Rotavirus-Caused Gastroenteritis Vaccine Rotarix: Approved by US FDA

Filed in archive Diarrhea , Digestive Disorders , FDA Approvals , Treatment , Viruses and Viral Infection on April 3, 2008

Rotarix - the second oral U.S. licensed vaccine for the prevention of rotavirus (an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children) - has been approved by the US FDA.

There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.

"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.

During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

Rotarix (pdf file) - available a liquid and given in a two-dose series to infants from 6 to 24 weeks of age - is a product of GlaxoSmithKline Biologicals (Rixensart, Belgium).

Find more details from the FDA News.