RSV vaccine for older adults approved by UK medicines regulator | Vaccines and immunisation

The UK’s medicines regulator has approved the first vaccine against respiratory syncytial virus (RSV) in older adults.

The virus typically causes cold-like symptoms, but is a leading cause of pneumonia in infants and elderly people, with infections in older adults accounting for about 8,000 deaths, 14,000 hospitalisations and 175,000 GP appointments in the UK each year – more than influenza during a typical winter season.

People with underlying medical conditions, such as diabetes and chronic heart or lung disease, are at greatest risk of severe illness. There are no specific treatments for RSV but those with severe infections may be supported with supplemental oxygen, intravenous fluids, or mechanical ventilation until they get better.

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the vaccine, Arexvy, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years and older – the first time an RSV vaccine for older adults has been authorised for use in the UK.

A study of 24,966 older adults published in the New England Journal of Medicine in February suggested vaccine efficacy against LRTD was 82.6%, while efficacy against serious disease was 94.1%.

The vaccine was generally well tolerated, with mild to moderate injection site pain, fatigue, muscle and joint aches or pain and headache the most commonly reported side events. The rate of serious adverse effects was similar between those receiving the vaccine or a placebo jab.

The vaccine, produced by GlaxoSmithKline, has already been approved for use in the US and Europe. Further adult RSV vaccines from Moderna and Pfizer are expected to be considered in the coming months.

On 22 June, the Joint Committee on Vaccination and Immunisation (JCVI), which advises UK governments on matters of immunisation, issued a short statement to the Department of Health and Social Care advising that a cost-effective RSV immunisation programme should be developed for infants and older adults.

The JCVI cited modelling by the London School of Hygiene & Tropical Medicine and other academic groups suggesting that a vaccination programme for older adults could be cost-effective.

It currently favours a “one-off vaccination campaign targeting several age cohorts and then a routine programme for those turning 75 years old”, the statement said.

A final statement to inform a policy decision about potential RSV immunisation programmes is expected later this summer.

Prof Sir Andrew Pollard, the chair of the JCVI said: “There is a substantial burden of RSV infection in older adults, which contributes to the seasonal winter pressures for the NHS.

“Clinical trials of several products have shown that vaccination can boost immunity and reduce the risk of infection and hospitalisation with the potential to improve population health.”

The JCVI is closely monitoring the development of products to protect newborns and infants against RSV, which is the leading cause of hospitalisation in infants worldwide.

Maternal vaccines, which are designed to be given during pregnancy, are now in late-stage clinical trials, while an antibody-based drug called nirsevimab was licensed by the MHRA in November 2022. It is designed to protect babies during their first RSV season, when they are most vulnerable.