[New rotavirus vaccines: a reality at last].

Rotavirus is the most common cause of severe acute diarrhea among children less than 3 years of age. This infection causes 25 million medical visits, 2 million hospitalizations and 440,000 deaths every year worldwide. The development of rotavirus vaccines has followed a long and difficult path seriously hampered by the abrupt withdrawal of Rotashield in 1999 due to its association with intestinal intussusception. After six years of intense research, the world celebrates the licensing of two new rotavirus vaccines, different in formulation and administration schemes albeit clearly safe and not associated with intussusception as demonstrated by large Phase III trials including more than 60,000 children. These vaccines, Rotarix from Glaxo SmithKline Biologicals and Rotateq from Merck Sharp & Dohme, have demonstrated to be highly efficacious against severe rotavirus gastroenteritis caused by the most prevalent serotypes. Prompt incorporation of these new vaccines into the immunization programs of countries, especially those in the poorest areas of the world where these vaccines are most needed, will require joint efforts between governments, vaccine manufacturers, international and non-governmental organizations and foundations.