New antibody treatment for RSV in infants highly effective in reducing hospitalisations

A new antibody treatment could reduce by 80 per cent the numbers of babies and young children admitted to hospital with respiratory syncytial virus (RSV), a “groundbreaking” study has found.

Published in the New England Journal of Medicine on Thursday, the study involved 8,058 healthy babies aged up to 12 months from the UK, France and Germany, who were approaching their first RSV season. Half were randomly assigned to receive the antibody nirsevimab by injection, while 4,021 babies received standard care.

Of the babies who received the treatment, only 11 (0.3 per cent) were hospitalised, in comparison with the 60 babies (1.5 per cent) who were hospitalised after receiving just the standard care.

RSV led to a large number of outbreaks in Ireland in recent months with a record number of hospitalisations up to early December. RSV is the leading cause of hospitalisation due to respiratory illness among young children aged less than five years. One to two out of every 100 children younger than 6 months with RSV infection may need to be hospitalised. As RSV cases declined in recent weeks, flu cases have increased among adults.

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RSV season normally begins in autumn and lasts until the following spring. Although RSV usually causes mild symptoms similar to the common cold, for some infants the virus can become more severe and lead to complications such as bronchiolitis and pneumonia.

The trial shows nirsevimab reduced 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, which is an efficacy rate of 83.2 per cent. It was funded by Sanofi and AstraZeneca.

Prof Calum Semple, professor of child health and outbreak medicine at the University of Liverpool and a respiratory consultant at the Alder Hey children’s hospital in the UK, said with nirsevimab proven to be highly effective in healthy infants, it may be time to extend seasonal RSV immunisation programmes to all newborn infants “to save them from the misery of bronchiolitis and to take the pressure off hospital services”.

Dr Simon Drysdale, co-study leader and consultant paediatrician at St George’s University hospitals in the UK, 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 highly distressing for families and cause a huge winter burden on [health services]. This ground-breaking study shows the potential impact and safety of a monoclonal antibody injection.”

Prof Peter Openshaw of Imperial College London said: “It’s an exciting time for those of us working in the RSV field. We now have licensed vaccines for older adults coming on-stream, and this new long-acting antibody [nirsevimab] that can be given as a single intramuscular injection to infants and prevents RSV disease throughout a whole winter.

“In effect this is a vaccine, working not by stimulating the immune system to make antibody but by providing that antibody directly. It replaces a preventive antibody [palivizumab or Synagis] that has been available for many years but hasn’t been in widespread use because it’s expensive and inconvenient,” he added.

Healthcare providers in Spain and Luxembourg have already decided to use this new “passive vaccine” approach to prevent RSV disease in all infants without contraindications, Prof Openshaw confirmed. “We are waiting to see what effect it has on the circulation of the virus in communities, on viral evolution. We are not certain if escape mutants will develop and on the wider health of babies and young children – some studies suggest that delaying RSV infection beyond the critical first 6 months of life will lead to reduced rates of recurrent wheeze and asthma diagnosis.”

Health Protection Surveillance Centre data indicates that by December 21st RSV in Ireland had dropped from record levels – though 300 people, mostly children, were hospitalised with this virus that week.

Some 829 RSV cases were notified in the first week in December, down from 985 the previous week. Hospitalisations were also down, from 370 to 335. While most cases were in children and their rate decreased, cases among older people were still on the rise. Six new RSV outbreaks were recorded, the highest number so far this winter.

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