The U.S. Food and Drug Administration (FDA) warned doctors and parents not to give patients Rotarix, a vaccine used to prevent rotavirus disease, until the agency can learn more about the presence of an extraneous virus in the vaccine that may pose a safety risk. According to a Rotarix Vaccine update issued by the FDA, the agency learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans and there is no evidence at this time that this finding poses a safety risk. However, the agency is suspending use of the vaccine as a precaution until an investigation can be done.

Rotavirus is one of the most common causes of diarrhea and severe gastrointestinal infection and is the leading cause of severe, dehydrating diarrhea in infants and young children. Most children have had a rotavirus infection by the time they are five. There are two licensed vaccines for rotavirus in the United States – RotaTeq and Rotarix. Both are given by mouth in a series of doses during the first year of life. The FDA advises that children who have received one dose of Rotarix should complete the series with RotaTeq. No medical follow-up is necessary for those who have received Rotarix. The FDA says clinical studies involving tens of thousands of patients supports the safety of the vaccine in question.

RotaTeq was licensed in 2006 and Rotarix in 2008. Thus, most children were vaccinated with RotaTeq. RotaTeq is made from different materials than Rotarix and there is no evdence that DNA from PCV1 is present in RotaTeq.

Parents with questions should consult their child’s doctor or nurse. The FDA is expected to announce its recommendations for Rotarix in the next  four to six weeks at www.FDA.gov.