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.
Highlights
One and a half year have passed since the beginning of the coronavirus disease 2019 (COVID-19) pandemic
Data Analysis We descriptively presented the main findings on safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents
In one study the participants received CoronaVac COVID-19 vaccine developed by Sinovac Life Sciences, and in the other seven the participants received BNT162b2 mRNA COVID-19 vaccine developed by Pfizer-BioNTech
Summary
One and a half year have passed since the beginning of the coronavirus disease 2019 (COVID-19) pandemic. With over 200 million confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and over 4 million COVID-19 related deaths, COVID-19 has brought great suffering and devastation to people worldwide. As an effective way to prevent and control disease infections, stimulate the human immune system to produce antibodies, increasing immunity to the disease and generating protection for the immunized individual [1]. Vaccination aims to curb the spread of the disease and helps to potentially achieve herd immunity. As of 18 September 2021, twenty-two COVID-19 vaccines worldwide have been approved [1]. Given that children and adolescents account for approximately one quarter of the world’s population [2], promoting vaccination of children and adolescents is crucial to end the spread of COVID-19
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