PMID- 36689319
OWN - NLM
STAT- MEDLINE
DCOM- 20230405
LR  - 20230906
IS  - 2168-6211 (Electronic)
IS  - 2168-6203 (Print)
IS  - 2168-6203 (Linking)
VI  - 177
IP  - 4
DP  - 2023 Apr 1
TI  - Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 
      11 Years: A Systematic Review and Meta-analysis.
PG  - 384-394
LID - 10.1001/jamapediatrics.2022.6243 [doi]
AB  - 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.
FAU - Watanabe, Atsuyuki
AU  - Watanabe A
AD  - Division of Hospital Medicine, University of Tsukuba Hospital, Tsukuba, Ibaraki, 
      Japan.
FAU - Kani, Ryoma
AU  - Kani R
AD  - School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.
FAU - Iwagami, Masao
AU  - Iwagami M
AD  - Department of Health Services Research, Faculty of Medicine, University of 
      Tsukuba, Tsukuba, Ibaraki, Japan.
AD  - Faculty of Epidemiology and Population Health, London School of Hygiene and 
      Tropical Medicine, London, United Kingdom.
FAU - Takagi, Hisato
AU  - Takagi H
AD  - Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.
FAU - Yasuhara, Jun
AU  - Yasuhara J
AD  - Center for Cardiovascular Research, The Abigail Wexner Research Institute and The 
      Heart Center, Nationwide Children's Hospital, Columbus, Ohio.
FAU - Kuno, Toshiki
AU  - Kuno T
AD  - Division of Cardiology, Montefiore Medical Center, Albert Einstein College of 
      Medicine, New York, New York.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
PL  - United States
TA  - JAMA Pediatr
JT  - JAMA pediatrics
JID - 101589544
RN  - 0 (COVID-19 Vaccines)
RN  - pediatric multisystem inflammatory disease, COVID-19 related
SB  - IM
CIN - JAMA Pediatr. 2023 Apr 1;177(4):333-334. PMID: 36689322
MH  - Humans
MH  - Child
MH  - Child, Preschool
MH  - *COVID-19/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - SARS-CoV-2
MH  - Parents
PMC - PMC9871947
COIS- Conflict of Interest Disclosures: None reported.
EDAT- 2023/01/24 06:00
MHDA- 2023/04/05 06:43
PMCR- 2023/01/23
CRDT- 2023/01/23 12:32
PHST- 2023/04/05 06:43 [medline]
PHST- 2023/01/24 06:00 [pubmed]
PHST- 2023/01/23 12:32 [entrez]
PHST- 2023/01/23 00:00 [pmc-release]
AID - 2800743 [pii]
AID - poi220101 [pii]
AID - 10.1001/jamapediatrics.2022.6243 [doi]
PST - ppublish
SO  - JAMA Pediatr. 2023 Apr 1;177(4):384-394. doi: 10.1001/jamapediatrics.2022.6243.