GSK Rotarix is a two-dose, orally-administered vaccine that offers protection against rotavirus to infants and children. Reportedly, more than 69 million doses of the vaccine have been distributed globally.
It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths globally over the next decade.
GSK has said that this statement was in line with the assessment of FDA earlier this month which stated that the benefits of the rotavirus vaccines were substantial, and include prevention of death in some parts of the world and hospitalisation for severe rotavirus disease in the US.
Thomas Breuer, head of global development at 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.”