The Technical Committee (CHMP) of the European Medicines Agency (EMA) has recommended extending the approval of GSK’s respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV, to adults aged 50 to 59 years at increased risk of infection by this virus. The pharmaceutical company announced this in a note, specifying that, once the next step is completed, with the marketing authorization of the European Commission, expected by September, this will be the first vaccine in the EU with this indication. Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) is in fact already approved in Europe, from June 2023, for adults aged 60 years and over for the prevention of RSV-LRTD.
RSV is a virus that affects the lungs and airways. Adults may be at increased risk of infection due to comorbidities, compromised immunity, or advanced age. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, leading to serious outcomes such as pneumonia, hospitalization, and death. Each year, RSV causes approximately 270,000 hospital admissions and 20,000 hospital deaths in adults aged 60 years and older in Europe. The burden of infection in adults aged 50 to 59 years, who are at increased risk of RSV infection, is similar to that of the general population aged 60 years and older.
The positive opinion of the CHMP is supported by the results of a phase 3 study evaluating the immune response and safety of the vaccine in adults, aged 50 to 59 years, including those at higher risk of RSV-LRTD with specific underlying clinical conditions. On June 7, Arexvy was approved by the US Agency (FDA) with this indication. Currently, the request for authorization for use in 50-59 year-olds at higher risk has been submitted by the pharmaceutical company in Japan. In other geographical areas, the practice is under review. The studies evaluating the immunogenicity and safety of the vaccine in adults aged 18 to 49 years at higher risk for particular medical conditions and in immunocompromised adults aged 18 years and older – the note concludes – should be published in the second half of 2024.
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