Posted by Michael Wonder on 21 Oct 2017
Shingrix approved in the US for prevention of shingles in adults aged 50 and over
20 October 2017 - Pooled clinical trial results showed > 90 percent efficacy across all age groups.
GlaxoSmithKline today announced that the US FDA has approved Shingrix (Zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
Approval of Shingrix is based on a comprehensive Phase III clinical trial program evaluating its efficacy, safety and immunogenicity in more than 38,000 people. In a pooled analysis of these studies, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years. By preventing shingles, Shingrix also reduced the overall incidence of post-herpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles.
