Safety of intramuscular COVID-19 vaccination in patients with haemophilia.
Haemophilia
; 28(5): 687-693, 2022 Sep.
Article
in English
| MEDLINE | ID: covidwho-1846209
ABSTRACT
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Vaccines
/
COVID-19
/
Hemophilia A
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Topics:
Long Covid
/
Vaccines
Limits:
Humans
Language:
English
Journal:
Haemophilia
Journal subject:
Hematology
Year:
2022
Document Type:
Article
Affiliation country:
Hae.14586
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