Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline (GSK) has said that the European Medicines Agency (EMA) has maintained its position that there is no evidence that the presence of porcine circovirus (PCV) in Rotarix vaccine presents a risk to public health and that there is no need to restrict its use in the European Union.
Subscribe to our email newsletter
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.”