Quantitative and qualitative features of acute phase-adverse events following SARS-CoV-2 vaccination in a large sample of people with multiple sclerosis

Porta, G. Della; Cuna, Francesco Saverio Robustelli della; Gervasio, L.; Guerra, Eva; Condemayta, M.A. Tejada; Filosa, A.; Montomoli, Chiara; Bergamaschi, Roberto

doi:10.1016/j.msard.2022.104120

Cited by 2 publications

(1 citation statement)

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“…Finally, we identified 19 eligible studies for inclusion. [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] All studies were observational, and their main characteristics are presented in Table 1, while per study definitions of MS relapse and transient neurological worsening are provided in Supplemental eTable 2. The PRISMA flow chart of the current meta-analysis is available in Figure 1.…”

Section: Literature Search and Included Studiesmentioning

confidence: 99%

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

et al. 2023

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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.

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