The drug Rotarix is the second oral vaccine against the rotavirus licensed in the United States, the agency said Thursday in a release. Rotarix, manufactured by GlaxoSmithKline Biologicals, is given in a two-dose series to infants from 6 to 24 weeks of age.
Rotavirus causes about 2.7 million cases of gastroenteritis in the United States each year, with as many as 70,000 of those cases requiring hospitalization and between 20 and 60 deaths attributed to the virus. The FDA said that without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research, said in a statement.
In 1999, a different rotavirus vaccine was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, the agency said.