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1.
Nat Commun ; 13(1): 4800, 2022 08 15.
Article in English | MEDLINE | ID: covidwho-1991587

ABSTRACT

We investigated thrombocytopenic, thromboembolic and hemorrhagic events following a second dose of ChAdOx1 and BNT162b2 using a self-controlled case series analysis. We used a national prospective cohort with 2.0 million(m) adults vaccinated with two doses of ChAdOx or 1.6 m with BNT162b2. The incidence rate ratio (IRR) for idiopathic thrombocytopenic purpura (ITP) 14-20 days post-ChAdOx1 second dose was 2.14, 95% confidence interval (CI) 0.90-5.08. The incidence of ITP post-second dose ChAdOx1 was 0.59 (0.37-0.89) per 100,000 doses. No evidence of an increased risk of CVST was found for the 0-27 day risk period (IRR 0.83, 95% CI 0.16 to 4.26). However, few (≤5) events arose within this risk period. It is perhaps noteworthy that these events all clustered in the 7-13 day period (IRR 4.06, 95% CI 0.94 to 17.51). No other associations were found for second dose ChAdOx1, or any association for second dose BNT162b2 vaccination. Second dose ChAdOx1 vaccination was associated with increased borderline risks of ITP and CVST events. However, these events were rare thus providing reassurance about the safety of these vaccines. Further analyses including more cases are required to determine more precisely the risk profile for ITP and CVST after a second dose of ChAdOx1 vaccine.


Subject(s)
BNT162 Vaccine , COVID-19 , ChAdOx1 nCoV-19 , Purpura, Thrombocytopenic, Idiopathic , Thromboembolism , Adult , BNT162 Vaccine/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , ChAdOx1 nCoV-19/adverse effects , Humans , Prospective Studies , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Scotland , Thromboembolism/chemically induced , Thromboembolism/epidemiology , Vaccination/adverse effects
2.
Int J Infect Dis ; 119: 130-139, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1889472

ABSTRACT

OBJECTIVES: To meta-analyse the clinical manifestations, diagnosis, treatment, and mortality of vaccine-induced immune thrombotic thrombocytopenia (VITT) after adenoviral vector vaccination. METHODS: Eighteen studies of VITT after ChAdOx1 nCoV-19 or Ad26.COV2.S vaccine administration were reviewed from PubMed, Scopus, Embase, and Web of Science. The meta-analysis estimated the summary effects and between-study heterogeneity regarding the incidence, manifestations, sites of thrombosis, diagnostic findings, and clinical outcomes. RESULTS: The incidence of total venous thrombosis after ChAdOx1 nCoV-19 vaccination was 28 (95% CI 12-52, I2=100%) per 100,000 doses administered. Of 664 patients included in the quantitative analysis (10 studies), the mean age of patients with VITT was 45.6 years (95% CI 43.8-47.4, I2=57%), with a female predominance (70%). Cerebral venous thrombosis (CVT), deep vein thrombosis (DVT)/pulmonary thromboembolism (PE), and splanchnic vein thrombosis occurred in 54%, 36%, and 19% of patients with VITT, respectively. The pooled incidence rate of CVT after ChAdOx1 nCoV-19 vaccination (23 per 100,000 person-years) was higher than that reported in the pre-pandemic general population (0.9 per 100,000 person-years). Intracranial haemorrhage and extracranial thrombosis accompanied 47% and 33% of all patients with CVT, respectively. The antiplatelet factor 4 antibody positivity rate was 91% (95% CI 88-94, I2=0%) and the overall mortality was 32% (95% CI 24-41, I2=69%), and no significant difference was observed between heparin- and non-heparin-based anticoagulation treatments (risk ratio 0.84, 95% CI 0.47-1.50, I2=0%). CONCLUSIONS: Patients with VITT after SARS-CoV-2 vaccination most frequently presented with CVT following DVT/PE and splanchnic vein thrombosis, and about one-third of patients had a fatal outcome. This meta-analysis should provide a better understanding of VITT and assist clinicians in identifying VITT early to improve outcomes and optimise management.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Thrombosis , Vaccines , Venous Thrombosis , Ad26COVS1 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Female , Humans , Male , Middle Aged , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/etiology , SARS-CoV-2 , Thrombocytopenia/etiology , Thrombosis/epidemiology , Thrombosis/etiology , Venous Thrombosis/chemically induced , Venous Thrombosis/etiology
3.
J Thromb Haemost ; 20(6): 1476-1484, 2022 06.
Article in English | MEDLINE | ID: covidwho-1854096

