Abstract：
BACKGROUND: The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Global Vaccine Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate the risk of adverse events of special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries.
METHODS: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.
RESULTS: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.
CONCLUSIONS: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
METHODS: Using a common protocol, this observational cohort study compared observed with expected rates of 13 selected AESI across neurological, haematological, and cardiac outcomes. Expected rates were obtained by participating sites using pre-COVID-19 vaccination healthcare data stratified by age and sex. Observed rates were reported from the same healthcare datasets since COVID-19 vaccination program rollout. AESI occurring up to 42 days following vaccination with mRNA (BNT162b2 and mRNA-1273) and adenovirus-vector (ChAdOx1) vaccines were included in the primary analysis. Risks were assessed using observed versus expected (OE) ratios with 95 % confidence intervals. Prioritised potential safety signals were those with lower bound of the 95 % confidence interval (LBCI) greater than 1.5.
RESULTS: Participants included 99,068,901 vaccinated individuals. In total, 183,559,462 doses of BNT162b2, 36,178,442 doses of mRNA-1273, and 23,093,399 doses of ChAdOx1 were administered across participating sites in the study period. Risk periods following homologous vaccination schedules contributed 23,168,335 person-years of follow-up. OE ratios with LBCI > 1.5 were observed for Guillain-Barré syndrome (2.49, 95 % CI: 2.15, 2.87) and cerebral venous sinus thrombosis (3.23, 95 % CI: 2.51, 4.09) following the first dose of ChAdOx1 vaccine. Acute disseminated encephalomyelitis showed an OE ratio of 3.78 (95 % CI: 1.52, 7.78) following the first dose of mRNA-1273 vaccine. The OE ratios for myocarditis and pericarditis following BNT162b2, mRNA-1273, and ChAdOx1 were significantly increased with LBCIs > 1.5.
CONCLUSIONS: This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis. Other potential safety signals that require further investigation were identified.
摘要：
背景：全球COVID疫苗安全（GCoVS）项目，2021年在跨国公司全球疫苗数据网络™(GVDN®)下成立，有利于全面评估疫苗的安全性。这项研究旨在评估来自8个国家10个地点的COVID-19疫苗接种后特殊关注不良事件(AESI)的风险。
方法：使用通用协议，这项观察性队列研究与13个选定的AESI在神经系统中的预期发生率进行了比较，血液学，和心脏结果。参与地点使用按年龄和性别分层的COVID-19疫苗接种前医疗保健数据获得了预期率。自COVID-19疫苗接种计划推出以来，观察到的发生率来自相同的医疗保健数据集。在用mRNA(BNT162b2和mRNA-1273)和腺病毒载体(ChAdOx1)疫苗接种后至多42天发生的AESI被包括在初步分析中。使用具有95%置信区间的观察与预期(OE)比率评估风险。优先考虑的潜在安全信号是95%置信区间(LBCI)下限大于1.5的信号。
结果：参与者包括99,068,901接种疫苗的个体。总的来说,在研究期间,跨参与位点施用183,559,462剂量的BNT162b2、36,178,442剂量的mRNA-1273和23,093,399剂量的ChAdOx1。同源疫苗接种时间表后的风险期贡献了23,168,335人年的随访。第一剂ChAdOx1疫苗后，观察到格林-巴利综合征（2.49，95％CI：2.15，2.87）和脑静脉窦血栓形成（3.23，95％CI：2.51，4.09）的OE比率>1.5。在第一剂mRNA-1273疫苗后，急性播散性脑脊髓炎的OE比率为3.78（95％CI：1.52，7.78）。随着LBCI>1.5，BNT162b2，mRNA-1273和ChAdOx1后心肌炎和心包炎的OE比率显着增加。
结论：这项多国分析证实了心肌炎的预先建立的安全性信号，心包炎,格林-巴利综合征,脑静脉窦血栓形成.确定了其他需要进一步调查的潜在安全信号。
方法：使用通用协议，这项观察性队列研究与13个选定的AESI在神经系统中的预期发生率进行了比较，血液学，和心脏结果。参与地点使用按年龄和性别分层的COVID-19疫苗接种前医疗保健数据获得了预期率。自COVID-19疫苗接种计划推出以来，观察到的发生率来自相同的医疗保健数据集。在用mRNA(BNT162b2和mRNA-1273)和腺病毒载体(ChAdOx1)疫苗接种后至多42天发生的AESI被包括在初步分析中。使用具有95%置信区间的观察与预期(OE)比率评估风险。优先考虑的潜在安全信号是95%置信区间(LBCI)下限大于1.5的信号。
结果：参与者包括99,068,901接种疫苗的个体。总的来说,在研究期间,跨参与位点施用183,559,462剂量的BNT162b2、36,178,442剂量的mRNA-1273和23,093,399剂量的ChAdOx1。同源疫苗接种时间表后的风险期贡献了23,168,335人年的随访。第一剂ChAdOx1疫苗后，观察到格林-巴利综合征（2.49，95％CI：2.15，2.87）和脑静脉窦血栓形成（3.23，95％CI：2.51，4.09）的OE比率>1.5。在第一剂mRNA-1273疫苗后，急性播散性脑脊髓炎的OE比率为3.78（95％CI：1.52，7.78）。随着LBCI>1.5，BNT162b2，mRNA-1273和ChAdOx1后心肌炎和心包炎的OE比率显着增加。
结论：这项多国分析证实了心肌炎的预先建立的安全性信号，心包炎,格林-巴利综合征,脑静脉窦血栓形成.确定了其他需要进一步调查的潜在安全信号。
