The U.S. Food and Drug Administration has approved Rotarix, the oral vaccine for the prevention of rotavirus, for children between the ages of 6 to 24 weeks.
Rotavirus is an infection that causes gastroenteritis, vomiting and diarrhea, which causes approximately 55,000 to 70,000 cases of hospitalization and 20 to 60 deaths in the U.S. every year. The vaccine is a liquid which is given orally to children in a two-dose series protects against the G1, G3, G4 and G9 strains of rotavirus gastroenteritis.
The FDA estimates that without the vaccine almost every child in the U.S. would be infected at least once by the age of 5.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
Rotarix is manufactured by GlaxoSmithKline who conducted clinical trials involving more than 24,000 infants during testing of the vaccine. There are only two FDA approved vaccines for the prevention of rotavirus: Rotarix and RotaTeq by Merck and Co. Inc.
[Source: FDA]
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