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CDC Backs New Kids' Diarrhea Vaccine

Vaccine Targets Rotavirus, a Leading Cause of Diarrhea in Babies and Kids
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CDC's Comments continued...

In developing countries, rotavirus is a major cause of childhood deaths, with an annual death toll of more than half a million children younger than 5 years.

The new rotavirus vaccine will not prevent gastroenteritis caused by other viruses, but it's "very effective against rotavirus disease," states the CDC.

Studies indicate the vaccine will prevent about 74% of all rotavirus cases and about 98% of the most severe cases, including 96% of rotavirus cases requiring hospitalization. In trials, the vaccine prevented 59% of all causes of gastroenteritis hospitalizations, which highlights the important role of rotavirus in severe childhood gastroenteritis, according to the CDC.

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In 1999, a rotavirus vaccine called RotaShield was withdrawn from the market after it was found to be associated with a rare cause of bowel obstruction called intussusception.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."

Close Monitoring

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.

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