Hamostaseologie 2021; 41(03): 190-196
DOI: 10.1055/a-1401-2691
Original Article

Consensus Recommendations for Intramuscular COVID-19 Vaccination in Patients with Hemophilia

Christian Pfrepper
1  Division of Hemostaseology, Medical Department I, University Hospital Leipzig, Leipzig, Germany
,
Katharina Holstein
2  University Medical Center Hamburg-Eppendorf, Hamburg, Germany
,
Christoph Königs
3  Pediatric Hemostaseology, University Hospital Frankfurt, Frankfurt, Germany
,
Christine Heller
3  Pediatric Hemostaseology, University Hospital Frankfurt, Frankfurt, Germany
,
Manuela Krause
4  Deutsche Klinik für Diagnostik, Wiesbaden, Germany
,
Martin Olivieri
5  Pediatric Thrombosis and Hemostasis Unit, Pediatric Hemophilia Centre, Dr. von Hauner Children's Hospital, LMU, Munich, Germany
,
Christoph Bidlingmaier
5  Pediatric Thrombosis and Hemostasis Unit, Pediatric Hemophilia Centre, Dr. von Hauner Children's Hospital, LMU, Munich, Germany
,
Michael Sigl-Kraetzig
6  Blaubeuren and Hemostasis Center South (Pediatric Practice), Institute for Pediatric Research and Further Education (IPFW), Blaubeuren, Germany
,
Jörg Wendisch
7  Health Department of the City of Dresden, Vaccination Centre, Dresden, Germany
,
Susan Halimeh
8  Hemostasis Center, Duisburg, Germany
,
Silvia Horneff
9  Institute for Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Bonn, Germany
,
Heinrich Richter
10  Münster Hemostasis Center, Münster, Germany
,
Ivonne Wieland
11  Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
,
Robert Klamroth
12  Vascular Medicine and Haemostaseology, Vivantes Klinikum im Friedrichshain, Berlin, Germany
,
Johannes Oldenburg
9  Institute for Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Bonn, Germany
,
Andreas Tiede
11  Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
,
On Behalf of the Hemophilia Board of the German, Austrian, Swiss Society on Thrombosis Hemostasis Research (GTH)› Author Affiliations

Abstract

Background Currently available coronavirus disease 2019 (COVID-19) vaccines are approved for intramuscular injection and efficacy may not be ensured when given subcutaneously. For years, subcutaneous vaccination was recommended in patients with hemophilia to avoid intramuscular bleeds. Therefore, recommendations for the application of COVID-19 vaccines are needed.

Methods The Delphi methodology was used to develop consensus recommendations. An initial list of recommendations was prepared by a steering committee and evaluated by 39 hemophilia experts. Consensus was defined as ≥75% agreement and strong consensus as ≥95% agreement, and agreement as a score ≥7 on a scale of 1 to 9. After four rounds, a final list of statements was compiled.

Recommendations Consensus was achieved that COVID-19 vaccines licensed only for intramuscular injection should be administered intramuscularly in hemophilia patients. Prophylactic factor replacement, given on the day of vaccination with a maximum interval between prophylaxis and vaccination of 24 hours (factor VIII and conventional factor IX concentrates) or 48 hours (half-life extended factor IX), should be provided in patients with moderate or severe hemophilia. Strong consensus was achieved that patients with mild hemophilia and residual factor activity greater than 10% with mild bleeding phenotype or patients on emicizumab usually do not need factor replacement before vaccination. Swelling, erythema, and hyperthermia after vaccination are not always signs of bleeding but should prompt consultation of a hemophilia care center. In case of injection-site hematoma, patients should receive replacement therapy until symptoms disappear.

Conclusions Consensus was achieved on recommendations for intramuscular COVID-19 vaccination after replacement therapy for hemophilia patients depending on disease severity.

Authors' Contributions

C.P., K.H., C.K., and A.T. developed the initial survey and the first set of recommendations. C.P. managed the consensus process and analyzed data. C.P. and A.T. wrote the final manuscript. All authors participated in the discussion of recommendations and Delphi results, reviewed the manuscript, and agreed with its final content.


Supplementary Material



Publication History

Received: 14 February 2021

Accepted: 25 February 2021

Publication Date:
15 April 2021 (online)

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