1. SARS-CoV-2 vaccination in patients with multiple sclerosis in Germany and the United Kingdom: Gender-specific results from a longitudinal observational study.
- Author
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Frahm N, Fneish F, Ellenberger D, Haas J, Loebermann M, Parciak T, Peters M, Pöhlau D, Rodgers J, Röper AL, Schilling S, Stahmann A, Temmes H, Zettl UK, and Middleton RM
- 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 (X2 ), 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 X1 (X2 ), 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 X2 vs. X1 (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X1 vs. X2 : 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., Competing Interests: Niklas Frahm is an employee of the MSFP. Moreover, he is an employee of Rostock's University Medical Center and received travel funds for research meetings from Novartis; none resulted in a conflict of interest. Firas Fneish, Melanie Peters, David Ellenberger and Sarah Schilling had no personal financial interests to disclose other than being employees of the German MS Registry; none resulted in a conflict of interest. Tina Parciak had no personal financial interests to disclose. Anna-Lena Röper is employee of the MSFP and Germany MS society, which is funded by many public and corporate sponsors. She received travel funds from Novartis. None resulted in a conflict of interest. Micha Löbermann received speaker honoraria from Sanofi, AbbVie and Pfizer, he served as investigator in vaccine studies sponsored by Janssen, GSK and Novartis; none resulted in a conflict of interest. Herbert Temmes has no personal pecuniary interests to disclose, other than being the Secretary General of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including Bundesgesundheitsministerium (BMG), The German Innovation Fund (G-BA), The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Judith Haas has no personal pecuniary interests to disclose, other than being the President of the German MS Society, federal association, which receives funding from a range of public and corporate sponsors, recently including BMG, G-BA, The German MS Trust, Biogen, Bristol Myers Squibb, Merck Serono, Novartis, Roche, Sanofi, Viatris (former Mylan); none resulted in a conflict of interest. Dieter Pöhlau received speaking fees, travel support and financial support for research projects from: Allmirall, Bayer, Biogen-Idec, Merck-Serono, Octapharm, Novartis, Roche, Sanofi-Aventis and Teva; none resulted in a conflict of interest. Jeff Rodgers has no personal pecuniary interests to disclose, other than being an employee of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest. Uwe K. Zettl has received speaking fees, travel support and /or financial support for research activities from Alexion, Almirall, Bayer, Biogen, Bristol-Myers-Squibb, Janssen, Merck Serono, Novartis, Octapharm, Roche, Sanofi Genzyme, Teva as well as EU, BMBF, BMWi and DFG; none resulted in a conflict of interest. Alexander Stahmann has no personal financial interests to disclose, other than being the leader of the German MS Registry, which receives funding from a range of public and corporate sponsors, recently including G-BA, The German MS Trust, German MS Society, Biogen, Bristol Myers Squibb, Merck, Novartis, Roche and Sanofi; none resulted in a conflict of interest. Rod Middleton has no personal pecuniary interests to disclose, other than being the lead of the UK MS Register which is funded by the MS Society, travel research and conference costs are also funded by them; none resulted in a conflict of interest., (© 2022 MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH).)- Published
- 2022
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