Safety of intramuscular COVID‐19 vaccination in patients with haemophilia

Tiede, Andreas; Leise, Hendrik; Horneff, S.; Oldenburg, J.; Halimeh, Susan; Heller, Christine; Königs, Christoph; Holstein, Katharina; Pfrepper, Christian

doi:10.1111/hae.14586

Cited by 7 publications

(5 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There are five studies, two from Iran, 22,23 one from the United Kingdom, 24 one from Türkiye, 25 and one from Europe (Germany, Austria, and Switzerland), 26 that contain informa-tion and data on patients with CBD who received COVID-19 vaccines. The total number of patients was 821, and the number of patients in each study ranged from 39 to 461.…”

Section: Covid-19 Vaccination In Cbd Patientsmentioning

confidence: 99%

“…22,24 Among other type of CBDs, the highest number of vaccines has been received by patients affected with VWD (n: 45; $5.5%). In four studies, [22][23][24]26 patients received first and second doses of vaccination. In the study from Türkiye, 39, 2, 3, and 4 patients received first, second, third, and forth doses of vaccination, respectively (►Table 6).…”

Section: Covid-19 Vaccination In Cbd Patientsmentioning

confidence: 99%

See 1 more Smart Citation

Congenital Bleeding Disorders and COVID-19—A Systematic Literature Review

Dorgalaleh,

Safdari,

Tabibian

et al. 2023

Semin Thromb Hemost

View full text Add to dashboard Cite

Hypercoagulability is a prominent feature of coronavirus disease 2019 (COVID-19) and can lead to fatal consequences. Although the impact of COVID-19 on several disorders is well-established, its effect on congenital bleeding disorders (CBDs) is not well-documented. To address this ambiguity, a systematic review was conducted on the available studies to determine the impact of COVID-19 and vaccination aimed to prevent COVID-19 on patients with CBDs. We performed a systematic literature review using relevant keywords and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) protocol. We conducted our search on the PubMed, Scopus, and Web of Science databases until July 2023. Out of 31 included studies, 12 case series covering 770 patients with CBD and COVID-19 were further analyzed. The majority of the patients had hemophilia A (n = 352, ∼46%) or hemophilia B (n = 74, ∼10%), while the remaining patients had von Willebrand disease (n = 43, 5.6%) or rare bleeding disorders (n = 27, 3.5%). A total of 25 deaths (3.2%) and 22 intensive care unit admissions (2.8%) were recorded. Bleeding complications were reported in the majority of the 12 case series (n = 7, 58.3%) and in most of the case reports (n = 8, ∼57%), while thrombotic complications were only reported in two studies (16.6%). The mortality rate ranged from 0% in five studies (41.6%) to 5.7% and the rate of hospitalization ranged from 0 to 40%. Bleeding complications were reported in a range of 0 to 81%, while the thrombotic complication rate in one study was 6.9%. The mortality rate varied from 0 to 5.7%, and the hospitalization rate ranged from 0 to 40%. Bleeding complications were reported in a range of 0 to 81%, while the rate of thrombotic complications in one study was 6.9%. Vaccination was reported in five case series, which included 821 patients with CBDs with the majority having hemophilia A (n = 479; 67.2%) and hemophilia B (n = 85; ∼12%). The most frequently reported side effects were myalgia (6.5%), flu-like symptoms (4.8%), fever (4.7%), and headache (4%). COVID-19 in patients with CBDs appears to provoke thrombotic complications and bleeding events more frequently, as well as a higher rate of hospitalization, which may be partially due to the increased risk of bleeding events. Although it seems that patients with CBD have lower mortality rates, further studies are necessary to fully understand this, especially considering comorbidities and low number of available studies.

show abstract

Section: Covid-19 Vaccination In Cbd Patientsmentioning

confidence: 99%

Section: Covid-19 Vaccination In Cbd Patientsmentioning

confidence: 99%

Congenital Bleeding Disorders and COVID-19—A Systematic Literature Review

Dorgalaleh,

Safdari,

Tabibian

et al. 2023

Semin Thromb Hemost

View full text Add to dashboard Cite

show abstract

“…Bleeding following the administration of an intramuscular vaccine in hemophiliacs is challenging to control. It may require several days, even weeks, of treatment with a clotting factor [36]. These precautions are also valid for patients on anticoagulants or antiplatelets [37].…”

