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The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first respiratory syncytial virus (RSV) vaccine for older adults in the UK.
Arexvy (produced by drug manufacture GSK) has been authorised for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older.
This is the first time an RSV vaccine for older adults has been authorised for use in Great Britain by the MHRA.
What is RSV?
RSV is a common respiratory virus that usually causes mild, cold-like symptoms. However, for vulnerable groups, such as older people and young children who are at risk of more severe respiratory disease, RSV infection might cause pneumonia or even death.
RSV is the leading cause of bronchiolitis, an infection of the small airways in the lung, in babies and infants which make breathing harder and cause difficulty feeding.
The virus often peaks in the winter months (from October through to February), and in the UK, RSV leads to an estimated 14,000 hospitalisations and an estimated 8,000 deaths in adults 60 years of age and older each year.
In Europe, RSV leads to over 270,000 hospitalisations and approximately 20,000 in-hospital deaths in adults each year.
How safe and effective is Arexvy?
Arexvy has already been approved in the US and in member states of the European Union and the European Economic Area, and the authorisation by the MHRA is based on phase III efficacy data in older adults.
Preliminary results of the ongoing, international, placebo-controlled, phase 3 trial showed that the RSV vaccine had an acceptable safety profile and prevented RSV-related acute respiratory infection and lower respiratory tract disease and severe RSV-related lower respiratory tract disease in adults 60 years of age or older, regardless of RSV subtype and the presence of underlying coexisting conditions.
Nearly 25,000 participants aged 60 and over took part in the trial. The participants were randomly assigned to receive one dose of the vaccine or placebo.
Over a median follow-up of 6.7 months, vaccine efficacy against RSV-related lower respiratory tract disease was 82.6, with seven cases in the vaccine group and 40 cases in the placebo group.
Vaccine efficacy was 94.1% against severe RSV-related lower respiratory tract disease and 71.7% against RSV-related acute respiratory infection.
The vaccine was generally well tolerated by participants, and the most frequently observed averse events were injection site pain, fatigue, myalgia, arthralgia, and headache. These were generally mild to moderate and transient.
A trial is currently underway to test the efficacy of a vaccine to protect babies from the virus. Nirsevimab has already been proven to be safe and the larger trial will now test its effectiveness.
Older adults drive the majority of RSV hospitalisations
While we await the results of the HARMONIE study, this new approval is set to protect thousands of older people from a potentially deadly virus.
Neale Belson, Senior Vice President, and General Manager UK at GSK said: “We are very excited by today’s announcement.
“Our ambition is to help protect adults 60 years of age and older in the UK who are at risk from RSV disease, including those with underlying medical conditions, who drive the majority of RSV hospitalisations.
“This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time, reinforcing GSK’s long history of vaccine innovation.”