The bronchiolitis vaccine Arexvy, developed by British pharmaceutical giant GSK, has been approved in the United States for adults aged 60 and over.
It’s a world first: the United States on Wednesday approved the first vaccine against respiratory syncytial virus (RSV), responsible for bronchiolitis and tens of thousands of deaths each year.
This authorization of the Arexvy vaccine, developed by the British pharmaceutical giant GSK, was granted by the United States Medicines Agency (FDA) for adults aged 60 and over.
This represents “a significant public health success in preventing a disease that can be fatal,” said FDA official Peter Marks in a statement.
Favorable opinion in Europe
Last week, this same vaccine received a favorable opinion from the European Medicines Agency (EMA). The final decision of the European Commission is expected in the coming months.
RSV is a very common and highly contagious virus, best known for causing bronchiolitis (infection of the small bronchi) in toddlers during the winter. But it also affects adults and can be dangerous for the elderly when it degenerates into a respiratory infection (bronchiolitis or pneumonia).
After decades of research, a race is engaged between several pharmaceutical groups to win this market which promises to be lucrative.
Pfizer and Moderna Laboratories are also each developing an RSV vaccine for the elderly. Pfizer said it expects a decision from the US FDA on its approval in May.
According to US health authorities, this virus causes the death of between 6,000 and 10,000 people aged 65 and over in the United States each year, and between 60,000 and 160,000 hospitalizations.
GSK said in a statement that its vaccine would be available from the next epidemic season this year.
Large clinical trial
GSK’s approval of the vaccine is based on a clinical trial with approximately 25,000 participants, half of whom received the vaccine and the other half a placebo. The vaccine was found to be 83% effective in preventing lower respiratory tract infections.
The side effects were mainly fatigue, muscle pain, or headaches.
In another smaller study, a participant developed Guillain-Barré syndrome, a rare neurological condition, nine days after receiving the Arexvy vaccine. The FDA has asked GSK to continue to conduct studies to monitor this risk.
Every winter, bronchiolitis is in the spotlight, but it was particularly talked about last year, in a context of the end of confinements linked to Covid-19, and therefore of increased circulation of viruses.
The United States and Europe have been particularly hard hit, particularly babies, who had avoided being exposed during the Covid pandemic.
At the end of 2022, the European Union also approved a preventive treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Intended for infants, nirsevimab is not strictly speaking a vaccine but works with the same preventive intention.
