The UK medicines regulator has approved the first ever respiratory syncytial virus (RSV) vaccine for older adults.
Arexvy (GSK) has been authorised by the Medicines and Healthcare products Regulatory Agency for the prevention of lower respiratory tract disease caused by RSV in adults aged over 60 years.
The authorisation has been granted less than one month after the Joint Committee on Vaccination and Immunisation (JCVI) recommended a routine RSV vaccination programme for babies and adults aged over 75 years in England.
On 22 June 2023, the JCVI said in a statement that there were currently three RSV vaccines in development for older adults — including Arexvy — that are expected to be licensed in 2023 or 2024.
The committee proposed the roll out of a one-off vaccination campaign, initially covering several older age groups before moving to routine vaccination for people reaching the age of 75 years. It said it had no preference for the vaccine used.
However, the committee added that the delivery and and implementation of the vaccination will be determined through further consultation between NHS England, the Department of Health and Social Care, public health officials and the devolved administrations.
At the time, Sir Andrew Pollard, chair of the JCVI, said it had recognised there was a “significant burden” of RSV illness in the UK population, which has a considerable impact on the NHS during winter.
Data suggest that RSV causes around 175,000 GP visits, 14,000 hospitalisations and 8,000 deaths each year in adults aged 60 years and over in the UK.
The MHRA approval was based on data from the international phase III AReSVi-006 trial of 25,000 participants published in the New England Journal of Medicine in February 2023.
The authors reported vaccine efficacy of 94.1% against severe RSV-related lower respiratory tract disease, as assessed on clinical signs or by the investigator, and 71.7% against RSV-related acute respiratory infection.
The results also suggested effective results regardless of RSV subtype or the presence of underlying conditions.
The UK government has yet to formally respond to the JCVI recommendation, but Alastair Buxton, director of NHS services at Community Pharmacy England, commented: “If there is a programme commissioned, community pharmacies would be well positioned to provide it to eligible patients.”