Effectiveness of the oral human attenuated pentavalent rotavirus vaccine (RotaTeq™) postlicensure: a meta-analysis—2006–2020

ABSTRACT

Background

Rotavirus (RV), which causes RV-associated gastroenteritis (RVGE), has accounted for considerable morbidity. We aimed to assess the effectiveness (VE) of the oral pentavalent RV vaccine (RotaTeq™) in real-world settings in children and infants with gastroenteritis.

Methods

We performed a systematic search for peer-reviewed studies published between 1 January 2006 and 1 May 2020 and a meta-analysis to calculate the VE of RotaTeq™ vaccine. The primary outcome was the pooled three-dose vaccine VE. Stratified analysis of the vaccine VEs was performed according to dosages, study design, population age, socioeconomic status (SES), introduction condition, control group types, outcomes of RV disease, and RV strains.

Results

After screening 2359 unique records, 28 studies were included and meta-analyzed. The overall VE estimate was 84% (95% confidence interval [CI], 80–87%). Stratified analyses revealed a nonnegligible impact of factors such as study design and SES. Other factors did not show great impart to VE with no significant differences between groups.

Conclusions

RotaTeq™ is effective against RV infection, especially in high-income countries. Adopting suitable study methods and expansion of RV surveillance in low-income regions is crucial to assess VE in real-life settings and provide feasible vaccine regimens to improve vaccine VE.

KEYWORDS:

• Effectiveness
• meta-analysis
• rotateq™
• rotavirus
• study design
• socioeconomic status

Article highlights

• Since stratified analyses revealed a nonnegligible impact of study design, choosing the suitable method of assessing VE for vaccine postlicensure deserved more attention.

• For achieving the goal of fully vaccination, it is necessary to continue advocating RotaTeq™ vaccine to be included in NIPs and promoting of RotaTeq™ vaccine, especially in low-income settings.

• When more and more studies targeted on the VE of RotaTeq™ vaccine postlicensure come out in the future, there are a desperate need to explore the factors like ages, RV strains, introduction of RotaTeq™ vaccine, concomitant administration with live oral polio vaccine, control types, outcomes of RV disease and disease severity.

• Future studies should target on evaluating the VE in middle-/low-income regions with high disease burden to fully understand the true VE in real-world.

• Since the two novel RV vaccines, Rotavac™ and RotaSiil™ were pre-qualified by the World Health Organization in 2018 and other RV vaccine candidates were undergoing investigation, further studies should assess the performance of these promising vaccines in low-middle income countries to explore more possibilities for improving VE and eliminating the safety concerns associated with prior vaccines.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors contributed to interpretation of the data and critical review of the paper for important intellectual content. PL and FZ were involved in the study conception and revising the manuscript. JL and PD performed the systematic literature search and the data extraction. YW conducted the meta-analysis and wrote the manuscript.

Supplemental material

Supplemental data for this article can be accessed here

Additional information

Funding

This study was not funded.