ABSTRACT

BACKGROUND: Immune thrombocytopenic purpura (ITP) relapse following vaccination remains poorly reported in the adult population. OBJECTIVES: This report details real world data from the largest single-center cohort of ITP relapse following severe acute respiratory syndrome (SARS-CoV-2) vaccination. METHODS: The vaccination status of 294 patients under active follow-up was reviewed. A total of 17 patients were identified resulting in an incidence of ITP relapse following SARS-CoV-2 vaccination in this cohort of 6.6% and an incidence of newly diagnosed ITP following SARS-CoV-2 vaccination of 1.4%. RESULTS: Patients were noted to develop marked deviation of platelet count from baseline following vaccination (P =< .0001). Fourteen patients had a prior diagnosis of ITP and median follow-up following diagnosis was 4 years (range 0-45 years). Days from vaccination to presentation ranged from 2-42 (median 14) and the follow-up period was 34 weeks. Fifteen patients (88%) presented with symptoms and all 17 patients developed symptoms during the follow-up period. Nine patients (53%) received a second dose of vaccine during the follow-up period with seven patients (78%) requiring therapeutic support to facilitate second vaccination. Decision to treat patients was multi-factorial and aimed at decreasing bleeding symptoms and obtaining a platelet count >30 × 109 /L. Sixteen patients (94%) required therapeutic intervention and at the end of the follow-up period, four patients (24%) remained unresponsive to treatment with a platelet count <30 × 109 /L. CONCLUSION: Vaccination of ITP patients continues to have important clinical benefit; however, recommendations for patients who relapse remain lacking. This report outlines the real-world patient outcomes in the era of widespread SARS-CoV-2 vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Purpura, Thrombocytopenic, Idiopathic/diagnosis , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Recurrence , SARS-CoV-2 , Vaccination/adverse effects
4.
Blood Adv ; 6(6): 1637-1644, 2022 03 22.
Article in English | MEDLINE | ID: covidwho-1741920

ABSTRACT

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder that is characterized by low platelet count and increased bleeding risk. COVID-19 vaccination has been described as a risk factor for de novo ITP, but the effects of COVID-19 vaccination in patients with ITP are unknown. We aimed to investigate the effects of COVID-19 vaccination in patients with ITP on platelet count, bleeding complications, and ITP exacerbation (≥50% decline in platelet count, or nadir platelet count < 30 × 109/L with a >20% decrease from baseline, or use of rescue therapy). Platelet counts in patients with ITP and healthy controls were collected immediately before and 1 and 4 weeks after the first and second vaccinations. Linear mixed-effects modeling was applied to analyze platelet counts over time. We included 218 patients with ITP (50.9% female; mean age, 55 years; and median platelet count, 106 × 109/L) and 200 healthy controls (60.0% female; mean age, 58 years; median platelet count, 256 × 109/L). Platelet counts decreased by 6.3% after vaccination. We did not observe any difference in decrease between the groups. Thirty patients with ITP (13.8%; 95% confidence interval [CI], 9.5-19.1) had an exacerbation and 5 (2.2%; 95% CI, 0.7-5.3) suffered from a bleeding event. Risk factors for ITP exacerbation were platelet count < 50 × 109/L (odds ratio [OR], 5.3; 95% CI, 2.1-13.7), ITP treatment at time of vaccination (OR, 3.4; 95% CI, 1.5-8.0), and age (OR, 0.96 per year; 95% CI, 0.94-0.99). Our study highlights the safety of COVID-19 vaccination in patients with ITP and the importance of the close monitoring of platelet counts in a subgroup of patients with ITP. Patients with ITP with exacerbation responded well on therapy.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , COVID-19/complications , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , Male , Middle Aged , Purpura, Thrombocytopenic, Idiopathic/complications , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Thrombocytopenia/complications , Thrombocytopenia/etiology , Vaccination/adverse effects
5.
Blood ; 139(10): 1564-1574, 2022 03 10.
Article in English | MEDLINE | ID: covidwho-1736325

