MHRA UK approves GSK vaccine for lower respiratory tract disease prevention

News Vaccines

Today, GSK (Middlesex, UK) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the vaccine Arexvy to aid in the immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults over the age of 60. This is the first time an RSV vaccine has been authorized by MHRA in Great Britain.

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 hospitalizations. This authorization 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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In the UK, an estimated 14,000 hospitalizations and 8,000 deaths in elderly adults aged 60 and over each year are caused by RSV. RSV is a common, contagious respiratory virus and recent studies have shown that the burden caused by RSV disease may be more significant than influenza in older adults that have been hospitalized. Additionally, those with existing medical conditions e.g. diabetes, lung disease, chronic heart disease, etc., drive the majority of hospitalizations.

The vaccine authorization is supported by data, published in the New England Journal of Medicine, from the Adult Respiratory Syncytial Virus Phase III vaccine efficacy trial. This trial found high efficacy against RSV-LRTD, including participants with underlying medical conditions, with the vaccine being well tolerated. The most frequently observed adverse events included fatigue, headache, injection site pain, myalgia and arthralgia, which ranged from generally mild to moderate and were short-lived.

Arexvy is the world’s first RSV vaccine approved by the US FDA and reviews are currently being conducted in Japan and several other countries.

Source: GSK press release, www.gsk.com/en-gb/media/press-releases/medicines-and-healthcare-products-regulatory-agency-authorises-gsk-s-arexvy-the-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/