5-11세 소아에서 코로나19 백신의 효능 및 안전성에 대한 체계적 문헌고찰
Efficacy and Safety of COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review
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목적: 5–11세 소아에서 코로나19 백신의 효능과 안전성을 평가하기 위해서 체계적 문헌고찰을 시행하였다. 방법: 2022년 1월 4일까지 Ovid-MEDLINE 및 medRxiv를 검색하여 문헌을 선정하고 자료를 추출하였다. 근거 수준을 평가하기 위해 GRADE 도구를 사용하였다. 결과: 총 1,675 건의 연구가 일차적으로 검색되었고 최종적으로 5편의 연구가 포함되었다. 서로 다른 4개의 코로나19 백신(BNT162b2, mRNA-1273, CoronaVac, BBIBP-CorV)에 대한 무작위 대조군 연구 결과들은 5–11세 연령에서 각 백신의 양호한면역원성과 안전성을 보여주었다. 미국에서 5–11세 소아 연령에서 BNT162b2 백신 접종 후 이상사례 모니터링 연구에서는 승인 전 임상시험을 통해 예상되었던 국소반응 및 전신반응이 보고되었으나 중대한 이상사례는 거의 보고되지 않았다. 결론: 5–11세 연령에서 코로나19 백신 접종에 대한 데이터는 제한적이다. 이 연령에서 코로나19 백신의 안전성과 효과에 대한 체계적인 평가를 위해 지속적이고 포괄적인 모니터링이 필요할 것으로 보인다.
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.
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