of age and coming into the 2nd RSV season nirsevimab is not commissioned (only 1st season is commissioned and funded)
will this still be suitable for term infants discharged on home oxygen during the season? This is currently not a Green Book indication, but may be considered in a future review.
is first year of life chronological? or adjusted for prematurity? Chronologically, time since birth
Is the 12 months of age, 12 months CGA or 12 months chronological age? Age = chronological
do we need to continue offering Palivizumab for those qualifying CHD patients aged 1-2 ? Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
Hi, is there any information regarding funding for nirsevimab in Wales? https://www.gov.wales/introduction-new-rsv-passive-immunisation-autumn-2025-whc2025029
Are babies who have received steroids recently to be given nirsevimab?  Thanks yes
what cost is the 50mg syringe? approx. £1683 per pre-filled syringe. Cost is the same for 50mg and 100mg syringes
For the inpatient administrations where has the recommendation to give 1 week prior to discharge come from and can this be added into the green book information so it is consistent across all units? Currently it states in the green book there is no need to wait until discharge and that there may be merit in giving it earlier to allow time for absorption and distribution before the infant goes home. Thanks This is a pragmatic approach and is not evidence based.
How soon after cardiac surgery can you give it? If the patient is clinically well enough based on the surgical team’s assessment, and there is not any antibody-depleting process that is time limited and associated with the surgery (unlikely there is such a think; expect loss of serum nisevimab is due to intraoperative transfusion etc)
As the new eligibility is for double the pt number; but no extra funding; how are trusts expected to cover the cost? Please see Trust letters from NHSE spec comm or equivalent from DA NHS/govt
Can we please have some clarification about the post cardiac bypass ‘top-up’ dose – is this covered in by commissioning? Confirmed with NHSE medicines commisioning team that a 2nd dose of nirsevimab will be funded for patients after a bypass IF they are still eligible for use (i.e. their underlying cardiac condition has not be resolved by surgery) and also in the current RSV season. For other CHD indications for patients <12 months of age and coming into the 2nd RSV season nirsevimab is not commissioned (only 1st season is commissioned and funded)
I asked our NHSE CC pharmacist yesterday about palivizumab if a parent refused nirsevimab and got this answer

“The use of palivizumab was raised at the NHSE meeting yesterday.

So palivizumab is technically no longer commissioned by NHSE and no Blueteq.

But NHSE are aware that there is some stock in trusts (I think we have a bit). If we did use it then we can bill NHSE under the block.”

Unfortunately there is no facility to reimburse for existing palivizumab stock. NHSE have confirmed that they are commissioning in line with the Green Book, which recommends nirsevimab as first-line immunisation for high-risk infants.  Only nirsevimab was shown to be cost-effective for the very/extremely preterm infants cohort. Need also to make sure that access to nirsevimab is equitable for all
Is 12 – months of age corrected gestational age or calculating from date of birth ? 12 months is from date of birth
If a mother has received RSV vaccination and infant born after 32nd week has SCID or Complex congenital Heart disease, would he be eligible in first season Yes, if SCID was not treated, or if the complex CHD patient fulfilled the high risk indication
Are there any plans to give it to all infants including term infants to reduce bronchialitis in the non preterm population? No, the mainstay of infant RSV prevention is the maternal antenatal immunisation programme
Can parents (of ineligible babies) purchase Nirsevimab privately? Yes – each Trust would have a private payment mechanism that should be followed.
In infants of Immunocompromised mum’s like HIV mum, Is Nirvesumab O.K? It is clinically safe but there is not a commissioned indication aligned to this to give nirsevimab outside of the very preterm or high risk selective immunisation programmes. In older adults, vaccine effectiveness is still strong in immunocompromised patients, albeit around 10 percentage points down from non-immunocompromised, so it is likely that many immunocompromised patients can respond successfully to antenatal RSV vaccine. HIV is principally a T-cell disease whereas the infant RSV protection is expected to be from antibodies produced by B cells.
Can we get a FAQ done from the questions in this as common themes being asked re stock, post bypass etc Confirmed with NHSE medicines commisioning team that a 2nd dose of nirsevimab will be funded for patients after a bypass IF they are still eligible for use (i.e. their underlying cardiac condition has not be resolved by surgery) and also in the current RSV season. For other CHD indications for patients <12 months of age and coming into the 2nd RSV season nirsevimab is not commissioned (only 1st season is commissioned and funded)
We will begin administering Nirsevimab in October for all eligible patients. So far, we have compiled a list of those scheduled to receive it during that month.

