tetano
Editor, Senior Moderator
Mult Scler
. 2023 Feb 1;13524585221150881.
doi: 10.1177/13524585221150881. Online ahead of print.
Safety of COVID-19 vaccines in multiple sclerosis: A systematic review and meta-analysis
Maria-Ioanna Stefanou[SUP] 1 [/SUP], Lina Palaiodimou[SUP] 1 [/SUP], Aikaterini Theodorou[SUP] 1 [/SUP], Maria Veatriki Christodoulou[SUP] 1 [/SUP], John S Tzartos[SUP] 1 [/SUP], Dimitrios Tzanetakos[SUP] 1 [/SUP], Dimitrios Kitsos[SUP] 1 [/SUP], Maria Chondrogianni[SUP] 1 [/SUP], Vasiliki Zouvelou[SUP] 2 [/SUP], Efthimios Dardiotis[SUP] 3 [/SUP], Elias Tzavellas[SUP] 4 [/SUP], Ekaterini Syrigou[SUP] 5 [/SUP], Vassiliki Benetou[SUP] 6 [/SUP], George P Paraskevas[SUP] 1 [/SUP], Sotirios Tsiodras[SUP] 7 [/SUP], Georgios Tsivgoulis[SUP] 8 [/SUP], Sotirios Giannopoulos[SUP] 1 [/SUP]
Affiliations
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%; I[SUP]2[/SUP] = 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.
. 2023 Feb 1;13524585221150881.
doi: 10.1177/13524585221150881. Online ahead of print.
Safety of COVID-19 vaccines in multiple sclerosis: A systematic review and meta-analysis
Maria-Ioanna Stefanou[SUP] 1 [/SUP], Lina Palaiodimou[SUP] 1 [/SUP], Aikaterini Theodorou[SUP] 1 [/SUP], Maria Veatriki Christodoulou[SUP] 1 [/SUP], John S Tzartos[SUP] 1 [/SUP], Dimitrios Tzanetakos[SUP] 1 [/SUP], Dimitrios Kitsos[SUP] 1 [/SUP], Maria Chondrogianni[SUP] 1 [/SUP], Vasiliki Zouvelou[SUP] 2 [/SUP], Efthimios Dardiotis[SUP] 3 [/SUP], Elias Tzavellas[SUP] 4 [/SUP], Ekaterini Syrigou[SUP] 5 [/SUP], Vassiliki Benetou[SUP] 6 [/SUP], George P Paraskevas[SUP] 1 [/SUP], Sotirios Tsiodras[SUP] 7 [/SUP], Georgios Tsivgoulis[SUP] 8 [/SUP], Sotirios Giannopoulos[SUP] 1 [/SUP]
Affiliations
- PMID: 36722184
- DOI: 10.1177/13524585221150881
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%; I[SUP]2[/SUP] = 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.