Unanimous FDA advisory panel vote for Shingrix approval

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration on Thursday voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over, UK pharma major GlaxoSmithKline (LSE: GSK) has announced.

Panel members said they were "very impressed" by efficacy data from Shingrix clinical trials, and that it represents an improvement over Zostavax, the only marketed shingles prevention vaccine from Merck & Co (NYSE: MRK). However, the panelists also expressed concern that the vast majority of trial subjects were white, saying they would like to see more data for other population groups.

Dr Emmanuel Hanon, senior vice president and head of vaccines R&D, for GSK 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.”