The U.S. panel voted 11 to 1 that the vaccine is safe for use in infants. The FDA was not obliged to follow the opinion of its panel though it usually does making Rotavirus near to final U.S. approval.
The result of clinical studies of Glaxo's vaccine on 63,000 patients suggests that the babies who received two-injections had a lower rate of intestinal problems compared to those who received placebo injections.
Rotavirus is the leading cause of severe diarrhea in infants and young children. By the age of five, nearly every child has been infected by this virus at least once. It is usually transmitted through fecal-oral route. This virus leads to diarrhea which sometimes causes dehydration and even death.
The decision of the U.S. FDA if Rotarix vaccine will be approved or not is on April 3, 2008.
