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Safety and antibody response of the BNT162b2 SARS-CoV-2 vaccine in children aged 5-11 years with underlying diseases: A prospective observational study.
Funaki, Takanori; Yamada, Masaki; Miyake, Kozue; Ueno, Saki; Myojin, Shota; Aiba, Hiroyuki; Matsui, Toshihiro; Ogimi, Chikara; Kato, Hitoshi; Miyairi, Isao; Shoji, Kensuke.
Afiliación
  • Funaki T; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan. Electronic address: funaki-t@ncchd.go.jp.
  • Yamada M; 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.
  • Miyake K; Department of Clinical Research Promotion, National Center for Child Health and Development, Tokyo, Japan.
  • Ueno S; Department of Clinical Research Promotion, National Center for Child Health and Development, Tokyo, Japan.
  • Myojin S; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Aiba H; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Matsui T; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Ogimi C; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
  • Kato H; National Center for Child Health and Development, Tokyo, Japan.
  • Miyairi I; 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.
  • Shoji K; Division of Infectious Diseases, Department of Medical Subspecialties, National Center for Child Health and Development, Tokyo, Japan.
J Infect Chemother ; 30(8): 773-779, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38387787
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 / Vacuna BNT162 / Anticuerpos Antivirales Límite: Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Infect Chemother Asunto de la revista: MICROBIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 / Vacuna BNT162 / Anticuerpos Antivirales Límite: Child / Child, preschool / Female / Humans / Male Idioma: En Revista: J Infect Chemother Asunto de la revista: MICROBIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos