FDA approves new rotavirus vaccine

April 4, 2008

The Food and Drug Administration (FDA) has approved GlaxoSmithKline's Rotarix, the second oral licensed vaccine in the US for the prevention of rotavirus.

The Food and Drug Administration (FDA) has approved GlaxoSmithKline's Rotarix, the second oral licensed vaccine in the US for the prevention of rotavirus.

Rotarix is a liquid administered in a two-dose series to infants ages 6 to 24 weeks. In studies of more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of gastroenteritis caused by rotavirus during the first two years of life. The most common adverse events that occurred during these trials were fussiness, irritability, cough, runny nose, fever, loss of appetite, and vomiting.

In a GlaxoSmithKline-conducted study of more than 63,000 infants, there was no increased risk of intussusception among those treated with Rotarix, compared with those who received placebo.

Rotavirus causes approximately 2.7 million cases of gastroenteritis in US children every year, according to the FDA. Nearly every child in the United States would likely contract the rotavirus infection at least once by age 5 without vaccination.