WHO recommends rotavirus vaccination for all children

CDC: Vaccination with RV5 reduced severe diarrhea in Nicaragua

WHO officials have recommended that rotavirus vaccination be included in all national immunization programs.

The recommendation by WHO’s Strategic Advisory Group of Experts extends an earlier recommendation made in 2005 on vaccination in the Americas and Europe, where clinical trials had demonstrated safety and efficacy in populations with low and intermediate mortality. New data from several clinical trials in developing countries led to the recommendation for global use of the vaccine.

One clinical trial, funded in part by GAVI and conducted by PATH, WHO, GlaxoSmithKline and research institutions in high-mortality, low-socioeconomic settings of South Africa and Malawi, found that the vaccine significantly reduced severe diarrhea episodes due to rotavirus.

While efficacy data from Asian countries are forthcoming, SAGE recommended rotavirus vaccines for all populations, including Asia, since available evidence indicates that efficacy data can be extrapolated to populations with similar mortality patterns regardless of geographic location.

“The GAVI Alliance welcomes this exciting recommendation,” GAVI CEO Julian Lob-Levyt said in a press release. “It represents another important step in our ability to achieve significant impact on under-5 deaths in the world’s poorest communities and make progress toward the Millennium Development Goals. We are extremely excited about the potential to offer African and Asian countries funding to introduce rotavirus vaccines.”

CDC researchers writing in the Journal of the American Medical Association this week noted reductions in severe rotavirus diarrhea rates in Nicaragua following routine use of the pentavalent rotavirus vaccine there.

In October of 2006, the Nicaraguan Ministry of Health added the vaccine to the immunization schedule. The schedule recommends recommending three doses of RV5 for all children between the ages of 2 and 6 months.

Children in four hospitals, in Managua, Jinotepe, Masaya and Matagalpa, Nicaragua were evaluated, as well as all age-eligible children to receive the vaccine who were admitted for confirmed cases of rotavirus diarrhea. CDC researchers selected one to three neighborhood and hospital controls for each patient.

About 1,600 patients provided stool samples, of which 285 were identified with a single rotavirus strain. Two-hundred fifty one children received intravenous hydration and 265 were admitted for about three days. “Of all the cases and controls, 18% and 12% respectively, had not been vaccinated. 12% and 15% received one dose of RV5, 15% and 17% received two doses, and 55% and 57% received three doses,” the researchers wrote.

The researchers concluded children who were administered three doses of RV5 had a lower risk of rotavirus diarrhea that required overnight hospitalization or intravenous hydration. They also noted an increasingly lower risk of severe and very severe rotavirus diarrhea following RV5 vaccination.

The CDC researchers noted that although vaccination reduced the risk of severe rotavirus diarrhea in children younger than 2, it was not to the same extent as has been reported in clinical trials in industrialized nations.

WER. 2009, 84:213–236

JAMA. 2009;301(21):2243-2251.