RSV immunisation for new born babies
What is RSV (respiratory syncytial virus?)
RSV is a common virus that causes respiratory infections. In young babies, symptoms include a runny nose, temperature, cough and wheezing.
The risk of severe infection is highest in the youngest infants, especially those born during the RSV season in winter. Each winter in Ireland one in two new born babies will get RSV and many will need medical care from their GP or the emergency department of a children’s hospital. Four out of a hundred new born babies are hospitalised due to RSV, with some babies needing special treatment in intensive care units.
Why is the HSE introducing the RSV immunisation now?
A new medication called nirsevimab which protects babies from RSV is now available. A ‘path finder’ programme is being introduced to ensure that infants are protected, and hospital services are not put under pressure with avoidable RSV related illness in infants.
Nirsevimab has been approved by the European Medicines Agency (EMA). It is recommended by the Department of Health, the HSE and the National Immunisation Advisory Committee (NIAC).
What is nirsevimab?
Nirsevimab is a monoclonal antibody. An antibody is a special protein that helps fight off infections. A monoclonal antibody is one that has been made in a laboratory to fight off a specific infection.
What is a pathfinder programme?
A pathfinder programme refers to an initiative designed to explore and establish innovative approaches to improving health outcomes within a community or population. Such programmes often serve as pilots or models that can be scaled up and replicated in other settings.
Who is the RSV immunisation being offered to?
It is recommended for all babies born from September 2024 to the end of February 2025, which corresponds with the time of year when RSV rates are highest.
How will the immunisation programme be delivered?
The programme will be delivered in all maternity settings in the Republic of Ireland after the baby is born and before the baby is discharged from hospital.
How long will the programme run for?
The programme will run for the period when RSV levels are highest in Ireland and will be offered to all babies born from September 2024 to the end of February 2025.
What happens to babies born outside of these dates?
The programme aims to protect new born babies born in the RSV season, which runs from October until the end of February, as new born babies are most vulnerable to RSV. This is the period when RSV levels in Ireland are at their highest. The risk of RSV infection in all babies can be reduced by:
- cleaning hands properly
- avoiding crowded places
- limiting contact with people who have cold-like symptoms or other infections
Information on preventing RSV infection is available at https://www2.hse.ie/conditions/rsv/
What is the RSV season?
The RSV season is a term used to describe the period when RSV is ‘circulating in the community’. In Ireland, RSV outbreaks typically occur in the winter months with the highest numbers of infections usually reported in December and January every year. RSV usually circulates in the community in Ireland from September right through to end of February. The RSV immunisation programme from September to February would offer protection to the youngest infants during the RSV season.
What happens if a new born baby is discharged home before being offered nirsevimab?
Nirsevimab is recommended for all new born babies before the new born baby leaves the maternity hospital. However, if for some reason a baby has not received nirsevimab before being discharged arrangements can be made for the baby to return to the hospital for immunisation.
Can nirsevimab cause RSV?
The nirsevimab injection does not contain RSV and cannot cause RSV or related illnesses.
What is the difference between nirsevimab and a vaccine?
Nirsevimab is an antibody that provides direct protection against RSV to the new born baby (passive immunsiation). A vaccine stimulates the baby’s own immune system to mount an immune response, which includes making antibodies (active immunisation).
How will nirsevimab be given?
It is administered by intramuscular injection into the new born baby’s thigh.
When is the best time to get immunised?
Nirsevimab can be given from birth and is recommended at the earliest opportunity to protect young babies in first days and weeks of life, when the risk of severe RSV infection is at its greatest. It will be given to the baby before they are discharged home from the maternity hospital.
How quickly does nirsevimab start working?
It starts providing protection again RSV infection straight away.
Will babies need a top-up injection?
No. One injection of nirsevimab is sufficient to provide cover against RSV infection throughout the baby’s first winter.
Does nirsevimab provide lifelong protection against RSV infection?
No. It provides protection for the first 150 days, corresponding to the period the virus circulates and when babies are most at risk from RSV infection. As babies get older, the infection is much milder with a less severe illness.
Will nirsevimab interfere with the baby’s other immunisations?
No. Nirsevimab is a passive antibody immunisation. It does not require the baby to generate its own antibodies using the baby’s own immune system, nor does it interfere with the baby’s immune response to vaccines in the current immunisation schedule. Therefore, babies can begin the normal course of immunisations that start at two months of age.
Is nirsevimab safe?
Yes. The detailed scientific trials and its use in other countries have found it to be very safe. Side effects are mild and uncommon. The most common side effect is mild to moderate rash (0.7%) occurring within 14 days after the injection. Also, fever may occur in 0.6% and tenderness at injection site in 0.4% of babies within 7 days after the injection. Allergic reactions or hypersensitivity reactions have been rarely reported. Babies will be monitored after the injection and necessary treatment will be available if needed.
How effective is nirsevimab?
It is over 80% effective.
Where do I get information about nirsevimab?
Parents will be provided with a parent information leaflet. The midwife/nurse giving nirsevimab to the baby will provide information and available to answer any queries.
What happens to preterm infants?
Premature babies (born before 30 weeks gestation or less than 1.25kg at birth), will also be offered nirsevimab.
Do l have to pay for the nirsevimab immunisation?
The nirsevimab immunisation is provided free of charge to all babies born between September 2024 and February 2025.
Will the HSE run the programme again in the winter 2025/2026?
A decision will be taken based on the outcomes of this initial pathfinder programme.
RSV immunisation parent information leaflets in multiple languages are available here.
Publication date: 14 August 2024