Bernardi, F.F.; Mascolo, A.; Sarno, M.; Capoluongo, N.; Trama, U.; Ruggiero, R.; Sportiello, L.; Fusco, G.M.; Bisogno, M.; Coscioni, E.; Iervolino, A.; Di Micco, P.; Capuano, A.; Perrella, A. Thromboembolic Events after COVID-19 Vaccination: An Italian Retrospective Real-World Safety Study. Vaccines2023, 11, 1575.
Bernardi, F.F.; Mascolo, A.; Sarno, M.; Capoluongo, N.; Trama, U.; Ruggiero, R.; Sportiello, L.; Fusco, G.M.; Bisogno, M.; Coscioni, E.; Iervolino, A.; Di Micco, P.; Capuano, A.; Perrella, A. Thromboembolic Events after COVID-19 Vaccination: An Italian Retrospective Real-World Safety Study. Vaccines 2023, 11, 1575.
Bernardi, F.F.; Mascolo, A.; Sarno, M.; Capoluongo, N.; Trama, U.; Ruggiero, R.; Sportiello, L.; Fusco, G.M.; Bisogno, M.; Coscioni, E.; Iervolino, A.; Di Micco, P.; Capuano, A.; Perrella, A. Thromboembolic Events after COVID-19 Vaccination: An Italian Retrospective Real-World Safety Study. Vaccines2023, 11, 1575.
Bernardi, F.F.; Mascolo, A.; Sarno, M.; Capoluongo, N.; Trama, U.; Ruggiero, R.; Sportiello, L.; Fusco, G.M.; Bisogno, M.; Coscioni, E.; Iervolino, A.; Di Micco, P.; Capuano, A.; Perrella, A. Thromboembolic Events after COVID-19 Vaccination: An Italian Retrospective Real-World Safety Study. Vaccines 2023, 11, 1575.
Abstract
Introduction: Real-world safety studies can provide important evidence on the thromboembolic risk associated with COVID-19 vaccines, considering that millions of people have been already vaccinated against COVID-19. In this study, we aimed to estimate the incidence of thromboembolic events after COVID-19 vaccination and to compare the Oxford–AstraZeneca vaccine with other COVID-19 vaccines.
Methods: We conducted a retrospective real-world safety study using data from two different data sources: the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza, RNF) and the Campania Region Health system (Sistema INFOrmativo saNità CampanIA, SINFONIA). From the start date of the COVID-19 vaccination campaign (December 27th, 2021) to September 27th, 2022, information on COVID-19 vaccinations and thromboembolic evets were extracted from the two databases. The reporting rate (RR) and its 95% confidence interval (95%CI) of thromboembolic events for 10,000 doses was calculated for each COVID-19 vaccine. Moreover, the odds of being vaccinated with the Oxford–AstraZeneca vaccine vs. the other COVID-19 vaccines in cases with thromboembolic events vs. controls without thromboembolic events were computed.
Results: A total of 12,692,852 vaccine doses were administered in Campania Region, of which 6,509,475 (51.28%) were in female and mostly related to the Pfizer-BioNtech vaccine (65.05%), followed by Moderna (24.31%), Oxford–AstraZeneca (9.71%), Janssen (0.91%), and Novavax (0.02%) vaccines. A total of 641 ICSRs with a COVID-19 vaccines and a vascular events were retrieved from the RNF for the Campania Region, of which 453 (70.67%) were in female. Most ICSRs reported the Pfizer-BioNtech vaccine (65.05%), followed by Oxford–AstraZeneca (9.71%), Moderna (24.31%), and Janssen (0.91%). A total of 2,451 events were reported in the ICSRs (3.8 events for ICSRs) of which 292 were thromboembolic events. The highe RRs of thromboembolic events were found with the Oxford–AstraZeneca vaccine (RR: 4.62, 95%CI: 3.50-5.99) and Janssen vaccine (RR: 3.45, 95%CI: 0.94-8.82). Thromboembolic events were associated with a higher likelihood of exposure to the Oxford–AstraZeneca vaccine compared to Pfizer-BioNtech (OR: 6.06; 95%CI: 4.22-8.68) and Moderna vaccines (OR: 6.46; 95%CI: 4.00-10.80).
Conclusion: We observed a higher reporting of thromboembolic events with viral-vector based vaccines (Oxford–AstraZeneca and Janssen) and an increased likelihood of being exposed to the Oxford–AstraZeneca vaccine compared to the mRNA vaccines (Pfizer-BioNtech and Moderna) among thromboembolic cases.
Medicine and Pharmacology, Endocrinology and Metabolism
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
,
,
