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Safety of Intramuscular COVID-19 Vaccination in Patients With Hemophilia

1Hannover Medical School, Hannover, Niedersachsen, Germany, 2Bonn University, Bonn, Nordrhein-Westfalen, Germany, 3University Clinic Bonn, Institute of Experimental Haematology and Transfusion Medicine, Bonn, Germany, Bonn, Berlin, Germany, 4Gerinnungszentrum Rhein-Ruhr, Duisburg, Nordrhein-Westfalen, Germany, 5Frankfurt University, Frankfurt, Hessen, Germany, 6University Hospital Frankfurt, Goethe University, Frankfurt, Hessen, Germany, 7Universitätstklinikum Eppendorf, Hamburg, Hamburg, Germany, 8University Hospital Leipzig, Leipzig, Germany, Leipzig, Sachsen, Germany

Abstract Number: OC 70.2

Meeting: ISTH 2022 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical

Background: Guidelines recommend that patients with hemophilia should preferably receive vaccination subcutaneously rather than intramuscularly. COVID-19 vaccines, however, are only licensed for intramuscular application.

Aims: To assess the safety of intramuscular COVID-19 vaccination in patients with hemophilia.

Methods: This observational multicenter study consisted of two parts. Part A enrolled consecutive patients with hemophilia A (HA) and B (HB) of all ages and severities and assessed injection site bleeding and other complications within 30 days of vaccination. Part B enrolled patients providing informed consent for more detailed data collection including medication and prophylaxis around the time of vaccination.

Results: Four hundred and sixty-one patients were enrolled by six institutions into part A (HA 389 [84%], HB 72 [16%]; severe 291 [63%], moderate 61 [13%], mild 109 [24%]). The primary endpoint injection site bleeding occurred in 7 patients (1.5%, 95% confidence interval 0.6-3.1%), including 5 with severe HA, 1 moderate HA, and 1 mild HB. Analysis of 214 patients in part B revealed that 97% of patients with severe hemophilia, who were not on emicizumab, had received factor prophylaxis before vaccination, either as part of their regular regime (60%) or additionally (40%). Only one patient on emicizumab received additional factor. The bleeding patients with severe HA had received factor within 2-17h before vaccination and had no clinical characteristics that could have explained the bleeding. Factor was also given to 26% and 60% of mild and moderate patients not on regular prophylaxis, respectively. The two bleeding patients in this group had not received concentrate before vaccination. Other side effects of vaccination were comparable with studies in the general population.

Conclusion(s): This is the first study reporting on the safety of intramuscular COVID-19 vaccination in hemophilia. The rate of injection site bleeding was below 3%, comparable with the general population.

To cite this abstract in AMA style:

Tiede A, Leise H, Horneff S, Oldenburg J, Halimeh S, Heller C, Königs C, Holstein K, Pfrepper C. Safety of Intramuscular COVID-19 Vaccination in Patients With Hemophilia [abstract]. https://abstracts.isth.org/abstract/safety-of-intramuscular-covid-19-vaccination-in-patients-with-hemophilia/. Accessed October 1, 2023.

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