Flacco Maria Elena, Acuti Martellucci Cecilia, Soldato Graziella, Di Martino Giuseppe, Carota Roberto, De Benedictis Marco, Di Marco Graziano, Parruti Giustino, Di Luzio Rossano, Caponetti Antonio, Manzoli Lamberto
Department of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.
Local Health Unit of Pescara, 65124 Pescara, Italy.
Vaccines (Basel). 2022 Dec 23;11(1):31. doi: 10.3390/vaccines11010031.
This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines.
这项针对意大利一个省份全体人口的队列研究，根据新冠疫苗接种状况评估了潜在疫苗相关严重不良事件（PVR-SAE）的发生率。2021年1月至2022年7月，我们从国家医疗系统官方数据中提取了所有因几种心血管疾病、肺栓塞和深静脉血栓形成导致的死亡和住院病例。在随访期间，5743人死亡，2097人因PVR-SAE住院。与未接种疫苗者（n = 56,494）相比，接种疫苗者（n = 259,821）在全因死亡、非新冠死亡或任何PVR-SAE方面未显示出风险增加。这些结果在不同性别、年龄组、疫苗类型和新冠病毒感染状况中均一致，并且在调整了年龄、性别、新冠病毒感染和选定合并症的Cox模型中也没有变化。在感染人群中，任何剂量的疫苗都与较低的死亡和PVR-SAE可能性相关。在未感染人群中，接种一剂或两剂疫苗的受试者大多数结局的发生率显著更高，这可能是由于意大利针对未接种三剂疫苗的未感染受试者的限制政策引入了较大的选择偏倚。总之，新冠疫苗接种与死亡率增加或选定的PVR-SAE发生率无关。有必要进行进一步研究以评估新冠疫苗的长期安全性。
