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      COVID‐19 mRNA‐1273 vaccine induces production of vaccine‐induced immune thrombotic thrombocytopenia antibodies

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          Thrombosis With Thrombocytopenia After the Messenger RNA–1273 Vaccine

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            Case Series of Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination—United States, December 2020 to August 2021

            Using the Vaccine Adverse Event Reporting System, the number and demographic characteristics of cases of thrombosis with thrombocytopenia syndrome occurring after receipt of COVID-19 vaccines in the United States were determined. Visual Abstract. Thrombosis With Thrombocytopenia Syndrome After COVID-19 Vaccination. Using the Vaccine Adverse Event Reporting System, the number and demographic characteristics of cases of thrombosis with thrombocytopenia syndrome occurring after receipt of COVID-19 vaccines in the United States were determined. Background: Thrombosis with thrombocytopenia syndrome (TTS) is a potentially life-threatening condition associated with adenoviral-vectored COVID-19 vaccination. It presents similarly to spontaneous heparin-induced thrombocytopenia. Twelve cases of cerebral venous sinus thrombosis after vaccination with the Ad26.COV2.S COVID-19 vaccine (Janssen/Johnson & Johnson) have previously been described. Objective: To describe surveillance data and reporting rates of all reported TTS cases after COVID-19 vaccination in the United States. Design: Case series. Setting: United States. Patients: Case patients receiving a COVID-19 vaccine from 14 December 2020 through 31 August 2021 with thrombocytopenia and thrombosis (excluding isolated ischemic stroke or myocardial infarction) reported to the Vaccine Adverse Event Reporting System. If thrombosis was only in an extremity vein or pulmonary embolism, a positive enzyme-linked immunosorbent assay for antiplatelet factor 4 antibodies or functional heparin-induced thrombocytopenia platelet test result was required. Measurements: Reporting rates (cases per million vaccine doses) and descriptive epidemiology. Results: A total of 57 TTS cases were confirmed after vaccination with Ad26.COV2.S ( n  = 54) or a messenger RNA (mRNA)–based COVID-19 vaccine ( n  = 3). Reporting rates for TTS were 3.83 per million vaccine doses (Ad26.COV2.S) and 0.00855 per million vaccine doses (mRNA-based COVID-19 vaccines). The median age of patients with TTS after Ad26.COV2.S vaccination was 44.5 years (range, 18 to 70 years), and 69% of patients were women. Of the TTS cases after mRNA-based COVID-19 vaccination, 2 occurred in men older than 50 years and 1 in a woman aged 50 to 59 years. All cases after Ad26.COV2.S vaccination involved hospitalization, including 36 (67%) with intensive care unit admission. Outcomes of hospitalizations after Ad26.COV2.S vaccination included death (15%), discharge to postacute care (17%), and discharge home (68%). Limitations: Underreporting and incomplete case follow-up. Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination. The different demographic characteristics of the 3 cases reported after mRNA-based COVID-19 vaccines and the much lower reporting rate suggest that these cases represent a background rate. Primary Funding Source: Centers for Disease Control and Prevention.
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              A prospective, blinded study of a PF4-dependent assay for HIT diagnosis

              Heparin-induced thrombocytopenia (HIT) is a life-threatening, pro-thrombotic, antibody-mediated disorder. To maximize the likelihood of recovery, early and accurate diagnosis is critical. Widely available HIT assays such as the Platelet Factor 4-Heparin ELISAs lack specificity, and the "gold standard" C14-labeled serotonin release assay (SRA) is of limited value for early patient management due to availability only through reference laboratories. Recent studies demonstrate that "pathogenic" HIT antibodies selectively activate PF4-treated platelets and that a technically simpler assay, the PF4-dependent P-selectin Expression Assay (PEA), may provide an option for rapid and conclusive results. Four hundred and nine consecutive adults suspected of HIT were classified as disease-positive, -negative or -indeterminate based upon predefined criteria that combined 4Ts scores and HIT ELISA results. Patients deemed "HIT-indeterminate" were considered disease-negative in the primary analysis and disease-positive in a sensitivity analysis. The ability of PEA and SRA to identify patients judged to have HIT was compared using receiver operating characteristic curve statistics. Using these predefined criteria, the diagnostic accuracy of PEA was high (Area under the curve [AUC] of 0.94; 0.87-1.0, 95% CI) and similar to that of SRA (0.91; 0.82-1.0, 95% CI). In sensitivity analysis, the AUCs of PEA and SRA were also similar at 0.88 (0.78-0.98, 95% CI) and 0.86 (0.77-0.96, 95% CI), respectively. The PEA, a technically simple non-radioactive assay that uses ~20-fold fewer platelets compared to the SRA had high accuracy for diagnosing HIT. Widespread use of the PEA may facilitate timely and more effective management of patients with suspected HIT.
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                Author and article information

                Contributors
                padmanabhan.anand@mayo.edu
                swathi.sangli@ahn.org
                Journal
                Am J Hematol
                Am J Hematol
                10.1002/(ISSN)1096-8652
                AJH
                American Journal of Hematology
                John Wiley & Sons, Inc. (Hoboken, USA )
                0361-8609
                1096-8652
                26 March 2022
                01 June 2022
                26 March 2022
                : 97
                : 6 ( doiID: 10.1002/ajh.v97.6 )
                : E223-E225
                Affiliations
                [ 1 ] Department of Laboratory Medicine and Pathology Mayo Clinic Rochester Minnesota USA
                [ 2 ] Department of Hematology and Cellular Therapy Allegheny Health Network Pittsburgh Pennsylvania USA
                [ 3 ] Department of Pulmonary and Critical Care Allegheny Health Network Pittsburgh Pennsylvania USA
                Author notes
                [*] [* ] Correspondence

                Swathi Sangli, Division of Pulmonary and Critical Care, Allegheny Health Network, 4800 Friendship Avenue, Pittsburgh, PA 15224, USA.

                Email: swathi.sangli@ 123456ahn.org

                Anand Padmanabhan, Division of Hematopathology, Transfusion Medicine & Experimental Pathology, 200 1 Avenue, Rochester, MN 55905, USA.

                Email: padmanabhan.anand@ 123456mayo.edu

                Author information
                https://orcid.org/0000-0003-2519-4377
                Article
                AJH26542
                10.1002/ajh.26542
                9081112
                35312193
                028a67e6-18ac-452e-870d-757a5473a161
                © 2022 Wiley Periodicals LLC.

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                : 15 March 2022
                : 03 March 2022
                : 17 March 2022
                Page count
                Figures: 2, Tables: 0, Pages: 2, Words: 1130
                Funding
                Funded by: National Heart, Lung, and Blood Institute , doi 10.13039/100000050;
                Award ID: HL158932
                Categories
                Correspondence
                Correspondences
                Custom metadata
                2.0
                1 June 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.5 mode:remove_FC converted:09.05.2022

                Hematology
                Hematology

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