Glaxo wins FDA clearance for rotavirus vaccine

By Lisa Richwine

WASHINGTON (Reuters) - A second oral vaccine to prevent a leading cause of severe diarrhea in infants won approval from U.S. health officials on Thursday.

The GlaxoSmithKline Plc vaccine Rotarix fights infection with the rotavirus, which causes about 55,000 hospitalizations in U.S. children each year and kills more than 600,000 children worldwide, mostly in developing countries.

Rotarix already is approved in more than 100 other countries throughout the world. The vaccine competes with Merck & Co Inc's rotavirus vaccine called RotaTeq.

Without vaccination, nearly every child in the United States likely would be infected at least once with rotavirus by age five, the Food and Drug Administration said.

In studies of more than 24,000 infants, Rotarix prevented severe and mild cases of rotavirus-caused diarrhea and vomiting during the first two years of life.

"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in a statement announcing the Rotarix approval.

The most common reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting, the FDA said.

An earlier oral rotavirus vaccine sold by Wyeth was pulled from the market in 1999 after it was linked to a rare, life-threatening type of bowel obstruction known as intussusception.