November 30, 2009 / 8:45 AM / 11 years ago

UPDATE 1-GSK files rotavirus vaccine for approval in Japan

* First rotavirus vaccine to be filed for approval in Japan

* WHO recommends rotavirus vaccines for all children

(Adds details and background)

LONDON, Nov 30 (Reuters) - GlaxoSmithKline Plc (GSK.L) has filed for approval in Japan of its Rotarix vaccine to prevent rotavirus gastroenteritis, a leading cause of severe gastroenteritis, including vomiting and diarrhoea, in children.

The vaccine, which is given orally, is the first to be filed for approval for the prevention of rotavirus gastroenteritis in infants in Japan, the British drug firm said in a statement on Monday.

The Geneva-based World Health Organisation (WHO) recommended in June that oral rotavirus vaccines be included in all national immunisation programmes to avert half a million deaths from diarrhoea deaths and 2 million hospitalisations a year.

The WHO’s new global guidance was expected to boost demand in Africa and Asia for GlaxoSmithKline’s (GSK.L) Rotarix and for another rotavirus made by Merck (MRK.N), called RotaTeq.

Rotavirus is a contagious infection that kills an estimated 1,600 children under the age of five every day, mostly in Africa and Asia.

GSK said this was its third potential vaccine in Japan following the approval of Cervarix for the prevention of cervical cancer in October 2009 and the filing of its pandemic influenza H1N1 flu vaccine on Oct. 16, 2009. (Reporting by Kate Kelland, editing by Will Waterman) ((; +44 (0)7990 567 059)) ((For more news, please click here [GSK.L]))

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