GSK’s RSV Vaccine Approved in Europe

On Jan. 26, 2026, GSK announced that the European Commission has approved the company’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, for use in adults aged 18 years and older in the European Union (1). Previously approved in the European Economic Areato prevent lower respiratory tract disease (LRTD) caused by RSV foradults aged 60 years and above and adults aged 50 to 59 years who are at increased risk for RSV disease, the new indication makes the vaccine available to all adults who are 18 and older.

How serious is RSV?

According to GSK, RSV, a contagious virus that affects the lungs, causes an average of 158,000 adults to be hospitalized each year in the EU and an estimated 64 million people globally (1–3). RSV can have a higher risk of complications in adults, compared to children, including a higher fatality rate, especially those with chronic conditions such as asthma and chronic obstructive pulmonary disease (COPD) (1).

“This approval helps protect all adults aged 18 and older in Europe against RSV, a potentially serious respiratory infection that can lead to significant illness, hospitalization, and even death, particularly for those with certain underlying health conditions,” Sanjay Gurunathan, GSK head of Vaccines and Infectious Diseases Research and Development, said in a press release (1). “GSK is proud to expand prevention options against RSV across Europe.”

The company is seeking expanded indications for Arexvy in other areas of the world including the United States and Japan.

What other GSK respiratory treatments have been approved?

On Jan. 23, 2026, GSK announced that a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium /vilanterol ‘FF/UMEC/VI’) was approved by China’s National Medical Products Administration (NMPA) (4) in 100/62.5/25mcg strength for both asthma and COPD indications and in 200/62.5/25mcg strength for asthma only.The new indication for the treatment of asthma in adults aged 18 and older makes it the first and only single inhaler triple maintenance therapy approved for COPD and asthma in China.

“Early intervention with a single inhaler triple therapy can improve clinical outcomes for suitable patients with uncontrolled asthma,” Kaivan Khavandi, Senior Vice President, Global Head, Respiratory, Immunology and Inflammation, R&D said in a press release at the time (4). “Today’s approval gives patients whose condition is not optimally managed, and therefore at increased risk of experiencing exacerbations, an important option in their care. As a company, we are committed to help change the course of disease and make clinical remission, where patients’ disease has sustained control, an ambitious but attainable treatment goal.”

FF/UMEC/VI was approved in China in 2019 for maintenance treatment of COPD and is a combination of three molecules in a single inhaler. It is taken in a single inhalation via GSK’s Ellipta dry powder inhaler once a day and contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist.

References

1. GSK. GSK’s RSV Vaccine, Arexvy, Receives European Approval for Expanded Use in All Adults 18 Years and Older. Press Release. Jan. 26, 2026. https://www.gsk.com/en-gb/media/press-releases/gsk-s-rsv-vaccine-arexvy-receives-european-approval-for-expanded-use-in-all-adults-18-years-and-older/
2. Osei-Yeboah, R.; et al. Estimation of the Number of Respiratory Syncytial Virus–Associated Hospitalizations in Adults in the European Union. J Infect Dis. 2023;228(11):1539–1548.
3. National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv.
4. GSK. Trelegy Ellipta Approved in China for Use in Adults with Uncontrolled Asthma. Press Release. Jan. 23, 2026. https://www.gsk.com/en-gb/media/press-releases/trelegy-ellipta-approved-in-china/