GSK’s RSV Vaccine, Arexvy is now approved for all adults in Europe | iPharmaCenter

GSK’s RSV Vaccine, Arexvy is now approved for all European adults

The European Commission has approved GSK’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for expanded use in adults aged 18 years and older. This update broadens the vaccine’s original authorization, which previously covered adults aged 60 years and above as well as individuals aged 50 to 59 years considered at higher risk for RSV-related lower respiratory tract disease (LRTD). With this latest decision, every adult in the European Union aged 18 and over becomes eligible to receive the vaccine.

Across the EU, approximately 158,000 adults are hospitalized each year due to illnesses linked to the RSV virus. Unlike children, adults admitted for RSV often face greater health complications, higher treatment costs, and increased mortality risk. Experts also believe the actual number of adult RSV hospitalizations is higher than reported, as routine testing for RSV infections in adults remains limited.

GSK is pursuing additional regulatory extensions for Arexvy in other regions, including the United States and Japan.

Details About the Vaccine Arexvy

Arexvy is a recombinant RSV vaccine formulated with an antigen based on the stabilized prefusion form of the RSV F glycoprotein (RSVPreF3) combined with GSK’s proprietary adjuvant system, AS01E. The adjuvant enhances immune response, helping the body build protection against the virus.

The vaccine is intended for use according to official national immunization guidelines, and as with all vaccines, not every individual may achieve complete immune protection following vaccination.

To date, Arexvy has received approval for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 years and older in more than 65 countries. It is also authorized for adults aged 50 to 59 years with underlying medical conditions that increase RSV risk in over 60 nations, including Japan and the United States.

RSV and Its Impact on Adults

Respiratory syncytial virus is a highly transmissible viral infection that affects the lungs and respiratory passages. It is estimated to infect around 64 million people globally each year across all ages. Adults face heightened vulnerability if they have chronic health conditions, compromised immune systems, or advanced age. Infections can worsen diseases such as asthma, chronic obstructive pulmonary disease (COPD), or heart failure, and in severe cases, can result in pneumonia, hospitalization, or death.