de Souza Ramon Andrade, Barreto Florisneide Rodrigues, de Jesus Lima Carla Cristina Oliveira, da Natividade Marcio Santos, de Souza Teles Santos Carlos Antônio, Ichihara Maria Yury, Pereira Marcos, de Castro Daniel Barros, Genser Bernd, Rodrigues Laura Cunha, Barreto Maurício Lima, Pereira Susan Martins
Institute of Collective Health, Federal University of Bahia, Bahia, Brazil.
Institute of Collective Health, Federal University of Bahia, Bahia, Brazil.
Vaccine. 2025 Apr 30;54:126911. doi: 10.1016/j.vaccine.2025.126911. Epub 2025 Mar 9.
Can vaccination with Bacille Calmette-Guérin prevent clinical progression of COVID-19? Data from the BCG-REVAC trial was archived in a database, creating an excellent opportunity to link it to notified cases of COVID-19 to evaluate the efficacy of BCG against incidence, severity and clinical progression to severe COVID-19 when given at birth day, at school age as a first dose or as a second dose.
This study was conducted in the population of the BCG-REVAC cluster randomisation trial including 354,403 schoolchildren, aged 7 to 14 years, from 767 schools from two cities, Salvador and Manaus. Cases of COVID-19 from the System for Notification of Infectious Diseases and the System for Notification of Severe Respiratory Illnesses were record linked to BCG-REVAC population. The exposure was Vaccination or revaccination obtained by the BCG-REVAC. The outcomes of interest in this study were incidence COVID-19; incidence of severe COVID-19; and clinical progression of COVID-19. This project was approved by the Ethics Committee of the Institute of Collective Health, Federal University of Bahia, Brazil.
The neonatal dose and a first dose of BCG at school age protect against the incidence of severe COVID-19 in multivariate models, whose efficacies were 30 % (95 %CI:1-51) and 64 % (95 %CI: 22-84), respectively. The neonatal dose showed an effect on severe clinical progression of symptomatic COVID-19 disease in COVID-19 infected subjects 39 % (95 %CI:11 % - 58 %).
Even 23 years after BCG vaccination and revaccination of school-age children our results suggesting a protective effect of BCG first dose against incidence of severe COVID-19 in infected individuals, a smaller effect of the neonatal dose and no effect of the second dose at school age.
卡介苗接种能否预防新冠病毒病（COVID-19）的临床进展？卡介苗重新接种（BCG-REVAC）试验的数据已存档于数据库中，这为将其与COVID-19报告病例相联系提供了绝佳机会，以评估卡介苗在出生时、学龄期作为首剂或第二剂接种时，对COVID-19发病率、严重程度及进展为重症COVID-19的疗效。
本研究在卡介苗重新接种集群随机试验人群中开展，该人群包括来自萨尔瓦多和马瑙斯两个城市767所学校的354403名7至14岁学童。将传染病报告系统和严重呼吸道疾病报告系统中的COVID-19病例与卡介苗重新接种人群进行记录关联。暴露因素为卡介苗重新接种所进行的接种或复种。本研究感兴趣的结局为COVID-19发病率；重症COVID-19发病率；以及COVID-19的临床进展。本项目经巴西巴伊亚联邦大学集体卫生研究所伦理委员会批准。
在多变量模型中，新生儿剂量和学龄期首剂卡介苗可预防重症COVID-19的发生，其疗效分别为30%（95%CI：1-51）和64%（95%CI：22-84）。新生儿剂量对COVID-19感染受试者中症状性COVID-19疾病的严重临床进展有影响，为39%（95%CI：11%-58%）。
即使在学龄儿童接种卡介苗和复种23年后，我们的结果表明，卡介苗首剂对感染个体中重症COVID-19的发生有保护作用，新生儿剂量的作用较小，学龄期第二剂则无作用。
