FDA panel backs GSK RSV vaccine ahead of approval

pharmafile | March 2, 2023 | News story | Medical Communications  

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine.

GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May.

The company’s vaccine is intended to prevent lower respiratory tract disease caused by RSV in adults aged 60 and over. The evidence presented to the committee was comprised of data from the pivotal AReSVi-006 phase 3 trial, which has been published in the New England Journal of Medicine. Following a review of this data, the Vaccines & Related Biologics Products Advisory Committee (VRBPAC) voted unanimously that it showed the candidate’s efficacy, with an additional 10:2 vote in support of the vaccine’s safety.

The vaccine candidate is also under review by various other regulatory agencies, including the EMA and Japan’s Ministry of Health, Labour and Welfare. Decisions from these regulatory bodies are expected throughout 2023.

Phil Dormitzer, global head of Vaccines Research & Development at GSK, commented: “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 conditions, are at increased risk of severe complications. We’re delighted that the Advisory Committee recognised 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.”


Betsy Goodfellow

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