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Rotavirus vaccine reduces incidence of severe rotavirus gastroenteritis, diarrhea-related deaths in pediatric patients, studies indicate

Wednesday, February 10 2010 | Comments

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The rotavirus vaccine can significantly reduce the incidence of severe rotavirus gastroenteritis during the first year of life and yield a significant reduction in diarrhea-related deaths in children aged younger than 5 years, according to recently published results from 2 studies.

The first study included 4,939 African infants (3,166 in South Africa, 1,773 in Malawi) who were randomized to receive 1 of 3 possible treatments: 3 doses of the oral vaccine, 3 doses of placebo, or 2 doses of the vaccine plus 1 dose of placebo. The primary endpoint of the double-blind study was the number of episodes of gastroenteritis caused by the wild-type rotavirus during the first year of life.

Among the 4,417 infants included in the primary efficacy analysis, severe gastroenteritis caused by circulating rotavirus occurred in 4.9% of the infants in the placebo group (n=70) and in 1.9% of the infants in the pooled vaccine group (n=56), resulting in a vaccine efficacy of 61.2% (95% CI, 44.0%-73.2%; P<.001).

The efficacy of the vaccine was 58.7% (95% CI, 35.7%-74.0%) for the infants who received 2 doses and 63.7% (95% CI, 42.4%-77.8%) for the infants who received 3 doses.

A total of 5 episodes of severe rotavirus gastroenteritis per 100 infant-years were prevented with the vaccine. The efficacy of the vaccine was higher in South Africa than in Malawi (76.9% vs 49.4%, respectively), but the number of cases prevented was higher in Malawi than in South Africa (6.7 episodes per 100 infant-years vs 4.2 episodes per 100-infant years).

The vaccine's efficacy against all-cause serious gastroenteritis was 30.2% (95% CI, 15.0%-42.6%; P<.001).

At least 1 serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group.

"[The] reduction in the incidence of the disease occurred in a trial that was designed to simulate real-world conditions of use," the authors concluded. "[T]hus, the rotavirus vaccine is expected to deliver a considerable public health benefit when it is introduced in similar settings." (Madhi SA, et al. N Engl J Med 2010;362:289-298.)

Results from a separate study showed that a significant decline in diarrhea-related deaths was seen among Mexican children after the rotavirus vaccine was introduced to that population.

For that study, investigators compared diarrhea-related mortality in 2008 and during the 2008 and 2009 rotavirus seasons with the diarrhea-related mortality during the baseline period (2003 to 2006), before the introduction of the vaccine. Most of the children who were vaccinated received 1 or 2 doses.

In 2008, 1,118 diarrhea-related deaths were recorded among children aged younger than 5 years, which was a reduction of 675 deaths from the annual median of 1,793 deaths recorded during the 2003-06 period. The study investigators said the reduction in the number of deaths from diarrhea continued through the 2 full rotavirus seasons (2008 and 2009). (Richardson V, et al. N Engl J Med 2010;362:299-305.)

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