Wednesday, March 24, 2010

FDA Suspends Use Of Major Glaxo Vaccine

Doses of Rotarix - Used to Combat Diarrhea-Causing rotavirus - Contaminated with Pig Virus, but Apparently Harmless


(AP) U.S. health officials told pediatricians Monday to temporarily quit using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus.

Glaxo's vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems - and the pig virus isn't known to cause any kind of illness in people or animals, said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration.

But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean - Merck's RotaTeq - the FDA decided to err on the side of caution...