Merck & Co's Rotateq gets FDA OK

US drug major Merck & Co says that the Food and Drug administration has approved Rotateq (rotavirus vaccine) for the prevention of rotaviral gastroenteritis. The drug is an oral, three-dose vaccine for infants aged between six and 32 weeks and is designed to protect against one of the leading causes of severe diarrhea in young children.

Regulatory approval is based on analysis of data from Merck's Phase III clinical trial of the product, during which 70,000 infants were given the compound. The results showed that Rotateq prevented 98% of severe gastroenteritis infections and 74% of all cases, regardless of severity. The firm added that the incidence of serious adverse events within six weeks of using the vaccince was comparable to that seen in placebo recipients.

Merck estimates that, among children under five years of age, 2.5 million cases of gastroenteritis occur each year, leading to around 250,000 emergency room visits and up to 70,000 hospitalizations.