UK regulator approves antibody shot for RSV

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Wednesday 16th November 2022

The UK regulator has approved a new antibody treatment for RSV, a common seasonal winter virus, which affects babies and young children. Respiratory syncytial virus (RSV) is the leading cause of hospital admission among under 5s in the UK. In most cases, RSV causes coughing and colds, but some children develop a more severe illness. In young children, the virus carries a risk of pneumonia and bronchiolitis, lung conditions, which can be very serious in infants. 

Almost 30,000 children require hospital treatment for RSV every year in the UK, but there are hopes that new treatments will enhance protection and reduce hospitalisation rates.
A new antibody shot for small children has been approved by the UK medicines regulator. The single-dose injection is designed to protect young children from developing severe symptoms, including pneumonia and chest infections, if they contract the virus. 

The antibody treatment, which has been developed by Sanofi and AstraZeneca, is called nirsevimab. Trials have shown that the shot reduces the risk of lower respiratory tract infections caused by RSV by 74.5%. The trial involved 4,000 babies. There are already treatments available for RSV and trials on a vaccine have produced positive results. However, the antibody shot offers additional protection, which is particularly important for infants due to the pandemic. Many young children lack robust immunity against common seasonal illnesses because they were born during lockdowns or periods of restrictions when exposure to winter viruses was significantly reduced. As natural protection is likely to be lower than in previous years, protective measures could help to lower risks for children under the age of 3. 

Data suggests that levels of RSV are higher than during the pandemic, but they are within the average pre-pandemic range. Studies show that RSV has also been more prevalent in the US this year. The next step is to trial the antibody treatment on a larger group. The shot is not yet available on the NHS, but it will be made available if subsequent trials show positive signs. Research teams are keen to see if the antibody treatment reduces the risk of hospitalisation, as well as collecting more data linked to infections caused by RSV. Parents of infants have been encouraged to sign up for the next phase of the trial. The study will involve babies up to the age of 12 months. 

Dr Simon Drysdale, co-leader of the study and consultant paediatrician in infectious diseases at St George’s Hospital in London, suggested that the treatment could eventually be given as a preventative measure at birth or as part of routine injections at 2 months. Christine Burlison has first-hand experience of dealing with the effects of RSV. Her daughter, Aria, started to develop symptoms shortly after Christine went home after giving birth. At first, she assumed that her newborn had a cold, but her symptoms got worse and she was grunting when breathing and her body went floppy. She was taken to hospital in an ambulance and received treatment for RSV. She stayed in hospital for a week, which was a scary experience for Christine and her partner. She had not been familiar with RSV and said that seeing her tiny daughter so weak and vulnerable was “heart-breaking.”

Christine’s first experience with RSV meant that she recognised the warning signs when her son, Jude, displayed symptoms when he was eight months old. Trials on an RSV vaccine developed by Pfizer have produced positive data in the US. Trials, which involve pregnant women being given the vaccine, show that the injection was 81% effective in preventing severe respiratory symptoms caused by RSV during the first 90 days and 69% effective in preventing severe illness for the first 6 months of the baby’s life. Pfizer plans to start seeking approval from regulators by the start of 2023.