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. 2019 Sep 4;2(9):e1912242.
doi: 10.1001/jamanetworkopen.2019.12242.

Association of Rotavirus Vaccination With Inpatient and Emergency Department Visits Among Children Seeking Care for Acute Gastroenteritis, 2010-2016

Daniel C Payne  1 , Janet A Englund  2   3 , Geoffrey A Weinberg  4 , Natasha B Halasa  5 , Julie A Boom  6   7 , Mary Allen Staat  8 , Rangaraj Selvarangan  9 , Parvin H Azimi  10 , Eileen J Klein  2   3 , Peter G Szilagyi  4   11 , James Chappell  5 , Leila C Sahni  6 , Monica McNeal  8 , Christopher J Harrison  10 , Mary E Moffatt  12 , Samantha H Johnston  13 , Slavica Mijatovic-Rustempasic  1 , Mathew D Esona  1 , Jacqueline E Tate  1 , Aaron T Curns  1 , Mary E Wikswo  1 , Iddrisu Sulemana  1 , Michael D Bowen  1 , Umesh D Parashar  1
Affiliations

Association of Rotavirus Vaccination With Inpatient and Emergency Department Visits Among Children Seeking Care for Acute Gastroenteritis, 2010-2016

Daniel C Payne et al. JAMA Netw Open. .

Abstract

Importance: Rotavirus vaccines have been recommended for universal US infant immunization for more than 10 years, and understanding their effectiveness is key to the continued success of the US rotavirus vaccine immunization program.

Objective: To assess the association of RotaTeq (RV5) and Rotarix (RV1) with inpatient and emergency department (ED) visits for rotavirus infection.

Design, setting, and participants: This case-control vaccine effectiveness study was performed at inpatient and ED clinical settings in 7 US pediatric medical institutions from November 1, 2009, through June 30, 2016. Children younger than 5 years seeking medical care for acute gastroenteritis were enrolled. Clinical and epidemiologic data, vaccination verification, and results of stool sample tests for laboratory-confirmed rotavirus were collected. Data were analyzed from November 1, 2009, through June 30, 2016.

Main outcomes and measures: Rotavirus vaccine effectiveness for preventing rotavirus-associated inpatient and ED visits over time for each licensed vaccine, stratified by clinical severity and age.

Results: Among the 10 813 children included (5927 boys [54.8%] and 4886 girls [45.2%]; median [range] age, 21 [8-59] months), RV5 and RV1 analyses found that compared with controls, rotavirus-positive cases were more often white (RV5, 535 [62.2%] vs 3310 [57.7%]; RV1, 163 [43.1%] vs 864 [35.1%]), privately insured (RV5, 620 [72.1%] vs 4388 [76.5%]; RV1, 305 [80.7%] vs 2140 [87.0%]), and older (median [range] age for RV5, 26 [8-59] months vs 21 [8-59] months; median [range] age for RV1, 22 [8-59] months vs 19 [8-59] months) but did not differ by sex. Among 1193 rotavirus-positive cases and 9620 rotavirus-negative controls, at least 1 dose of any rotavirus vaccine was 82% (95% CI, 77%-86%) protective against rotavirus-associated inpatient visits and 75% (95% CI, 71%-79%) protective against rotavirus-associated ED visits. No statistically significant difference during this 7-year period was observed for either rotavirus vaccine. Vaccine effectiveness against inpatient and ED visits was 81% (95% CI, 78%-84%) for RV5 (3 doses) and 78% (95% CI, 72%-82%) for RV1 (2 doses) among the study population. A mixed course of both vaccines provided 86% (95% CI, 74%-93%) protection. Rotavirus patients who were not vaccinated had severe infections 4 times more often than those who were vaccinated (74 of 426 [17.4%] vs 28 of 605 [4.6%]; P < .001), and any dose of rotavirus vaccine was 65% (95% CI, 56%-73%) effective against mild infections, 81% (95% CI, 76%-84%) against moderate infections, and 91% (95% CI, 85%-95%) against severe infections.

Conclusions and relevance: Evidence from this large postlicensure study of rotavirus vaccine performance in the United States from 2010 to 2016 suggests that RV5 and RV1 rotavirus vaccines continue to perform well, particularly in preventing inpatient visits and severe infections and among younger children.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Englund reported receiving grants from GlaxoSmithKline, Merck & Co, Chimerix, Inc, MedImmune, and Novavax, Inc, and personal fees from Sanofi Pasteur outside the submitted work. Dr Weinberg reported receiving personal fees from Merck & Co outside the submitted work. Dr McNeal reported laboratory service agreements from Merck & Co and PATH outside the submitted work. Dr Harrison reported receiving grants from GlaxoSmithKline and Merck & Co and grants and other from Pfizer, Inc, outside the submitted work. Dr Moffatt reported receiving grants from R-Biopharm, Inc, outside the submitted work. Dr Johnston reported ownership of public stock in Merck & Co outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Rotavirus Vaccine Effectiveness (VE)
Bar graph depicts effectiveness of at least 1 dose of vaccine in preventing inpatient or emergency department visits for acute gastroenteritis among children younger than 5 years, 2010 to 2016. Rotavirus positivity is depicted as percentage of inpatients admitted with acute gastroenteritis with positive results of testing for rotavirus. Rotavirus vaccine coverage was measured from the same population under active surveillance in Staat et al. Error bars indicate 95% CIs.
Figure 2.
Figure 2.. Aggregate Rotavirus Vaccine Effectiveness
Graph depicts effectiveness of at least 1 vaccine dose in preventing inpatient or emergency department visits for acute gastroenteritis among children younger than 5 years, 2010 to 2016. Error bars indicate 95% CIs.
Figure 3.
Figure 3.. Rotavirus Vaccine Effectiveness by Disease Severity Classification and Clinical Setting
Graph depicts effectiveness of at least 1 vaccine dose among children younger than 5 years, 2010 to 2016. Classification of disease severity is determined using the modified Vesikari Severity Score (mild indicates ≤10; moderate, 11-15; and severe, ≥16). Error bars indicate 95% CIs. ED indicates emergency department.
Figure 4.
Figure 4.. Rotavirus Vaccine Effectiveness for Complete Courses and Mixed Doses for Both Vaccines
Graph depicts effectiveness in preventing inpatient and emergency department clinical visits for acute gastroenteritis by year of life, 2010 to 2016. RV1 indicates Rotarix; RV5, RotaTeq. Error bars indicate 95% CIs.
See this image and copyright information in PMC

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