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Assays for the Specific Growth Rate and Cell-binding Ability of Rotavirus
Published on: January 28, 2019
The first oral rotavirus vaccine, 1998-1999: estimates of uptake from the National Immunization Survey
Philip J Smith1, Ben Schwartz, Ali Mokdad
1National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. PSmith3@cdc.gov
Insights
The rhesus-human reassortant rotavirus vaccine (RRV-TV) showed varied uptake rates. This study highlights challenges in linking vaccines to rare adverse events like intussusception.
Area of Science:
- Vaccinology
- Pediatric Public Health
- Epidemiology
Background:
- The rhesus-human reassortant rotavirus vaccine (RRV-TV) was licensed in the U.S. in 1998.
- Post-licensure surveillance identified potential associations between RRV-TV and intussusception.
- Conflicting results from early case-control/cohort versus later ecologic studies necessitated further investigation into vaccine uptake.
Purpose of the Study:
- To estimate state and national RRV-TV uptake rates using National Immunization Survey (NIS) data.
- To identify demographic and socioeconomic factors associated with RRV-TV receipt.
- To provide crucial data for evaluating ecologic studies on RRV-TV and intussusception.
Main Methods:
- Analysis of NIS data for children aged 19-35 months eligible for RRV-TV between September 1998 and July 1999.
- Estimation of vaccine coverage and doses administered by state, quarter, and birth cohort.
- Statistical analysis of demographic and socioeconomic variables in relation to vaccine uptake.
Main Results:
- Approximately 1 million doses of RRV-TV were administered to over 500,000 eligible children, representing 13.4% uptake.
- Significant state-to-state variation in RRV-TV administration and coverage rates was observed.
- Children from higher socioeconomic households demonstrated a greater likelihood of receiving the RRV-TV vaccine.
Conclusions:
- Ecologic studies faced limitations in detecting RRV-TV's impact on intussusception due to low vaccine coverage in study populations.
- Assessing the association between vaccines and rare adverse events presents significant methodological challenges.
- The RRV-TV case illustrates difficulties in evaluating vaccine safety for uncommon adverse events.
Objective:
On August 31, 1998, the rhesus-human reassortant rotavirus vaccine (RRV-TV) was licensed for use in the U.S. During the next nine months, 15 cases of intussusception were reported among infants who received the vaccine. Case-control and cohort studies showed a significantly increased risk of developing intussusception within one week of receiving the vaccine; subsequent ecologic studies did not. In this study, the authors used data on RRV-TV vaccination rates from the National Immunization Survey (NIS) to estimate state and national RRV-TV uptake rates and factors associated with receiving RRV-TV. These estimates are a key component in evaluating published ecologic studies designed to investigate the relationship between receipt of the vaccine and intussusception.
Methods:
The authors analyzed NIS data for children ages 19 to 35 months who were eligible to receive RRV-TV between September 1998 and July 1999. The authors estimated vaccine coverage and the number of doses administered by state, NIS sampling quarter, and birth cohort, and analyzed demographic and socioeconomic variables to evaluate their relationship with receiving RRV-TV.
Results:
It was estimated that approximately 1 million doses of RRV-TV were administered to 504,585 (+/-61,854) children, 13.4% (+/-1.6%) of children who were eligible. The estimated number of doses administered and the vaccination coverage rate varied greatly from state to state. Children living in households with higher socioeconomic conditions were more likely to receive the vaccine.
Conclusion:
Ecologic studies had a limited ability to detect a significant increase in the population incidence rate of intussusception that could be attributed to RRV-TV because populations in these studies consisted primarily of children who did not receive the vaccine. The example from RRV-TV demonstrates some of the challenges of assessing the magnitude of the association between a vaccine and an uncommon or rare adverse event.
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