Sunday, June 4, 2023

US approves world’s first bronchiolitis vaccine

Authorization for the Arexvy vaccine, developed by British pharmaceutical giant GSK, has been granted by the US Drug Regulatory Agency (FDA) for adults aged 60 and over.

“This is a major public health achievement in preventing a potentially fatal disease,” FDA chief Peter Marks said in a statement.

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 widespread and highly contagious virus, best known for causing bronchiolitis, or infection of the bronchioles, in young children during the winter.

However, it also affects adults and can be dangerous for the elderly when it degenerates into a respiratory infection (bronchiolitis or pneumonia).

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.

After decades of research, several pharmaceutical groups are in a race to conquer this promising and lucrative market.

Pfizer and Moderna labs are also developing RSV vaccines for the elderly. Pfizer said it expects an FDA decision in May.

GSK reported in a statement that its vaccines will be available in the next epidemic season this year.

Extensive clinical trials

GSK’s vaccine license is based on a clinical trial with approximately 25,000 participants, half of whom received the vaccine and half of whom 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 headache.

In another, smaller study, a participant developed Guillain-Barré syndrome, a rare neurological condition, nine days after receiving the Arexvy vaccine.

The FDA asked GSK to continue conducting studies to monitor this risk.

Every winter bronchiolitis is in the spotlight, but was especially talked about last year, in the context of the end of the prison linked to covid-19, and therefore to the greater circulation of the virus.

The United States and Europe have been particularly affected, especially babies, especially little exposure during the covid pandemic.

At the end of 2022, the European Union also approved a preventive treatment for bronchiolitis jointly developed by AstraZeneca and Sanofi. Designed for infants, nirsevimab is not a prohibited vaccine, but works with the same preventive intent.

Nation World News Desk
Nation World News Desk
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