Rotavirus is the most common cause of severe diarrhoeal disease in infants and young children globally. Rotaviruses are estimated to be responsible for approximately 527,000* deaths each year, with more than 85% of these deaths occurring in low-income countries in Africa and Asia, and over two million are hospitalized each year with pronounced dehydration. Among 43 countries participating in the Global Surveillance Network for rotavirus in 2009, 36% of hospitalizations for diarrhea among children aged <5 years were caused by rotavirus infection (WER 29 April 2011). Children under five years of age, especially those between 6 months and two years are most vulnerable to the disease. Vaccines against rotavirus gastroenteritis are available and are the single prevention and control measure with the most significant impact on reducing severe disease incidence. Currently, two oral vaccines in four presentations compatible with traditional EPI immunization schedules are available, licensed in most countries, and introduced in national immunization programmes of several American, European and Eastern Mediterranean countries. Several other live oral rotavirus vaccines are in various stages of development in conjunction with vaccine manufacturers in developing countries.
Recent data from clinical trials, which evaluated vaccine efficacy in countries with high child mortality, has led the WHO Strategic Advisory Committee on Immunization (SAGE) to provide a recommendation for inclusion of rotavirus vaccination of infants into all national immunization programmes. Furthermore, in countries where diarrhoeal deaths account for ≥10% of under-5 mortality the introduction of the vaccine is strongly recommended.
In order to minimise a potential risk of intussuception, SAGE recommends that the first dose of either RotaTeq™ or Rotarix™ vaccine be administered during the period of 6 weeks to 15 weeks of age. The maximum age for administering the last dose of either vaccine is recommended to be at 32 weeks of age. Large safety studies with the two commercially available rotavirus vaccines, however, have demonstrated these vaccines are safe and that an intussusception risk of the order of that which had been associated with the earlier Rotashield™ vaccine can be ruled out with confidence.
WHO also recommends that sentinel surveillance for severe rotavirus gastroenteritis should be in place to monitor vaccine impact. Currently, proposed strategies rely on a network of sentinel hospitals reporting to WHO, where young children with diarrhoea are tested for rotavirus infections. Moreover, post-marketing surveillance systems should be established to monitor possible vaccine adverse events, including intussusception. Absence of such post-marketing surveillance at the onset should not be an obstacle to introducing the vaccine.
Rotavirus vaccines are an important measure to reduce severe rotavirus-associated diarrhoea and mortality and the ensuing impact on public health resources. Use of the vaccine should be part of a comprehensive diarrhoeal disease control strategy including, among other interventions, improvements of hygiene and sanitation, zinc supplementation, community-based administration of oral rehydration solution and overall improved case management.
This website provides the latest summary information in a set of slides and reference materials available to WHO about progress with decision-making and implementation of rotavirus vaccine introduction.
*Figures taken from Parashar UD et al. Global mortality associated with rotavirus disease among children in 2004. Journal of Infectious Diseases, 2009, 200:9-15
Last updated: October 2011