Safety of two-dose schedule of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan) and heterologous additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised and immunocompetent individuals
Authors: Miyaji Karina Takesaki , Ibrahim Karim Yaqub , Infante Vanessa , Moreira Raquel Megale , Santos Carolina Ferreira dos , Belizário Juliana de Cássia , Pinto Maria Isabel de Moraes , Marinho Ana Karolina Barreto Berselli , Pereira Juliana Marquezi , Mello Liliane Saraiva de , Silva Vitor Gabriel Lopes da , Sato Paula Keiko , Strabelli Tânia Mara Varejão , Ragiotto Lucas , Pacheco Pedro Henrique Theotonio de Mesquita , Braga Patricia Emilia , Loch Ana Paula , Precioso Alexander Roberto , Sartori Ana Marli Christovam , França João Ítalo , Lima Marcos Alves de , Ando Mauricio Cesar Sampaio , Rodrigues Camila Cristina Martini , Song Alice Tung Wan , Lara Amanda Nazareth , Belizário Ana Cristina , Lima Anna Helena Simões Bortulucci de , Zanetti Ariane Cristina Barboza , Paulo Audrey Rose da Silveira Amancio de , Rosa Barbara Miranda dos Santos , Moraes Bruna Del Guerra de Carvalho , Oliveira Bruna Ribeiro de , Picone Camila de Melo , Aranda Carolina Sanches , Troli Carolinne Paioli , Kokron Cristina M. , Terrabuio Debora Raquel Benedita , Abdala Edson , David Neto Elias , Nakanishi Érika Yoshie Shimoda , Lima Fabiana Mascarenhas Souza , Firmino Fabio Batista , Santos Fernanda Barone Alves dos , Bacal Fernando , Fatobene Giancarlo , Santana Jaqueline Oliveira , Kalil Jorge , Barbosa Julia , Gonçalves Leandro Peres , Otuyama Leonardo Jun , Pierrotti Ligia Camera , Compte Livia Caroline Mariano , Marinho Livia , Chaer Livia Netto , Seguro Luis Fernando , Azevedo Luiz Sergio , Ueda Márcia Aiko , Terreri Maria Teresa , Barros Myrthes Anna Maragna Toledo , Grecco Octávio , Sejas Odeli Nicole Encinas , Musqueira Priscila Tavares , Ito Raquel Keiko de Luca , Teixeira Samia Silveira Souza , Fidalgo Serafim , Costa Silvia Figueiredo , Campos Silvia Vidal , Fernandes Tamiris Hinsching , Rocha Vanderson Geraldo , Coelho Vivian Caso 
Published: January 2025

ABSTRACT Immunocompromised individuals were considered high-risk for severe disease due to SARS COV-2 infection. This study aimed to describe the safety of two doses of COVID-19 adsorbed inactivated vaccine (CoronaVac; Sinovac/Butantan), followed by additional doses of mRNA BNT162b2 (Pfizer/BioNTech) in immunocompromised (IC) adults, compared to immunocompetent/healthy (H) individuals. This phase 4, multicenter, open label study included solid organ transplant and hematopoietic stem cell transplant recipients, cancer patients and people with inborn errors of immunity with defects in antibody production, rheumatic, end-stage chronic kidney or liver disease, who were enrolled in the IC group. Participants received two doses of CoronaVac and additional doses of mRNA BNT162b2. Adverse reactions (AR) data were collected within seven days after each vaccination. Serious adverse events and of special interest (AESI) were monitored throughout the study. We included 241 immunocompromised and 100 immunocompetent subjects. Arthralgia, fatigue, myalgia, and nausea were more frequent in the IC group after CoronaVac. Following the first additional dose of mRNA BNT162, pain, induration, and tenderness at injection site, fatigue and myalgia were more frequent in the H group. A heart transplant recipient had a graft rejection temporally associated with the second CoronaVac dose, but there was no literature evidence of causal association. Four cases of AESI were considered related to the vaccine: three erythema multiforme after CoronaVac, all in IC participants, and one paresthesia after mRNA, in a H participant. Our findings were comparable to other studies that evaluated the safety of COVID-19 vaccines in different immunocompromised populations. Both vaccines were safe for immunocompromised participants.