FDA: GSK rotavirus vaccine appears safe and effective

Rotarix, the rotavirus vaccine developed by GSK, moved closer to U.S. licensure on Friday, as an FDA staff report stated that clinical trial results suggest that the vaccine is safe and effective.

Here is coverage of the news from The Wall Street Journal, Associated Press and Dow Jones. Rates of intussusception -- the gastrointestinal condition that doomed the first rotavirus vaccine, Rotashield, in 1999 -- were not significantly different in those receiving Rotarix versus control groups receiving a placebo.

A positive recommendation from government advisors at next week's meeting of FDA's Vaccines and Related Biological Products Advisory Committee would likely be the final step prior to licensure in the U.S. Rotarix is already approved in over 90 countries, according to GSK.

Merck's rotavirus vaccine, RotaTeq, was approved in February 2006 and is currently recommended for all infants at 2, 4, and 6 months of age