Self-reported safety of the BBIBP-CorV (Sinopharm) COVID-19 vaccine among Iranian people with multiple sclerosis

Etemadifar, M.; Abhari, A. P.; Nouri, H.; Akhavan Sigari, A.; Piran Daliyeh, S. M.; Maracy, M. R.; Salari, M.; Maleki, S.; Sedaghat, N.

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.