Key Highlights :
GSK's RSV vaccine, Arexvy, is undergoing EMA review for expanded use in adults 18+.
EU regulator will be poised to make a decision in the first half of 2026.
Key Background :
Arexvy is GSK's pipeline lead RSV vaccine and is already approved in the European Union for administration in adults of 60 years and older, and high-risk adults aged 50-59 years. The vaccine will be used to offer protection against RSV, a seasonal and widespread respiratory virus that can cause serious illness, particularly in older individuals and those with weakened health.
After poor first-quarter sales and slow commercial adoption, GSK wants to add an indication for the vaccine in all adults aged 18 and above. Indication expansion to young adults, especially those with risk factors, may entice a greater portion of the RSV market and uncover unmet medical needs.
Competition is also changing at a very fast pace. Merck has only obtained U.S. approval for its RSV vaccine for high-risk adults between 18 and 59 years of age. Pfizer has followed suit with a vaccine for these same patients. GSK's decision to add indications for Arexvy seems timely and strategic given that these rivals are making advances in American and international markets.
Despite the initial sales debacle, GSK is still confident in the long-term prospects of Arexvy. Wider approval will be an important route to delivering greater take-up in subsequent RSV seasons, getting closer to GSK's initial sales estimates and positioning it as a vaccine market contender.
A favorable EMA opinion would not only bring more access to RSV protection to more adults but also be a business and public health victory for GSK. The choice, due in 2026, can potentially ride on the company's regulatory strategy as it paves the way for its vaccine business.