Thousands of premature babies at risk of life-threatening infection can now be protected against the common respiratory syncytial virus (RSV) this winter, with a single long-lasting injection available on the NHS for the first time.
The NHS in England is rolling out drug nirsevimab from late September to provide protection against RSV to around 7,000 high-risk infants and babies born before 32 weeks this year, helping hundreds of the most vulnerable infants avoid hospitalisation.
Nirsevimab – which offers six months’ protection in a single dose – will replace monthly injections of palivizumab previously offered to a smaller number of vulnerable babies.
According to clinical trial data, palivizumab provides around 55% protection while nirsevimab offers more than 80% protection against the virus.
In addition, nirsevimab will be offered seasonally to eligible high-risk infants and young children with complex heart, lung or weakened immune system conditions.
RSV infects 90% of children by the age of two and is one of the leading causes of hospitalisation – it can lead to life-threatening pneumonia and infant bronchiolitis, a lung infection.
Data shows that babies born prematurely are three times more likely to need hospital admission due to RSV, and ten times more likely to need intensive care, compared to full-term babies.
Unlike a vaccine, nirsevimab provides infants with ready-made immune protection that helps to create a barrier to RSV infecting their cells.
NHS England estimates that if 95% of eligible infants receive nirsevimab, there could be nearly 350 fewer hospital admissions, including in paediatric intensive care units, this year.
Eligible infants entering their first RSV season – from September to February – will receive the injection under the ongoing care of their specialist neonatal team, or their family will be directed by the clinical team managing their child’s health on how to receive the immunisation ahead of winter.
Dr Claire Fuller, Co-National Medical Director for NHS England said: “This injection will provide premature babies with a protective bubble against RSV just in time for the colder months.
“It will offer a long-lasting defence helping to avoid unnecessary hospitalisations and serious illness – giving babies the best possible start in life and shielding them from harm.”
In the UK, every year around 30,000 children under the age of five are hospitalised with RSV, and it causes around 30 infant deaths.
This drug works differently to the RSV vaccine offered to pregnant women – vaccination boosts the mother’s immune system to make extra protective antibodies which are passed to the baby in the womb, giving protection from birth. However, babies born before 32 weeks have limited or no protection from vaccinations given to pregnant women at the recommended time of around 28 weeks.
John Stewart, Director of Specialised Commissioning at NHS England said: “For babies born very prematurely, the risk of contracting RSV in their first winter is high and extremely serious.
“This new medication will provide vulnerable infants with their own suit of armour that protects against what can be a life-threatening infection.
“I am delighted that we will be able to offer nirsevimab to protect these babies from this winter onwards and I’m extremely grateful to colleagues in specialist neonatal clinics across the country who will deliver this life-saving service.”
In addition to the NHS in England, health systems in Scotland, Wales and Northern Ireland are also set to offer nirsevimab from this Autumn after NHS England and the UK Health Security Agency (UKHSA) negotiated an agreement with the manufacturer, Sanofi, to purchase stocks of the medicine. Around 9,000 babies and infants in the UK are expected to benefit per year.
The innovative injection further strengthens the NHS winter preparedness to prevent avoidable admissions, following the first-ever launch of an RSV vaccine for pregnant women last September, and follows Joint Committee on Vaccination and Immunisation (JCVI) recommendations.
Ceri Cox, 33, and her son, Harry, 2, took part in an international clinical trial of the immunisation at University Hospital Southampton, said: “I wanted Harry to be protected as much as he could against RSV. I know quite a bit about the virus from working as a paediatric nurse in a unit where we see a lot of children with RSV every year. It’s amazing that this immunisation will now be offered to young babies around the country. I hope we will see fewer little ones in our hospital this winter.”
Minister for Public Health and Prevention Ashley Dalton said: “This is excellent news for thousands of vulnerable babies and their families. By rolling out nirsevimab this September, we’re ensuring that our most at-risk infants, including those who are born too early to benefit from maternal vaccination, are protected in the best possible way.
“This rollout is a prime example of how this government is shifting the focus from sickness to prevention, as part of our 10 Year Health Plan.”
Dr Conall Watson, consultant epidemiologist at the UK Health Security Agency said: “Having an RSV vaccine from week 28 in every pregnancy is key to protecting your baby against RSV bronchiolitis. Most RSV hospital admissions in babies can be prevented by vaccination.
“This new NHS nirsevimab immunisation programme will offer really important protection for very premature babies born before they can be protected by mum’s antenatal vaccination.
“UKHSA has been working closely with JCVI and the NHS to provide evidence in support of this programme and we are delighted to see this launch ahead of winter 2025.”