FRIDAY, April 4, 2008 (HealthDay News) -- Rotarix, a vaccine to prevent gastroenteritis caused by several strains of rotavirus, has been approved by the U.S. Food and Drug Administration.
The liquid vaccine is given in a two-dose series to infants aged 6 weeks to 24 weeks. Gastroenteritis, affecting some 2.7 million children in the United States each year, causes vomiting and diarrhea. As many as 70,000 of these cases require hospitalization, and as many as 60 deaths are caused by the virus each year, the FDA said.
The agency estimated that without vaccination, nearly every child in the United States would be infected at least once by age 5. Rotarix is the second vaccine approved in the United States to prevent rotavirus.
Rotarix, manufactured by GlaxoSmithKline, proved effective in clinical testing involving more than 24,000 infants, the FDA said. Reported side effects included fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.
The FDA has more about this approval.