(ANSA) – ROME, APRIL 27 – The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion on the approval of Gsk’s vaccine against respiratory syncytial virus in over- 60 years. This was announced by the company, which anticipated that the final go-ahead from the European Commission is expected by next July.
Respiratory syncytial virus causes 270,000 hospitalizations and around 20,000 hospital deaths in adults aged 60 years and over in Europe each year. To date, there are no vaccines available to prevent the infection and its complications in this age group.
The CHMP’s decision is based on data from the AReSVi-006 phase III clinical study which showed a vaccine efficacy of 82.6% in the over 60s; efficacy was 94.6% in older adults with at least one underlying disease, such as cardiorespiratory or metabolic disease. The vaccine was generally well tolerated with an acceptable safety profile; the most common adverse events were injection site pain, fatigue, muscle and joint pain, and headache.
The vaccine is also currently under review by other regulatory authorities such as the US Food and Drug Administration. (HANDLE).
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