GSK says FDA Advisory Committee supports effectiveness and safety of RSV vaccine

GSK plc announced that the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee, or VRBPAC, voted that the available data support the safety and effectiveness of GSK‘s respiratory syncytial virus, or RSV, older adult vaccine candidate for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older. The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety. Phil Dormitzer, Global Head of Vaccines R&D, GSK said: "Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems. Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications. We’re delighted that the Advisory Committee recognized the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine."