MHRA authorises GSK’s RSV vaccine for older adults
GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised its Arexvy respiratory syncytial virus (RSV) vaccine for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60.
This approval marks the first time an RSV vaccine for older adults has been approved by the MHRA for use in Great Britain.
The approval follows data from the pivotal AReSVi-006 phase 3 vaccine efficacy trial, which was published in the New England Journal of Medicine. In this trial, the vaccine showed high overall efficacy against RSV-LRTD, including in patients with underlying medical conditions. The vaccine was generally well-tolerated, with the most frequently-reported adverse events being injection site pain, fatigue, myalgia, arthralgia and headaches – however, these were all generally mild to moderate and transient.
Neale Belson, senior vice president and general manager UK at GSK, commented: “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.”
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