European authorities say GSK’s Rotarix vaccine is safe despite presence of pig virus
By APFriday, May 21, 2010
European authorities say Rotarix is safe
LONDON — The European Medicines Agency said the unexpected presence of a pig virus in GlaxoSmithKline’s Rotarix vaccine poses no threat and should continue to be used, the drugmaker said Friday.
The agency was confirming a statement it made in March, GSK said in a news release. The European agency’s statement came after a review by its Committee for Medicinal Products for Human Use.
The vaccine is designed to protect babies against a leading cause of diarrhea.
In March, the U.S. Food and Drug Administration urged pediatricians to stop using the rotavirus vaccine after discovering it had been contaminated with the apparently benign pig virus. The FDA cleared Rotarix for use earlier this month.
The European Medicines Agency initially issued the same advice, but reversed it after a few days.
Rotavirus causes severe diarrhea and is a leading killer of children in developing countries. GSK said that more than 69 million doses of their orally administered vaccine have been distributed around the world.
