Components of PCV1 Detected in Human Rotavirus Vaccine; No Known Safety Risk

March 31, 2010 — 

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline. PCV1 is not known to cause illness in humans or other animals. In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

Subsequent testing has confirmed that viral components have been present since the early stages of the vaccine's development, including during clinical studies. It has not been determined whether the viral components detected include intact virus or just DNA fragments.

A recent epidemiological study of PCV1 and PCV2 in the U.S. swine herd, conducted by researchers at the University of Minnesota and funded by the National Pork Board, showed that PCV1 is essentially absent from pigs in the USA. The manuscript is currently under review for publication.

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year. FDA licensed RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the United States received RotaTeq.

For more information; http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm205585.htm