Ministry of Health New Zealand, Wellington, New Zealand; Te Whatu Ora, Health New Zealand, New Zealand.
Ministry of Health New Zealand, Wellington, New Zealand.
Thromb Res. 2023 Feb;222:102-108. doi: 10.1016/j.thromres.2022.12.012. Epub 2022 Dec 28.
An association between thrombotic events and SARS-CoV-2 infection and the adenovirus-based COVID-19 vaccines has been established, leading to concern over the risk of thrombosis after BNT162b2 COVID-19 vaccination.
To evaluate the risk of arterial thrombosis, cerebral venous thrombosis (CVT), splanchnic thrombosis, and venous thromboembolism (VTE) following BNT162b2 vaccination in New Zealand.
This was a self-controlled case series using national hospitalisation and immunisation records to calculate incidence rate ratios (IRR). The study population included individuals aged ≥12 years, unvaccinated, or vaccinated with BNT162b2, who were hospitalised with one of the thrombotic events of interest from 19 February 2021 through 19 February 2022. The risk period was 0-21 days after receiving a primary or booster dose of BNT162b2.
6039 individuals were hospitalised with one of the thrombotic events examined, including 5127 with VTE, 605 with arterial thrombosis, 272 with splanchnic thrombosis, and 35 with CVT. The proportion of individuals vaccinated with at least one dose of BNT162b2 ranged from 82.7 % to 91.4 %. Compared with the control unexposed period, the IRR (95 % CI) of VTE, arterial thrombosis, splanchnic thrombosis, and CVT were 0.87 (0.76-1.00), 0.73 (0.56-0.95), 0.71 (0.43-1.16), and 0.87 (0.31-2.50) in the 21 days after BNT162b2 vaccination, respectively. There was no statistically significant increased risk of thrombosis following BNT162b2 in different ethnic groups in New Zealand.
The BNT162b2 vaccine was not found to be associated with thrombosis in the general population or different ethnic groups in New Zealand, providing reassurance for the safety of the BNT162b2 vaccine.
已经确定了血栓事件与 SARS-CoV-2 感染和基于腺病毒的 COVID-19 疫苗之间的关联，这导致了人们对 BNT162b2 COVID-19 疫苗接种后发生血栓的风险的担忧。
评估在新西兰，BNT162b2 疫苗接种后发生动脉血栓、脑静脉血栓形成（CVT）、内脏静脉血栓形成和静脉血栓栓塞症（VTE）的风险。
这是一项使用全国住院和免疫接种记录的自身对照病例系列研究，以计算发病率比值比（IRR）。研究人群包括年龄≥12 岁的个体，包括未接种疫苗或接种了 BNT162b2 的个体，他们在 2021 年 2 月 19 日至 2022 年 2 月 19 日期间因上述血栓性疾病之一住院。风险期为接种 BNT162b2 初级或加强剂量后 0-21 天。
6039 名个体因所检查的血栓性疾病之一住院，包括 5127 例 VTE、605 例动脉血栓形成、272 例内脏静脉血栓形成和 35 例 CVT。至少接种一剂 BNT162b2 的个体比例为 82.7%至 91.4%。与对照未暴露期相比，BNT162b2 接种后 21 天 VTE、动脉血栓形成、内脏静脉血栓形成和 CVT 的发病率比值比（95%CI）分别为 0.87（0.76-1.00）、0.73（0.56-0.95）、0.71（0.43-1.16）和 0.87（0.31-2.50）。在新西兰不同种族群体中，未发现 BNT162b2 疫苗接种后血栓形成的风险增加。
在新西兰的一般人群或不同种族群体中，未发现 BNT162b2 疫苗与血栓形成相关，为 BNT162b2 疫苗的安全性提供了保证。
