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

Niklas Frahm; Firas Fneish; David Ellenberger; Judith Haas; Micha Loebermann; Tina Parciak; Melanie Peters; Dieter Pöhlau; Jeff Rodgers; Anna-Lena Röper; Sarah Schilling; Alexander Stahmann; Herbert Temmes; Uwe K Zettl; Rodden M Middleton

doi:10.1016/j.lanepe.2022.100502

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

Lancet Reg Health Eur. 2022 Sep 2:22:100502. doi: 10.1016/j.lanepe.2022.100502. eCollection 2022 Nov.

Authors

Niklas Frahm^{1

2}, Firas Fneish¹, David Ellenberger¹, Judith Haas³, Micha Loebermann⁴, Tina Parciak⁵, Melanie Peters⁶, Dieter Pöhlau³, Jeff Rodgers⁷, Anna-Lena Röper^{1

3}, Sarah Schilling¹, Alexander Stahmann¹, Herbert Temmes³, Uwe K Zettl², Rodden M Middleton⁷

Affiliations

¹ German MS-Registry, MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]) Krausenstr. 50, 30171 Hannover, Germany.
² Department of Neurology, Neuroimmunological Section, University Medical Center of Rostock, Gehlsheimer Str. 20, 18147 Rostock, Germany.
³ Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V. (German MS Society Federal Association [DMSG]), Krausenstr. 50, 30171 Hannover, Germany.
⁴ Department of Tropical Medicine, Infectious Diseases and Nephrology, University Medical Center of Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany.
⁵ Biomedical Research Institute & Data Science Institute, Hasselt University, Diepenbeek 3590, Belgium.
⁶ Gesellschaft für Versorgungsforschung mbH (Society for Health Care Research [GfV]), Krausenstr. 50, 30171 Hannover, Germany.
⁷ UK MS Register, Swansea University Medical School, Data Science Building, Swansea SA2 8PP, United Kingdom.

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 (X¹) 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.

Keywords: Adverse events; COVID-19; Gender; Multiple sclerosis; SARS-CoV-2; Vaccination; Vaccination reaction.