tetano
Editor, Senior Moderator
Rev Inst Med Trop Sao Paulo
. 2025 Jan 20:67:e2.
doi: 10.1590/S1678-9946202567002. eCollection 2025. 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
Karina Takesaki Miyaji[SUP] 1 2 3 [/SUP], Karim Yaqub Ibrahim[SUP] 1 4 [/SUP], Vanessa Infante[SUP] 3 [/SUP], Raquel Megale Moreira[SUP] 5 [/SUP], Carolina Ferreira Dos Santos[SUP] 6 [/SUP], Juliana de Cássia Belizário[SUP] 4 [/SUP], Maria Isabel de Moraes Pinto[SUP] 7 [/SUP], Ana Karolina Barreto Berselli Marinho[SUP] 8 [/SUP], Juliana Marquezi Pereira[SUP] 9 [/SUP], Liliane Saraiva de Mello[SUP] 10 [/SUP], Vitor Gabriel Lopes da Silva[SUP] 11 [/SUP], Paula Keiko Sato[SUP] 12 [/SUP], Tânia Mara Varejão Strabelli[SUP] 13 [/SUP], Lucas Ragiotto[SUP] 3 [/SUP], Pedro Henrique Theotonio de Mesquita Pacheco[SUP] 3 [/SUP], Patricia Emilia Braga[SUP] 3 [/SUP], Ana Paula Loch[SUP] 3 [/SUP], Alexander Roberto Precioso[SUP] 3 [/SUP], Ana Marli Christovam Sartori[SUP] 2 14 [/SUP]; Study Group[SUP] 1 10 12 13 15 16 [/SUP]; João Ítalo França[SUP] 3 [/SUP], Marcos Alves de Lima[SUP] 3 [/SUP], Mauricio Cesar Sampaio Ando[SUP] 16 [/SUP], Camila Cristina Martini Rodrigues[SUP] 3 [/SUP], Alice Tung Wan Song[SUP] 1 [/SUP], Amanda Nazareth Lara[SUP] 1 2 [/SUP], Ana Cristina Belizário[SUP] 4 [/SUP], Anna Helena Simões Bortulucci de Lima[SUP] 6 [/SUP], Ariane Cristina Barboza Zanetti[SUP] 3 [/SUP], Audrey Rose da Silveira Amancio de Paulo[SUP] 16 [/SUP], Barbara Miranda Dos Santos Rosa[SUP] 9 [/SUP], Bruna Del Guerra de Carvalho Moraes[SUP] 6 [/SUP], Bruna Ribeiro de Oliveira[SUP] 7 [/SUP], Camila de Melo Picone[SUP] 1 2 [/SUP], Carolina Sanches Aranda[SUP] 7 [/SUP], Carolinne Paioli Troli[SUP] 7 [/SUP], Cristina M Kokron[SUP] 7 [/SUP], Debora Raquel Benedita Terrabuio[SUP] 9 [/SUP], Edson Abdala[SUP] 1 [/SUP], Elias David Neto[SUP] 5 [/SUP], Érika Yoshie Shimoda Nakanishi[SUP] 12 [/SUP], Fabiana Mascarenhas Souza Lima[SUP] 8 [/SUP], Fabio Batista Firmino[SUP] 5 [/SUP], Fernanda Barone Alves Dos Santos[SUP] 16 [/SUP], Fernando Bacal[SUP] 16 [/SUP], Giancarlo Fatobene[SUP] 6 [/SUP], Jaqueline Oliveira Santana[SUP] 3 [/SUP], Jorge Kalil[SUP] 8 [/SUP], Julia Barbosa[SUP] 9 [/SUP], Leandro Peres Gonçalves[SUP] 9 [/SUP], Leonardo Jun Otuyama[SUP] 6 [/SUP], Ligia Camera Pierrotti[SUP] 1 [/SUP], Livia Caroline Mariano Compte[SUP] 6 [/SUP], Livia Marinho[SUP] 6 [/SUP], Livia Netto Chaer[SUP] 6 [/SUP], Luis Fernando Seguro[SUP] 16 [/SUP], Luiz Sergio Azevedo[SUP] 5 [/SUP], Márcia Aiko Ueda[SUP] 2 [/SUP], Maria Teresa Terreri[SUP] 7 [/SUP], Myrthes Anna Maragna Toledo Barros[SUP] 8 [/SUP], Octávio Grecco[SUP] 8 [/SUP], Odeli Nicole Encinas Sejas[SUP] 4 [/SUP], Priscila Tavares Musqueira[SUP] 4 [/SUP], Raquel Keiko de Luca Ito[SUP] 4 [/SUP], Samia Silveira Souza Teixeira[SUP] 3 [/SUP], Serafim Fidalgo[SUP] 8 [/SUP], Silvia Figueiredo Costa[SUP] 1 13 [/SUP], Silvia Vidal Campos[SUP] 10 [/SUP], Tamiris Hinsching Fernandes[SUP] 4 [/SUP], Vanderson Geraldo Rocha[SUP] 6 [/SUP], Vivian Caso Coelho[SUP] 12 [/SUP]
Affiliations
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.
