Safety, Immunogenicity, and Efficacy of COVID-19 Vaccines in Children and Adolescents: A Systematic Review

Meng Lv; Xufei Luo; Quan Shen; Ruobing Lei; Xiao Liu; Enmei Liu; Qiu Li; Yaolong Chen

doi:10.3390/vaccines9101102

Safety, Immunogenicity, and Efficacy of COVID-19 Vaccines in Children and Adolescents: A Systematic Review

Vaccines (Basel). 2021 Sep 29;9(10):1102. doi: 10.3390/vaccines9101102.

Authors

Meng Lv^{1

2

3}, Xufei Luo⁴, Quan Shen^{2

3

5}, Ruobing Lei^{2

3

5}, Xiao Liu⁴, Enmei Liu^{2

3

6}, Qiu Li^{1

2

3}, Yaolong Chen^{7

8

9

10

11

12}

Affiliations

¹ Department of Nephrology, Children's Hospital of Chongqing Medical University, Chongqing 400014, China.
² National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children's Hospital of Chongqing Medical University, Chongqing 400014, China.
³ Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.
⁴ School of Public Health, Lanzhou University, Lanzhou 730000, China.
⁵ Chevidence Lab Child & Adolescent Health, Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing 400014, China.
⁶ Department of Respiratory Medicine, Children's Hospital of Chongqing Medical University, Chongqing 400014, China.
⁷ Institute of Health Data Science, Lanzhou University, Lanzhou 730000, China.
⁸ Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China.
⁹ WHO Collaborating Centre for Guideline Implementation and Knowledge Translation, Lanzhou 730000, China.
¹⁰ Guideline International Network Asia, Lanzhou 730000, China.
¹¹ Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province, Lanzhou University, Lanzhou 730000, China.
¹² Lanzhou University GRADE Center, Lanzhou 730000, China.

Abstract

Aim: To identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccines in children and adolescents.

Methods: We conducted a systematic review of published studies and ongoing clinical studies related to the safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents (aged < 18 years). Databases including PubMed, Web of Science, WHO COVID-19 database, and China National Knowledge Infrastructure (CNKI) were searched on 23 July 2021. International Clinical Trials Registry Platform (ICTRP) was also searched to identify ongoing studies.

Results: Eight published studies with a total of 2852 children and adolescents and 28 ongoing clinical studies were included. Of the eight published studies, two were RCTs, two case series, and four case reports. The investigated COVID-19 vaccines had good safety profiles in children and adolescents. Injection site pain, fatigue, headache, and chest pain were the most common adverse events. A limited number of cases of myocarditis and pericarditis were reported. The RCTs showed that the immune response to BNT162b2 in adolescents aged 12-15 years was non-inferior to that in young people aged 16-25 years, while with 3 μg CoronaVac injection the immune response was stronger than with 1.5 μg. The efficacy of BNT162b2 was 100% (95% CI: 75.3 to 100), based on one RCT. Of the 28 ongoing clinical studies, twenty-three were interventional studies. The interventional studies were being conducted in fifteen countries, among them, China (10, 43.5%) and United States(9, 39.1%) had the highest number of ongoing trials. BNT162b2 was the most commonly studied vaccine in the ongoing trials.

Conclusion: Two COVID-19 vaccines have potential protective effects in children and adolescents, but awareness is needed to monitor possible adverse effects after injection. Clinical studies of the COVID-19 vaccination in children and adolescents with longer follow-up time, larger sample size, and a greater variety of vaccines are still urgently needed.

Keywords: COVID-19; adolescents; children; systematic review; vaccine.

Publication types

Review