A vaccine could reduce the number of babies and young children hospitalized with respiratory syncytial virus (RSV) by 80%, a “groundbreaking” study has found.
The study, published in the peer-reviewed New England Journal of Medicine, involved 8,058 healthy infants up to 12 months of age from the United Kingdom, France and Germany who were approaching their first RSV season.
Of this group, 4,037 infants were randomly assigned to receive the vaccine nirsevimab, while 4,021 infants received standard care.
The research found that of the babies who received the vaccine, only 11 (0.3%) were hospitalized, compared to the 60 babies (1.5%) who were hospitalized after receiving only standard care.
Researchers said the trial showed that the vaccine nirsevimab reduced the likelihood of hospital admission from six admissions per 1,000 in previously healthy infants to one admission per 1,000 in previously healthy infants who received the vaccine, giving an effectiveness of 83, 2% is.
The research was funded by Sanofi and AstraZeneca.
RSV is a common chest infection that affects infants and young children. RSV season usually begins in the fall and lasts until the following spring.
Although RSV usually causes mild symptoms similar to the common cold, for some babies the virus can become more severe and lead to complications such as bronchiolitis and pneumonia.
In England, RSV is a leading cause of infant hospitalisation, with almost 31,000 children aged four and under admitted each year with conditions linked to the virus. RSV causes between 20 and 30 infant deaths a year in the UK, and worldwide the virus kills 100,000 children under the age of five annually.
Nirsevimab was approved for use in the UK by the Medicines and Healthcare Products Regulatory Agency in November 2022, but has yet to be offered within a vaccination programme.
Prof Calum Semple, professor of child health and outbreak medicine at the University of Liverpool and a respiratory consultant at Alder Hey Children’s Hospital, said the results of the trial were “wonderful”.
He said: “Respiratory syncytial virus causes misery for tens of thousands of babies in their first year of life in the UK. RSV usually causes an unpleasant heavy runny nose and earache in babies, but can lead to bronchiolitis, a serious illness characterized by feeding problems, dehydration, chest infections requiring hospital admission and respiratory failure requiring intensive care.
“The winter surge in bronchiolitis admissions, caused by RSV infection of infants, regularly places severe pressure on children’s health services.
“With nirsevimab, we have a single injection that has now proven very effective in healthy babies. It may be time for the UK to extend the seasonal RSV immunization program to all new-born babies to save them the misery of bronchiolitis and to take the pressure off hospital services.”
Dr Simon Drysdale, co-study leader and consultant pediatrician at St George’s University Hospitals, said: “RSV is a very contagious infection and every year our wards are full of babies with breathing and feeding problems. The thousands of winter hospital admissions are extremely distressing for families and cause a huge winter burden on the NHS. This ground-breaking study shows the potential NHS impact and safety of a monoclonal antibody injection.
