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      SARS-CoV-2 vaccination in patients with multiple sclerosis in Germany and the United Kingdom: Gender-specific results from a longitudinal observational study

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          Abstract

          Background

          Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German and United Kingdom (UK) PwMS, especially regarding gender-specific differences.

          Methods

          The German Multiple Sclerosis Society and the UK MS Registry acquired health data via an online system following the first (X 1) and second SARS-CoV-2 vaccination (X 2), respectively: sociodemographic and clinical data, vaccines used, VRs, MS deterioration (worsened or new MS symptoms, Germany only) and relapses (Germany only). The frequencies of VRs and MS deterioration were analysed stratified by gender.

          Findings

          Following X 1 (X 2), 2346 (1835) German PwMS and 3796 (683) UK PwMS participated in the study. The most frequent vaccination scheme was two-dose tozinameran for Germany (77·1%, 1424/1847) and two-dose AZD1222 for the UK (61·3%, 419/683). The most common VRs were fatigue, headache and pain (at the injection site) and occurred more often in women compared with men. German PwMS reported VRs more frequently after X 2 vs. X 1 (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X 1 vs. X 2: 48·7% [1849/3796] vs. 30·0% [205/683]). MS deterioration occurred in 19·0% (445/2346) of the German PwMS without resulting in gender-specific differences. Fatigue and gait impairment were the most frequent deteriorated MS symptoms.

          Interpretation

          Female PwMS reported experiencing VRs more often than men. Longitudinal data are needed to enable valid statements regarding long-term MS deterioration and long-lasting VRs.

          Funding

          German Multiple Sclerosis Society (DMSG Bundesverband e.V.), Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche and Sanofi.

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          Hadley Wickham, Mara Averick, Jennifer Bryan … (2019)
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            Factors That Influence the Immune Response to Vaccination

            Petra Zimmermann, Nigel Curtis (2019)
            SUMMARY There is substantial variation between individuals in the immune response to vaccination. In this review, we provide an overview of the plethora of studies that have investigated factors that influence humoral and cellular vaccine responses in humans. These include intrinsic host factors (such as age, sex, genetics, and comorbidities), perinatal factors (such as gestational age, birth weight, feeding method, and maternal factors), and extrinsic factors (such as preexisting immunity, microbiota, infections, and antibiotics). Further, environmental factors (such as geographic location, season, family size, and toxins), behavioral factors (such as smoking, alcohol consumption, exercise, and sleep), and nutritional factors (such as body mass index, micronutrients, and enteropathy) also influence how individuals respond to vaccines. Moreover, vaccine factors (such as vaccine type, product, adjuvant, and dose) and administration factors (schedule, site, route, time of vaccination, and coadministered vaccines and other drugs) are also important. An understanding of all these factors and their impacts in the design of vaccine studies and decisions on vaccination schedules offers ways to improve vaccine immunogenicity and efficacy.
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              Sex and Gender Differences in the Outcomes of Vaccination over the Life Course

              Ashley L. Fink, Magdalena Plebanski, Sabra L. Klein … (2017)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Lancet Reg Health Eur
                Journal ID (iso-abbrev): Lancet Reg Health Eur
                Title: The Lancet Regional Health - Europe
                Publisher: MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH). Published by Elsevier Ltd.
                ISSN (Electronic): 2666-7762
                Publication date PMC-release: 2 September 2022
                Publication date (Print): November 2022
                Publication date (Electronic): 2 September 2022
                Volume: 22
                Page: 100502
                Affiliations
                [a ]German MS-Registry, MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]) Krausenstr. 50, 30171 Hannover, Germany
                [b ]Department of Neurology, Neuroimmunological Section, University Medical Center of Rostock, Gehlsheimer Str. 20, 18147 Rostock, Germany
                [c ]Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), Krausenstr. 50, 30171 Hannover, Germany
                [d ]Department of Tropical Medicine, Infectious Diseases and Nephrology, University Medical Center of Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany
                [e ]Biomedical Research Institute & Data Science Institute, Hasselt University, Diepenbeek 3590, Belgium
                [f ]Gesellschaft für Versorgungsforschung mbH (Society for Health Care Research [GfV]), Krausenstr. 50, 30171 Hannover, Germany
                [g ]UK MS Register, Swansea University Medical School, Data Science Building, Swansea SA2 8PP, United Kingdom
                Author notes
                [* ]Corresponding author at: MS Research and Project Development gGmbH, Krausenstr. 50, 30171 Hannover, Germany.
                Article
                Publisher Item ID: S2666-7762(22)00198-3 Publisher ID: 100502
                DOI: 10.1016/j.lanepe.2022.100502
                PMC ID: 9438509
                PubMed ID: 36090519
                SO-VID: 3df80dac-05cb-47ea-b5f7-6f799880f275
                Copyright statement: © 2022 MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH)
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                Categories
                Subject: Articles

                Keywords: sars-cov-2,covid-19,vaccination,vaccination reaction,multiple sclerosis,gender,adverse events
                Data availability:
                Keywords: sars-cov-2, covid-19, vaccination, vaccination reaction, multiple sclerosis, gender, adverse events

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