Safety of Sinopharm vaccine for people with Multiple Sclerosis: Study of adverse reactions and disease activity

Kavosh, Aryan; Ashtari, Fereshteh; Naghavi, Saba; Adibi, Iman; Shaygannejad, Vahid; Karimi, Zahra; Arabi, Sina; Rahimi, Maryam; Mazaheri, Shahbanoo

doi:10.1016/j.msard.2022.103708

Cited by 11 publications

(6 citation statements)

References 27 publications

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“…After removing the outliers [ 19 – 24 , 26 , 27 , 31 , 33 – 35 , 40 – 46 , 50 – 52 , 54 – 58 , 60 , 62 , 63 , 65 , 68 – 70 , 74 – 77 , 79 – 82 , 87 , 88 , 90 , 91 ], the prevalence of relapse, flare, or exacerbation was 6.24% (95% CI 5.57%; 6.95%, test of heterogeneity: I 2 = 65.1%, p -value < 0.0001, Fig. 2 b).…”

Section: Resultsmentioning

confidence: 99%

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Risk of flare or relapse in patients with immune-mediated diseases following SARS-CoV-2 vaccination: a systematic review and meta-analysis

Shabani,

Shobeiri,

Nouri

et al. 2024

Eur J Med Res

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Background Patients with autoimmune and immune-mediated diseases (AI-IMD) are at greater risk of COVID-19 infection; therefore, they should be prioritized in vaccination programs. However, there are concerns regarding the safety of COVID-19 vaccines in terms of disease relapse, flare, or exacerbation. In this study, we aimed to provide a more precise and reliable vision using systematic review and meta-analysis. Methods PubMed-MEDLINE, Embase, and Web of Science were searched for original articles reporting the relapse/flare in adult patients with AI-IMD between June 1, 2020 and September 25, 2022. Subgroup analysis and sensitivity analysis were conducted to investigate the sources of heterogeneity. Statistical analysis was performed using R software. Results A total of 134 observations of various AI-IMDs across 74 studies assessed the rate of relapse, flare, or exacerbation in AI-IMD patients. Accordingly, the crude overall prevalence of relapse, flare, or exacerbation was 6.28% (95% CI [4.78%; 7.95%], I2 = 97.6%), changing from 6.28% (I2 = 97.6%) to 6.24% (I2 = 65.1%) after removing the outliers. AI-IMD patients administering mRNA, vector-based, and inactive vaccines showed 8.13% ([5.6%; 11.03%], I2 = 98.1%), 0.32% ([0.0%; 4.03%], I2 = 93.5%), and 3.07% ([1.09%; 5.9%], I2 = 96.2%) relapse, flare, or exacerbation, respectively (p-value = 0.0086). In terms of disease category, nephrologic (26.66%) and hematologic (14.12%) disorders had the highest and dermatologic (4.81%) and neurologic (2.62%) disorders exhibited to have the lowest crude prevalence of relapse, flare, or exacerbation (p-value < 0.0001). Conclusion The risk of flare/relapse/exacerbation in AI-IMD patients is found to be minimal, especially with vector-based vaccines. Vaccination against COVID-19 is recommended in this population.

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Section: Resultsmentioning

confidence: 99%

“…Thirteen observations of nine studies [ 19 – 21 , 37 – 39 , 42 , 54 , 76 ] were included in this analysis. Therefore, we conducted a subgroup meta-analysis of the vaccine category among participants with neurologic disorders.…”

Section: Resultsmentioning

confidence: 99%

Risk of flare or relapse in patients with immune-mediated diseases following SARS-CoV-2 vaccination: a systematic review and meta-analysis

Shabani,

Shobeiri,

Nouri

et al. 2024

Eur J Med Res

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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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“… 7 However, adverse neurological events such as myelitis, Bell's palsy, demyelinating neuropathy, and cerebral venous embolism are reported following COVID‐19 vaccination, but exact neuropathogenesis is still obscure. 8 , 9 Spontaneous intramedullary hematoma or hematomyelia is a devastating medical condition that causes serious mortality and morbidity. Tumors, anticoagulants, and vascular lesions are associated with hematomyelia; still, the majority of them are idiopathic.…”

Section: Introductionmentioning

confidence: 99%

“…Injection site reactions, fever, headache, myalgia, and rash are the most common vaccine reactions 7 . However, adverse neurological events such as myelitis, Bell's palsy, demyelinating neuropathy, and cerebral venous embolism are reported following COVID‐19 vaccination, but exact neuropathogenesis is still obscure 8,9 . Spontaneous intramedullary hematoma or hematomyelia is a devastating medical condition that causes serious mortality and morbidity.…”

Section: Introductionmentioning

confidence: 99%

Spontaneous intramedullary hematoma following COVID‐19 vaccination: A case report

Sourani

Rezvani

Foroughi

et al. 2022

Clinical Case Reports

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Safety of Sinopharm vaccine for people with Multiple Sclerosis: Study of adverse reactions and disease activity

Cited by 11 publications

References 27 publications

Risk of flare or relapse in patients with immune-mediated diseases following SARS-CoV-2 vaccination: a systematic review and meta-analysis

Risk of flare or relapse in patients with immune-mediated diseases following SARS-CoV-2 vaccination: a systematic review and meta-analysis

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

Spontaneous intramedullary hematoma following COVID‐19 vaccination: A case report

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