FDA approves GSK’s Rotarix

WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s rotavirus prevention vaccine Rotarix. This is the second oral vaccine to be approved after Merck’s RotaTeq.

Rotavirus is an infection that causes gastroenteritis in infants and children and affects almost 3 million children each year.

Rotarix is a liquid and given in a two-dose series to infants from six to 24 weeks of age. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4 and G9 strains.

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.