Additional information on Rotarix vaccine


The European Medicines Agency (EMA) at a special meeting of its Committee for Medicinal Products for Human Use held on 25 March 2010 concluded that the unexpected presence of the DNA fragments of a non-pathogenic virus strain in two lots of the oral vaccine Rotarix did not represent any public health concern and that no restrictions need to be put in place in connection with the use of this vaccine.

Rotarix is an oral vaccine intended for children aged 6 weeks and older for protection from gastroenteritis (diarrhoea and vomiting), caused by rotavirus infection.

There was unexpected presence of the DNA fragments of the porcine type 1 circo virus (non-pathogenic virus strain) in the vaccine. This virus is often found in meat and other food products and it is not known to cause any disease in animals or in humans. The DNA in question was not found in other live attenuated vaccines of the same manufacturer, GSK Biologicals.

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 determine the origin of the viral DNA and to undertake necessary measures in the production so as to avoid its presence in the vaccine.

The Committee will review the new data and discuss the need for additional recommendations at the regular meetings in April and May 2010.

The Agency for Medicinal Products and Medical Devices 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.

The first information issued by the Agency for Medicinal Products and Medical Devices about Rotarix vaccine can be accessed from the following link.