key: cord-0813020-2f6pekwm
authors: Peck, Rachel C.; Clark, Amanda; Shapiro, Susan
title: Experience of Covid 19 vaccination in patients with bleeding disorders
date: 2021-10-18
journal: Haemophilia
DOI: 10.1111/hae.14437
sha: e884aa03f91ba27efae34fc85895b43144c6782d
doc_id: 813020
cord_uid: 2f6pekwm

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cations to COVID-19 vaccination for people with inherited bleeding disorders.

The COVID vaccine trials demonstrating efficacy have only been performed using an intramuscular (IM) route of administration. Therefore, subcutaneous administration, which is an option for other types of vaccines for people in people with bleeding disorders, 1 is not recommended. However, there is surprisingly little data on the safety of intramuscular (IM) injections in people with bleeding disorders, with only two retrospective surveys based in paediatric populations identified in the literature. 2, 3 Expert consensus guidelines were rapidly published to guide management of COVID vaccination in people with haemophilia 4 and all bleeding disorders, 5 with the latter representing consensus from the WFH and other major medical and patient organisations which advise to use the smallest gauge needle available (25-27 gauge) and apply pressure to the site for at least 10 min. Both guidelines state that patients with severe or moderate haemophilia should receive prophylactic replacement therapy prior to IM vaccination if available, but for patients with a basal factor level of greater than 10 IU/ml, or patients on Emicizumab, no haemostatic precautions are required. For those patients with factor activity between 05 and 10 IU/ml individual consideration is advised. 4 Patients with Type 3 VWD, should receive VWF concentrate prophylaxis prior to IM vaccination, and for patients with Type 1 or 2 VWD, depending on VWF activity levels therapies such as DDAVP or tranexamic acid can be considered in consultation with their haemophilia treatment centre. Haemostatic support for patients with rare bleeding disorders should depend on the severity of the disorder and be decided in consultation with their treatment centre. 5 The haemostatic advice given to people with bleeding disorders at Bristol and Oxford UK Haemophilia Comprehensive care centres in December 2020 was in line with these published guidelines. We 5. Local pressure. 9.2% (16) respondents reported that pressure was applied for a minimum of 10 min, 18% (33) reported pressure was applied for 5 min and 65% (114) of respondents reported that pressure was applied for less than 5 min. Overall, only a minority of patients applied pressure for at least 10 min as per the WFH guidelines, and 65% applied pressure for less than 5 min. The rate of self-reported general flu-like symptoms and local swelling around the vaccination site is similar to a large prospective observational study in the general population which found selfreported systemic side-effects of 13.5%; local swelling of 6.4% and local bruising of 2.4%. 6 Our survey reports a higher rate of bruising around the vaccination site (8%).

The limitations of our survey are that it relied on people retrospectively self-reporting bleeding disorder, haemostatic treatments and side effects. People with more significant side effects may have been more likely to complete and return the survey. Some respondents did not answer all the questions and in particular data on bleeding disorder severity was therefore not fully captured, and the exact haemostatic management is not known. Thus, the results of the survey are limited by recall bias.

The survey demonstrates that in adults with bleeding disorders that 10 min of pressure following IM COVID vaccine is generally not applied, and that self-reported bruising is slightly higher than expected for the general population. In this heterogenous group of 177 patients, serious local haematoma requiring intervention did not occur.

In conclusion, our survey suggests that intramuscular vaccination in people with bleeding disorders following general haemostatic guidance from haemophilia centres was not associated with significant local bleeding complications. Specifically, it supports the guidance that people with factor levels more than .10IU/ml, or on Emicizumab, do not need additional haemostatic support. For those patients with factor levels less than .10IU/ml this survey was not able to reliably inform this decision and thus individual consideration is advised in line with published guidelines.

Data available on request from the authors. 

WFH guidelines for the management of hemophilia

Intramuscular vaccination of haemophiliacs: is it really a risk for bleeding?

Safety of intramuscular injection of hepatitis B vaccine in haemophiliacs

Consensus recommendations for intramuscular COVID-19 vaccination in patients with hemophilia

Vaccination against COVID-19: rationale, modalities and precautions for patients with haemophilia and other inherited bleeding disorders

Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study