ABSTRACT

Cases of de novo immune thrombocytopenia (ITP), including a fatality, following SARS-CoV-2 vaccination in previously healthy recipients led to studying its impact in preexisting ITP. In this study, 4 data sources were analyzed: the Vaccine Adverse Events Reporting System (VAERS) for cases of de novo ITP; a 10-center retrospective study of adults with preexisting ITP receiving SARS-CoV-2 vaccination; and surveys distributed by the Platelet Disorder Support Association (PDSA) and the United Kingdom (UK) ITP Support Association. Seventy-seven de novo ITP cases were identified in VAERS, presenting with median platelet count of 3 [1-9] ×109/L approximately 1 week postvaccination. Of 28 patients with available data, 26 responded to treatment with corticosteroids and/or intravenous immunoglobulin (IVIG), and/or platelet transfusions. Among 117 patients with preexisting ITP who received a SARS-CoV-2 vaccine, 19 experienced an ITP exacerbation (any of: ≥50% decline in platelet count, nadir platelet count <30 × 109/L with >20% decrease from baseline, and/or use of rescue therapy) following the first dose and 14 of 70 after a second dose. Splenectomized persons and those who received 5 or more prior lines of therapy were at highest risk of ITP exacerbation. Fifteen patients received and responded to rescue treatment. In surveys of both 57 PDSA and 43 UK patients with ITP, prior splenectomy was associated with worsened thrombocytopenia. ITP may worsen in preexisting ITP or be identified de novo post-SARS-CoV2 vaccination; both situations responded well to treatment. Proactive monitoring of patients with known ITP, especially those postsplenectomy and with more refractory disease, is indicated.


Subject(s)
COVID-19 Vaccines , COVID-19 , Purpura, Thrombocytopenic, Idiopathic , SARS-CoV-2 , Aged , Aged, 80 and over , Blood Platelets/immunology , Blood Platelets/metabolism , COVID-19/blood , COVID-19/epidemiology , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Female , Humans , Male , Middle Aged , Purpura, Thrombocytopenic, Idiopathic/blood , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/immunology , Retrospective Studies , Risk Factors , SARS-CoV-2/immunology , SARS-CoV-2/metabolism , Splenectomy , United Kingdom/epidemiology
6.
Semin Hematol ; 59(2): 72-75, 2022 04.
Article in English | MEDLINE | ID: covidwho-1671675

ABSTRACT

Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a life-threatening syndrome of aggressive thrombosis, often profound thrombocytopenia, and frequently overt disseminated intravascular coagulation. It has been associated with 2 adenovirus vector COVID-19 vaccines: ChAdOx1 nCoV-19 (AstraZeneca) and Ad26.COV2.S (Janssen). Unlike the myriad of other conditions that cause thrombosis and thrombocytopenia, VITT has an important distinguishing feature: affected individuals have platelet activating anti-PF4 antibodies that appear in a predictable time frame following vaccination. The reported incidence of VITT differs between jurisdictions; it is dependent on accurate ascertainment of cases and accurate estimates of the size of the vaccinated population. The incidence ranges from 1 case per 26,500 to 127,3000 first doses of ChAdOx1 nCoV-19 administered. It is estimated at 1 case per 518,181 second doses of ChAdOx1 nCoV-19 administered, and 1 case per 263,000 Ad26.COV2.S doses administered. There are no clear risk factors for VITT, including sex, age, or comorbidities. VITT is a rare event, but its considerable morbidity and mortality merit ongoing pharmacovigilance, and accurate case ascertainment.


Subject(s)
COVID-19 Vaccines , COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombosis , Ad26COVS1/adverse effects , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19/adverse effects , Humans , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Thrombosis/chemically induced , Thrombosis/epidemiology
7.
Vaccine ; 39(48): 7052-7057, 2021 11 26.
Article in English | MEDLINE | ID: covidwho-1487997

