MHRA approves GSK’s RSV vaccine for older adults in the UK

Older adults in the UK will soon be able to receive protection against respiratory syncytial virus (RSV) after the Medicines and Healthcare products Regulatory Agency (MHRA) approved GSK’s vaccine.

Each year in the UK, RSV is estimated to cause 14,000 hospitalisations and 8,000 deaths in adults ages 60 and over. The burden of RSV on the National Health Service (NHS) had been the subject of government debate in 2022. UK government scientific advisors have pointed to changing patterns of RSV infection that could lead to unpredictable epidemics. Moreover, the number of RSV infections in adults is likely underestimated, because older patients are not tested as often as children with respiratory infections.

GSK’s Arexvy specifically prevents RSV-related lower respiratory tract disease (LRTD). The vaccine has already been greenlit for use in the US and Europe. It was approved by the US Food and Drug Administration (FDA) in May, and then by the European Commission (EC) in June.

After years of challenges, this year marked a flashpoint in the effort to develop and market effective RSV vaccines. Arexvy was the first approved RSV vaccine. Pfizer had its Abrysvo vaccine approved shortly after – both have since been recommended by the Centers for Disease Control and Prevention (CDC). Moderna recently announced it has started regulatory submissions for its RSV vaccine.

Data from GSK’s Phase III study, which was published in The New England Journal of Medicine, backed the authorisation. The company demonstrated the vaccine was 82.6% effective in protecting against LRTD, and 94.1% effective against severe LRTD.

“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,” said Neale Belson, GSK’s Senior Vice President, and General Manager UK.