GSK’s RSV vaccine candidate gains positive EMA CHMP opinion

pharmafile | April 27, 2023 | News story | Medical Communications  

GSK has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has shared a positive opinion on its respiratory syncytial virus (RSV) vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60.

This positive opinion is a pivotal step in GSK receiving marketing authorisation prior to approval by the European Commission (EC).

Currently, there are no RSV vaccines or specific treatments available to older adults, despite the fact that it causes over 270,000 hospitalisations and around 20,000 in-hospital deaths each year in adults over 60 in Europe. If it receives approval, GSK’s vaccine is likely to become the first available to protect older adults from the disease.

A final decision is expected from the EC by July 2023, as the company’s marketing authorisation application has been reviewed under accelerated assessment due to its interest for public health and therapeutic innovation.

According to the press release: “The positive opinion is supported by data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 vaccine efficacy trial. In the trial, the vaccine candidate showed 82.6% (96.95% Cl, 57.9-94.1, 7 of 12,466 vs 40 of 12,494) overall vaccine efficacy against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. […] The vaccine was generally well-tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache and arthralgia. These were generally mild to moderate and transient.”


Betsy Goodfellow

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