European Medicines Agency maintains position on the continued use of Rotarix™ (rotavirus vaccine)
GlaxoSmithKline (GSK) today confirmed that following a meeting of the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA) has maintained its position that there is no evidence that the presence of porcine circovirus (PCV) in Rotarix™ presents a risk to public health and that there is no need to restrict its use in the European Union. This announcement is in line with the assessment of the US Food and Drug Administration earlier this month which stated that the benefits of the rotavirus vaccines are substantial, and include prevention of death in some parts of the world and hospitalisation for severe rotavirus disease in the United States.
Thomas Breuer, Head of Global Development, GSK Biologicals said: “The announcement today by the EMA is further confirmation that the benefit/risk profile of Rotarix remains positive and unchanged. The availability of rotavirus vaccines is critical from a public health perspective and GSK is dedicated to continuing to work with the EMA and other regulatory agencies around the world to help protect to children from rotavirus disease.”
Rotavirus is the leading cause of severe gastroenteritis among children below five years of age. It is estimated that more than half a million children die of rotavirus gastroenteritis each year, a child a minute worldwide.1,2 It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade.3 A randomised, double-blind, placebo-controlled study conducted in six European countries (Czech Republic, Finland, France, Germany, Italy and Spain) demonstrated that, during the first year of life, the efficacy of Rotarix against severe rotavirus gastroenteritis (RVGE) was 96% (95.8%) and against hospitalisation due to RVGE was 100%.4,5
Notes to Editors
Rotarix is a two-dose, orally-administered vaccine that offers protection against rotavirus to infants and children. More than 69 million doses of the vaccine have been distributed globally. The safety profile of Rotarix is based on extensive clinical data from the largest vaccine clinical trial program conducted by GSK, enrolling more than 90,000 participants in Europe, Latin America, Asia, Africa, and the U.S.5
Rotavirus is the leading cause of severe gastroenteritis among children below five years of age and a major disease burden in developing countries.1.2It is estimated that more than half a million children die of rotavirus gastroenteritis each year, a child a minute worldwide. Of these deaths, 90% occur in Asia and Africa. More than 100,000 deaths each year occur in India and sub-Saharan Africa and 35,000 in China.6 It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade.4
Globally, 25% to 55% of all children under the age of five hospitalized with diarrhoea or acute gastroenteritis are infected with rotavirus.6
GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. For further information please visit www.gsk.com.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2009.
1. Parashar UD, Bresee JS, Gentsch JR, Glass RI. Rotavirus. Emerg Infect Dis. 1998 Oct-Dec;4(4):561-70.
2. Bresee JS, Hummelman E, Nelson EA, Glass RI. Rotavirus in Asia: the value of surveillance for informing decisions about the introduction of new vaccines. The Journal of infectious diseases. 2005 Sep 1;192 Suppl 1:S1-5.
3. Santosham, M. Rotavirus Vaccine—A Powerful Tool to Combat Deaths from Diarrhea. New England Journal of Medicine; 2010: 362:4.
4. Vesikari T, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63.
5. RotarixTM Summary of Product Characteristics. 2006.
6. Glass RI, Bresee JS, Turcios R, Fischer TK, Parashar UD, Steele AD. Rotavirus vaccines: targeting the developing world. The Journal of infectious diseases. 2005 Sep 1;192 Suppl 1:S160-6
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