Premature babies to receive new protection against common virus

Ceri and Harry took part in a clinical trial at University Hospital Southampton.

Thousands of premature babies at risk of serious infection will be protected against respiratory syncytial virus (RSV) this winter.

A single long-lasting injection will be made available on the NHS for the first time from September.

The immunisation is known as nirsevimab. It is approved around the globe following years of clinical research.

The HARMONIE study, co-led by experts in Southampton, suggested the antibody jab could help ease winter pressures on the NHS. It was a collaboration between Sanofi and the National Institute for Health and Care Research (NIHR).

Southampton researchers are welcoming news of the NHS roll-out. They are thanking families in the south who took part in vital research to support the treatment.

Common winter virus

Respiratory syncytial virus (RSV) infects 90% of children by the age of two. It is one of the leading causes of hospitalisation in young children.

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.

They are also ten times more likely to need intensive care, compared to full-term babies.

Fewer hospital admissions

The NHS will roll out nirsevimab to protect around 9,000 UK babies born before 32 weeks this year.

If 95% of eligible infants receive the injection, it is estimated there could be nearly 350 fewer hospital admissions this winter.

Nirsevimab offers six months’ protection in a single dose. Unlike a vaccine, nirsevimab provides infants with ready-made immune protection.

It will replace monthly injections of palivizumab. This was previously offered to a smaller number of vulnerable babies.

In addition, nirsevimab will be offered seasonally to eligible high-risk infants and young children with complex heart, lung or weakened immune system conditions.

Research impact

The international HARMONIE study was co-led by experts from the NIHR Southampton Clinical Research Facility.

Over 8,000 babies took part across the UK, France and Germany, including at University Hospital Southampton (UHS).

The study found the injection reduced numbers needing hospital treatment by over 80%, paving the way for the treatment’s approval around the world.

Dr Katrina Cathie, UHS consultant paediatrician, was the Southampton study lead.

She said: “Babies born very prematurely are significantly more vulnerable to hospitalisation from RSV. These infants often have underdeveloped lungs and their immune systems are not as robust as full-term babies.

“I’m really pleased that this preventative treatment is being offered to premature babies for the first time in the UK. The antibody jab can offer immediate protection for these young lives. It will hopefully reduce hospital admissions and ease pressures on the NHS this winter.

“This roll-out all stems from years of clinical research into the treatment, and I would like to thank the thousands of families whose participation over the years has led to this transformative impact.”

Ceri Cox, 33, and her son, Harry, 2, took part in the international trial at UHS.

She 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.”

‘Suit of armour’

In the UK, every year around 30,000 children under the age of five are hospitalised with RSV. It causes around 30 infant deaths.

Nirsevimab 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. This gives 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.”

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.”