PMID- 37896930
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231030
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 11
IP  - 10
DP  - 2023 Sep 26
TI  - Different Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac((R))) 
      According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an 
      Open-Label Study in Chile.
LID - 10.3390/vaccines11101526 [doi]
LID - 1526
AB  - During the COVID-19 pandemic, the importance of vaccinating children against 
      SARS-CoV-2 was rapidly established. This study describes the safety of 
      CoronaVac((R)) in children and adolescents between 3- and 17-years-old in a 
      multicenter study in Chile with two vaccine doses in a 4-week interval. For all 
      participants, immediate adverse events (AEs), serious AEs (SAEs), and AEs of 
      special interest (AESIs) were registered throughout the study. In the safety 
      subgroup, AEs were recorded 28 days after each dose. COVID-19 surveillance was 
      performed throughout the study. A total of 1139 individuals received the first 
      and 1102 the second dose of CoronaVac((R)); 835 were in the safety subgroup. The 
      first dose showed the highest number of AEs: up to 22.2% of participants reported 
      any local and 17.1% systemic AE. AEs were more frequent in adolescents after the 
      first dose, were transient, and mainly mild. Pain at the inoculation site was the 
      most frequent AE for all ages. Fever was the most frequent systemic AE for 3-5 
      years old and headache in 6-17 years old. No SAEs or AESIs related to vaccination 
      occurred. Most of the COVID-19 cases were mild and managed as outpatients. 
      CoronaVac((R)) was safe and well tolerated in children and adolescents, with 
      different safety patterns according to age.
FAU - Le Corre, Nicole
AU  - Le Corre N
AUID- ORCID: 0000-0002-9361-4049
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
FAU - Abarca, Katia
AU  - Abarca K
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
FAU - Astudillo, Patricio
AU  - Astudillo P
AUID- ORCID: 0000-0002-2600-630X
AD  - Division de Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de 
      Chile, Santiago 8330077, Chile.
FAU - Potin, Marcela
AU  - Potin M
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
AD  - Clinica San Carlos de Apoquindo, Red de Salud UC Christus, Santiago 7610437, 
      Chile.
FAU - Lopez, Sofia
AU  - Lopez S
AD  - Clinica San Carlos de Apoquindo, Red de Salud UC Christus, Santiago 7610437, 
      Chile.
FAU - Goldsack, Macarena
AU  - Goldsack M
AD  - Departamento de Pediatria, Division de Pediatria, Escuela de Medicina, Pontificia 
      Universidad Catolica de Chile, Santiago 8330077, Chile.
AD  - Centro Medico San Joaquin, Red de Salud UC Christus, Santiago 7820436, Chile.
FAU - Valenzuela, Vania
AU  - Valenzuela V
AD  - Departamento de Medicina Familiar, Escuela de Medicina, Pontificia Universidad 
      Catolica de Chile, Santiago 8330077, Chile.
FAU - Schilling, Andrea
AU  - Schilling A
AUID- ORCID: 0000-0002-8339-779X
AD  - Facultad de Medicina, Clinica Alemana Universidad del Desarrollo, Santiago 
      7610658, Chile.
AD  - Departamento de Pediatria, Clinica Alemana de Santiago, Santiago 7650568, Chile.
FAU - Gaete, Victoria
AU  - Gaete V
AD  - Facultad de Medicina, Clinica Alemana Universidad del Desarrollo, Santiago 
      7610658, Chile.
FAU - Rubio, Lilian
AU  - Rubio L
AD  - Departamento de Pediatria, Clinica Alemana de Santiago, Santiago 7650568, Chile.
AD  - Servicio de Neonatologia, Hospital Luis Tisne, Santiago 7910000, Chile.
FAU - Calvo, Mario
AU  - Calvo M
AD  - Instituto de Pediatria, Universidad Austral de Chile, Valdivia 5110566, Chile.
FAU - Twele, Loreto
AU  - Twele L
AD  - Hospital Puerto Montt, Puerto Montt 5507798, Chile.
AD  - Facultad de Medicina y Ciencia, Universidad San Sebastian, Puerto Montt 5501842, 
      Chile.
FAU - Gonzalez, Marcela
AU  - Gonzalez M
AD  - Hospital Dr. Gustavo Fricke, Vina Del Mar 2340000, Chile.
AD  - Departamento de Pediatria, Universidad de Valparaiso, Valparaiso 2361845, Chile.
FAU - Fuentes, Daniela
AU  - Fuentes D
AD  - Departamento de Pediatria, Universidad de Valparaiso, Valparaiso 2361845, Chile.
FAU - Gutierrez, Valentina
AU  - Gutierrez V
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
AD  - Unidad de Infectologia Pediatrica, Servicio de Pediatria, Complejo Asistencial 
      Dr. Sotero del Rio, Santiago 8150215, Chile.
FAU - Reyes, Felipe
AU  - Reyes F
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
AD  - Unidad de Infectologia Pediatrica, Servicio de Pediatria, Complejo Asistencial 
      Dr. Sotero del Rio, Santiago 8150215, Chile.
FAU - Tapia, Lorena I
AU  - Tapia LI
AD  - Departamento de Pediatria y Cirugia Infantil Norte, Hospital Roberto del Rio, 
      Facultad de Medicina, Universidad de Chile, Santiago 8380418, Chile.
AD  - Programa de Virologia, Instituto de Ciencias Biomedicas, Facultad de Medicina, 
      Universidad de Chile, Santiago 8380453, Chile.
FAU - Villena, Rodolfo
AU  - Villena R
AD  - Hospital Exequiel Gonzalez Cortes, Facultad de Medicina, Departamento de 
      Pediatria y Cirugia Infantil Campus Sur, Universidad de Chile, Santiago 8900085, 
      Chile.