Section: Inherited Blood Coagulation Disorders and Covid-19 Vaccinesmentioning

confidence: 99%

Blood Coagulation and Thrombotic Disorders following SARS-CoV-2 Infection and COVID-19 Vaccination

Sekulovski,

Mileva,

Vasilev

et al. 2023

Biomedicines

View full text Add to dashboard Cite

Although abundant data confirm the efficacy and safety profile of the developed vaccines against COVID-19, there are still some concerns regarding vaccination in high-risk populations. This is especially valid for patients susceptible to thrombotic or bleeding events and hesitant people due to the fear of thrombotic incidents following vaccination. This narrative review focuses on various inherited and acquired thrombotic and coagulation disorders and the possible pathophysiologic mechanisms interacting with the coagulation system during immunization in view of the currently available safety data regarding COVID-19 vaccines. Inherited blood coagulation disorders and inherited thrombotic disorders in the light of COVID-19, as well as blood coagulation and thrombotic disorders and bleeding complications following COVID-19 vaccines, along with the possible pathogenesis hypotheses, therapeutic interventions, and imaging for diagnosing are discussed in detail. Lastly, the lack of causality between the bleeding and thrombotic events and COVID-19 vaccines is debated, but still emphasizes the importance of vaccination against COVID-19, outweighing the minimal risk of potential rare adverse events associated with coagulation.

show abstract

“…Current guidelines suggest that the general recommendations regarding SARS-CoV-2 vaccination can be applied in patients with hemophilia as well [3][4][5][6][7]. Patients with human immunodeficiency virus (HIV) infection may be characterized by an increased risk of severe COVID-19 due to immunosuppression and higher rates of multimorbidity; therefore, these subjects may benefit from SARS-CoV-2 vaccination [8,9].…”

Section: Introductionmentioning

confidence: 99%

Characterization of Immunogenicity and Safety of COVID-19 mRNA-1273 in HIV-Positive Italian Patients with Hemophilia: A Prospective Single-Center Cohort Study

Suffritti,

Gualtierotti,

Arcudi

et al. 2023

JCM

View full text Add to dashboard Cite

To characterize the immunogenicity of mRNA-1273 (Moderna, Cambridge, MA, USA) vaccine in HIV-positive hemophilic patients during the third COVID-19 wave in Italy and to investigate biomarkers of coagulation and endothelial perturbation before and after complete vaccination schedule, twenty-three consecutive adult HIV-positive patients with hemophilia were included. Blood was collected before and two weeks after vaccination. We measured anti-SARS-CoV-2 spike protein antibodies to assess immunogenicity; circulating biomarkers of coagulation (protein C and D-dimer), endothelial perturbation (von Willebrand factor (VWF)) and anti-Platelet Factor 4 (PF4) antibodies were analyzed. Flow-based analysis of thrombus formation was performed in nine patients using a flow-chamber device. Two weeks after completing the vaccination schedule, all patients had anti-spike antibodies values consistent with an effective immunization. Mean (±standard deviation) basal values of protein C and VWF (106 ± 21% and 171 ± 45%, respectively) were not significantly different from data obtained two weeks after the second dose (103 ± 20%, 162 ± 43%, respectively). D-dimer median values (interquartile range) were not significantly different at baseline (442 (603–142) ng/mL) and after the second dose (477 (654–262) ng/mL). Anti-PF4 antibodies were detected in three patients with no associated clinical manifestations. No significant differences were found in flow-based analysis of thrombus formation. Our data demonstrate that in HIV-positive patients with hemophilia, SARS-CoV-2 vaccination is effective and safe, with no effects on coagulation and endothelial perturbation.

show abstract

Safety of intramuscular COVID‐19 vaccination in patients with haemophilia

Cited by 7 publications

References 29 publications

Congenital Bleeding Disorders and COVID-19—A Systematic Literature Review

Congenital Bleeding Disorders and COVID-19—A Systematic Literature Review

Blood Coagulation and Thrombotic Disorders following SARS-CoV-2 Infection and COVID-19 Vaccination

Characterization of Immunogenicity and Safety of COVID-19 mRNA-1273 in HIV-Positive Italian Patients with Hemophilia: A Prospective Single-Center Cohort Study

Contact Info

Product

Resources

About