New rotavirus vaccine receives FDA nod

February 13, 2006

Merck's Rotateq, an oral, live, pentavalent vaccine, has received FDA approval for the prevention of rotavirus gastroenteritis in infants, an illness that causes vomiting, watery diarrhea, fever, and abdominal pain and results in 55,000 hospitalizations annually. Clinical studies of the vaccine included more than 72,000 healthy infants and closely examined the risk of intussusception, a serious life-threatening condition in which the intestines become twisted.

New rotavirus vaccine receives FDA nod

Merck's Rotateq, an oral, live, pentavalent vaccine, has received FDA approval for the prevention of rotavirus gastroenteritis in infants, an illness that causes vomiting, watery diarrhea, fever, and abdominal pain and results in 55,000 hospitalizations annually. Clinical studies of the vaccine included more than 72,000 healthy infants and closely examined the risk of intussusception, a serious life-threatening condition in which the intestines become twisted. This is the same side effect that led to the removal of the previous rotavirus vaccine from the market. The FDA's Jesse L. Goodman, M.D., MPH, director of the agency's Center for Biologics Evaluation and Research, assured that the new vaccine has yet to show an increased risk of intussusception; however, he said, due to the events that occurred previously, both the FDA and Merck will closely monitor the vaccine's usage. As part of the postmarketing agreement, Merck is required to conduct a study of 44,000 children. In addition, CDC will conduct its own study designed to detect any association of the new vaccine to intussusception through its Vaccine Safety Datalink Project, which evaluates vaccine safety in 80,000 infants per year. Rotateq is a liquid vaccine that is given in three doses between the ages of six and 32 weeks.

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