CDC Backs New Kids' Diarrhea Vaccine
Vaccine Targets Rotavirus, a Leading Cause of Diarrhea in Babies and Kids
No Sign of Intestinal Problem
In 1999, a rotavirus vaccine called RotaShield was withdrawn from the market after it was found to be associated with a rare cause of bowel obstruction called intussusception.
The risk of intussusception for RotaTeq, the new vaccine, was evaluated in a large-scale trial of more than 70,000 children. In that study, no association was found between the RotaTeq vaccine and an increased risk of intussusception, and RotaTeq did not cause fever to the extent caused by RotaShield, states the CDC.
"This is a different vaccine than the vaccine removed from the market because of problems with bowel obstructions," says Schuchat. "It is made differently and was not associated with intussusception in a large clinical trial.
"Nevertheless, we will continue to very closely monitor this vaccine to ensure there are no problems," Schuchat continues. "At the same time, it's important to remember that the known benefits of the vaccine far outweigh any known risks."
The CDC will conduct a large study to rapidly detect any association between RotaTeq and intussusception as well as other potential adverse events through its Vaccine Safety Datalink Program that evaluates vaccine safety in approximately 90,000 infants every year.
The CDC and FDA will also regularly monitor reports of intussusception and other serious adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).
RotaTeq's marketer, Merck and Company, has also committed to conducting a post-licensure study of approximately 44,000 children. In addition, the manufacturer will report cases of intussusception to the FDA within 15 days of receiving them. Merck is a WebMD sponsor.