key: cord-0309568-thkp6iay
authors: Etemadifar, M.; Abhari, A. P.; Nouri, H.; Akhavan Sigari, A.; Piran Daliyeh, S. M.; Maracy, M. R.; Salari, M.; Maleki, S.; Sedaghat, N.
title: Self-reported safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among Iranian people with multiple sclerosis
date: 2021-10-18
journal: nan
DOI: 10.1101/2021.10.17.21265114
sha: 059cd456c203b100cd4f522f3a3115a2c012572b
doc_id: 309568
cord_uid: thkp6iay

To affirm the short-term safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among people with multiple sclerosis (pwMS), 517 vaccinated and 174 unvaccinated pwMS were interviewed. 16.2% of the vaccinated pwMS reported at least one neurological event in their respective at-risk periods (ARP), a period from the first until two weeks after the second vaccine dose. In a multivariable logistic regression model, presence of comorbidities (P = 0.01), being on natalizumab (P = 0.03), and experiencing post-vaccination myalgia (P < 0.01) predicted the development of post-vaccination neurological symptoms. One MS relapse, one COVID-19 contraction, and one ulcerative colitis flare after the first, and five MS relapses after the second dose, were the only reported serious adverse events during the ARPs. A multivariable Poisson regression model accounting for possible confounders failed to show any statistically-significant increase in relapse rates during the ARPs of vaccinated, compared to the prior year of unvaccinated pwMS (P = 0.78). Hence, the BBIBP-CorV vaccine does not seem to affect short-term MS activity. Furthermore, as 83.33% of the unvaccinated pwMS reported fear of possible adverse events to be the reason of their vaccination hesitancy; hence, provision of misinformed pwMS with evidence-based consultations in this regard is encouraged.

baseline characteristics, and Table 3 two were on dimethyl fumarate, one on glatiramer acetate, one on fingolimod, and one 115 on rituximab therapy. One of the relapses followed the first and five followed the second 116 dose of the vaccine. All relapses were followed by either partial or complete 117 improvement after treatment with corticosteroids. The multivariable Poisson regression 118 model did not indicate any significant difference between the relapse rates of vaccinated 119 pwMS in the ARP and the unvaccinated pwMS in the prior year (Table 4) . Furthermore, 120 apart from one case of COVID-19 and one case of ulcerative colitis flare -both after the 121 first dose -no other serious adverse events were reported. 122

Among the unvaccinated pwMS, the main reason for vaccination hesitancy was 123 reported to be fear of possible adverse events (83.33%). Other reasons included 124 pregnancy and lactation-related reasons (4.60%), believing that they have already 125 obtained immunity after their COVID-19 contraction (4.02%), waiting for other types of 126 vaccines (1.72%), fears of conspiracy (2.30%), disbelieving vaccination (3.45%), and 127 unawareness of eligibility (0.57%). 128

Our results suggest that the BBIVP-CorV vaccine does not increase the risk of relapse 130 in pwMS, although a relatively small proportion of vaccinated pwMS may experience 131 neurological symptoms. 83.7% of our participants did not develop any neurological 132 sequelae following vaccination, and only 6 (1.2%) experienced post-vaccination MS 133 All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted October 18, 2021. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted October 18, 2021. Several limitations apply to this work because of its remote nature: I) considering the 175 limited framework of the study, we could not review the participants' medical records to 176 perform self-controlled analyses, II) the outcome measurements were performed in a 177 All rights reserved. No reuse allowed without permission.

(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint this version posted October 18, 2021. ; https://doi.org/10.1101/2021.10.17.21265114 doi: medRxiv preprint

COVID-19 vaccination in patients with multiple sclerosis: What we have learnt by

Humoral immune response to COVID-19 mRNA vaccine in patients with multiple 203 sclerosis treated with high-efficacy disease-modifying therapies

Abbreviations: pwMS, people with multiple sclerosis

No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity