Merck’s Rotateq Approved

Merck & Co. has received FDA approval for Rotateq, the only vaccine available in the U.S. to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children. Rotateq is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks.

The FDA approval of Rotateq is based on data from the company’s Phase III trials of more than 70,000 infants, including the Rotavirus Efficacy and Safety Trial (REST). Among infants observed, Rotateq prevented 98% of severe cases of rotavirus gastroenteritis and prevented 74% of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to placebo through the first full rotavirus season after vaccination. In REST, Rotateq reduced hospitalizations by 96% and ER visits by 94% for rotavirus gastroenteritis caused by serotypes targeted by the vaccine through the first two years after the third dose.