FDA committee recommends GSK shingles vaccine
StockMarketWire.com - GlaxoSmithKline has announced that the US Food and Drug Administration's vaccines and related biological products advisory committee has voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults aged 50 and over.
FDA advisory committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA.
GSK senior vice-president and head of vaccines R&D, Dr. Emmanuel Hanon, said: "Shingles is a painful and potentially serious condition.
"The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles.
"Today's vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system."
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