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FDA OKs New Vaccine for Kids' Diarrhea

RotaTeq Vaccine Targets Rotavirus, the No. 1 Cause of Kids' Severe Diarrhea
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Aggressive Monitoring

"Sometimes when a medicine is used in much larger numbers of individuals, you might detect an adverse event that wasn't seen in the studies before licensure, even in very large numbers like this," Goodman says.

"I think we have a lot of data here that are reassuring. That's the way I would put it," Goodman says.

"But people would need to consider that [the studies are] not conclusive that this side effect could not potentially occur and just not have been noticed, or occur at a much lower incidence, or maybe in a different manner. So this is why we put into place what I would say is an extremely aggressive program to try to get as much information about the vaccine in its early period of use as possible," Goodman says.

In clinical trials, reports of diarrhea, vomiting, ear infection, runny nose, sore throat, wheezing, and coughing were more common among babies given RotaTeq than a fake vaccine (placebo), according to an FDA news release.

Other Vaccines in the Works

Other rotavirus vaccines are in the works in the U.S. and other countries but have not been approved by the FDA, Goodman notes.

RotaTeq is one of two rotavirus vaccines that were recently called "promising" in The New England Journal of Medicine. The other vaccine, called Rotarix, hasn't been FDA-approved.

An editorial in the journal also stated that "hundreds of thousands of children will need to be immunized before a clean bill of health can be given to these vaccines. The editorialists included the CDC's Roger Glass, MD, PhD.

RotaTeq is made by Merck. Rotarix is made by GlaxoSmithKline. GlaxoSmithKline and Merck are WebMD sponsors.

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