. 2025 Jan 20:67:e2.
doi: 10.1590/S1678-9946202567002. eCollection 2025. 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
Karina Takesaki Miyaji[SUP] 1 2 3 [/SUP], Karim Yaqub Ibrahim[SUP] 1 4 [/SUP], Vanessa Infante[SUP] 3 [/SUP], Raquel Megale Moreira[SUP] 5 [/SUP], Carolina Ferreira Dos Santos[SUP] 6 [/SUP], Juliana de Cássia Belizário[SUP] 4 [/SUP], Maria Isabel de Moraes Pinto[SUP] 7 [/SUP], Ana Karolina Barreto Berselli Marinho[SUP] 8 [/SUP], Juliana Marquezi Pereira[SUP] 9 [/SUP], Liliane Saraiva de Mello[SUP] 10 [/SUP], Vitor Gabriel Lopes da Silva[SUP] 11 [/SUP], Paula Keiko Sato[SUP] 12 [/SUP], Tânia Mara Varejão Strabelli[SUP] 13 [/SUP], Lucas Ragiotto[SUP] 3 [/SUP], Pedro Henrique Theotonio de Mesquita Pacheco[SUP] 3 [/SUP], Patricia Emilia Braga[SUP] 3 [/SUP], Ana Paula Loch[SUP] 3 [/SUP], Alexander Roberto Precioso[SUP] 3 [/SUP], Ana Marli Christovam Sartori[SUP] 2 14 [/SUP]; Study Group[SUP] 1 10 12 13 15 16 [/SUP]; João Ítalo França[SUP] 3 [/SUP], Marcos Alves de Lima[SUP] 3 [/SUP], Mauricio Cesar Sampaio Ando[SUP] 16 [/SUP], Camila Cristina Martini Rodrigues[SUP] 3 [/SUP], Alice Tung Wan Song[SUP] 1 [/SUP], Amanda Nazareth Lara[SUP] 1 2 [/SUP], Ana Cristina Belizário[SUP] 4 [/SUP], Anna Helena Simões Bortulucci de Lima[SUP] 6 [/SUP], Ariane Cristina Barboza Zanetti[SUP] 3 [/SUP], Audrey Rose da Silveira Amancio de Paulo[SUP] 16 [/SUP], Barbara Miranda Dos Santos Rosa[SUP] 9 [/SUP], Bruna Del Guerra de Carvalho Moraes[SUP] 6 [/SUP], Bruna Ribeiro de Oliveira[SUP] 7 [/SUP], Camila de Melo Picone[SUP] 1 2 [/SUP], Carolina Sanches Aranda[SUP] 7 [/SUP], Carolinne Paioli Troli[SUP] 7 [/SUP], Cristina M Kokron[SUP] 7 [/SUP], Debora Raquel Benedita Terrabuio[SUP] 9 [/SUP], Edson Abdala[SUP] 1 [/SUP], Elias David Neto[SUP] 5 [/SUP], Érika Yoshie Shimoda Nakanishi[SUP] 12 [/SUP], Fabiana Mascarenhas Souza Lima[SUP] 8 [/SUP], Fabio Batista Firmino[SUP] 5 [/SUP], Fernanda Barone Alves Dos Santos[SUP] 16 [/SUP], Fernando Bacal[SUP] 16 [/SUP], Giancarlo Fatobene[SUP] 6 [/SUP], Jaqueline Oliveira Santana[SUP] 3 [/SUP], Jorge Kalil[SUP] 8 [/SUP], Julia Barbosa[SUP] 9 [/SUP], Leandro Peres Gonçalves[SUP] 9 [/SUP], Leonardo Jun Otuyama[SUP] 6 [/SUP], Ligia Camera Pierrotti[SUP] 1 [/SUP], Livia Caroline Mariano Compte[SUP] 6 [/SUP], Livia Marinho[SUP] 6 [/SUP], Livia Netto Chaer[SUP] 6 [/SUP], Luis Fernando Seguro[SUP] 16 [/SUP], Luiz Sergio Azevedo[SUP] 5 [/SUP], Márcia Aiko Ueda[SUP] 2 [/SUP], Maria Teresa Terreri[SUP] 7 [/SUP], Myrthes Anna Maragna Toledo Barros[SUP] 8 [/SUP], Octávio Grecco[SUP] 8 [/SUP], Odeli Nicole Encinas Sejas[SUP] 4 [/SUP], Priscila Tavares Musqueira[SUP] 4 [/SUP], Raquel Keiko de Luca Ito[SUP] 4 [/SUP], Samia Silveira Souza Teixeira[SUP] 3 [/SUP], Serafim Fidalgo[SUP] 8 [/SUP], Silvia Figueiredo Costa[SUP] 1 13 [/SUP], Silvia Vidal Campos[SUP] 10 [/SUP], Tamiris Hinsching Fernandes[SUP] 4 [/SUP], Vanderson Geraldo Rocha[SUP] 6 [/SUP], Vivian Caso Coelho[SUP] 12 [/SUP]
Affiliations
- PMID: 39841781
- DOI: 10.1590/S1678-9946202567002
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.