ABSTRACT

Emerging evidence suggest a possible association between immune thrombocytopenia (ITP) and some formulations of COVID-19 vaccine. We conducted a retrospective case series of ITP following vaccination with Vaxzevria ChadOx1-S (AstraZeneca) and mRNA Comirnaty BNT162b2 COVID-19 (Pfizer-BioNTech) vaccines and compare the incidence to expected background rates for Victoria during the first six months of the Australian COVID-19 vaccination roll-out in 2021. Cases were identified by reports to the Victorian state vaccine safety service, SAEFVIC, of individuals aged 18 years or older presenting with thrombocytopenia following COVID-19 vaccination without evidence of thrombosis. Twenty-one confirmed or probable cases of ITP were identified following receipt of AstraZeneca (n = 17) or Pfizer-BioNTech (n = 4) vaccines. This translates to an observed incidence of 8 per million doses for AstraZeneca vaccine, twice the expected background rate of 4.1 per million. The observed rate for Pfizer-BioNTech was consistent with the expected background rate. The median time to onset for the cases post AstraZeneca vaccination was 10 days (range 1-78) and median platelet nadir 5 × 109/L (range 0-67 × 109/L). Hospital presentations or admissions for management of symptoms such as bleeding occurred in 18 (86%) of the cases. The majority of cases (n = 11) required intervention with at least 2 therapy modalities. In conclusion, we observed a substantially higher than expected rate of ITP following AstraZeneca vaccination. ITP is the second haematological adverse event, distinct from that of thrombosis with thrombocytopenia syndrome (TTS), observed following AstraZeneca vaccination.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Vaccines , COVID-19 Vaccines , Humans , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Retrospective Studies , SARS-CoV-2 , Vaccination , Victoria/epidemiology
8.
Lancet ; 398(10306): 1147-1156, 2021 09 25.
Article in English | MEDLINE | ID: covidwho-1437625

ABSTRACT

BACKGROUND: A new syndrome of vaccine-induced immune thrombotic thrombocytopenia (VITT) has emerged as a rare side-effect of vaccination against COVID-19. Cerebral venous thrombosis is the most common manifestation of this syndrome but, to our knowledge, has not previously been described in detail. We aimed to document the features of post-vaccination cerebral venous thrombosis with and without VITT and to assess whether VITT is associated with poorer outcomes. METHODS: For this multicentre cohort study, clinicians were asked to submit all cases in which COVID-19 vaccination preceded the onset of cerebral venous thrombosis, regardless of the type of vaccine, interval between vaccine and onset of cerebral venous thrombosis symptoms, or blood test results. We collected clinical characteristics, laboratory results (including the results of tests for anti-platelet factor 4 antibodies where available), and radiological features at hospital admission of patients with cerebral venous thrombosis after vaccination against COVID-19, with no exclusion criteria. We defined cerebral venous thrombosis cases as VITT-associated if the lowest platelet count recorded during admission was below 150 × 109 per L and, if the D-dimer was measured, the highest value recorded was greater than 2000 µg/L. We compared the VITT and non-VITT groups for the proportion of patients who had died or were dependent on others to help them with their activities of daily living (modified Rankin score 3-6) at the end of hospital admission (the primary outcome of the study). The VITT group were also compared with a large cohort of patients with cerebral venous thrombosis described in the International Study on Cerebral Vein and Dural Sinus Thrombosis. FINDINGS: Between April 1 and May 20, 2021, we received data on 99 patients from collaborators in 43 hospitals across the UK. Four patients were excluded because they did not have definitive evidence of cerebral venous thrombosis on imaging. Of the remaining 95 patients, 70 had VITT and 25 did not. The median age of the VITT group (47 years, IQR 32-55) was lower than in the non-VITT group (57 years; 41-62; p=0·0045). Patients with VITT-associated cerebral venous thrombosis had more intracranial veins thrombosed (median three, IQR 2-4) than non-VITT patients (two, 2-3; p=0·041) and more frequently had extracranial thrombosis (31 [44%] of 70 patients) compared with non-VITT patients (one [4%] of 25 patients; p=0·0003). The primary outcome of death or dependency occurred more frequently in patients with VITT-associated cerebral venous thrombosis (33 [47%] of 70 patients) compared with the non-VITT control group (four [16%] of 25 patients; p=0·0061). This adverse outcome was less frequent in patients with VITT who received non-heparin anticoagulants (18 [36%] of 50 patients) compared with those who did not (15 [75%] of 20 patients; p=0·0031), and in those who received intravenous immunoglobulin (22 [40%] of 55 patients) compared with those who did not (11 [73%] of 15 patients; p=0·022). INTERPRETATION: Cerebral venous thrombosis is more severe in the context of VITT. Non-heparin anticoagulants and immunoglobulin treatment might improve outcomes of VITT-associated cerebral venous thrombosis. Since existing criteria excluded some patients with otherwise typical VITT-associated cerebral venous thrombosis, we propose new diagnostic criteria that are more appropriate. FUNDING: None.


