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

Authors: Pfrepper Ch; Holstein, K; Königs, Ch; Heller, Ch; Krause, M; Olivieri, M; Bidlingmaier, Ch; Sigl-Kraetzig, M; Wendisch, J; Halimeh, S; Horneff, S; Richter, H; Wieland, I; Klamroth, R; Oldenburg, J; Tiede, A.

Affiliations: Division of Hemostaseology, Medical Department I, University Hospital Leipzig, Leipzig, Germany ; University Medical Center Hamburg-Eppendorf, Hamburg, Germany ; Pediatric Hemostaseology, University Hospital Frankfurt, Frankfurt, Germany ; Deutsche Klinik für Diagnostik, Wiesbaden, Germany ; Pediatric Thrombosis and Hemostasis Unit, Pediatric Hemophilia Centre, Dr. von Hauner Children’s Hospital, LMU, Munich, Germany ; Blaubeuren and Hemostasis Center South (Pediatric Practice), Institute for Pediatric Research and Further Education (IPFW), Blaubeuren, Germany ; Health Department of the City of Dresden, Vaccination Centre, Dresden, Germany ; Hemostasis Center, Duisburg, Germany ; Institute for Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Bonn, Germany ; Münster Hemostasis Center, Münster, Germany ; Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany ; Vascular Medicine and Haemostaseology, Vivantes Klinikum im Friedrichshain, Berlin, Germany ; Institute for Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Bonn, Germany ; Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.

Publication: HAMOSTASEOLOGIE ; 2021 ; 41. 190–196; July 2021

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.