Ab Rahman Norazida, King Teck Long, Peariasamy Kalaiarasu M, Sivasampu Sheamini
Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.
Clinical Research Centre, Sarawak General Hospital, Ministry of Health, Sarawak, Malaysia.
Vaccine. 2024 Dec 2;42(26):126465. doi: 10.1016/j.vaccine.2024.126465. Epub 2024 Oct 23.
To assess the potential risk of major adverse cerebro-cardiovascular events (MACCE) associated with COVID-19 vaccination and SARS-CoV-2 infection.
This self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods.
The risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9-12.1) (BNT162b2), 9.2 (95% CI 9.1-9.3) (CoronaVac), and 6.8 (95% CI 6.6-7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08-2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32-3.76) and with CVD (IRR 1.98; 95% CI 1.61-2.34).
Our findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.
评估与2019冠状病毒病（COVID-19）疫苗接种和严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染相关的重大不良心脑血管事件（MACCE）的潜在风险。
这项自我对照病例系列研究使用了马来西亚的全国健康数据库。该研究纳入了2021年2月24日至2022年6月30日期间住院的年龄≥18岁的个体。结局为MACCE的复合指标：中风、急性缺血性心脏病和心血管死亡。暴露因素为COVID-19疫苗接种和SARS-CoV-2感染。风险期为暴露后第1天至第21天。使用条件泊松回归模型估计发病率比（IRR）和95%置信区间（CI），以比较风险期和对照期的结局。
每100,000剂疫苗接种后21天内发生MACCE的风险分别为：BNT162b2疫苗为12.0（95%CI 11.9-12.1），科兴疫苗为9.2（95%CI 9.1-9.3），腺病毒载体疫苗为6.8（95%CI 6.6-7.0）。发病率比显示，对于既往无心血管疾病（CVD）的个体，接种第一剂、第二剂或第三剂BNT162b2、科兴疫苗和腺病毒载体疫苗与MACCE风险增加无关。这一发现对于患有CVD的个体也是一致的。疫苗加强剂量，无论是同源还是异源接种方案，均未显示MACCE风险增加。按种族分析发现，在未患CVD的个体中，接种第一剂腺病毒载体疫苗后，印度人的MACCE风险略有升高（IRR 1.64；95%CI 1.08-2.48）。在其他亚组分析中未观察到显著关联。SARS-CoV-2感染与未患CVD的个体（IRR 3.54；95%CI 3.32-3.76）和患CVD的个体（IRR 1.98；95%CI 1.61-2.34）的MACCE风险显著增加相关。
我们的研究结果支持这些COVID-19疫苗良好的安全性，并表明COVID-19疫苗的总体效益风险比仍然是正向的。
