European marketing authorization for the first RSV vaccine

European marketing authorization for the first RSV vaccine

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    This is an announcement from the European Medicines Agency (EMA): it recommends the marketing authorization of the very first vaccine against the respiratory syncytial virus, in people aged 60 and over.

    Developed by GSK laboratories, the very first vaccine against the respiratory syncytial virus (RSV) has just received a marketing authorization recommendation from the EMA. From now on, Arexvy, that’s its name, must wait for the approval of the European Commission to be put on the market.

    Authorization based on a study of more than 25,000 people

    This Arexvy vaccine is intended for people aged 60 and over to immunize them against respiratory conditions caused by RSV. The EMA made its findings based on one study, a randomized trial including 25,000 adults in 17 countries. The development of such a vaccine is an important advance because in Europe, RSV is the cause, each year, of 250,000 hospitalizations and 17,000 deaths among people aged 65 and over.

    Mild and minor side effects

    According to the results of this work, still in progress, the vaccine confers protection that reaches 83% for a period of at least six months. Side effects are classic, with muscle and joint pain, headache, fatigue and pain at the injection site. Scientists now want to determine the duration of the effectiveness of a single dose and the time required before a new injection.

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