Subject(s)
COVID-19 Vaccines/adverse effects , Intracranial Thrombosis/epidemiology , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Vaccination/adverse effects , Adult , COVID-19 Vaccines/immunology , Cohort Studies , Female , Fibrin Fibrinogen Degradation Products , Humans , Intracranial Thrombosis/drug therapy , Intracranial Thrombosis/mortality , Male , Middle Aged , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/drug therapy , SARS-CoV-2 , United Kingdom/epidemiology , Venous Thrombosis/drug therapy , Venous Thrombosis/epidemiology
11.
Br J Haematol ; 196(2): 351-355, 2022 01.
Article in English | MEDLINE | ID: covidwho-1373796

ABSTRACT

The COVID-19 pandemic has created many challenges in the management of immune thrombocytopenic purpura (ITP). The recommendation for avoidance of steroids by WHO led to the off-licence use, supported by NHS England, of thrombopoietin mimetics (TPO-RA) for newly diagnosed or relapsed ITP. This is a real-world prospective study which investigated the treatment patterns and outcomes in this setting. Twenty-four hospitals across the UK submitted 343 cases. Corticosteroids remain the mainstay of ITP treatment, but TPO-RAs were more effective. Incidental COVID-19 infection was identified in a significant number of patients (9·5%), while 14 cases were thought to be secondary to COVID-19 vaccination.


Subject(s)
COVID-19/epidemiology , Pandemics , Purpura, Thrombocytopenic, Idiopathic/therapy , Adolescent , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Autoimmune Diseases/complications , COVID-19/blood , COVID-19 Vaccines/adverse effects , Combined Modality Therapy , Comorbidity , Connective Tissue Diseases/complications , Contraindications, Drug , Disease Management , Female , Hemorrhage/epidemiology , Hemorrhage/etiology , Hospitals, District/statistics & numerical data , Humans , Immunoglobulins, Intravenous/therapeutic use , Immunosuppressive Agents/therapeutic use , Male , Middle Aged , Neoplasms/complications , Off-Label Use , Platelet Transfusion , Prospective Studies , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/etiology , Tertiary Care Centers/statistics & numerical data , Thromboembolism/epidemiology , Thromboembolism/etiology , Thrombopoietin/agonists , Tranexamic Acid/therapeutic use , Treatment Outcome , United Kingdom/epidemiology , Young Adult
12.
Nat Med ; 27(7): 1290-1297, 2021 07.
Article in English | MEDLINE | ID: covidwho-1263501

ABSTRACT

Reports of ChAdOx1 vaccine-associated thrombocytopenia and vascular adverse events have led to some countries restricting its use. Using a national prospective cohort, we estimated associations between exposure to first-dose ChAdOx1 or BNT162b2 vaccination and hematological and vascular adverse events using a nested incident-matched case-control study and a confirmatory self-controlled case series (SCCS) analysis. An association was found between ChAdOx1 vaccination and idiopathic thrombocytopenic purpura (ITP) (0-27 d after vaccination; adjusted rate ratio (aRR) = 5.77, 95% confidence interval (CI), 2.41-13.83), with an estimated incidence of 1.13 (0.62-1.63) cases per 100,000 doses. An SCCS analysis confirmed that this was unlikely due to bias (RR = 1.98 (1.29-3.02)). There was also an increased risk for arterial thromboembolic events (aRR = 1.22, 1.12-1.34) 0-27 d after vaccination, with an SCCS RR of 0.97 (0.93-1.02). For hemorrhagic events 0-27 d after vaccination, the aRR was 1.48 (1.12-1.96), with an SCCS RR of 0.95 (0.82-1.11). A first dose of ChAdOx1 was found to be associated with small increased risks of ITP, with suggestive evidence of an increased risk of arterial thromboembolic and hemorrhagic events. The attenuation of effect found in the SCCS analysis means that there is the potential for overestimation of the reported results, which might indicate the presence of some residual confounding or confounding by indication. Public health authorities should inform their jurisdictions of these relatively small increased risks associated with ChAdOx1. No positive associations were seen between BNT162b2 and thrombocytopenic, thromboembolic and hemorrhagic events.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Hemorrhage/epidemiology , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Thrombocytopenia/epidemiology , Thromboembolism/epidemiology , Venous Thromboembolism/epidemiology , Adolescent , Adult , Aged , Case-Control Studies , Cohort Studies , Female , Humans , Incidence , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Scotland/epidemiology , Sinus Thrombosis, Intracranial/epidemiology , Young Adult
14.
Vaccine ; 39(25): 3329-3332, 2021 06 08.
Article in English | MEDLINE | ID: covidwho-1213556

