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Background: <p>Vaccine-induced immune thrombocytopenia and thrombosis (VITT) was first described after administration of adenovirus-vectored COVID-19 vaccines including Ad26.COV2.S and ChAdOx1 nCoV-19. It is not known if the clinical characteristics and outcomes of VITT after Ad26.COV2.S and ChAdOx1 nCoV-19 vaccination are different. We assessed demographic and clinical characteristics, laboratory findings and outcomes in patients with VITT after each vaccine.</p> Methods: <p>Spontaneous postmarketing reports of VITT after Ad26.COV2.S were identified from Janssen’s Global Safety Database and classified using NICE criteria (<i>n</i> = 86). Cases after ChAdOx1 nCoV-19 were identified from a published case series (<i>n</i> = 220). The analysis is descriptive.</p> Results: <p>The median age of patients with definite/probable VITT after Ad26.COV2.S or ChAdOx1 nCoV-19 vaccination is 43 and 48 years, respectively. Median time-to-onset is 11 days and 14 days post-vaccination, cerebral venous thrombosis (CVT) is present in 50.6% and 50%, and mortality is 30% and 22% of patients, respectively. Women make up 55.3% of cases after Ad26.COV2.S and 55% after ChAdOx1 nCoV-19, 74%/60% of CVT cases and 68%/62.5% of deaths. Patients present with severe thrombocytopenia, grossly elevated D-dimer, and most test positive for anti-platelet factor-4 antibodies. Patients with preexisting rare autoimmune diseases are observed despite the small sample sizes.</p> Conclusion: <p>Within the limitations of the data, our study finds no strong evidence for a clinically relevant difference in VITT occurring after Ad26.COV2.S or ChAdOx1 nCoV-19. Observed differences in some parameters likely result from the demographic of the populations vaccinated, and the situational and reporting differences in how, when, and where patients were identified and treated.</p>

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Comparison of vaccine-induced immune thrombocytopenia and thrombosis cases following two adenovirus-vectored COVID-19 vaccines

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月10日

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  • Rian Van Rampelbergh,
  • Sue Pavord,
  • Luis Anaya-Velarde,
  • Vitalija van Paassen,
  • Karin Hardt,
  • Emiliano Tatar,
  • Javier Ruiz-Guiñazú,
  • Dawn Baumgardner,
  • Valérie Oriol Mathieu,
  • Nicolas Praet,
  • Hendy Kristyanto,
  • Jerald Sadoff,
  • Macaya Douoguih,
  • Yimei Xu,
  • Frank Struyf

摘要

Background:

Vaccine-induced immune thrombocytopenia and thrombosis (VITT) was first described after administration of adenovirus-vectored COVID-19 vaccines including Ad26.COV2.S and ChAdOx1 nCoV-19. It is not known if the clinical characteristics and outcomes of VITT after Ad26.COV2.S and ChAdOx1 nCoV-19 vaccination are different. We assessed demographic and clinical characteristics, laboratory findings and outcomes in patients with VITT after each vaccine.

Methods:

Spontaneous postmarketing reports of VITT after Ad26.COV2.S were identified from Janssen’s Global Safety Database and classified using NICE criteria (n = 86). Cases after ChAdOx1 nCoV-19 were identified from a published case series (n = 220). The analysis is descriptive.

Results:

The median age of patients with definite/probable VITT after Ad26.COV2.S or ChAdOx1 nCoV-19 vaccination is 43 and 48 years, respectively. Median time-to-onset is 11 days and 14 days post-vaccination, cerebral venous thrombosis (CVT) is present in 50.6% and 50%, and mortality is 30% and 22% of patients, respectively. Women make up 55.3% of cases after Ad26.COV2.S and 55% after ChAdOx1 nCoV-19, 74%/60% of CVT cases and 68%/62.5% of deaths. Patients present with severe thrombocytopenia, grossly elevated D-dimer, and most test positive for anti-platelet factor-4 antibodies. Patients with preexisting rare autoimmune diseases are observed despite the small sample sizes.

Conclusion:

Within the limitations of the data, our study finds no strong evidence for a clinically relevant difference in VITT occurring after Ad26.COV2.S or ChAdOx1 nCoV-19. Observed differences in some parameters likely result from the demographic of the populations vaccinated, and the situational and reporting differences in how, when, and where patients were identified and treated.