Blood clots and bleeding events following BNT162b2 and ChAdOx1 nCoV-19 vaccine: An analysis of European data

• Published in: Journal of autoimmunity Vol. 122; p. 102685
• Main Authors: Cari, Luigi, Fiore, Paolo, Naghavi Alhosseini, Mahdieh, Sava, Gianni, Nocentini, Giuseppe
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.08.2021; The Authors. Published by Elsevier Ltd
• Subjects: Adolescent; Adult; Anti-CoViD-19 vaccines; BNT162 Vaccine; ChAdOx1 nCoV-19; COVID-19 - prevention & control; COVID-19 Vaccines - adverse effects; Europe; Female; Hemorrhage - epidemiology; Hemorrhage - etiology; Humans; Male; Middle Aged; Risk factors; SARS-CoV-2; Severe adverse events; Thrombocytopenia; Thrombocytopenia - epidemiology; Thrombocytopenia - etiology; Thrombosis - epidemiology; Thrombosis - etiology; Venous thrombosis; Young Adult; Europe; Thrombocytopenia; Venous thrombosis; Anti-CoViD-19 vaccines; Risk factors; Severe adverse events
• DOI: 10.1016/j.jaut.2021.102685
• ISSN: 0896-8411; 1095-9157

The involvement of viruses and SARS-CoV-2 in autoimmune diseases is well known. The recent demonstration that ChAdOx1 nCoV-19 Covid-19 (AstraZeneca) vaccine (ChA) favors the production of anti-platelet factor 4 (anti-PF4) antibodies, blood clots, and thrombocytopenia raises the question of whether other anti-CoViD-19 vaccines favor the same patterns of events. We assessed the frequency of severe adverse events (SAEs) documented in the EudraVigilance European database up to April 16, 2021 related to thrombocytopenia, bleeding, and blood clots in recipients of ChA compared to that of recipients of the BNT162b2 Covid-19 (Pfizer/BioNTech) vaccine (BNT). ChA administration was associated with a much higher frequency of SAEs in each AE Reaction Group as compared with that elicited by BNT. When considering AEs caused by thrombocytopenia, bleeding and blood clots, we observed 33 and 151 SAEs/1 million doses in BNT and ChA recipients, respectively. When considering patients with AEs related to cerebral/splanchnic venous thrombosis, and/or thrombocytopenia, we documented 4 and 30 SAEs and 0.4 and 4.8 deaths/1 million doses for BNT and ChA recipients, respectively. The highest risk following ChA vaccination is in young people and, likely, women of reproductive age, as suggested by hypothesized scenarios. In conclusion, the immune reaction promoted by ChA vaccine may lead to not only thrombocytopenia and cerebral/splanchnic venous thrombosis but also other thrombotic and thromboembolic SAEs. These events are not favored by BNT vaccine. Our study may help in the evaluation of the benefit/risk profile of the ChA vaccine considering the epidemic curve present in a country. •Frequency of severe adverse events (SAEs) following anti-CoViD-19 vaccines.•Comparison between ChAdOx1 nCoV-19 (ChA) and BNT162b2 (BNT) vaccines.•Higher frequency of SAEs in ChA than BNT recipients.•Higher frequency of thrombohemorrhagic SAEs in ChA than BNT recipients.•Two-five times higher SAE risk in young than older ChA recipients.