ABSTRACT

BACKGROUND: The objective of this study is to assess cases of thrombocytopenia, including immune thrombocytopenia (ITP), reported to the Vaccine Adverse Event Reporting System (VAERS) following vaccination with mRNA COVID-19 vaccines. METHODS: This case-series study analyzed VAERS reports of thrombocytopenia after vaccination with Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. RESULTS: Fifteen cases of thrombocytopenia were identified among 18,841,309 doses of Pfizer-BioNTech COVID-19 Vaccine and 13 cases among 16,260,102 doses of Moderna COVID-19 Vaccine. The reporting rate of thrombocytopenia was 0.80 per million doses for both vaccines. Based on an annual incidence rate of 3.3 ITP cases per 100,000 adults, the observed number of all thrombocytopenia cases, which includes ITP, following administration of mRNA COVID-19 vaccines is not greater than the number of ITP cases expected. CONCLUSIONS: The number of thrombocytopenia cases reported to VAERS does not suggest a safety concern attributable to mRNA COVID-19 vaccines at this time.


Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Vaccines , Adult , Adverse Drug Reaction Reporting Systems , COVID-19 Vaccines , Humans , Purpura, Thrombocytopenic, Idiopathic/epidemiology , RNA, Messenger , SARS-CoV-2 , Thrombocytopenia/chemically induced , Thrombocytopenia/epidemiology , United States , Vaccines/adverse effects
15.
Ir J Med Sci ; 191(2): 919-920, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1160656

ABSTRACT

INTRODUCTION: Based on the severity of thrombocytopenia, patients with immune thrombocytopenic purpura (ITP) are at an increased risk of mucocutaneous or major bleeding. DISCUSSION: There has been an increased risk of ITP after administration of various vaccines like influenza, measles-mumps-rubella, hepatitis B, and diphtheria-tetanus-pertussis. The pathogenesis of vaccine-related thrombocytopenia is not completely clear and is probably caused by molecular mimicry. Till date, there have been few reported cases of thrombocytopenia in the pharmacovigilance databases after patients received the Pfizer and Moderna coronavirus disease-19 (COVID-19) vaccines. CONCLUSION: Emergency physicians should be aware of the occurrence of vaccine-induced ITP in patients who present with bleeding manifestations, especially after the current boost in COVID-19 vaccination drive worldwide.


Subject(s)
COVID-19 , Measles , Purpura, Thrombocytopenic, Idiopathic , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Purpura, Thrombocytopenic, Idiopathic/chemically induced , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Vaccination/adverse effects
16.
Transfusion ; 61(7): 2014-2018, 2021 07.
Article in English | MEDLINE | ID: covidwho-1136057

