Rotarix provides broad protection in EU trial

New data from a large-scale European trial of GlaxoSmithKline's oral rotavirus vaccine Rotarix suggest that the agent prevents infection by five of the most commonly circulating virus types. The UK-drug major said that, if cleared by the US Food and Drug Administration, which is currently reviewing the product under a Biologics License Application submitted earlier this year (Marketletter August 20), Rotarix would be available for the vaccination of infants less than four months old.

The new data, which is published in the current issue of The Lancet, are from a multicenter, randomized, double-blind Phase III trial that recruited around 4,000 infants. The results show that two doses of Rotarix provided highly effective and sustained protection during two consecutive rotavirus seasons. Specifically, the vaccine was shown to be effective against infection-related hospitalizations (96%), while it also cut the rate of severe rotaviral gastroenteritis around 90%. Gastroenteritis of any severity was reduced 79%.

David Bernstein, director of infectious disease at Cincinnati Children's Hospital Medical Center, USA, said that the data confirm "that immunization with two doses of the rotavirus candidate vaccine could provide broad protection against rotavirus gastroenteritis caused by emerging types in addition to those that are already commonly circulating."