Rotavirus infection is the most common cause of diarrhoea in infants and young children, and the symptoms can range from non-severe illness, to hospitalization and death. Rotavirus infections cause over half a million deaths per year in children younger than five years, especially in low- and middle-income countries. Since 2009, the World Health Organization has recommended vaccination be included in national immunization programmes. This review evaluates three vaccines currently in use: Rotarix and RotaTeq, which have been evaluated in several large trials and are approved for use in many countries; and Lanzhou Lamb Rotavirus vaccine (LLR), which is approved for use in China only. The review includes 34 trials with about 175,944 participants; all trials compared a rotavirus vaccine with a placebo. The vaccines tested were Rotarix (26 trials with 99,841 participants) and RotaTeq (eight trials with 76,103 participants). None of the identified trials used LLR. The trials took place all over the world. Compared to placebo, Rotarix and RotaTeq were both effective at reducing rotavirus diarrhoea. They also reduced severe diarrhoea from all causes, hospitalizations and need for medical attention. The vaccines were particularly effective at one and two years of follow-up. The vaccines tested against placebo gave similar numbers of adverse events such as deaths, reactions to the vaccine, and others that required discontinuation of the vaccination schedule. In conclusion, data from this review show that Rotarix and RotaTeq are effective vaccines, and support the World Health Organization's recommendation to include rotavirus vaccination of infants into national immunization programmes, especially in countries with a high burden of diarrhoeal deaths in children younger than five years. New trials with head-to-head comparisons of both vaccines are needed, as well as trials comparing LLR with placebo, data for special groups of children, such as preterm infants and malnourished children, and extensive monitoring of adverse events where vaccines are routinely used.
Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD008521. DOI: 10.1002/14651858.CD008521