Rotavirus vaccine effectiveness and coverage among children younger than 5 years old in Shanghai, China: A test-negative case control study.

OBJECTIVES

The number of post-marketing studies assessing the vaccine effectiveness (VE) of the Lanzhou lamb rotavirus vaccine (LLR, licensed in 2000 exclusively in China) and the oral human attenuated pentavalent rotavirus vaccine (RotaTeq, licensed in China in 2018) in China is limited.

METHODS

A test-negative case-control study based on prospective surveillance was conducted among diarrhea patients aged 5 years and younger at five hospitals in Shanghai, China. Cases and controls were defined based on the results of real-time fluorescent quantitative reverse transcription polymerase chain reaction (rRT-PCR) of fecal samples for rotavirus. Both matched and unmatched case-control study designs were employed using logistic regression models, with adjustments for age at onset age and the rotavirus epidemic season.

RESULTS

In the LLR-specific analysis (247 cases, 2191 controls), the VE of partial LLR vaccination (2 doses) was 49.09 % (95 % CI: 1.69 % ∼ 73.64 %) in multivariate analyses. In the RotaTeq-specific analysis (42 cases and 523 controls), the VE of complete RotaTeq vaccination was 87.13 % (95 % CI: 45.87 % ∼ 96.94 %), 89.46 % (95 % CI: 55.03 % ∼ 97.53 %), and 85.69 % (95 % CI: 33.43 % ∼ 96.93 %) respectively in univariate, multivariate, and matched analyses, respectively. The vaccination coverage for any dose among 2893 patients with rotavirus-negative diarrhea born between 2011 and 2022 was 49.78 %. Following the licensure of RotaTeq in 2018, this coverage increased from 45.02 % to 61.77 %.

CONCLUSIONS

RotaTeq demonstrates a robust protective effectiveness, while LLR provides a certain level of protection against mild to moderate rotavirus diarrhea in children in Shanghai. For privately purchased (non-NIP) vaccines, we estimate that the coverage for rotavirus vaccines among children in Shanghai is high. Complete rotavirus vaccination is recommended for age-eligible children. Further post-marketing research on rotavirus vaccines is necessary to inform decision-making regarding the introduction of rotavirus vaccination in China.