Association of Rotavirus Vaccines With Reduction in Rotavirus Gastroenteritis in Children Younger Than 5 Years

Abstract

IMPORTANCERotavirus vaccines have been introduced worldwide, and the clinical association of different rotavirus vaccines with reduction in rotavirus gastroenteritis (RVGE) after introduction are noteworthy.OBJECTIVE To evaluate the comparative benefit, risk, and immunogenicity of different rotavirus vaccines by synthesizing randomized clinical trials (RCTs) and observational studies.DATA SOURCES Relevant studies published in 4 databases: Embase, PubMed, the Cochrane Library, and Web of Science were searched until July 1, 2020, using search terms including "rotavirus" and "vaccin*."STUDY SELECTION Randomized clinical trials and cohort and case-control studies involving more than 100 children younger than 5 years that reported the effectiveness, safety, or immunogenicity of rotavirus vaccines were included. DATA EXTRACTION AND SYNTHESISA random-effects model was used to calculate relative risks (RRs), odds ratios (ORs), risk differences, and 95% CIs. Adjusted indirect treatment comparison was performed to assess the differences in the protection of Rotarix and RotaTeq. MAIN OUTCOMES AND MEASURESThe primary outcomes were RVGE, severe RVGE, and RVGE hospitalization. Safety-associated outcomes involved serious adverse events, intussusception, and mortality. RESULTSA meta-analysis of 20 RCTs and 38 case-control studies revealed that Rotarix (RV1) significantly reduced RVGE (RR, 0.316 [95% CI, 0.224-0.345]) and RVGE hospitalization risk (OR, 0.347 [95% CI, 0.279-0.432]) among children fully vaccinated; RotaTeq (RV5) had similar outcomes (RVGE: RR, 0.350 [95% CI, 0.275-0.445]; RVGE hospitalization risk: OR, 0.272 [95% CI,). Rotavirus vaccines also demonstrated higher protection against severe RVGE. Additionally, no significant differences in the protection of RV1 and RV5 against rotavirus disease were noted in adjusted indirect comparisons. Moderate associations were found between reduced RVGE risk and Rotavac (RR, 0.664 [95% CI, 0.548-0.804]), Rotasiil (RR, 0.705 [95% CI, 0.605-0.821]), and Lanzhou lamb rotavirus vaccine (RR, 0.407 [95% CI, 0.332-0.499]). All rotavirus vaccines demonstrated no risk of serious adverse events. A positive correlation was also found between immunogenicity and vaccine protection (eg, association of RVGE with RV1: coefficient, −1.599; adjusted R 2 , 99.7%). CONCLUSIONS AND RELEVANCEThe high protection and low risk of serious adverse events for rotavirus vaccines in children who were fully vaccinated emphasized the importance of worldwide introduction of rotavirus vaccination. Similar protection provided by Rotarix and RotaTeq relieves the pressure of vaccines selection for health care authorities.

Rotavirus Vaccines—Going Strong After 15 Years

“…Thus, the relative risk of developing rotavirus gastroenteritis after a full dose of Rotarix (2 doses) was 0.316, and for RotaTeq (3 doses), it was 0.350. These findings confirm the results of a previous meta-analysis in which median vaccine effectiveness in low-mortality countries was similar for Rotarix (83%), RotaTeq (85%), and mixed series (86%). The success of rotavirus vaccines is also supported by recent data showing that there has been a reduction of between 18% to 39% in diarrhea-associated (but not rotavirus-specific) mortality in children younger than 5 years in several Latin American countries.…”

“…Overall, their findings confirm the overall efficacy of rotavirus vaccines and the equivalence of Rotarix and RotaTeq. Thus, the relative risk of developing rotavirus gastroenteritis after a full dose of Rotarix (2 doses) was 0.316, and for RotaTeq (3 doses), it was 0.350.…”

“…Since licensure of RotaTeq in 2006 and Rotarix in 2008, rotavirus vaccines have been introduced in more than 100 countries. In an article in this issue of JAMA Pediatrics , Sun et al have conducted a thorough evaluation of the comparative benefits, risks, and immunogenicity of different rotavirus vaccines by reviewing randomized clinical trials and observational studies of vaccines to perform a meta-analysis. Because there are far more studies evaluating RotaTeq and Rotarix than the newer licensed vaccines (Rotavaq and Rotasiil in India and Niger and LLC in China), most of the comparisons concern these 2 vaccines.…”

“…The success of rotavirus vaccines is also supported by recent data showing that there has been a reduction of between 18% to 39% in diarrhea-associated (but not rotavirus-specific) mortality in children younger than 5 years in several Latin American countries. Other key questions addressed in this article include the duration of protection, the breadth of protection against heterologous strains, and differences in efficacy comparing low-income with high-income settings.…”

“…At this point, I thought it would be of interest to take some of the lessons learned from rotavirus vaccines over the past 15 years, as put forth in this article, and apply them to COVID-19 vaccines. I propose that several principles of vaccines and vaccination can be illustrated with rotavirus and projected to COVID-19.…”