FAU - Retamal-Diaz, Angello
AU  - Retamal-Diaz A
AD  - Departamento de Biotecnologia, Facultad de Ciencias del Mar y de Recursos 
      Biologicos, Universidad de Antofagasta, Antofagasta 1271155, Chile.
AD  - Hospital Clinico Universidad de Antofagasta, Universidad de Antofagasta, 
      Antofagasta 1270001, Chile.
AD  - Millennium Institute on Immunology and Immunotherapy, Santiago 8331150, Chile.
FAU - Cardenas, Antonio
AU  - Cardenas A
AD  - Hospital Clinico Universidad de Antofagasta, Universidad de Antofagasta, 
      Antofagasta 1270001, Chile.
AD  - Departamento de Ciencias Medicas, Facultad de Medicina y Odontologia, Universidad 
      de Antofagasta, Antofagasta 1271155, Chile.
AD  - Servicio de Pediatria, Hospital Regional de Antofagasta, Antofagasta 1240835, 
      Chile.
FAU - Alarcon-Bustamante, Eduardo
AU  - Alarcon-Bustamante E
AUID- ORCID: 0000-0003-3121-483X
AD  - Faculty of Mathematics, Pontificia Universidad Catolica de Chile, Santiago 
      7820436, Chile.
AD  - Millennium Nucleus on Intergenerational Mobility: From Modelling to Policy (MOVI) 
      [NCS2021072], Santiago 7820436, Chile.
AD  - Interdisciplinary Laboratory of Social Statistics, Facultad de Matematicas, 
      Pontificia Universidad Catolica de Chile, Santiago 7820436, Chile.
FAU - Meng, Xing
AU  - Meng X
AD  - Sinovac Biotech, Beijing 100085, China.
FAU - Xin, Qianqian
AU  - Xin Q
AD  - Sinovac Biotech, Beijing 100085, China.
FAU - Gonzalez-Aramundiz, Jose V
AU  - Gonzalez-Aramundiz JV
AUID- ORCID: 0000-0001-7856-9211
AD  - Departamento de Farmacia, Facultad de Quimica y de Farmacia, Pontificia 
      Universidad Catolica de Chile, Santiago 7820436, Chile.
FAU - Alvarez-Figueroa, Maria Javiera
AU  - Alvarez-Figueroa MJ
AD  - Departamento de Farmacia, Facultad de Quimica y de Farmacia, Pontificia 
      Universidad Catolica de Chile, Santiago 7820436, Chile.
FAU - Gonzalez, Pablo A
AU  - Gonzalez PA
AUID- ORCID: 0000-0001-7709-6870
AD  - Millennium Institute on Immunology and Immunotherapy, Santiago 8331150, Chile.
AD  - Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
FAU - Bueno, Susan M
AU  - Bueno SM
AUID- ORCID: 0000-0002-7551-8088
AD  - Millennium Institute on Immunology and Immunotherapy, Santiago 8331150, Chile.
AD  - Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
FAU - Soto, Jorge A
AU  - Soto JA
AD  - Millennium Institute on Immunology and Immunotherapy, Santiago 8331150, Chile.
AD  - Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
AD  - Departamento de Ciencias Biologicas, Facultad de Ciencias de la Vida, Universidad 
      Andres Bello, Santiago 8370251, Chile.
FAU - On Behalf Of The PedCoronaVac Cl Study Group
AU  - On Behalf Of The PedCoronaVac Cl Study Group
FAU - Perret, Cecilia
AU  - Perret C
AUID- ORCID: 0000-0002-1535-1204
AD  - Departamento de Enfermedades Infecciosas e Inmunologia Pediatricas, Division de 
      Pediatria, Escuela de Medicina, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
FAU - Kalergis, Alexis M
AU  - Kalergis AM
AUID- ORCID: 0000-0001-7622-5263
AD  - Millennium Institute on Immunology and Immunotherapy, Santiago 8331150, Chile.
AD  - Facultad de Ciencias Biologicas, Pontificia Universidad Catolica de Chile, 
      Santiago 8330077, Chile.
AD  - Departamento de Endocrinologia, Facultad de Medicina, Escuela de Medicina, 
      Pontificia Universidad Catolica de Chile, Santiago 8330077, Chile.
LA  - eng
GR  - PRO-nCOV- 3002/Sinovac Biotech/
PT  - Journal Article
DEP - 20230926
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC10611329
OTO - NOTNLM
OT  - COVID-19 vaccines
OT  - CoronaVac(R)
OT  - SARS-CoV-2
OT  - adolescents
OT  - children
OT  - inactivated virus vaccine
OT  - safety pattern
COIS- All authors and coordinators of the PedCoronaVac03CL Study have no conflict of 
      interest or commercial interests to disclose.
EDAT- 2023/10/28 11:43
MHDA- 2023/10/28 11:44
PMCR- 2023/09/26
CRDT- 2023/10/28 01:30
PHST- 2023/06/06 00:00 [received]
PHST- 2023/08/25 00:00 [revised]
PHST- 2023/09/13 00:00 [accepted]
PHST- 2023/10/28 11:44 [medline]
PHST- 2023/10/28 11:43 [pubmed]
PHST- 2023/10/28 01:30 [entrez]
PHST- 2023/09/26 00:00 [pmc-release]
AID - vaccines11101526 [pii]
AID - vaccines-11-01526 [pii]
AID - 10.3390/vaccines11101526 [doi]
PST - epublish
SO  - Vaccines (Basel). 2023 Sep 26;11(10):1526. doi: 10.3390/vaccines11101526.