It’s a world first: The United States on Wednesday approved the first vaccine against the 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 years and over.
This represents “significant public health success in preventing a potentially fatal disease,” FDA official Peter Marks said 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 young children 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, several pharmaceutical groups are embarking on a race to conquer this promisingly lucrative market.
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 over the age of 65 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 vaccine approval is based on a clinical trial with approximately 25,000 participants, half of whom received the vaccine and half received a placebo. The vaccine was found to be 83% effective in preventing lower respiratory tract infections.
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 conducting studies to monitor this risk.
Every winter, bronchiolitis is in the spotlight, but it was especially talked about last year, in a context of the end of the confinements linked to Covid-19, and therefore of greater circulation of the virus.
The United States and Europe have been particularly affected, particularly babies, who had avoided exposure 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 a vaccine, but works with the same preventive intent.
Source: BFM TV
