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Rotavirus vaccine efficacy in routine practice similar to that observed in clinical trials, study shows

Wednesday, February 24 2010 | Comments

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What's This? The pentavalent rotavirus vaccine is highly effective in preventing rotavirus gastroenteritis (RGE) and all-cause acute gastroenteritis (AGE), and its use has been associated with reductions in health care resource use and associated costs, study findings suggest.

The study researchers noted that the vaccine was approved in February 2006 for the prevention of RGE caused by serotypes G1 through G4, which combined account for approximately 90% of all RGE in the United States. The vaccine is administered to infants in 3 oral doses, with the first dose given at age 6 to 12 weeks and the third dose by age 32 weeks.

Prior to the vaccine's approval, they added, rotavirus was associated with approximately 410,000 physician visits, 70,000 hospitalizations, and 272,000 emergency department (ED) visits each year, with an estimated annual societal cost of almost $1 billion.

To evaluate the vaccine's postapproval efficacy, the investigators conducted a retrospective analysis of a large, national health insurance claims database. They compared RGE- and AGE-related hospitalizations, ED visits, and physician visits during the 2007 and 2008 rotavirus seasons in 2 cohorts of infants: 33,140 infants who received all 3 doses of the rotavirus vaccine and 26,167 infants who received 3 doses of diphtheria-tetanus-acellular pertussis (DTaP) vaccine (but not the rotavirus vaccine).

The rotavirus vaccine's effectiveness against RGE-related hospitalizations and ED visits combined was 100% (95% CI, 87%-100%). In the outpatient setting, the effectiveness against RGE was 96% (95% CI, 76%-100%).

The rotavirus vaccine's effectiveness against AGE-related hospitalizations and ED visits combined was 59% (95% CI, 46%-69%); its effectiveness against AGE in the outpatient setting was 27% (95% CI, 22%-33%).

In addition, the rotavirus vaccine was associated with a 100% reduction (95% CI, 96%-100%) in rotavirus-related hospitalization and ED visit days and a 100% reduction (95% CI, 100%-100%) in RGE-related hospitalization and ED costs. The vaccine was also associated with a 66% reduction (95% CI, 59%-73%) in AGE-related hospitalization and ED visit days and a 74% reduction (95% CI, 74%-74%) in AGE-related costs.

These estimates of vaccine effectiveness are similar to those reported in prelicensure efficacy trials, the study authors noted.

However, they remarked that more research is necessary to evaluate the effectiveness of the vaccine in patients who do not receive the full 3-dose regimen. (Wang FT, et al. Pediatrics 2010;125:e208-e213.)

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