FDA Approves Merck's Rotateq

The Food and Drug Administration approved

Merck's

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Rotateq, a vaccine meant to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children that can ultimately be fatal.

Rotateq is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks. Among children under 5 in the U.S., estimates indicate that 2.7 million cases of rotavirus gastroenteritis occur each year, leading to around 250,000 emergency room visits and up to 70,000 hospitalizations, Merck said.

Rotavirus can cause diarrhea, vomiting, fever and dehydration. Death from rotavirus is rare in the U.S., but in developing countries, it is suspected of causing up to several hundred thousand deaths annually in infants and young children.