Kenya tests rotavirus vaccine

NAIROBI, Kenya, Aug 18 - A new clinical trial on rotavirus vaccine in Kenya has shown it to prevent 83.4 percent of children from contracting severe rotavirus, the most common cause of severe diarrhoea among infants during the first year of life.

The Kenya Medical Research Institute-Centers for Disease Control and Prevention, served as a clinical research site for the African study, along with facilities in Ghana and Mali.

Pooled data from these sites estimated that rotavirus vaccination prevented 64 percent of severe rotavirus in the region during the first year of life, when children were at greatest risk for life-threatening diarrhoea.

"The toll of rotavirus in Sub-Saharan Africa is devastating," Kenya Paediatric Association National Chairman Dr Fred Were said.

"Rotavirus vaccines can have a powerful impact in our region, saving the lives of tens of thousands of children each year if they are used widely. WHO has recommended that all countries introduce rotavirus vaccines and now it is time for national governments throughout Africa to make rotavirus vaccines available for all of our children," Dr Were said.

Earlier this year, the government launched a policy reinforcing the comprehensive prevention and treatment recommendations for the diarrhoeal disease outlined by the World Health Organisation (WHO) and UNICEF, which include zinc supplementation and oral rehydration solution to treat diarrhoea-related dehydration, as well as rotavirus vaccines to prevent severe, life-threatening diarrhoea.

The new clinical studies examined the effectiveness of rotavirus vaccines in developing countries of Africa and Asia and were published in a leading medical journal "The Lancet."

The clinical studies conducted in Africa and Asia examined Merck & Co., Inc.'s orally administered, pentavalent rotavirus vaccine RotaTeq®.

"Rotavirus vaccination will be needed as part of a package of strategies to improve child survival and to achieve Millennium Development Goal 4," said Anthony Nelson, a Professor of pediatrics at Chinese University in a commentary accompanying the findings.

"Some countries that introduced rotavirus vaccines into their national programs early on have already begun to see tremendous benefit," he said.

More than 5,000 infants in Kenya, Ghana and Mali were enrolled in the study to evaluate the efficacy of the rotavirus vaccine in low-income, high-burden settings of Africa.

The Asian clinical study conducted in Bangladesh and Vietnam found that rotavirus vaccines reduced severe cases by 51 percent during the first year of life. More than 2,000 infants were enrolled in Asia.

"These findings support the WHO's recommendation for expanding use of rotavirus vaccines into the poorest nations in Asia and Africa where they can be of most benefit," said Dr Jean-Marie Okwo-Bele, Director Immunization, Vaccines and Biologicals at the World Health Organisation.

"Such vaccines have the potential to re-energize diarrhoeal control programs around the globe and make major strides toward stopping one of the leading killers of children," Dr Okwo-Bele said.

According to WHO estimates, rotavirus claimed more than 7,500 lives in Kenya in 2004. Annually, diarrhoeal diseases cause 20 percent of deaths among children under five years of age in the country.

"The evidence is clear; immunisation against rotavirus is one of the best ways to protect millions of children from severe, fatal diarrhoea," said Dr Tachi Yamada, President, Global Health Program at the Bill & Melinda Gates Foundation.

"Funders and political leaders must now ensure we can deliver the vaccines to the children who need them most," Dr Yamada said.

The clinical studies were coordinated and co-funded through a partnership between vaccine manufacturer Merck and the Rotavirus Vaccine Program, a collaboration between PATH, WHO, and the US Centers for Disease Control and Prevention, funded by the GAVI Alliance.