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. 2019 Jul;25(4):656-667.
doi: 10.1111/hae.13756. Epub 2019 Apr 16.

Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project

Elena Santagostino  1 , Agostino Riva  2 , Simone Cesaro  3 , Susanna Esposito  4 , Davide Matino  5 , Renata Ilde Mazzucchelli  6 , Angelo Claudio Molinari  7 , Rosamaria Mura  8 , Lucia Dora Notarangelo  9 , Annarita Tagliaferri  10 , Giovanni Di Minno  11 , Mario Clerici  12   13 ; the HEVA Study Group
Collaborators, Affiliations

Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project

Elena Santagostino et al. Haemophilia. 2019 Jul.

Abstract

Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in patients with haemophilia. The consensus was based on a literature search of the available evidence, which was used by the experts to design 27 consensus statements. A group of clinicians then rated these statements using the 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). The main issues identified by the expert panel included vaccination schedule for haemophilic patients; protocol and optimal route of vaccine administration; vaccination of haemophilic patients with antibodies inhibiting coagulation factor VIII (inhibitors); and vaccination and risk of inhibitor development. This manuscript discusses these controversial areas in detail supported by the available literature evidence and provides evidence- and consensus-based recommendations. Overall, participants agreed on most statements, except those addressing the potential role of vaccination in inhibitor formation. Participants agreed that patients with haemophilia should receive vaccinations according to the institutional schedule for individuals without bleeding disorders; however, vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk. Data also suggest vaccination timing does not need to take into consideration when the patient received factor VIII replacement.

Keywords: bleeding disorder; factor VIII inhibitor; haemophilia; immunization; vaccination.

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Conflict of interest statement

Elena Santagostino has acted as a member of advisory boards and/or speaker bureaus for Bayer, Shire, CSL Behring, Sobi, Bioverativ, Roche, Octapharma, Grifols, Kedrion, Novo Nordisk and Pfizer. Agostino Riva has received speaker's honoraria from Gilead, ViiV Health Care, Merck Sharp & Dohme, Novartis, Sobi, Sanofi and Roche. Simone Cesaro has received a fee for participation to advisory boards from Sobi. Davide Matino has received unrestricted educational grants and research funding from Pfizer, Bayer, Sobi and BIOviiix, and has also received honoraria for participating in educational events and advisory boards funded by Bayer, Sobi, Pfizer and BIOviiix. Renata Ilde Mazzucchelli is an employee of Swedish Orphan Biovitrum srl (Sobi). Giovanni Di Minno has received honoraria for scientific activities from Bayer, Novo Nordisk, Pfizer, Kedrion, CSL Behring and Boehringer Ingelheim. Susanna Esposito, Angelo Claudio Molinari, Rosamaria Mura, Lucia Dora Notarangelo, Annarita Tagliaferri, and Mario Clerici declare no conflicts of interest related to the present work.

Figures

Figure 1
Figure 1
Flow diagram of the literature search and selection process
See this image and copyright information in PMC

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