Peer-reviewed article
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 et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This systematic review examined the safety, immunogenicity, and effectiveness of COVID-19 vaccines in children and adolescents under 18 years old. The analysis included eight published studies covering 2,852 children and adolescents, plus 28 ongoing clinical trials. COVID-19 vaccines showed good safety profiles with common side effects like injection site pain, fatigue, and headache; rare cases of myocarditis and pericarditis were reported. Two vaccines demonstrated immune responses and efficacy in adolescents, though more research with larger samples and longer follow-up is needed.
Key points
- Common adverse events were injection site pain, fatigue, headache, and chest pain; myocarditis and pericarditis were rare
- BNT162b2 showed non-inferior immune response in adolescents aged 12-15 years compared to young people aged 16-25 years
- Higher dose CoronaVac (3 μg) produced stronger immune response than lower dose (1.5 μg)
- BNT162b2 showed 100% efficacy based on one RCT (95% CI: 75.3 to 100)
- Of 28 ongoing trials, China and United States had the highest number (10 and 9 trials respectively)
Limitations
The review included only eight published studies with limited sample sizes and study designs (two RCTs, two case series, four case reports), making it difficult to draw definitive conclusions. The review does not provide detailed information on specific adverse events, long-term safety outcomes, or efficacy across different age groups within children and adolescents.
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.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- COVID-19 vaccination (BNT162b2 and CoronaVac)
- Population
- Children and adolescents aged less than 18 years; BNT162b2 tested in adolescents aged 12-15 years; CoronaVac tested with 1.5 μg and 3 μg doses
Key finding
BNT162b2 immune response in adolescents aged 12-15 years was non-inferior to young people aged 16-25 years