Rotavirus vaccine reduces health care-related costs; no risk of intussusceptions

Pediatrics. 2010;126:e1499-e1506.

Rotavirus vaccination of children lessens the burden of costs associated with treatment of rotavirus gastroenteritis, according to a new study from Pediatrics.

Results of a post-hoc subgroup analysis of the international, placebo-controlled Rotavirus Efficacy and Safety Trial (REST) indicate that the pentavalent rotavirus vaccine (RV5, RotaTeq, Merck) reduced the rate of hospitalizations related to rotavirus infection. No increased risk of intussusceptions or other serious adverse events among infants were noted.

The researchers evaluated the vaccine’s effect on hospitalization rates and emergency department visits in Jamaica for both the modified intention-to-treat and per-protocol analyses. A total of 1,804 infants aged 6 weeks to 12 weeks of age received one for more doses of vaccine.

The study included 1,804 infants from Jamaica aged 6 to 12 weeks who received one or more doses of RV5. The infants were primarily from low- to middle-income families of African heritage. During the first year following vaccine receipt, two hospitalizations or emergency department visits were reported among vaccine recipients and 11 among children in the placebo group.

Based on the per-protocol analysis, all eight events attributable to serotypes G1-G4 that occurred 2 weeks or longer after dose three were in the placebo group. Of the 1,802 children in the safety analyses, intussusception was confirmed in one child who received the vaccine and three children in the placebo group. Four deaths occurred (one in the vaccine group and three in the placebo group) but none were considered to be vaccine-related.

The results from this study are consistent with those in the parent study, which revealed that RV5 was well tolerated and efficacious in the prevention of rotavirus gastroenteritis. This reduction in disease results in substantial reductions in costs associated with utilization of health care resources.

“Our findings provide hope that rotavirus vaccination has the potential to be safe and effective in reducing the enormous burden of serve rotavirus gastroenteritis in areas around the world where relief is needed urgently,” the researchers wrote.

In pre-licensure trials, RV5 was tested primarily in the United States and Finland. In those trials the vaccine was found to be safe and highly effective. In developing world countries, however, the results might be confounded by the fact that children are more likely to be malnourished or infected with parasites or toxin-producing bacteria. It is heartening to see that the results seen in the developed world can be extended to the developing world."

– Paul Offit, MD

Infectious Diseases in Children Editorial Board

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