PMID- 38387787
OWN - NLM
STAT- Publisher
LR  - 20240227
IS  - 1437-7780 (Electronic)
IS  - 1341-321X (Linking)
DP  - 2024 Feb 20
TI  - Safety and antibody response of the BNT162b2 SARS-CoV-2 vaccine in children aged 
      5-11 years with underlying diseases: A prospective observational study.
LID - S1341-321X(24)00055-2 [pii]
LID - 10.1016/j.jiac.2024.02.020 [doi]
AB  - BACKGROUND: Data on the safety and antibody response of the BNT162b2 severe acute 
      respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine in children aged 
      5-11 years with underlying diseases are limited. Thus, our study aimed to address 
      this gap. METHODS: This prospective observational study investigated the antibody 
      titers for SARS-CoV-2 spike protein receptor-binding domain (S-IgG) and 
      nucleocapsid protein (N-IgG) in patients aged 5-11 years with chronic underlying 
      diseases following two doses of BNT162b2. Additionally, a questionnaire was used 
      to assess adverse events (AEs) arising within 7 days after each dose. Data on 
      severe AEs arising within 28 days after each dose were extracted from the 
      patients' electronic medical records. RESULTS: Among 122 patients, 24.6% (30/122) 
      were immunocompromised. Furthermore, 79 patients experienced at least one AE 
      following vaccination, but all recovered without sequelae, including one severe 
      case after the first dose. The seropositivity rate after the second dose was 
      99.1% (116/117). Excluding 19 N-IgG-positive patients, the geometric mean 
      antibody titer (GMT) was significantly higher in immunocompetent patients than in 
      immunocompromised patients (1496 U/mL [95% confidence interval 1199-1862] vs. 472 
      U/mL [200-1119], p = 0.035). Additionally, the GMT of S-IgG was higher in 
      N-IgG-positive patients than in N-IgG-negative patients (8203 [5847-11482] U/mL 
      vs. 1127 [855-1486] U/mL, p < 0.001). CONCLUSIONS: BNT162b2 is acceptably safe 
      and immunogenic for children aged 5-11 years with underlying diseases. Although 
      seroconversion was satisfactory in immunocompromised patients, the titers were 
      lower than in immunocompetent patients.
CI  - Copyright (c) 2024 Japanese Society of Chemotherapy, Japanese Association for 
      Infectious Diseases, and Japanese Society for Infection Prevention and Control. 
      Published by Elsevier Ltd. All rights reserved.
FAU - Funaki, Takanori
AU  - Funaki T
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan. Electronic address: 
      funaki-t@ncchd.go.jp.
FAU - Yamada, Masaki
AU  - Yamada M
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan; Department of Advanced 
      Medicine for Viral Infections, National Center for Child Health and Development, 
      Tokyo, Japan.
FAU - Miyake, Kozue
AU  - Miyake K
AD  - Department of Clinical Research Promotion, National Center for Child Health and 
      Development, Tokyo, Japan.
FAU - Ueno, Saki
AU  - Ueno S
AD  - Department of Clinical Research Promotion, National Center for Child Health and 
      Development, Tokyo, Japan.
FAU - Myojin, Shota
AU  - Myojin S
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan.
FAU - Aiba, Hiroyuki
AU  - Aiba H
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan.
FAU - Matsui, Toshihiro
AU  - Matsui T
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan.
FAU - Ogimi, Chikara
AU  - Ogimi C
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan.
FAU - Kato, Hitoshi
AU  - Kato H
AD  - National Center for Child Health and Development, Tokyo, Japan.
FAU - Miyairi, Isao
AU  - Miyairi I
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan; Department of Pediatrics, 
      Hamamatsu University School of Medicine, Shizuoka, Japan.
FAU - Shoji, Kensuke
AU  - Shoji K
AD  - Division of Infectious Diseases, Department of Medical Subspecialties, National 
      Center for Child Health and Development, Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20240220
PL  - Netherlands
TA  - J Infect Chemother
JT  - Journal of infection and chemotherapy : official journal of the Japan Society of 
      Chemotherapy
JID - 9608375
SB  - IM
OTO - NOTNLM
OT  - BNT162b2
OT  - Immunocompromised patients
OT  - Immunogenicity
OT  - SARS-CoV-2
OT  - Safety
OT  - Young child
COIS- Declaration of competing interest K. Shoji received payment for lectures from 
      bioMerieux Japan, Gilead Sciences, Inc., Viatris, Inc., and Moderna Japan Co., 
      Ltd. C. Ogimi received payment for lectures from Pfizer, AstraZeneca, and 
      bioMerieux Japan. I. Miyairi received payment for lectures from bioMerieux Japan, 
      Gilead Sciences, Inc., Pfizer, AstraZeneca, Sanofi, and Shionogi Pharmaceuticals. 
      All other authors declare that they do not have any potential, perceived, or real 
      conflicts of interest.
EDAT- 2024/02/23 00:42
MHDA- 2024/02/23 00:42
CRDT- 2024/02/22 19:19
PHST- 2023/12/03 00:00 [received]
PHST- 2024/01/20 00:00 [revised]
PHST- 2024/02/19 00:00 [accepted]
PHST- 2024/02/23 00:42 [pubmed]
PHST- 2024/02/23 00:42 [medline]
PHST- 2024/02/22 19:19 [entrez]
AID - S1341-321X(24)00055-2 [pii]
AID - 10.1016/j.jiac.2024.02.020 [doi]
PST - aheadofprint
SO  - J Infect Chemother. 2024 Feb 20:S1341-321X(24)00055-2. doi: 
      10.1016/j.jiac.2024.02.020.