Q1) My question is regarding patients who are referred externally after October. How can we ensure that they also receive Nirsevimab if they miss the October clinic? AS we were told it was only for inpatient use.

Q2) If a child is unable to attend the clinic due to poor health, can they be offered another appointment for Nirsevimab, or would they miss the opportunity to receive it altogether?

Q1) If missed with original catch up clinic then should receive as soon as aware dose has been missed – probably attend the Trust for a dose as per local arrangements

Q2) Just need to rearrange the appointment

Is it possible to change the green book to state age in months and not the descriptor of ‘infant’ ? This will be updated
Should we advise prophylaxis course of paracetamol (same as advice for men B vaccine at 8 weeks)  or only if a fever presents? Not required. Men B vax is exceptional.
How many doses  of the vaccination? None. No RSV vaccines for infants and young children. Nirsevimab immunisation is a stat dose that lasts the season, 5-6months
Just for clarity, if an infant was born <32 weeks and only discharged from NICU after 1/3/25 and are still less than 12 months at the start of Sept, do they qualify for nirsevimab? Yes
For the CHD population do we pause/ stop rivoxaban prior to injection. If so, how long do we stop it for? Would manage as per previous palivizumab arrangement
Is there a template for invitation letters that we can post out to parents please? This would be a local approach, so no suggested template is available.
Are we likely to get an RSV vaccine for infants anytime? Excellent question. there is a live attenuated RSV vaccine in clinical trials which could be a follow-on vaccine that gets scheduled after maternally derived or monoclonal antibodies wane, though this is certainly not imminent. Otherwise RSV vaccines for infants and young children are currently contraindicated outside of clinical trials.  Further details are in the Green Book.
when do the blueteq forms open Forms were enabled 18 August 2025
When will blueteq forms be available? As notification to parents for attendance will be time critical Forms were enabled 18 August 2025.
Is there a minimum gestation or weight when it can be given . As some will go home at 34 OR 1.5 kg? No
If nirsevimab left out of fridge for short period of time and not used, can it be returned to fridge? Would depend on what a ‘short period of time is’, but in general would suggest not returning to fridge without clear quaratine labelling – any temperature excursion should be discussed with your pharmacy team. If left out of fridge and protected from light, then can be used up to 8 hours before discarding. [Conall has written to Sanofi]
Will SMA infants be included under the ‘clinical judgement’ criteria in the Green Book A request to include infants with SMA was considered by the RSV sub-group of JCVI last year, where it was felt that the cohort are likely wider than just those with SMA type 1 and would include those with other neuromuscular disorders. UKHSA colleagues need to undertake a review of the risk groups more across the paediatric population, which will include those with neuromuscular conditions, so nirsevimab is not yet routinely commissioned for this cohort.
The clinical judgement clause is really for one off cases, rather than where there is known identifiable cohort of infants e.g. SMA or other neuromuscular disorder.
Blueteq forms are aligned to the Green Book eligibility criteria and not for one-off cases where clinical judgement has been applied.

 

Related resources

RCPCH Webinar: Respiratory syncytial virus (RSV) – an update

In this webinar, Dr Elizabeth Whittaker, Dr Alison Kent and Dr Conall Watson will provide an update on respiratory syncytial virus (RSV), discussing the epidemiology of RSV, the maternal vaccination programme and what to expect this winter.

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Speakers

  • Dr Conall Watson

    Consultant Epidemiologist – RSV lead | Head of Respiratory Virus Section – secondary care and outcomes, Immunisation and Vaccine-Preventable Diseases Division

  • Dr Thomas Williams MRCPCH PhD

    Senior Clinical Research Fellow, University of Edinburgh & Honorary Consultant in Paediatric Respiratory and Sleep Medicine

  • Dr Anoo Jain

    Consultant in Neonatal Medicine, University Hospitals Bristol and Weston NHS Foundation Trust, Honorary Treasurer of the British Association of Perinatal Medicine (BAPM)

  • Nigel Gooding

    Consultant Pharmacist - Neonates and Paediatrics, Cambridge University Hospitals NHS Foundation Trust

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