Background: Guidelines recommend that patients with haemophilia should preferably
receive vaccination subcutaneously. COVID-19 and other vaccines, however, are only
licenced for intramuscular application.
Aims: To assess the safety of intramuscular COVID-19 vaccination in patients living
with haemophilia.
Methods: Part A of this prospective observational study enrolled consecutive patients
with haemophilia 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 detailed data collection including medication
and prophylaxis around the time of vaccination. Logistic regression was performed to
assess potential risk factors for bleeding.
Results: Four hundred and sixty-one patients were enrolled into part A. The primary
endpoint injection site bleeding occurred in seven patients (1.5%, 95% confidence
interval .7–3.1%). Comprehensive analysis of 214 patients (404 vaccinations, part B)
revealed that 97% of patients with severe haemophilia had prophylaxis before vaccination, either as part of their routine prophylaxis or using additional doses. 56% and
30% of patients with moderate and mild haemophilia, respectively, received prophylaxis before vaccination. Among the seven bleeds recorded, three occurred when intramuscular vaccination was done without prophylaxis (odds ratio 12).
Conclusions: This is the first prospective study reporting on the safety of intramuscular vaccination in haemophilia. The rate of injection site bleeding was low in mild
haemophilia, and in moderate and severe haemophilia if patients received factor prophylaxis.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:88855 |
| Date | 04 January 2024 |
| Creators | Tiede, Andreas, Leise, Hendrik, Horneff, Silvia, Oldenburg, Johannes, Halimeh, Susan, Heller, Christine, Königs, Christoph, Holstein, Katharina, Pfrepper, Christian |
| Publisher | Wiley |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
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