GlaxoSmithKline plc's (LON: GSK) Shingrix has received approval from the European Commission (EC) and the Japanese Ministry of Health, Labour and Welfare (MHLW), the company announced on Friday.
The EC approved Shingrix as a prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults aged 50 years and older.
Meanwhile, the Japanese MHLW approved the vaccine as a prevention of shingles in adults aged 50 and above. In Japan, the vaccine is registered to the Japan Vaccine Co Ltd, a joint venture between GSK and Daiichi Sankyo Co Ltd (TYO: 4568).
Shingrix is a non-live, recombinant subunit adjuvanted vaccine that is given intramuscularly in two doses. It is the first approved shingles vaccine to combine a non-live antigen, triggering a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.
The vaccine was approved in the US and in Canada in October 2017. It has also been recommended by the US Centers for Disease Control and Prevention's Advisory Committee on Immunisation Practices as the preferred vaccine for the prevention of shingles and related complications for immunocompetent adults aged 50 and older.
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