FDA warns doctors about Glaxo rotavirus vaccine
By LAURAN NEERGAARDThe Associated Press
Monday, March 22, 2010; 5:00 PM
WASHINGTON -- U.S. health officials urged pediatricians Monday to temporarily stop 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.
"We don't want to scare parents," Hamburg told reporters. "This was a difficult decision for us to make because there is no evidence at this time that there is a risk to patients who have received this vaccine, and we know there are real benefits for children to be vaccinated against rotavirus."