EMA Confirms Positive Benefit-Risk Balance Of Rotarix

22nd Jul 2010 16:38

LONDON (Dow Jones)--The European Medicines Agency or EMA said Thursday that following a review of the oral vaccine Rotarix, the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has concluded that the vaccine continues to have a positive benefit-risk balance and that the presence of a very small amount of viral particles does not present a risk to public health. MAIN FACTS: -Results from a very large clinical study database, together with safety data from millions of children who have already received the vaccine, show no safety concern with the vaccine. -Rotarix is a vaccine given by mouth to children of 6 weeks and older, to protect against gastroenteritis (diarrhoea and vomiting) due to rotavirus infection. -Data from tests carried out by the manufacturer, GlaxoSmithKline Biologicals S.A., showed that the vaccine contained only very small amounts of live PCV--1. -The Committee concluded that the detection of PCV--1 did not change the benefit-risk balance of Rotarix, and noted that the vaccine is effective in preventing rotavirus infections which are responsible for half a million deaths each year, mostly in developing countries. -However, since PCV-1 should not be present in the Rotarix vaccine, the manufacturer has proposed measures to manufacture the vaccine free of the virus. -By Razak Musah Baba, Dow Jones Newswires; 44-20-7842-9275; [email protected] (END) Dow Jones Newswires July 22, 2010 11:38 ET (15:38 GMT)