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FDA Ad Com votes to support GSK RSV OA vaccine
FDA Ad Com votes to support GSK RSV OA vaccine.
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[{"type":"text","content":"\n \n \n Issued: 1 March 2023, London UK\n \n \n \n \n \n \n \n \n US FDA Advisory Committee votes to support effectiveness and safety of GSK's respiratory syncytial virus older adult vaccine candidate\n \n \n \n \n \n \n \n \n ·\n Committee votes unanimously that the data support the effectiveness of the vaccine, and 10-2 that the data support the safety of the vaccine\n \n \n ·\n FDA decision on US approval expected by 3 May 2023, with\n the potential for the vaccine to be the first approved for older adults\n \n \n ·\n Evidence reviewed by the Committee was supported by pivotal data recently published in the New England Journal of Medicine\n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA)\n Vaccines and Related Biological Products Advisory Committee (VRBPAC)\n voted that the available data support the safety and effectiveness of\n GSK's respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.\n \n \n \n Phil Dormitzer, Global Head of Vaccines R&D, GSK said\n \n : \"Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus\n that causes potentially debilitating disease and imposes a major burden on healthcare systems.\n Thousands of\n older adults in the US are\n impacted by RSV and\n those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications\n \n .\n \n We're delighted that the Advisory Committee recognised the strength of our vaccine's data and its potential to make a\n positive public health impact with a unanimous vote on the effectiveness of the vaccine.\"\n \n \n \n \n \n \n \n The Committee based its vote on the robust data package supporting the vaccine candidate. This includes results from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, recently published in the\n \n \n New England Journal of Medicine\n \n \n . In addition, GSK presented positive data on concomitant administration with seasonal quadrivalent influenza vaccination previously shared at IDWe...