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Meta-Analysis
. 2023 Apr;29(4-5):585-594.
doi: 10.1177/13524585221150881. Epub 2023 Feb 1.

Safety of COVID-19 vaccines in multiple sclerosis: A systematic review and meta-analysis

Maria-Ioanna Stefanou  1 , Lina Palaiodimou  1 , Aikaterini Theodorou  1 , Maria Veatriki Christodoulou  1 , John S Tzartos  1 , Dimitrios Tzanetakos  1 , Dimitrios Kitsos  1 , Maria Chondrogianni  1 , Vasiliki Zouvelou  2 , Efthimios Dardiotis  3 , Elias Tzavellas  4 , Ekaterini Syrigou  5 , Vassiliki Benetou  6 , George P Paraskevas  1 , Sotirios Tsiodras  7 , Georgios Tsivgoulis  8 , Sotirios Giannopoulos  1
Affiliations
Meta-Analysis

Safety of COVID-19 vaccines in multiple sclerosis: A systematic review and meta-analysis

Maria-Ioanna Stefanou et al. Mult Scler. 2023 Apr.

Abstract

Background: Data are sparse regarding the safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with multiple sclerosis (MS).

Objective: To estimate (1) the pooled proportion of MS patients experiencing relapse among vaccine recipients; (2) the rate of transient neurological worsening, adverse events, and serious adverse events; (3) the previous outcomes of interest for different SARS-CoV-2 vaccine types.

Methods: Systematic review and meta-analysis of pharmacovigilance registries and observational studies.

Results: Nineteen observational studies comprising 14,755 MS patients who received 23,088 doses of COVID-19 vaccines were included. Mean age was 43.3 years (95% confidence interval (CI): 40-46.6); relapsing-remitting, secondary-progressive, primary-progressive MS and clinically isolated syndrome were diagnosed in 82.6% (95% CI: 73.9-89.8), 12.6% (95% CI: 6.3-20.8), 6.7% (95% CI: 4.2-9.9), and 2.9% (95% CI: 1-5.9) of cases, respectively. The pooled proportion of MS patients experiencing relapse at a mean time interval of 20 days (95% CI: 12-28.2) from vaccination was 1.9% (95% CI: 1.3%-2.6%; I2 = 78%), with the relapse risk being independent of the type of administered SARS-CoV-2-vaccine (p for subgroup differences = 0.7 for messenger RNA (mRNA), inactivated virus, and adenovector-based vaccines). After vaccination, transient neurological worsening was observed in 4.8% (95% CI: 2.3%-8.1%) of patients. Adverse events and serious adverse events were reported in 52.8% (95% CI: 46.7%-58.8%) and 0.1% (95% CI: 0%-0.2%) of vaccinations, respectively.

Conclusion: COVID-19 vaccination does not appear to increase the risk of relapse and serious adverse events in MS. Weighted against the risks of SARS-CoV-2-related complications and MS exacerbations, these safety data provide compelling pro-vaccination arguments for MS patients.

Keywords: COVID-vaccines; adverse events; inactivated virus; mRNA vaccines; multiple sclerosis; relapse; viral-vector vaccines.

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Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Flow chart presenting the selection of eligible studies.
Figure 2.
Figure 2.
Forest plot presenting the pooled proportion of patients experiencing relapses among the total MS patients having received COVID-19 vaccination, stratified by vaccine type.
Figure 3.
Figure 3.
Forest plot presenting the pooled proportion of patients experiencing relapses among the total MS patients having received COVID-19 vaccination, stratified by vaccine dose.
See this image and copyright information in PMC

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