FDA Approves New GlaxoSmithKline Vaccine Against Rotavirus

April 9, 2008
BioPharm International Editors

The US FDA announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.

The US Food and Drug Administration announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix, manufactured by GlaxoSmithKline Biologicals (Rixensart, Belgium), is a liquid and given in a two-dose series to infants from six to 24 weeks of age.

Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in US children each year, about 55,000 to 70,000 of which require hospitalization. Of those, between 20 to 60 cases lead to death. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5. 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.

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

GlaxoSmithKline release

Related Content:

News