QuickScan Reviews in Pediatrics, April 30 2009

Background: The rotavirus vaccine, introduced in 2006, has had a difficult history. Rotavirus accounts for 30% to 50% of hospitalizations for acute gastroenteritis and perhaps even more emergency department (ED) visits. Because rotavirus is not always tested for and detected, data are incomplete. Without knowing the actual burden of rotavirus, it is impossible to determine how the vaccination will affect it. Objective: To accurately estimate the burden of rotavirus caused acute gastroenteritis hospitalizations and (ED) visits in the United States. Design/Methods: This retrospective cohort study used data from the Vaccine Safety Datalink project, a collaboration between the Centers for Disease Control and Prevention and several managed care organizations. The cohort studied involved children eligible to receive the RotaShield vaccine in 1998 to 1999. Data on hospitalizations and ED visits were gathered for 2 follow-up periods in 1999 and 2000. Vaccination status was determined by records of administration. The main outcomes of interest included hospital and ED discharges for acute gastroenteritis. Comparison data were gathered during non-rotavirus season and in years after the vaccine was recalled. Results: During the time of the RotaShield vaccine, almost 65,000 children were eligible to receive it. Approximately 20% received at least 1 dose of the vaccine, 5% received 2 doses only, and 3% received all 3 doses. The effectiveness of the RotaShield series was 83% in preventing hospitalizations for all-cause gastroenteritis, and the effectiveness was 43% against ED visits. Although there appeared to be an increased effectiveness against hospitalizations with increased number of doses, no true effect could be established against ED visits. The number of visits and hospitalizations prevented was greater than the number thought to be caused by rotavirus. Conclusions: A rotavirus vaccine appears to have been (and would be) very effective in preventing hospitalizations and ED visits for acute gastroenteritis. The percentage of all-cause gastroenteritis caused by rotavirus may be higher than previously estimated. Once again, vaccines appear to work and should be encouraged. Reviewer's Comments: We cannot rewrite history, but it seems that the old rotavirus vaccine was very effective. One does not need to do a cost-benefit analysis to show that expensive hospitalizations were decreased by a relatively inexpensive immunization. In some third-world countries where many young children die from rotavirus, the benefit is lives saved rather than decreased hospitalizations. Many experts have opined that the withdrawal of RotaShield was premature; public alarm outweighed the science. Now that we have a new vaccine available, we need to make sure it gets used.