Pediatr Infect Vaccine.  2024 Apr;31(1):12-24. 10.14776/piv.2024.31.e16.

Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

Affiliations
  • 1Department of Pediatrics, Pusan National University Hospital, Pusan National University School of Medicine, Busan, the Republic of Korea
  • 2Department of Pharmacy, College of Pharmacy, Kangwon National University, Chuncheon, the Republic of Korea
  • 3Division of Healthcare Technology Assessment Research, National Evidence-based Healthcare Collaborating Agency, Seoul, the Republic of Korea
  • 4Department of Pediatrics, National Medical Center, Seoul, the Republic of Korea
  • 5Department of Pediatrics, Jeju National University School of Medicine, Jeju, the Republic of Korea
  • 6Department of Pediatrics, Seoul National University College of Medicine, Seoul, the Republic of Korea
  • 7Department of Pediatrics, Korea University Anam Hospital, Seoul, the Republic of Korea

Abstract

The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22–0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01–0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97–5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

Keyword

COVID-19 vaccines; Adolescent; Systematic review; Meta-analysis
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