Roncati Luca, Manenti Antonio, Corsi Lorenzo
Institute of Pathology, Department of Surgery, Medicine, Dentistry and Morphological Sciences with Interest in Transplantation, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, 41125 Modena, Italy.
Unit of Surgery, Department of Surgery, Medicine, Dentistry and Morphological Sciences with Interest in Transplantation, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, 41125 Modena, Italy.
Pathogens. 2022 Apr 3;11(4):435. doi: 10.3390/pathogens11040435.
Coronavirus disease 2019 (COVID-19) is the most dramatic pandemic of the new millennium; to counteract it, specific vaccines have been launched in record time under emergency use authorization or conditional marketing authorization by virtue of a favorable risk/benefit balance. Among the various technological platforms, there is that exploiting a nucleoside-modified messenger RNA (modRNA), such as Comirnaty, and that which is adenoviral vector-based. In the ongoing pharmacovigilance, the product information of the latter has been updated about the risk of thrombotic thrombocytopenia, venous thromboembolism without thrombocytopenia and immune thrombocytopenia without thrombosis. However, from an in-depth literature review, the same adverse events can rarely occur with modRNA vaccines too. In support of this, we here report a three-case series of thrombotic deaths in patients over 50 with comorbidities temporally after Comirnaty, investigated by means of post-mortem histopathology and immunohistochemistry. In two out of three cases, the cause of death is traced back to pulmonary microthromboses rich in activated platelets, quite similar morphologically to those described in patients who died from severe COVID-19. Even if remote in the face of millions of administered doses, clinicians should be aware of the possible thrombotic risk also after Comirnaty, in order to avoid a misdiagnosis with potentially lethal consequences. Since COVID-19 vaccines are inoculated in subjects to be protected, maximum attention must be paid to their safety, and prophylactic measures to increase it are always welcome. In light of the evidence, the product information of modRNA COVID-19 vaccines should be updated about the thrombotic risk, as happened for adenoviral vector-based vaccines.
2019冠状病毒病(COVID-19)是新千年以来最严重的大流行病;为应对这一疫情,凭借有利的风险/收益平衡,特定疫苗已在紧急使用授权或有条件上市授权下以创纪录的时间推出。在各种技术平台中,有利用核苷修饰信使核糖核酸(modRNA)的,如Comirnaty,还有基于腺病毒载体的。在正在进行的药物警戒中,后者的产品信息已更新了关于血栓性血小板减少症、无血小板减少的静脉血栓栓塞症和无血栓形成的免疫性血小板减少症的风险。然而,通过深入的文献综述发现,modRNA疫苗也很少会出现同样的不良事件。为支持这一观点,我们在此报告一组三例50岁以上合并症患者在接种Comirnaty后出现血栓性死亡的病例系列,通过尸检组织病理学和免疫组织化学进行调查。在三例病例中的两例中,死亡原因可追溯到富含活化血小板的肺微血栓,其形态与死于重症COVID-19的患者所描述的微血栓非常相似。即使在面对数百万剂的接种量时这种情况很罕见,但临床医生也应意识到接种Comirnaty后可能存在的血栓形成风险,以避免可能导致致命后果的误诊。由于COVID-19疫苗是接种在需要保护的人群中,必须高度重视其安全性,增加安全性的预防措施总是值得欢迎的。鉴于现有证据,modRNA COVID-19疫苗的产品信息应像基于腺病毒载体的疫苗那样更新关于血栓形成风险的内容。