SCHILLING REDLICH, ANDREA INGRID
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SCHILLING REDLICH, ANDREA INGRID
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aschilling@udd.cl
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7101797606

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Different Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac®) According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an Open-Label Study in Chile

2023 , Nicole Le Corre , Katia Abarca , Patricio Astudillo , Marcela Potin , Sofía López , Macarena Goldsack , Vania Valenzuela , SCHILLING REDLICH, ANDREA INGRID , Victoria Gaete , Lilian Rubio , Mario Calvo , Loreto Twele , Marcela González , Daniela Fuentes , Valentina Gutiérrez , Felipe Reyes , Lorena I. Tapia , Rodolfo Villena , Angello Retamal-Díaz , Antonio Cárdenas , Eduardo Alarcón-Bustamante , Xing Meng , Qianqian Xin , José V. González-Aramundiz , María Javiera Álvarez-Figueroa , Pablo A. González , Susan M. Bueno , Jorge A. Soto , Cecilia Perret , Alexis M. Kalergis

During the COVID-19 pandemic, the importance of vaccinating children against SARS-CoV-2 was rapidly established. This study describes the safety of CoronaVac® 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®; 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® was safe and well tolerated in children and adolescents, with different safety patterns according to age.

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Publication

Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children

2022 , Jorge A. Soto , Felipe Melo-González , Cristián Gutierrez-Vera , Bárbara M. Schultz , Roslye V. Berríos-Rojas , Daniela Rivera-Pérez , Alejandro Piña-Iturbe , Guillermo Hoppe-Elsholz , Luisa F. Duarte , Yaneisi Vázquez , Daniela Moreno-Tapia , Mariana Ríos , Pablo A. Palacios , Richard Garcia-Betancourt , Álvaro Santibañez , Gaspar A. Pacheco , Constanza Mendez , Catalina A. Andrade , Pedro H. Silva , Benjamín Diethelm-Varela , Patricio Astudillo , Mario Calvo , Antonio Cárdenas , Marcela González , Macarena Goldsack , Valentina Gutiérrez , Marcela Potin , SCHILLING REDLICH, ANDREA INGRID , Lorena I. Tapia , Loreto Twele , Rodolfo Villena , Alba Grifoni , Alessandro Sette , Daniela Weiskopf , Rodrigo A. Fasce , Jorge Fernández , Judith Mora , Eugenio Ramírez , Aracelly Gaete-Argel , Mónica L. Acevedo , Fernando Valiente-Echeverría , Ricardo Soto-Rifo , Angello Retamal-Díaz , Nathalia Muñoz-Jofré , Xing Meng , Qianqian Xin , Eduardo Alarcón-Bustamante , José V. González-Aramundiz , Nicole Le Corre , María Javiera Álvarez-Figueroa , CEA GONZALEZ, PABLO ANTONIO , Katia Abarca , Cecilia Perret , Leandro J. Carreño , Susan M. Bueno , Alexis M. Kalergis , Patricio Astudillo Paredes , Epifanía Hernández Jara , Héctor Morán Fernández , Javiera Arenas Urra , Stephani Ascui Baeza , María Olivia Cabrera , José Romero Muñoz , Gonzalo Alarcón Andrade , Rocío Rodríguez Espósito , Anwar Gutiérrez Silva , Fernanda Pérez Gutiérrez , Alma Muñoz Muñoz , Marcela Potin Santander , Sofia López , Tania Weil , Macarena Goldsack , Deidyland Arenas , Javiera Moore , ARAYA CASTRO, PAULINA ANDREA , Lorena Pilicita , Vania Valenzuela , Catalina Campos , Mauricio Soto , SCHILLING REDLICH, ANDREA INGRID , Alberto Trautmann , Ana Fritis , Daniela Pavez , Javiera Arancibia , Lilian Rubio , Paula Viviani , Vinka Basic , Cassandra Cárcamo , Mario Calvo Gil , Marisol Wenzel , Nicole Carey , Roberto Burgos , Loreto Twele , Daniel Beltrán , Silvana Grandón , Carlos Tovar , Marcela González , Daniela Fuentes , Teresa Ramírez , Mariela Cepeda Corrales , Nataly Martínez López , Valentina Gutiérrez , Felipe Reyes , Armando Lavayen , Melissa González , Monserrat Gutiérrez , Noris Rengifo , Carla Ortega , Florencia Saver , Lorena Tapia , Mirta Acuña , Javiera Albornoz , Tania Cariqueo , Alejandro Velásquez , Yennybeth Leiva Chamorro , Rodolfo Villena , Paola Flores , Francisca Bartsch , Belén Sepúlveda , Daniela Garmendia , Antonio Cárdenas , Angello Retamal , Carmen Ludeña , Lorena González , Carolina Hermosilla , Gustavo Keilhold , Francisco Cammarata-Scalisi , Jessica Álvarez , Jessica Romero , Pía Villarroel , Francisca Muñoz , Jorge Maya , Andrés Canales , Margarita K. Lay , Christian Muñoz , Roylester Araya , Kanta Subbarao

This work evaluated the immune response induced by two doses of CoronaVac separated by 4 weeks in healthy children and adolescents in Chile. To date, few studies have described the effects of CoronaVac in the pediatric population.

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Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial

2022 , Katia Abarca , Carolina Iturriaga , Marcela Urzúa , Nicole Le Corre , Augusto Pineda , Carolina Fernández , Angélica Domínguez , CEA GONZALEZ, PABLO ANTONIO , Susan M. Bueno , Paulina Donato , Pilar Espinoza , Daniela Fuentes , Marcela González , Paula Guzmán , MUÑOZ VENTURELLI, PAULA ANDREA , Carlos M. Pérez , Marcela Potin , Álvaro Rojas , José V. González-Aramundiz , Nicolás M. S. Gálvez , Francisca Aguirre-Boza , Sofía Aljaro , Luis Federico Bátiz , Yessica Campisto , Mariela Cepeda , Aarón Cortés , Sofía López , María Loreto Pérez , SCHILLING REDLICH, ANDREA INGRID , Alexis M. Kalergis

Several vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.

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