Safety, immunogenicity, and efficacy of an mRNA COVID-19 vaccine (RQ3013) given as the fourth booster following three doses of inactivated vaccines: a double-blinded, randomised, controlled, phase 3b trial

Liu, Xiaoqiang; Sun, Zhonghan; Wang, Zhongfang; Chen, Jingjing; Wu, Qianhui; Zheng, Yan; Yang, Xiaoyun; Mo, Luhui; Yan, Xuemei; Li, Wei; Zou, Yanxiang; Song, Huiling; Qian, Feng; Lu, Jing; Zhou, Hui; Wang, Yaping; Xiang, Zuoyun; Yu, Hongjie; Lin, Jinzhong; Yuan, Lin; Zheng, Yan

doi:10.1016/j.eclinm.2023.102231

Cited by 4 publications

(1 citation statement)

References 30 publications

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“…While mRNA-based vaccines, such as those developed by Pfizer-BioNTech and Moderna, have been widely discussed and are recognized for their high efficacy, especially against the omicron variants 4 , it is crucial to consider the safety and efficacy of other vaccine types 5 . In particular, inactivated vaccines, such as those predominantly used in the MENA region and China 6 , 7 , represent a significant portion of the global vaccination effort. These vaccines, which use a traditional approach of employing killed viral particles to stimulate an immune response, have shown differing safety profiles compared to mRNA vaccines 8 , 9 .…”

Section: Introductionmentioning

confidence: 99%

COVID-19 vaccination and major cardiovascular and haematological adverse events in Abu Dhabi: retrospective cohort study

Pimentel,

Shaikh,

Al Safi

et al. 2024

Nat Commun

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The widespread administration of COVID-19 vaccines has prompted a need to understand their safety profile. This investigation focuses on the safety of inactivated and mRNA-based COVID-19 vaccines, particularly concerning potential cardiovascular and haematological adverse events. A retrospective cohort study was conducted for 1.3 million individuals residing in Abu Dhabi, United Arab Emirates, who received 1.8 million doses of the inactivated BBIBP CorV (by SinoPharm) and mRNA-based BNT162b2 (Pfizer-BioNTech) vaccines between June 1, 2021, and June 30, 2022. The study’s primary outcome was to assess the occurrence of selected cardiovascular and haematological events leading to hospitalization or emergency room visits within 21 days post-vaccination. Results showed no significant increase in the incidence rates of these events compared to the subsequent 22 to 42 days following vaccination. Analysis revealed no elevated risk for adverse outcomes following first (IRR 1·03; 95% CI 0·82-1·31), second (IRR 0·92; 95% CI 0·72-1·16) and third (IRR 0·82; 95% CI 0·66-1·00) doses of either vaccine. This study found no substantial link between receiving either mRNA and inactivated COVID-19 vaccines and a higher likelihood of cardiovascular or haematological events within 21 days after vaccination.

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