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. 2023 Jul;29(8):904-925.
doi: 10.1177/13524585231168043. Epub 2023 Jun 9.

ECTRIMS/EAN consensus on vaccination in people with multiple sclerosis: Improving immunization strategies in the era of highly active immunotherapeutic drugs

Susana Otero-Romero  1 , Christine Lebrun-Frénay  2 , Saúl Reyes  3 , Maria Pia Amato  4 , Magda Campins  5 , Mauricio Farez  6 , Massimo Filippi  7 , Yael Hacohen  8 , Bernhard Hemmer  9 , Rosa Juuti  10 , Melinda Magyari  11 , Celia Oreja-Guevara  12 , Aksel Siva  13 , Sandra Vukusic  14   15 , Mar Tintoré  16
Affiliations

ECTRIMS/EAN consensus on vaccination in people with multiple sclerosis: Improving immunization strategies in the era of highly active immunotherapeutic drugs

Susana Otero-Romero et al. Mult Scler. 2023 Jul.

Abstract

Background: With the new highly active drugs available for people with multiple sclerosis (pwMS), vaccination becomes an essential part of the risk management strategy.

Objective: To develop a European evidence-based consensus for the vaccination strategy of pwMS who are candidates for disease-modifying therapies (DMTs).

Methods: This work was conducted by a multidisciplinary working group using formal consensus methodology. Clinical questions (defined as population, interventions, and outcomes) considered all authorized DMTs and vaccines. A systematic literature search was conducted and quality of evidence was defined according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. The recommendations were formulated based on the quality of evidence and the risk-benefit balance.

Results: Seven questions, encompassing vaccine safety, vaccine effectiveness, global vaccination strategy and vaccination in sub-populations (pediatric, pregnant women, elderly and international travelers) were considered. A narrative description of the evidence considering published studies, guidelines, and position statements is presented. A total of 53 recommendations were agreed by the working group after three rounds of consensus.

Conclusion: This first European consensus on vaccination in pwMS proposes the best vaccination strategy according to current evidence and expert knowledge, with the goal of homogenizing the immunization practices in pwMS.

Keywords: Multiple sclerosis; consensus; disease-modifying therapy; infections; vaccination.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.O.R. has received speaking and consulting honoraria from Genzyme, Biogen Idec, Novartis, Roche, Excemed and MSD; as well as research support from Novartis. S.R. has received speaking honoraria or scientific advisory fees from Merck, Novartis and Biogen. M.P.A. has served on Scientific Advisory Boards for Biogen, Novartis, Roche, Merck, Sanofi Genzyme, and Teva; has received speaker honoraria from Biogen, Merck, Sanofi Genzyme, Roche, Novartis, and Teva; has received research grants for her Institution from Biogen, Merck, Sanofi Genzyme, Novartis, and Roche. She is co-editor of the Multiple Sclerosis Journal and Associate Editor of Frontiers in Neurology. M.C. has received compensation for consulting services and speaking honoraria from GSK, Novartis, Sanofi Pasteur, MSD, Pfizer and Sequirus. M.F.F. has received a grant from Biogein Idec Argentina. M.F. is Editor-in-Chief of the Journal of Neurology, Associate Editor of Human Brain Mapping, Associate Editor of Radiology, and Associate Editor of Neurological Sciences; received compensation for consulting services and/or speaking activities from Alexion, Almirall, Bayer, Biogen, Celgene, Eli Lilly, Genzyme, Merck-Serono, Novartis, Roche, Sanofi, Takeda, and Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck-Serono, Novartis, Roche, Teva Pharmaceutical Industries, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA). B.H. has served on scientific advisory boards for Novartis; he has served as DMSC member for AllergyCare, Polpharma Sandoz and TG therapeutics; he or his institution have received speaker honoraria from Desitin; His institution received research grants from Regeneron for multiple sclerosis research. He holds part of two patents; one for the detection of antibodies against KIR4.1 in a sub-population of patients with multiple sclerosis and one for genetic determinants of neutralizing antibodies to interferon. All conflicts are not relevant to the topic of the study. R.J. has received advisory board honoraria from Bristol-Myers Squibb. M.M. has served on scientific advisory board, received support for congress participation or speaker honoraria from Biogen, Sanofi, Roche, Novartis, Merck, Abbvie, Alexion, BMS. The Danish MS Registry received research support from Biogen, Genzyme, Roche, Merck, Novartis. C.O.G. has received speaking and consulting honoraria from Biogen Idec, Sanofi Genzyme, Novartis, Merck, Teva, Roche, Jannsen and BMS. A.S. has received honoraria or consultancy fees for participating to advisory boards, giving educational lectures and/or travel and registration coverage for attending scientific congresses or symposia from F. Hoffmann-La Roche Ltd, Sanofi Genzyme, Merck-Serono, Novartis, Teva, Biogen Idec/Gen Pharma of Turkey and Abdi İbrahim İlaç. S.V. received grants, personal fees and/or non-financial support from Biogen, BMS-Celgène, Sanofi Genzyme, Merck, Novartis, Roche, Teva. M.T. has received compensation for consulting services and speaking honoraria from Almirall, Bayer Schering Pharma, Biogen Idec, Genzyme, Merck-Serono, Novartis, Roche, Sanofi-Aventis Viela-Bio and Teva Pharmaceuticals M.T. has received compensation for consulting services and speaking honoraria from Almirall, Bayer Schering Pharma, Biogen Idec, Genzyme, Merck-Serono, Novartis, Roche, Sanofi-Aventis Viela-Bio and Teva Pharmaceuticals. C.L.F. and Y.H. report no disclosures.

Figures

Figure 1.
Figure 1.
Immunization strategy in pwMS. (a) Immunization strategy and immunosuppression: timings and precautions. a. For ocrelizumab and alemtuzumab according to the Summary of product characteristics. b. If absolute lymphocyte counts < 800/mm3 (grade 2 and 3 lymphopenia). c. In very exceptional cases, such as a high risk of infection, vaccination with live attenuated vaccines in patients treated with NTZ and DMF could be considered if the potential risk of acquiring the infection is superior to the risk of developing vaccine-related infections. IS: immunosuppression; Ab: antibody; S1 P: selective sphingosin-1-phosphate-receptor-1; CLAD: cladribine; ALZ: alemtuzumab; DMF: dimethyl fumarate; TER: teriflunomide; NTZ: natalizumab. (b) Recommended vaccines in special sub-populations (pregnancy, children, elderly and international travel). a. During any trimester at the beginning of the influenza season. b. During the third trimester of pregnancy (between week 20 and 36), unless national recommendations state otherwise. c. See Table 1. d. With a background of chickenpox disease or live-attenuated varicella vaccination (otherwise consider varicella immunization). e. Follow most updated local/country guidance on COVID-19 vaccination for high-risk patients. dTap: diphtheria, tetanus and acellular pertussis; IS: immunosuppression; IPV: inactivated polio vaccine; OPV: oral polio vaccine.
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