PB0056 - Bleeding risk of intramuscular injection of COVID-19 vaccines in adult patients with therapeutic anticoagulation

Sunday, July 10, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Ng

Nicolas gendron, PharmD, PhD

Clinical fellow
AP-HP
Paris, Ile-de-France, France

Co-Author(s)

LK

Lina Khider

Vascular medicine
HEGP
Paris, Ile-de-France, France
CL

Christine Le Beller

Pharmacovigilance
HEGP
Paris, Ile-de-France, France
BE

Benjamin Espinasse

MD
INSERM U1304-GETBO, Univ Brest, FCRIN INNOVTE, Brest, France
Brest, Bretagne, France
CA

Claire Auditeau

PhD Student
Laboratory for Hemostasis, Inflammation and Thrombosis, Unité Mixte de Recherche S1176, Institut National de la Santé et de la Recherche Médicale, Université Paris-Saclay, Le Kremlin-Bicêtre, France
LE KREMLIN BICETRE, Ile-de-France, France
WA

Wafa Amara

Hematology
HEGP
Paris, Ile-de-France, France
GP

Germain Perrin

Pharmacy
HEGP
Paris, Ile-de-France, France
DL

David Lebeaux

Infectious disease
HEGP
Paris, Ile-de-France, France
AG

Anais Gaiffe

Pharmacovigilance
CHU Besançon
Besançon, Franche-Comte, France
SC

Sandrine Combret

Pharmacovigilance
CHU Dijon
Dijon, Bourgogne, France
BB

Blandine Bertin

Pharmacovigilance
Hospices civils de Lyon
Lyon, Rhone-Alpes, France
TM

Tristan Mirault

Vascular medicine
HEGP
Paris, Ile-de-France, France
DS

David M. Smadja

Professor
Université Paris Cité, INSERM U1140, Innovative Therapies in Haemostasis, France
Paris, Ile-de-France, France
OS

Olivier Sanchez

MD, PhD
Georges Pompidou European Hospital, Paris, France
Paris, Ile-de-France, France
CT

Cecile Tromeur

MD, PhD
Centre Hospitalo-Universitaire de Brest, Département de Médecine Interne et Pneumologie, INSERM U1304, CIC INSERM 1412, Univ_Brest, Brest, FCRIN INNOVTE, France.
Brest, Bretagne, France
BP

Benjamin Planquette

Physician MD
APHP
Paris, Ile-de-France, France
FC

Francis Couturaud

MD, PhD
Centre Hospitalo-Universitaire de Brest, Département de Médecine Interne et Pneumologie, INSERM U1304, CIC INSERM 1412, Univ_Brest, Brest, FCRIN INNOVTE, France.
Brest, Bretagne, France

Background: Concerns emerged for the management of intramuscular (IM) injections for COVID-19 vaccines in patients with therapeutic anticoagulation.

Aims: The aim of the study was to evaluate the risk of bleeding events following IM vaccination in patients under therapeutic anticoagulation

Methods: We first performed a French multicentre prospective study including patient treated by anticoagulant therapy for venous thromboembolism between May 2021 and September 2021. Consecutive patients were asked to report bleeding events at the site of COVID-19 vaccine injection during follow-up. We next performed a request in the French national pharmacovigilance database to identify cases of bleeding events at the site of injections following COVID-19 vaccine in patients under therapeutic anticoagulation between December, 27th, 2020 and June, 30th, 2021.

Results: Between May and September 2021, a total of 348 patients with anticoagulant therapy received 561 IM injections of COVD-19 vaccines. Median age of patients was 68.4 years and 65.2% were males. Almost all patients were treated with direct oral anticoagulant (DOAC 96.6%), 11 (3.2%) patients with vitamin K antagonist and one (0.2%) with tinzaparin.
Among them, 17.9% had pressure at the injection site after the injection and 4.2% had anticoagulant dose skipping before vaccination. After IM injections, a total of 3 (0.6%) bleeding events were observed, 2 (0.4%) minor and one (0.2%) clinically relevant non-major bleeding.
We next observed in the French national pharmacovigilance database a total of 13 bleeding events (all minor bleeding) at the site of injection in patients on therapeutic anticoagulation between December, 27th, 2020 and June, 30th, 2021. In France, 69,089,410 doses of COVID-19 vaccine were administered during this period. These bleeding events correspond to a spontaneous notification rate of 0.19 cases (95% CI 0.09–0.29) reported per million of doses administered.

Conclusion(s): IM vaccination appears safe in patients under therapeutic anticoagulation in particular with DOAC, and may not require skipping doses.