The Hindu Business Line : Merck-PATH duo to conduct clinical trials for rotavirus vaccine

MERCK & Co and international non-profit organisation PATH will work together to conduct clinical studies of the former's investigational rotavirus vaccine, Rotateq, in some developing nations.

The announcement was made at the Global Alliance for Vaccines and Immunisation (GAVI Alliance) partners meeting. Rotavirus is the most common cause of severe dehydrating diarrhoea in infants and children. World-wide, among children under five, it is estimated to be responsible for two million hospitalisations, five lakh deaths and more than 25 million clinic visits every year.

Efficacy studies: Clinical trial sites will be identified in Africa and Asia over the next six months, with the goal of starting at least one trial by the end of 2006. Efficacy studies of Rotateq will be conducted in regions where it has not been studied before and where factors, including poor nutrition and the presence of intestinal bacteria or viruses, might play a role in the response to the vaccine. The studies also will assess how Rotateq fits into the range of childhood vaccine schedules used in different countries.

In a statement, Dr Adel A.F. Mahmoud, Chief Medical Advisor, Vaccines and Infectious Diseases, Merck & Co, said: "Merck is as committed to identifying innovative ways to bring our vaccines to children in the developing world as we are to developing the innovative vaccines themselves."

Added Mr John Wecker, Director of PATH's Rotavirus Vaccine Programme: "We're pleased to partner with Merck on this important initiative and it is our hope that demonstrating the impact of rotavirus vaccines in developing countries will ultimately reduce the potentially serious effects of this disease on children."

Rotavirus infections occur both in industrialised and developing countries. However, life-saving intravenous treatments to rehydrate children with severe rotavirus diarrhoea are often unavailable. Consequently, both the World Health Organisation (WHO) and the Pan American Health Organisation (PAHO) believe that availability of a rotavirus vaccine will be a major contribution to children around the world.

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