GlaxoSmithKline (GSK) 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. It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade. 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%.

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 US.

Rotavirus is the leading cause of severe gastroenteritis among children below five years of age and a major disease burden in developing countries.It 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. It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade.

Globally, 25% to 55% of all children under the age of five hospitalized with diarrhoea or acute gastroenteritis are infected with rotavirus.