March 23, 2010

US FDA: Evidence of porcine circovirus in rotavirus vaccine does not pose public health risk

The US Food and Drug Administration (FDA) has temporarily suspended use of the Rotarix® rotavirus vaccine, pending further investigation of the presence of porcine circovirus within the vaccine. Porcine circovirus is commonly found in meat and other food products, and is not known to cause disease in either humans or other animals. The FDA stressed that there is no evidence of an associated health risk. An investigation by the European Medicines Agency similarly concluded that there is no evidence of a public health risk, and the World Health Organization concurred with both the FDA and the European Medicines Agency.

While rotavirus occurs worldwide, developing countries suffer the greatest burden, with more than half a million children dying every year due to severe infections. Recent publications in the New England Journal of Medicine showed a substantial reduction in deaths of Mexican children due to diarrheal disease after the introduction of Rotarix®, and in clinical trials in impoverished, high-mortality communities in Africa, the vaccine significantly reduced severe rotavirus disease in African infants. Because of the tremendous burden of disease in developing countries, the director of the US Centers for Disease Control and Prevention stressed that the known benefits of continued use of Rotarix® far outweigh a theoretical risk of harm and encouraged its continued use in countries where rotavirus burden is acute.

The PATH Rotavirus Vaccine Trials Partnership is a collaboration between PATH, WHO, the US CDC, clinical study sites, and vaccine manufacturers. The partnership’s activities are funded by the GAVI Alliance.