Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years

Journal Article 2 Mentions

Atsuyuki Watanabe•2023

Ryoma KaniMasao Iwagami

Top 1% · 99th Percentile

92 citations · Infectious Diseases

Open Access

TLDR

COVID-19 mRNA vaccines help protect children ages 5 to 11 from getting sick with COVID-19 or needing to go to the hospital, and serious side effects are very rare.

Summary

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1 Study Aim

The main goal of this paper is to find out how well messenger RNA (mRNA) COVID-19 vaccines work and how safe they are for children aged 5 to 11 years. The authors want to give clear information to doctors, families, and policy makers by combining results from many studies that compare vaccinated and unvaccinated children, focusing on both protection against COVID-19 and possible side effects. The study wants to see if COVID-19 vaccines keep kids safe and if they cause any serious problems.

2 Study Design

The authors conducted a systematic review and meta-analysis, which means they searched for and combined data from many studies. They included two randomized clinical trials (studies where children were randomly given the vaccine or not) and fifteen observational studies (studies that watched what happened to children who did or did not get the vaccine). In total, the analysis covered over 10.9 million vaccinated and 2.6 million unvaccinated children aged 5 to 11 years. The researchers looked at how often children got COVID-19, how many were hospitalized, and what side effects happened after vaccination. They used statistical methods to compare the risks and to check for any patterns or biases in the data. The researchers gathered and analyzed results from many studies to see how well the vaccine works and if it is safe for kids.

3 Findings

The research demonstrates that children aged 5 to 11 who received two doses of mRNA COVID-19 vaccines had a lower chance of getting COVID-19, having symptoms, being hospitalized, or developing multisystem inflammatory syndrome in children (MIS-C, a rare but serious condition involving inflammation in different body parts). Most children who got the vaccine experienced mild side effects like pain or swelling at the injection site, and these usually went away in a few days. Serious side effects, such as myocarditis (inflammation of the heart muscle), were very rare, occurring in about 1 to 2 cases per million doses. The authors argue that these results support the safety and effectiveness of mRNA COVID-19 vaccines for this age group and suggest that vaccination can help protect children from severe illness. The study found that the vaccine helps prevent COVID-19 and serious illness in kids, and most side effects are mild and go away quickly.

Abstract

Importance: Evidence of the efficacy and safety of messenger RNA (mRNA) COVID-19 vaccines in children aged 5 to 11 years has been emerging. Collecting these data will inform clinicians, families, and policy makers. Objective: To evaluate the efficacy and safety of mRNA COVID-19 vaccines in children aged 5 to 11 years in a systematic review and meta-analysis. Data Sources: PubMed and Embase databases were searched on September 29, 2022, without language restrictions. Study Selection: Randomized clinical trials and observational studies comparing vaccinated vs unvaccinated children aged 5 to 11 years and reporting efficacy or safety outcomes were included. Studies reporting safety outcomes in vaccinated children only (ie, no control group) were also included. Data Extraction and Synthesis: Two investigators independently extracted relevant data from each study. Odds ratios (ORs) for efficacy and safety outcomes and incidences of adverse events (AEs) following vaccination were synthesized using a random-effects model. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses and Meta-analysis of Observational Studies in Epidemiology reporting guidelines. Main Outcomes and Measures: The primary outcome was SARS-CoV-2 infections with or without symptoms. The secondary outcomes included symptomatic SARS-CoV-2 infections, hospitalizations, and multisystem inflammatory syndrome in children. The incidences of each AE following vaccination were also evaluated. Results: Two randomized clinical trials and 15 observational studies involving 10 935 541 vaccinated children (median or mean age range, 8.0-9.5 years) and 2 635 251 unvaccinated children (median or mean age range, 7.0-9.5 years) were included. Two-dose mRNA COVID-19 vaccination compared with no vaccination was associated with lower risks of SARS-CoV-2 infections with or without symptoms (OR, 0.47; 95% CI, 0.35-0.64), symptomatic SARS-CoV-2 infections (OR, 0.53; 95% CI, 0.41-0.70), hospitalizations (OR, 0.32; 95% CI, 0.15-0.68), and multisystem inflammatory syndrome in children (OR, 0.05; 95% CI, 0.02-0.10). Two randomized clinical trials and 5 observational studies investigated AEs among vaccinated children. Most vaccinated children experienced at least 1 local AE following the first injection (32 494 of 55 959 [86.3%]) and second injection (28 135 of 46 447 [86.3%]). Vaccination was associated with a higher risk of any AEs compared with placebo (OR, 1.92; 95% CI, 1.26-2.91). The incidence of AEs that prevented normal daily activities was 8.8% (95% CI, 5.4%-14.2%) and that of myocarditis was estimated to be 1.8 per million (95% CI, 0.000%-0.001%) following the second injection. Conclusions and Relevance: In this systematic review and meta-analysis, COVID-19 mRNA vaccines among children aged 5 to 11 years were associated with measures of efficacy in preventing SARS-CoV-2 infection and severe COVID-19-related illnesses. While most children developed local AEs, severe AEs were rare, and most of AEs resolved within several days. These data provide evidence for future recommendations.

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