Analysis of Side Effects Following Vaccination Against COVID-19 Among Individuals With Multiple Sclerosis Treated With DMTs in Poland.

Background and Objectives

Since vaccination against COVID-19 is available for over a year and the population of immunized individuals with autoimmune disorders is higher than several months before, an evaluation of safety and registered adverse events can be made. We conducted a large study of side effects following the COVID-19 vaccine among patients with multiple (MS) sclerosis treated with disease-modifying therapies (DMTs) and analyzed factors predisposing for particular adverse events.

Methods

We gathered data of individuals with MS treated with DMTs from 19 Polish MS Centers, who reported at least one adverse event following COVID-19 vaccination. The information was obtained by neurologists using a questionnaire. The same questionnaire was used at all MS Centers. To assess the relevance of reported adverse events, we used Fisher's exact test,

Results

A total of 1,668 patients with MS and reports of adverse events after COVID-19 vaccination were finally included in the study. Besides one case marked as "red flag", all adverse events were classified as mild. Pain at the injection site was the most common adverse event, with a greater frequency after the first dose. Pain at the injection site was significantly more frequent after the first dose among individuals with a lower disability (EDSS ≤2). The reported adverse events following immunization did not differ over sex. According to age, pain at the injection site was more common among individuals between 30 and 40 years old, only after the first vaccination dose. None of the DMTs predisposed for particular side effects.

Conclusions

According to our findings, vaccination against COVID-19 among patients with MS treated with DMTs is safe. Our study can contribute to reducing hesitancy toward vaccination among patients with MS.

Informations de copyright

Copyright © 2022 Czarnowska, Tarasiuk, Zajkowska, Wnuk, Marona, Nowak, Słowik, Jamroz-Wiśniewska, Rejdak, Lech, Popiel, Rościszewska-Żukowska, Perenc, Bartosik-Psujek, Świderek-Matysiak, Siger, Ciach, Walczak, Jurewicz, Stasiołek, Kania, Dyczkowska, Kalinowska-Łyszczarz, Galus, Walawska-Hrycek, Krzystanek, Chojdak-Łukasiewicz, Ubysz, Pokryszko-Dragan, Kapica-Topczewska, Chorąży, Bazylewicz, Mirończuk, Kulikowska, Kochanowicz, Białek, Stolarz, Kubicka-Bączyk, Niedziela, Warmus, Adamczyk-Sowa, Podlecka-Piçtowska, Nojszewska, Zakrzewska-Pniewska, Jasińska, Zaborski, Milewska-Jȩdrzejczak, Zwiernik, Zwiernik, Potemkowski, Brola and Kułakowska.

Déclaration de conflit d'intérêts

AK, WB, HB-P, AP-D, MA-S, EK, and KK received compensation for speaking and consulting services from Biogen, Bayer, Novartis, Roche, Merck, Teva, and Sanofi-Genzyme. MS received compensation for speaking from Roche, Novartis, Sanofi-Genzyme, and Biogen. MŚ-M received compensation for speaking and consulting services from Biogen, Novartis, Roche, Merck, and Sanofi-Genzyme. AJ received compensation for speaking services from Merck and SanofiGenzyme. MS received grant funding from Biogen and received compensation for speaking and consulting services from Biogen, Novartis, Roche, Merck, Sanofi-Genzyme, Bristol Myers Squibb, and Teva. AS, MM, KN, and MW received compensation for speaking and consulting services from Biogen, Bayer, Novartis, Roche, Merck, Teva, and Sanofi-Genzyme. They received also a grant from NCBIR (nr SZPITALE-JEDNOIMIENNE/18/2020). AK-L received grant funding from Novartis and received compensation for speaking and consulting services from Biogen, Bayer, Novartis, Roche, Merck, Teva, CSL Behring, Shire, and Sanofi-Genzyme. None of the agreements are relevant to the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.