[Systematic reviews and evidence quality assessment on effectiveness of 1 dose varicella attenuated live vaccine for healthy children aged 1-12 years in China].

Objective: To assess the effectiveness of 1 dose varicella attenuated live vaccine (VarV) for healthy children aged 1-12 years in China and explore the application of the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework in observational studies of vaccine effectiveness (VE). Methods: We searched studies about the VE of 1-dose VarV for children aged 1-12 years in China which published before 2019 and evaluated the quality of the studies by the Newcastle Ottawa Scale (NOS) table. We used Meta-analysis models to obtain the pooled 1-dose VE and that in subgroups by study design, outbreak or not, study quality and age of subjects. The evidences of VEs were rated by means of the GRADE system. Results: Thirty-two studies were included and the pooled 1-dose VE was 75% [95% confidence interval (CI): 68%-80%]. The VE of outbreak studies [VE=66% (95%CI: 57%-73%)] was lower than non-outbreak studies [VE=85% (95%CI: 78%-89%)], and the VE in <6 years old children [VE=84% (95%CI:77%-89%)] was higher than that in ≥6 years old children [VE=60% (95%CI: 51%-68%)]. There was no significant difference in VE among studies with different design and quality. The quality of the evidences of pooled 1-dose VE was"very low", which was downgraded in bias risk and inconsistency and not downgraded in indirectness, imprecision and publication bias. Conclusions: The 1-dose VarV can provide medium level protection for 1-12 years old children in China, but it will decrease significantly for ≥6 years old children, so it is suggested to implement the strategies of two-dose vaccination of VarV in children <6 years old. The GRADE framework can be used in the observational studies of VE and it is suggested that the technical guidelines of observational study should be worked out to improve the overall quality of evidence.