Source – GSK
GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted authorization for the use of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older. This marks the first time that an RSV vaccine for older adults has been approved for use in Great Britain by the MHRA.
“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.”
– Neale Belson, Senior Vice President, and General Manager UK at GSK
Respiratory syncytial virus (RSV) is a common and contagious respiratory virus that causes lower respiratory tract disease (LRTD). In the UK, it leads to approximately 175,000 visits to general practitioners, 14,000 hospitalizations, and 8,000 deaths in adults aged 60 and over each year. Recent studies have shown that the burden of RSV disease may be even greater than that of influenza in hospitalized older adults. Most RSV-related hospitalizations occur in individuals with underlying medical conditions such as diabetes, chronic heart disease, and lung disease.
The authorization is based on data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial, which was published in the New England Journal of Medicine. The trial demonstrated high overall vaccine efficacy against RSV-LRTD, including in participants with certain underlying medical conditions.
The vaccine was generally well tolerated, with the most commonly observed adverse events being injection site pain, fatigue, myalgia, arthralgia, and headache. These events were mostly mild to moderate and of short duration.
The MHRA’s decision follows the European Commission’s authorization of Arexvy on June 6, 2023. GSK’s application for marketing authorization in the EU underwent an accelerated assessment process due to the significant public health interest in preventing RSV illness in the older adult population.
Arexvy was the first RSV vaccine for older adults to be approved by the US Food and Drug Administration. Regulatory reviews are still ongoing in Japan and several other countries.