Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration (2024) / Chapter Skim
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5 Thrombosis with Thrombocytopenia Syndrome, Immune Thrombocytopenic Purpura, Capillary Leak Syndrome, and COVID-19 Vaccines
5 Thrombosis with Thrombocytopenia Syndrome, Immune Thrombocytopenic Purpura, Capillary Leak Syndrome, and COVID-19 Vaccines
Pages 133-156
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From page 133... ...
Conclusion 5-4: The evidence is inadequate to accept or reject a causal relationship between the NVX-CoV2373 vaccine and thrombosis with thrombocytopenia syndrome. Background Within months of the introduction of ChAdOx1-S 1 in Europe and the United Kingdom, three reports appeared of an unusual safety signal characterized by the acute onset of unusual thrombotic events and thrombocytopenia 6–24 days after the first dose (Greinacher et al., 2021; Schultz et al., 2021; Scully et al., 2021)
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Cerebral venous sinus thrombosis was observed in 6 of 15 patients with spontaneous HIT in nonsurgical settings, a presentation infrequently seen in patients with HIT receiving heparin (Warkentin, 2022)
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vaccine is less than the estimated background incidence of cerebral venous sinus thrombosis with thrombocytopenia during the years before COVID-19 (See et al., 2022)
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136 VACCINE EVIDENCE REVIEW Observational Studies Table 5-1 presents three studies that contributed to the causality assessment.
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mRNA- (0.58–1.27) million 1273 doses NOTES: BNT162b2 refers to the COVID-19 vaccine manufactured by Pfizer-BioNTech under the name Comirnaty®.
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health plans, to study the risk of 23 outcomes with BNT162b2 and mRNA-1273. TTS was defined as having an emergency room or inpatient diagnosis code for cerebral venous sinus thrombosis, splanchnic vein thrombosis, and arterial thrombosis and a platelet count less than 150 × 109 per L (Klein et al., 2021)
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Conclusion 5-2: The evidence favors rejection of a causal relationship between the mRNA-1273 vaccine and thrombosis with thrombocytopenia syndrome. The committee was not able to identify any data from comparative epidemiology studies on the association between Ad26.COV2.S and TTS.
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140 VACCINE EVIDENCE REVIEW Conclusion 5-3: The evidence favors acceptance of a causal relationship between the Ad26.COV2.S vaccine and thrombosis with thrombocytopenia syndrome. Conclusion 5-4: The evidence is inadequate to accept or reject a causal relationship between the NVX-CoV2373 vaccine and thrombosis with thrombocytopenia syndrome.
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Chronic ITP more frequently affects adults primarily aged 20–50 years, with a higher prevalence in women, and may present with prolonged bleeding episodes and fluctuating platelet counts. Mechanisms ITP is highlighted by multiple immunological mechanisms, predominantly involving producing autoantibodies against platelet antigens.
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It is generally recommended that patients with pre-existing ITP still get vaccinated, but that platelet counts should be monitored afterwards. Recurrent ITP is not considered further in the text below.
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Dose 2: 61 comparator records vaccinees Dose 2: SIR 0.69 (0.53–0.88) 6.8 BNT162b2 million doses BNT12b2 and Vaccine BNT12b2 and mRNA Klein et United mRNA-1273 Cohort Safety 12+ 1273 combined: al.
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mRNA 6.2 1273 million Booster dose: Booster dose: vaccinees 22 IRR 1.54 (0.82–2.91) Matched National Dose 1: Simpson case control Health 2.5 et al.
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The primary series for mRNA vaccines is two doses. Number of events refers to events in vaccinees only.
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Diagnosis codes from inpatient and outpatient claims were extracted; a medical review of health records of a random sample of cases was performed to validate the claims-based definition. From 91 cases of ITP identified in claims data and with health records available, only two were adjudicated as confirmed, one as probable, and six as possible.
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ITP was defined using diagnosis codes from emergency department and inpatient and outpatient claims (Klein et al., 2021)
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(2023) , who performed a medical review of electronic health record data, the totality of the epidemiology evidence on the potential association of BNT162b2 and mRNA-1273 and ITP is based on diagnosis codes.
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Background Capillary leak syndrome (CLS) , also known as "Clarkson disease," is a complex and potentially lethal condition characterized by an initial phase of nonspecific symptoms followed by the hallmark features of diffuse severe edema and hypovolemia, hemoconcentration, and hypoalbuminemia (Bichon et al., 2021)
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Acute kidney injury is a common complication in these conditions, and cytokines are believed to play a significant role in acute kidney injury in CLS. Fluid management is critical in treating CLS, as both hypovolemia and hypotension can cause organ injury, and capillary leakage of administered fluid can worsen organ edema, leading to progressive organ injury (Ruggiero et al., 2022)
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Conclusion 5-9: The evidence is inadequate to accept or reject a causal relationship between the BNT162b2 vaccine and capillary leak syndrome. Conclusion 5-10: The evidence is inadequate to accept or reject a causal relationship between the mRNA-1273 vaccine and capillary leak syndrome.
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2021. Capillary leak syndrome: State of the art in 2021.
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2010. Idiopathic systemic capillary leak syndrome (Clarkson's Disease)
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2022. Capillary leak syndrome following COVID-19 vaccination: Data from the European pharmacovigilance database EudraVigilance.
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2017. Capillary leak syndrome: Etiologies, pathophysiology, and management.
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2023. Immune checkpoint inhibitor-associated capillary leak syndrome: A systematic review and a worldwide pharmacovigilance study.
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