Consensus Recommendations for Intramuscular COVID-19 Vaccination in Patients with Hemophilia
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Consensus Recommendations for Intramuscular COVID-19 Vaccination in Patients with Hemophilia. / Pfrepper, Christian; Holstein, Katharina; Königs, Christoph; Heller, Christine; Krause, Manuela; Olivieri, Martin; Bidlingmaier, Christoph; Sigl-Kraetzig, Michael; Wendisch, Jörg; Halimeh, Susan; Horneff, Silvia; Richter, Heinrich; Wieland, Ivonne; Klamroth, Robert; Oldenburg, Johannes; Tiede, Andreas; Hemophilia Board of the German, Austrian, Swiss Society on Thrombosis Hemostasis Research (GTH).
In: HAMOSTASEOLOGIE, Vol. 41, No. 3, 06.2021, p. 190-196.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Consensus Recommendations for Intramuscular COVID-19 Vaccination in Patients with Hemophilia
AU - Pfrepper, Christian
AU - Holstein, Katharina
AU - Königs, Christoph
AU - Heller, Christine
AU - Krause, Manuela
AU - Olivieri, Martin
AU - Bidlingmaier, Christoph
AU - Sigl-Kraetzig, Michael
AU - Wendisch, Jörg
AU - Halimeh, Susan
AU - Horneff, Silvia
AU - Richter, Heinrich
AU - Wieland, Ivonne
AU - Klamroth, Robert
AU - Oldenburg, Johannes
AU - Tiede, Andreas
AU - Hemophilia Board of the German, Austrian, Swiss Society on Thrombosis Hemostasis Research (GTH)
N1 - Thieme. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Antibodies, Bispecific/therapeutic use
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - COVID-19/prevention & control
KW - COVID-19 Vaccines/administration & dosage
KW - Factor IX/therapeutic use
KW - Factor VIII/therapeutic use
KW - Hemophilia A/drug therapy
KW - Hemophilia B/drug therapy
KW - Humans
KW - Injections, Intramuscular
KW - SARS-CoV-2/isolation & purification
KW - Severity of Illness Index
U2 - 10.1055/a-1401-2691
DO - 10.1055/a-1401-2691
M3 - SCORING: Journal article
C2 - 33860513
VL - 41
SP - 190
EP - 196
JO - HAMOSTASEOLOGIE
JF - HAMOSTASEOLOGIE
SN - 0720-9355
IS - 3
ER -
