Institute for Clinical Research, National Institutes of Health, Block B4, No 1, Jalan Setia Murni U13/52, 40170, Shah Alam, Selangor, Malaysia.
Clinical Research Centre, Selayang Hospital, Ministry of Health, Kepong, Selangor, Malaysia.
Sci Rep. 2023 Nov 22;13(1):20471. doi: 10.1038/s41598-023-47486-x.
This study assessed the association between COVID-19 vaccines, SARS-CoV-2 infection and the risk of thrombocytopenia and venous thromboembolism (VTE). This self-controlled case series study used hospital records between 1st February 2021 and 28th February 2022 linked to the national immunisation registry and COVID-19 surveillance data in Malaysia. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) of events in the risk period (day 1-21 post-exposure) relative to control period with the corresponding 95% confidence interval (CI) adjusted for calendar period. We found no significant increased risk of thrombocytopenia in 1-21 days following BNT162b2, CoronaVac and ChAdOx1 vaccines while the risk was increased following SARS-CoV-2 infection (IRR 15.52, 95% CI 13.38-18.00). Similarly, vaccination with BNT162b2, CoronaVac, or ChAdOx1 was not associated with an increased risk of VTE during the 1-21 days risk period. SARS-CoV-2 infection was associated with increased risk of VTE (IRR 39.84, 95% CI 27.45-32.44). Our findings showed low event rates of thrombocytopenia and VTE following booster vaccination with comparable safety profiles between those who received homologous and heterologous booster combinations. Our findings showed the risk of thrombocytopenia and VTE was not increased after COVID-19 vaccination while the risks were substantially higher after SARS-CoV-2 infection.
本研究评估了 COVID-19 疫苗、SARS-CoV-2 感染与血小板减少症和静脉血栓栓塞症(VTE)风险之间的关联。这项自身对照病例系列研究使用了 2021 年 2 月 1 日至 2022 年 2 月 28 日期间的医院记录,这些记录与马来西亚的国家免疫登记处和 COVID-19 监测数据相关联。采用条件泊松回归估计风险期(暴露后 1-21 天)相对于对照期的事件发生率比(IRR),并用日历期进行了相应的 95%置信区间(CI)调整。我们发现,BNT162b2、CoronaVac 和 ChAdOx1 疫苗接种后 1-21 天内血小板减少症的风险没有显著增加,而 SARS-CoV-2 感染后风险增加(IRR 15.52,95%CI 13.38-18.00)。同样,BNT162b2、CoronaVac 或 ChAdOx1 疫苗接种与 1-21 天风险期内 VTE 的风险增加无关。SARS-CoV-2 感染与 VTE 的风险增加相关(IRR 39.84,95%CI 27.45-32.44)。我们的研究结果表明,在加强接种后,血小板减少症和 VTE 的事件发生率较低,且同源和异源加强组合之间的安全性相似。我们的研究结果表明,COVID-19 疫苗接种后血小板减少症和 VTE 的风险没有增加,而 SARS-CoV-2 感染后的风险则显著增加。