EMA Committee Recommends Expanding GSK's RSV Vaccine to All Adults 18 and Over
Key Insights
The European Medicines Agency (search)'s CHMP (search) has recommended expanding GSK's Arexvy RSV (search) vaccine indication to include all adults aged 18 and over, extending from its current approval for those 50 and older.
The expanded approval, expected in February 2026, would put Arexvy on equal footing with Pfizer's Abrysvo and Moderna's mResvia, which are already approved for the 18+ age group.
RSV (search) causes an average of 158,000 hospitalizations annually in adults aged 18 and over across the EU, with adults facing higher risks of severe complications compared to children.
The European Medicines Agency (search)'s Committee for Medicinal Products for Human Use (CHMP (search)) has recommended expanding the indication for GSK's respiratory syncytial virus (search) vaccine Arexvy to include all adults aged 18 and over, marking a significant broadening from its current approval for individuals aged 50 and older.
The recommendation positions GSK to compete more effectively in the adult RSV (search) vaccine market, as the expanded approval would put Arexvy on equal footing with Pfizer's Abrysvo and Moderna's mResvia, both of which are already approved for use in the 18 and over age group. The European Commission's final decision is expected in February 2026.
Market Performance and Competitive Landscape
Arexvy has emerged as a key growth driver for GSK's vaccines business, contributing £251 million ($286 million) in third-quarter sales, representing a 36% increase from the prior year. This growth has been primarily driven by demand outside the US, which has experienced weak demand following changes to immunization recommendations and an increasingly challenging regulatory environment for vaccines.
In comparison, Pfizer reported that total third-quarter sales of Abrysvo fell 22% to $279 million, though the company saw a 75% increase in ex-US sales. Pfizer's shot holds the additional distinction of being approved for use in pregnancy to protect infants from birth up to six months of age. Moderna's mResvia recorded significantly lower sales of just $2 million in the same period.
Clinical Significance and Disease Burden
RSV (search) represents a substantial healthcare burden across Europe, causing hundreds of thousands of hospitalizations annually, particularly affecting infants under five and older adults. According to a 2023 paper published in the Journal of Infectious Diseases, an average of 158,000 adults aged 18 and over are hospitalized in the EU due to RSV infections each year, highlighting what the authors described as "an important finding in a condition considered in the past to be primarily a disease of young children."
While serious RSV (search) disease in younger adults is relatively rare, the risk increases significantly in individuals with underlying chronic conditions, including obesity (search), diabetes (search), chronic obstructive pulmonary disease (search) (COPD (search)), heart failure (search), chronic kidney disease (search), and asthma (search). Adults hospitalized for RSV face higher risks of severe complications compared to children, require more costly treatments, and have a higher fatality rate.
Vaccine Technology and Regulatory Status
Arexvy was the first RSV (search) vaccine approved in Europe for preventing lower respiratory tract disease (search) caused by RSV in adults, initially approved for those over 60 and subsequently expanded to include people aged 50 to 59 who are at elevated risk of RSV disease.
The vaccine contains recombinant RSV glycoprotein F (search) stabilized in the prefusion conformation (RSVPreF3), combined with GSK's proprietary AS01E adjuvant system. The vaccine has received approval for preventing RSV (search)-related lower respiratory tract disease (search) in individuals 60 years and older in more than 65 countries, and for use in those aged 50-59 with increased risk due to underlying medical conditions in more than 55 countries, including the US, Japan, and Europe.
"Today's positive CHMP (search) opinion is an important step towards bringing more options to prevent severe RSV (search) disease for adults in Europe," said Sanjay Gurunathan, head of vaccines and infectious diseases R&D at GSK. "GSK is dedicated to increasing access to our vaccines in broader adult populations and we continue to drive innovation to help make it easier for healthcare professionals to offer protection against severe RSV disease."
GSK continues to pursue expanded indications for its RSV (search) vaccine in other geographies, including the US and Japan, as the company seeks to broaden access to RSV prevention across adult populations globally.