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The benefits of GlaxoSmithKline’s Rotarix and Merck & Co’s Rotateq outweigh any potential risks posed by the presence of porcine circovirus (PCV) DNA in the vaccines, a health panel has found.
Members of a Food and Drug Administration (FDA) advisory board said the products carried impressive positive effects, explaining the risk to humans was minimal.
Any risks “are at best theoretical,” said Dr Melinda Wharton, a panelist and deputy director of the Center for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
“Based on where we are with current knowledge, to me the known benefits clearly outweigh the risks.”
The news comes after the FDA in March advised doctors to stop using Rotarix following an instance when PCV was found in the vaccine. An internal investigation by Merck also discovered the DNA.
The regulator said it would issue its latest advice “in the very near future”.
PCV is common in pigs, where it is believed to cause postweaning multisystemic wasting syndrome, marked by diarrhoea and an inability to gain weight. There is no evidence of similar effects in humans.
Copyright Press Association 2010
GlaxoSmithKline
