Posted by Michael Wonder on 27 Jan 2018
GSK’s Shingrix receives positive opinion from the CHMP in Europe for the prevention of shingles in adults aged 50 and over
26 January 2018 - GlaxoSmithKline today announced that the EMA's CHMP has issued a positive opinion recommending marketing authorisation for Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN), the most common and often painful shingles-related complication, in adults aged 50 years or older.
Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses, with a two-to-six month interval between doses.
Shingrix was approved in Canada and the US in October 2017 and has been recommended by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older. Regulatory reviews of the vaccine are currently underway in Australia and Japan.
