key: cord-0737321-iwuhgjw9
authors: Gendron, Nicolas; Khider, Lina; Le Beller, Christine; Espinasse, Benjamin; Auditeau, Claire; Amara, Wafa; Perrin, Germain; Lebeaux, David; Gaiffe, Anais; Combret, Sandrine; Bertin, Blandine; Lillo‐Le Louet, Agnès; Mirault, Tristan; Smadja, David M.; Sanchez, Olivier; Tromeur, Cécile; Planquette, Benjamin; Couturaud, Francis
title: Bleeding risk of intramuscular injection of COVID‐19 vaccines in adult patients with therapeutic anticoagulation
date: 2022-04-05
journal: J Thromb Haemost
DOI: 10.1111/jth.15709
sha: ebe74d5b97b44a749ffb41cf06bdaa44dfd2ab81
doc_id: 737321
cord_uid: iwuhgjw9

nan

Dear Editor, Efficacy and safety of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was demonstrated, 1, 2 however an additional booster dose is recommended in most countries. Intramuscular (IM) injections for patients with therapeutic anticoagulation 3 is a major concerns because of risk of bleeding and muscle hematomas. 4 Regarding anticoagulants, the warning about IM administration is present in the monograph for vitamin K antagonist (VKA), but not for direct oral anticoagulants (DOACs). Evidence supporting IM injection in patients with anticoagulant exists but generally focused on IM influenza vaccination in patients treated with VKA therapy. 3 However, in line with the growing number of patients treated with DOACs, generalizing the conclusions of literature review 3 to patients treated with DOACs receiving IM vaccine was hazardous. Several national guidelines described the practical aspects of IM vaccination in patients treated with anticoagulants. [5] [6] [7] Concerning the bleeding risk associated with IM vaccination, Public Health England addressed the specific case of administering COVID-19 vaccine to individuals receiving anticoagulants. 7 These guidelines stated that individuals on stable anticoagulation therapy, including individuals on VKA who are up-to-date with their scheduled INR testing and whose latest INR was below the upper threshold of their therapeutic range, could receive IM vaccination. If there is any doubt, a consultation with the clinician responsible for prescribing or monitoring the individual's anticoagulant therapy is recommended. Overall, for IM route, the injection should be performed in the deltoid muscle, 5 with a fine needle (23-gauge at least) 4,6 and performed by medically trained personnel. A firm pressure, without rubbing, at the injection site should be maintained 2 to 5 min after. 5 The aim of our study was to evaluate the risk of bleeding events at the site of injection following IM vaccination in patients treated with therapeutic anticoagulation.

We first performed a French multicenter prospective study in- Comorbidities -n (%) 

None.

All authors have nothing to disclose with the present study. 

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Lina Khider 3 

Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysis

Vaccination against COVID-19: insight from arterial and venous thrombosis occurrence using data from VigiBase

Intramuscular vaccination in adults with therapeutic anticoagulation in the era of COVID-19 vaccines outbreak: a practical review

ACIP General Best Practice Guidelines for Immunization | Recommendations | CDC

RKI -STIKO Recommendations -STIKO vaccination recommendations 2017/18

Direction générale de la Santé, Comité technique des vaccinations. Guide des vaccinations

COVID-19 vaccination programme Information for healthcare practitioners

Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients

Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH

Periprocedural management of patients receiving a vitamin K antagonist or a direct oral anticoagulant requiring an elective procedure or surgery

Periinterventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry

Management of direct oral anticoagulants in patients undergoing elective surgeries and invasive procedures: updated guidelines from the French working group on perioperative hemostasis (GIHP