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Multiple sclerosis (MS) is a chronic, immune-mediated disorder of the central nervous system. A novel coronavirus, namely SARS-CoV-2, has been recently responsible for the highly infectious disease referred as COVID-19, rapidly spreading all over the world. Many vaccines have been developed to control COVID-19 pandemic, including the mRNA vaccines Pfizer/BioNTech (BNT162b2) and Moderna (mRNA1273).1 The vaccination of people with MS (pwMS) has been recommended by several national and international MS societies. However, effectiveness and safety of anti-COVID-19 mRNA vaccines in MS need to be confirmed. The aim of this study was to evaluate the short-term risk of clinical relapses in pwMS in the 2 months after the first administration of an mRNA COVID-19 vaccine.
Patients and methods
Twenty-five Italian MS tertiary centres participated to this prospective, self-controlled, multicentric observational study. In Italy, COVID-19 population vaccination started at the end of December 2020 and first involved healthcare professionals. All pwMS, diagnosed according to McDonald’s 2017 criteria, who underwent the first dose of an mRNA COVID-19 vaccine within January 2021 were recruited from each participating centre. All patients received Pfizer/BioNTech BNT162b2 vaccine according to vaccine availability in Italy. Database lock was planned on 31 March so that all patients were followed for at least 2 months after the first dose. The following data were collected: (1) sex; (2) age and disease duration; (3) disease course (relapsing remitting; secondary progressive; primary progressive); (4) disability score (Expanded Disability Status Scale, EDSS); (5) clinical relapses in the year before vaccination, with specific regard to the 2
months immediately preceding vaccination; (6) MRI activity in the year before vaccination (new T2 or Gd enhancing—Gd+—lesions); (7) previous molecular swab confirmed SARS-CoV-2 infection; (8) vaccine administration date and (9) disease-modifying treatments at the time of vaccination. The presence, characteristics and number of relapses in the 60 days after the first administration of …
Contributors MDF and CT conceived the study. All authors provided clinical data of patients and contributed to the writing of the manuscript and approved its final version. MDF, AB and CT prepared the draft of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests MDF participated on advisory boards for and received speaker or writing honoraria and funding for traveling from Bayer, Biogen Idec, Genzyme, Merck, Mylan, Novartis, Roche and Teva. CC received consulting fees for speaking and advisory board from Biogen, Novartis, Merck Serono, Almirall and Roche. SM received honoraria from speaking and advisory board from Biogen, Merck Serono, Novartis and Sanofi Genzyme. PC participated on advisory boards for, received speaker or writing honoraria and funding for traveling from Almirall, Biogen, Sanofi Genzyme, Merck-Serono, Novartis, Roche and Teva. VN has received consulting fees from Novartis, Roche, Mylan, Biogen Idec, Merck, Teva and Bayer; speaker and writing honoraria from Mylan, Teva, Biogen Idec, Bayer, Sanofi Genzyme and Merck and travel grants from Teva, Biogen Idec, Sanofi Genzyme, Roche and Novartis. MR received honoraria or consultation fees from Biogen Idec, Sanofi Genzyme, Novartis and Merck Serono. AL received grants from Fondazione Italiana Sclerosi Multipla, Italian Ministry of Health, Italian Ministry of University and received honoraria or consultation fees from Biogen, Roche, Merck, Genzyme and Novartis. FB received honoraria for speaking or consultation fees from Biogen, Roche, Merck Serono, Novartis, Sanofi Genzyme and Teva. LL received travel grant, speaker fees and consultancy from Biogen Idec, Teva, Genzyme, Merck Serono, Novartis, Roche and Almirall. DF has received travel grants and/or speaker/advisory board honoraria from Merck, Sanofi Genzyme, Roche, Teva, Binding Site, Biogen and Novartis. RF received honoraria or consultation fees from Roche, Novartis, Merck and Sanofi Genzyme. RL received honoraries from Biogen, Merck, Sanofi, Roche and Novartis for lectures or scientific boards. MM has received research grants from ECTRIMS-MAGNIMS, UK MS Society and Merck; honoraria from EMD Serono, Ipsen, Merck, Roche and Sanofi Genzyme and consultant fees from Veterans Evaluation Services. MaCl received personal compensations for public speaking from Merck, Biogen, Novartis, Sanofi Genzyme, Almirall, Roche and Viatris and received research grants from Merck, Biogen and Novartis. GDL served on scientific advisory boards and received speaking honoraria or travel grants from Biogen, Merck Serono, Novartis, Roche and Sanofi Genzyme. VT participated on advisory boards for and received speaker or writing honoraria and funding for traveling from Biogen, Sanofi Genzyme, Merck, Novartis, Roche and Almirall. MaCa has received consulting and/or lecture fees and/or travel grants from Roche, Biogen Idec, Sanofi Genzyme, Novartis and Merck Serono. AB received funding for traveling from Almirall. DP received honoraria for consultancy from and/or speaking at Biogen Idec, Merck‐Serono, Almirall, Sanofi‐Aventis, Teva, Novartis and Genzyme. GTM received personal compensation from Serono, Biogen, Novartis, Roche and Teva for public speaking and advisory boards. PG has received honoraria/consultation fees from Novartis, Merck and Sanofi Genzyme. CS received travel grant and honoraria from Merck, Biogen, Novartis and Amgen. EC has received consulting and/or lecture fees and/or travel grants from Biogen Idec, Sanofi Genzyme, Merck Serono, Novartis and Roche. CG received fees for speaking and advisory boards from Merck, Biogen, Novartis, Teva, Roche, Almirall, Bayer, Mylan and Sanofi. CT received honoraria for speaking and travel grants from Biogen, Sanofi Aventis, Merck Serono, Bayer Schering, Teva, Genzyme, Almirall and Novartis.
Provenance and peer review Not commissioned; externally peer reviewed.