GlaxoSmithKline announced that the European Commission has approved Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults aged 50 years or older. The Japanese Ministry of Health, Labour and Welfare (MHLW) has also approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older.
Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses. In Japan, the vaccine is registered to the Japan Vaccine Co., Ltd., a joint venture of GlaxoSmithKline and Daiichi Sankyo Co., Ltd.
Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age.
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: “The approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents. It has shown over 90% efficacy across all age groups studied for the prevention of shingles, a painful and potentially serious disease that affects around one in three people.
Shingrix is the first approved shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.
Shingrix was approved in the US and Canada in October 2017 and has been recommended by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older.