US FDA approves GSK's Rotarix

The US Food and Drug Administration has approved UK drug major GlaxoSmithKline's Rotarix, an infant vaccine for the prevention of rotavirus gastroenteritis. The Centers for Disease Control and Prevention currently recommends that children complete the rotavirus immunization series by six months of age. The virus infects virtually every child in the USA by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide. Rotarix may help prevent many of the 55,000 to 70,000 hospitalizations by young children that result from rotavirus in the USA each year, GSK noted.

According to the London-headquartered firm, not only does Rotarix confer protection at an early age, but clinical trials have shown that this is broad and sustained. Clinical data published on the two-dose series of the agent show that immunity was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, Rotarix was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%) and G9 (85%), the most commonly-circulating rotavirus types in the USA.