The FDA has approved a live vaccine called RotaTeq to fight rotavirus, the most common cause of severe diarrhea in infants and young children.

The vaccine, taken orally in three doses when babies are between 6 weeks old and 32 weeks old, is intended to protect infants against rotavirus infection.

Every year, about 55,000 U.S. children are hospitalized due to rotavirus, and more than 600,000 children worldwide die of diarrhea caused by rotavirus, according to the CDC.

Few children in the U.S. die of rotavirus. Most deaths occur in developing countries due to problems with the water supply.

The FDA's approval doesn't put RotaTeq on the CDC's schedule of recommended vaccines. The CDC's Advisory Committee on Immunization Practices is already evaluating RotaTeq and will discuss the vaccine at a meeting later this month, says the FDA's Jesse Goodman, MD, MPH.

Goodman directs the FDA's Center for Biologics Evaluation and Research. He spoke to reporters about RotaTeq in a conference call.

No Sign of Intestinal Problem

In clinical trials of about 72,000 healthy infants in the U.S. and other countries, RotaTeq prevented 74% of all rotavirus diarrhea cases and 98% of the severe cases. The vaccine also prevented about 96% of rotavirus-related hospitalizations.

RotaTeq will get aggressive safety monitoring by the vaccine's maker and the CDC, Goodman says.

Unlike an earlier rotarvirus vaccine that had been pulled from the market, RotaTeq hasn't been found to raise the risk of a serious and potentially fatal condition called intussusception.

In intussusception, the intestine folds into itself like a telescope. The problem can cause intestinal blockage due to swelling and inflammation at the intussusception site. Intussussception is usually seen in very young children -- those less than 2 years old -- and is rare in adults.

In clinical trials, RotaTeq wasn't linked to an increased risk of intussusception. However, no medicine can ever be guaranteed to be absolutely safe, even vaccines, which are among our safest medicines, Goodman says.

He suggests that parents and doctors discuss the vaccine and look carefully at the CDC's discussions about RotaTeq. I think those will be informative, Goodman says.