Efficacy and Safety of COVID-19 Vaccines in Children Aged 5 to 11 Years:A Systematic Review

ABSTRACT

Purpose@#To evaluate the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in children aged 5–11 years, a rapid systematic review was conducted on published clinical trials of COVID-19 vaccines and studies that analyzed real-world data on adverse events after COVID-19 vaccination. @*Methods@#A systematic search was conducted on medical literature in international (Ovid-MEDLINE) and pre-published literature databases (medRxiv), followed by handsearching up to January 4, 2022. We used terms including COVID-19, severe acute respiratory syndrome coronavirus 2, and vaccines, and the certainty of evidence was graded using the GRADE approach. @*Results@#A total of 1,675 studies were identified, of which five were finally selected. Among the five studies, four consisted of data from clinical trials of each of the four types of COVID-19 vaccines (BNT162b2, mRNA-1273, CoronaVac, and BBIBP-CorV). The remaining study consisted of real-world data on the safety of the BNT162b2 vaccine in children aged 5–11 years. This systematic review identified that COVID-19 vaccines in recipients aged 5–11 years produced a favorable immune response, and were vaccines were effective against COVID-19. The safety findings for the BNT162b2 vaccine in children and early adolescents aged 5–11 years were similar to those data noted in the clinical trial. @*Conclusions@#There is limited data on COVID-19 vaccines in children aged 5–11 years.Consequently continuous and comprehensive monitoring is necessary for the evaluation of the safety and effectiveness of the COVID-19 vaccines.