Efficacy and Safety of mRNA COVID-19 Vaccines in Children between the Ages of 5 to 11 Years

Evidence supports the use of messenger RNA (mRNA) COVID-19 vaccines in children aged 5 to 11 years. Hence the present study evaluated the efficacy and safety of these vaccines in children aged 5 to 11 years in a systematic review and meta-analysis.

It included randomized clinical trials and observational studies comparing vaccinated vs. unvaccinated children aged 5 to 11 years and reporting efficacy or safety outcomes. It also included investigations documenting safety outcomes in vaccinated children only (without a control group).

 The study looked for SARS-CoV-2 infections with or without symptoms; it also monitored symptomatic SARS-CoV-2 infections, hospitalizations, and multisystem inflammatory syndrome in children, along with the incidences of each AE following vaccination.

The study observed-

• Inclusion of two randomized clinical trials and 15 observational studies involving 10935541 vaccinated children and 2635251 unvaccinated children.
• Two-dose mRNA COVID-19 vaccination compared with no vaccination showed lower risks of SARS-CoV-2 infections with or without symptoms, symptomatic SARS-CoV-2 infections, hospitalizations, and multisystem inflammatory syndrome in children. 
• Two randomized clinical trials and five observational studies examined AEs among vaccinated children. 
• Most vaccinated children experienced at least one local AE after the first and second injections. 
• Vaccination showed a higher risk of any AEs compared with placebo. 
• The incidence of AEs that prevented normal daily activities was 8.8%, and that of myocarditis was estimated to be 1.8 per million following the second injection.

This study proves the efficacy of COVID-19 mRNA vaccines in preventing SARS-CoV-2 infection and severe COVID-19 illnesses in children between the ages of 5 and 11. Although most children experienced minor side effects, serious side effects were uncommon, most of which resolved within a few days. These findings offer support for potential recommendations in the future.

Watanabe A, Kani R, Iwagami M, Takagi H, Yasuhara J, Kuno T. Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review and Meta-analysis. JAMA Pediatr. 2023;177(4):384–394. doi:10.1001/jamapediatrics.2022.6243