EMEA sees no safety concerns with GlaxoSmithKline's Rotarix oral vaccine; emphasises the importance of the European medicines network

The European Medicines Agency (EMEA) says it has concluded that the unexpected presence of DNA of a non-disease causing viral strain in batches of the oral vaccine Rotarix, made by UK drug giant GlaxoSmithKline, does not present a risk to public health. At an extraordinary meeting held on March 25, the Committee for Medicinal Products for Human Use (CHMP) endorsed the recommendations from its Vaccines Working Party and agreed that there was no need to restrict the use of Rotarix, which is given to children and infants to protect against rotavirus, which causes severe diarrhea and vomiting and is a leading killer of children in developing countries.