GSK plc (LSE/NYSE: GSK) has made a significant announcement regarding its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended an expansion of the vaccine’s indication to include all adults aged 18 years and older. The final decision from the European Commission is anticipated in February 2026, which, if approved, would broaden access to the vaccine among a wider adult demographic.
Previously, GSK’s RSV vaccine, known as Arexvy, was the first of its kind authorized in Europe to prevent lower respiratory tract disease (LRTD) caused by RSV, specifically for those aged 60 and above, as well as for adults aged 50-59 who are considered at higher risk for RSV-related complications.
Sanjay Gurunathan, GSK’s Head of Vaccines and Infectious Diseases Research and Development, expressed optimism over the CHMP’s opinion, emphasizing the importance of enhancing options for preventing severe RSV disease among adults in Europe. He noted GSK’s commitment to improving access and fostering innovation in vaccination to aid healthcare professionals in addressing severe RSV disease.
Respiratory syncytial virus (RSV) is a widespread, contagious virus that impacts the lungs and air passages, affecting an estimated 64 million people globally each year. In the European Union alone, approximately 158,000 adults aged 18 and older are hospitalized annually due to RSV infections. Adults face a greater risk of significant health complications from RSV than children, often requiring more advanced treatment and experiencing higher mortality rates; experts caution that hospitalization figures may be underestimated due to inadequate routine testing.
In light of these concerns, GSK is pursuing expanded indications for its RSV vaccine across various international markets, including the United States and Japan.
The RSV vaccine employs recombinant RSV glycoprotein F, stabilized in its prefusion configuration (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant. The vaccine is currently approved for adults over 60 in over 65 countries and for at-risk individuals aged 50-59 in more than 55 countries, including the US, Japan, and various European nations.
Healthcare professionals are advised to administer the vaccine following official guidelines, bearing in mind that not all vaccinated individuals may achieve a protective immune response.
GSK remains focused on its mission as a global biopharmaceutical company, aiming to integrate science, technology, and talent to combat diseases effectively. With ongoing efforts to expand access to RSV vaccination, the company underscores the urgency of addressing the substantial public health challenge posed by this virus, particularly among adult populations with pre-existing health conditions or advanced age.
