GSK (NYSE: GSK) gains EU clearance to offer RSV vaccine Arexvy to all adults 18+
Rhea-AI Filing Summary
GSK plc reports that its RSV vaccine Arexvy has been approved by the European Commission for expanded use in adults aged 18 years and older. The vaccine was previously authorised in the European Economic Area for preventing lower respiratory tract disease caused by RSV in adults 60 and over and in adults 50 to 59 at increased risk.
This broader indication means European countries can now make Arexvy available to all adults 18+, potentially addressing a substantial disease burden. In the European Union, an average of 158,000 adults aged 18 and over are hospitalised each year with RSV-related illness. GSK notes that RSV can worsen chronic conditions such as COPD, asthma and chronic heart failure and can lead to pneumonia, hospitalisation and death.
The company highlights that Arexvy combines a recombinant RSV glycoprotein F antigen with GSK’s AS01E adjuvant, and that its use should follow official recommendations since not all vaccinees may develop protective immunity. GSK is also seeking expanded indications for this RSV vaccine in other geographies, including the US and Japan.
Positive
- European Commission approval expands Arexvy’s indication to all adults 18+, broadening potential use beyond previously approved higher‑risk and older age groups.
- Addresses a significant disease burden, with an average of 158,000 adults 18+ hospitalised annually in the EU for RSV-related illness, highlighting substantial potential public health impact.
Negative
- None.
Insights
EU approval broadens Arexvy’s addressable adult population and supports GSK’s RSV franchise.
The European Commission has approved Arexvy for adults aged 18 and older, expanding beyond prior labels limited to adults 60+ and 50–59 at increased risk. This turns a risk‑focused indication into a broad adult label, allowing European countries to offer the vaccine to the full adult population, subject to each market’s recommendations and policies. The move builds on Arexvy’s status as the first RSV vaccine authorised in the European Economic Area for prevention of RSV lower respiratory tract disease.
The filing cites an estimated average of 158,000 RSV‑related hospitalisations annually among adults 18+ in the EU, underscoring the potential public health relevance, especially given RSV’s ability to exacerbate COPD, asthma and chronic heart failure. The vaccine’s design, combining an RSVPreF3 antigen with the AS01E adjuvant, remains unchanged, and GSK cautions that not all recipients will mount a protective immune response.
GSK is also pursuing expanded indications in other key markets including the US and Japan, which, if granted, could further entrench its RSV position. Future disclosures in company filings may provide clarity on uptake patterns across adult age groups and how national recommendations in EU member states translate this broader authorization into real‑world vaccination programmes.
FAQ
What did GSK (GSK) announce about its RSV vaccine Arexvy in this 6-K?
GSK announced that the European Commission has approved its RSV vaccine Arexvy for use in all adults aged 18 years and older. Previously, the vaccine was authorised in the European Economic Area only for adults 60+ and adults 50–59 who are at increased risk for RSV disease.
How does the new European approval change Arexvy’s indicated population?
Arexvy’s indication has expanded from older and higher‑risk adults to all adults 18 years and older in the European Union and European Economic Area. This updated label allows European countries to make the vaccine available to the full adult population, according to their official recommendations.
How large is the RSV disease burden in European adults mentioned by GSK?
GSK cites research estimating that in the European Union an average of 158,000 adults aged 18 and over are hospitalised each year due to RSV infections. The company notes that adults hospitalised for RSV face higher risks of severe complications, more costly treatments and higher fatality rates than children.
In which other countries is GSK seeking expanded indications for Arexvy?
GSK states that it continues to seek expanded indications for its RSV vaccine in other geographies, including the United States and Japan. The vaccine is already approved for prevention of RSV lower respiratory tract disease in adults 60+ in more than 65 countries and in adults 50–59 at increased risk in more than 60 countries, including the US and Japan.
What is the composition of GSK’s RSV vaccine Arexvy?
Arexvy is described as a Respiratory Syncytial Virus Vaccine, Adjuvanted. It contains a recombinant RSV glycoprotein F antigen stabilised in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system. GSK notes that, as with any vaccine, a protective immune response may not be elicited in all vaccinees.
Why does GSK emphasize RSV risk in adults in this disclosure?
GSK highlights that RSV affects an estimated 64 million people of all ages globally every year and that adults can be at increased risk due to chronic conditions, immune compromise or advanced age. RSV can worsen COPD, asthma and chronic heart failure and lead to pneumonia, hospitalisation and death, underlining the rationale for vaccination in adults.
