Rotavirus vaccine: early introduction in Latin America-risks and benefits.

Rotavirus infection is the cause of severe gastroenteritis of young children worldwide, leading to an estimate of 600,000 deaths a year. Efforts to develop an effective and safe vaccine resulted in licensing in 1998 of a live oral vaccine (RotaShield) that was withdrawn less than 1 year later when reports of cases of intussusception were linked to its application. This led to development of new rotavirus vaccine candidates that are currently in late phase III clinical trials. One of these vaccines, GlaxoSmithKline's Rotarix, was licensed in July 2004 to be used in Mexico. This review describes the general background for rotavirus vaccine development, the different vaccine candidates that have been tested or are currently being evaluated, the association of rotavirus vaccination with the bowel blockage known as intussuception, and discusses the benefits and risks of the fast-track introduction of Rotarix in Latin America, and particularly in Mexico.