ABSTRACT

BACKGROUND: Immune thrombocytopenia (ITP) is an acquired disease characterized by thrombocytopenia secondary to autoantibodies against platelets. Here, we report the clinical characteristics of coronavirus disease 2019 (COVID-19)-induced ITP cases. STUDY DESIGN AND METHODS: We retrospectively reviewed 3255 COVID-19 patients. COVID-19-induced ITP was diagnosed after excluding possible common causes. Bleeding severity was assessed based on the modified World Health Organization (WHO) bleeding severity score. RESULTS: We identified 11 (0.34%) patients with COVID-19-induced ITP. Of all patients, 63.6% were males and the median age was 63 years. The median time from COVID-19 diagnosis to the onset of ITP was 10 days. Bleeding observed in 63.6% of the patients. Clinically significant bleeding (WHO Grade 3) occurred in single patient who required blood transfusion. Standard treatment with glucocorticoids and intravenous immunoglobulin (IVIG) was effective in achieving excellent response in most cases. Of all patients, complete response and response to treatment were achieved in 45.5% and 27.3% patients, respectively. The median time to ITP recovery was 4 days. Eltrombopag was used in three patients who relapsed. Four patients required mechanical ventilation, and none of them survived secondary to hypoxic respiratory failure. CONCLUSION: ITP secondary to COVID-19 usually presents after the first week of symptoms beginning. Most of our patients had WHO Grade 1-2 bleeding scores. Standard treatment with glucocorticoids and IVIG is effective in achieving an excellent response. The safety of eltrombopag is not very well established in COVID-19 patients, and additional studies are needed for a better safety profile.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/etiology , Adult , Aged , Aged, 80 and over , Biomarkers , COVID-19/diagnosis , COVID-19/virology , COVID-19 Testing , Disease Management , Disease Susceptibility , Female , Humans , Immunoglobulins, Intravenous/therapeutic use , Male , Middle Aged , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/diagnosis , Purpura, Thrombocytopenic, Idiopathic/therapy , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
17.
Medicina (Kaunas) ; 57(3)2021 Mar 01.
Article in English | MEDLINE | ID: covidwho-1124743

ABSTRACT

Background and Objectives: The aim of this study was to determine the impact of the COVID-19 pandemic on the lives of patients with immune thrombocytopaenia (ITP) treated at our hospital. Materials and Methods: The study was conducted in the Community of Madrid, which has the highest number of COVID-19 cases in Spain. We included 143 adult patients with ITP (130 with chronic ITP, 8 with persistent ITP, and 5 with newly diagnosed ITP). We conducted a telephone survey to collect the data and created a registry. Materials and Methods: Overall, 24 patients presented symptoms suggestive of COVID-19, which was confirmed by RT-PCR in 8 cases. The cumulative incidence of confirmed SARS-CoV-2 infection was higher in the patients with ITP than in the Madrid population. There were no differences in the disease incidence or clinical course of infection in the patients treated with immunosuppressants. Almost all of the patients reported adherence to the prescribed treatment, although 49.2% of the hospital visits were either cancelled or postponed, 17.2% because of the patients' fear of coming to the centre. Nearly half of the cohort was considered vulnerable, and 17% had been granted a dependency or disability benefit. Conclusions: COVID-19 had a major impact on the psychosocial, occupational, and quality of care of patients with ITP.


Subject(s)
COVID-19/epidemiology , Immunosuppressive Agents/therapeutic use , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Telemedicine , Adult , Aged , Aged, 80 and over , Cohort Studies , Delivery of Health Care , Female , Humans , Incidence , Male , Medication Adherence , Middle Aged , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Quality of Health Care , Risk , SARS-CoV-2 , Spain/epidemiology , Young Adult
20.
Br J Haematol ; 189(6): 1038-1043, 2020 06.
Article in English | MEDLINE | ID: covidwho-186388

ABSTRACT

This document aims to provide practical guidance for the assessment and management of patients with thrombocytopenia, with a particular focus on immune thrombocytopenia (ITP), during the COVID-19 pandemic. The intention is to support clinicians and, although recommendations have been provided, it is not a formal guideline. Nor is there sufficient evidence base to conclude that alternative approaches to treatment are incorrect. Instead, it is a consensus written by clinicians with an interest in ITP or coagulation disorders and reviewed by members of the UK ITP forum.


Subject(s)
Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , Purpura, Thrombocytopenic, Idiopathic , Adult , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/etiology , Coronavirus Infections/therapy , Female , Humans , Male , Pneumonia, Viral/epidemiology , Pneumonia, Viral/etiology , Pneumonia, Viral/therapy , Practice Guidelines as Topic , Purpura, Thrombocytopenic, Idiopathic/congenital , Purpura, Thrombocytopenic, Idiopathic/epidemiology , Purpura, Thrombocytopenic, Idiopathic/therapy , SARS-CoV-2
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