The United States approved the drug, named Arexvy, last month, while the vaccine is the culmination of a decades-long hunt to protect vulnerable people from the common illness.
RSV normally causes mild, cold-like symptoms, but can be serious for infants and the elderly, as well as those with weak immune systems and underlying conditions.
In severe cases it can cause pneumonia and bronchiolitis, an inflammation of the small airways deep inside the lungs.
Analysts predict the market could be worth more than $10 billion in the next decade, with similar shots from other makers including Pfizer and Moderna expected to follow soon.
“This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time,” GSK’s chief scientific officer Tony Wood said in a statement.
GSK said RSV is “a common, contagious respiratory virus that leads to… approximately 20,000 in-hospital deaths each year in adults aged 60 years and over in Europe”.
The company’s shares traded flat in early London deals following the expected approval announcement.
Rates of RSV and flu fell during Covid-19 lockdowns, but surged when restrictions were lifted, with young children hit hard.
Stella Kyriakides, EU commissioner for health and food safety, said she hoped the vaccine would prevent problems encountered last winter.
“The Covid pandemic clearly showed the need for decisive action to better prepare the EU for emerging health threats,” she said in separate statement.
“I now encourage member states to quickly build on this authorisation and define national vaccination strategies so that those most at risk can access them in the coming months ahead of the next autumn season.”
The European Union’s drug watchdog in April recommended Arexvy’s approval following a trial on 25,000 participants in 17 countries.
The results showed that the vaccine was 83 percent effective at protecting against RSV-related diseases in people aged 60 years or over, with generally mild side effects, according to the European Medicines Agency.
The vaccine uses an engineered protein and an adjuvant substance to promote antibodies and T cells that help fight off RSV infection.
Moderna hopes its RSV vaccine will be approved and be made available by the end of the year.
The EU in 2022 approved a preventative treatment against RSV, developed by British pharmaceutical firm AstraZeneca and France’s Sanofi, which works similarly to a vaccine.
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