Press release concerning the new information on Rotarix vaccine


The European Medicines Agency (EMA) issued a press release concerning the new information provided by GlaxoSmithKline Biologicals, manufacturer of Rotarix vaccine. The information concerns unexpected presence of porcine circo virus type 1 DNA (non-pathogenic virus strain) in two lots of the vaccine. This vaccine is often found in meat and other food products and it is not known to cause any disease in animals or in humans.

On 17 March 2010, the Committee for Medicinal Products for Human Use of the EMA discussed the available data and concluded that at the moment it was not necessary to undertake any further steps. The Committee stressed that these data did not represent any public health risk and that there were no safety signals that would indicate otherwise.

However, it is clear that the viral DNA should not be present in the vaccine and that its origin in the vaccine is unclear. Therefore, the Committee asked the manufacturer to provide additional information urgently.

The Working Group on Vaccines of the EMA's Committee for Medicinal Products for Human Use will meet on 23-24 March 2010, and the representatives of the World Health Organisation (WHO) and regulators from Canada and the USA will be present at the meeting. Further steps will be agreed on the special meeting of the Committee, which will take place on 25 March 2010.

Rotarix is an oral vaccine intended for children aged 6 weeks and older for protection from gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.
The WHO estimates that rotavirus is responsible for about 527 000 deaths each year, with over 85% of these deaths occurring in African and Asian countries.

Rotarix was authorised for marketing in the European Union in February 2006, and in the Republic of Croatia in June 2008. Rotarix vaccine is usually not included in the children vaccination programme in the EU Member Countries, nor is it included in the mandatory vaccination programme in the Republic of Croatia. Approximately 100.000 children received this new vaccine during the clinical trials and around 68 million doses have been distributed around the world to this date.

The Agency for Medicinal Products and Medical Devices did not observe in Croatia any sign that would indicate any changes in the vaccine safety profile. The Agency will continue to monitor the safe use of Rotarix vaccine and promptly inform the public in case any additional measures are required.

The EMA press release is available here.