GlaxoSmithKline's shingles vaccine Shingrix gains approval in Europe, Japan

GlaxoSmithKline reported Friday that Shingrix gained approval in Europe and Japan for the prevention of shingles in adults aged 50 years or older. The non-live, recombinant subunit adjuvanted vaccine, which is given intramuscularly in two doses, was also cleared in Europe to prevent post-herpetic neuralgia. In Japan, the vaccine will be marketed by Japan Vaccine, a joint venture between GlaxoSmithKline and Daiichi Sankyo.  

Thomas Breuer, chief medical officer of GSK Vaccines, remarked "the approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents," adding "it has shown over 90 percent efficacy across all age groups studied for the prevention of shingles, a painful and potentially serious disease that affects around one in three people."  

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The safety and efficacy of the vaccine were previously demonstrated in the ZOE-50, ZOE-70 and Zoster-048 clinical studies, with the European filing involving more than 37 000 participants, including data from the ZOE-50 and ZOE-70 studies. Specifically results from ZOE-50 showed that a two-dose schedule of Shingrix reduced the risk of herpes zoster by 97.2 percent in adults aged 50 years and older compared to placebo, while in the ZOE-70 trial, the vaccine demonstrated 90-percent efficacy against shingles versus placebo in people aged 70 years and over. 

Shingrix was approved in the US and Canada in October last year 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. 

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