COVID-19 vaccination in patients with multiple sclerosis: What we have learnt by February 2021

Abstract

Background: Since vaccination against coronavirus disease 2019 (COVID-19) became available, risks related to vaccinating patients with multiple sclerosis (MS) need to be carefully assessed. Objective: Characterize safety and occurrence of immediate relapses following COVID-19 vaccination in a large cohort of MS patients. Methods: We assessed the safety of BNT162b2 COVID-19 vaccination in adult MS patients. Results: Between 20 December 2020 and 25 January 2021, 555 MS patients received the first dose of BNT162b2 vaccine and 435 received the second dose. There were three cases of COVID-19 infection encountered after the first dose. Safety profile of COVID-19 vaccine was characterized by pain at the injection site, fatigue, and headache. No increased risk of relapse activity was noted over a median follow-up of 20 and 38 days after first and second vaccine doses, respectively. The rate of patients with acute relapse was 2.1% and 1.6% following the first and second doses, respectively, similar to the rate in non-vaccinating patients during the corresponding period. Mild increase in the rate of adverse events was noted in younger patients (18–55 years), among patients with lower disability (Expanded Disability Status Scale (EDSS) ⩽3.0), and in patients treated with immunomodulatory drugs. Conclusion: COVID-19 BNT162b2 vaccine proved safe for MS patients. No increased risk of relapse activity was noted.

Experience with the COVID-19 AstraZeneca vaccination in people with multiple sclerosis

“…The majority of symptoms resolved within seven days of vaccine administration matching the experience in our small cohort. Recently, a significantly lower frequency of adverse events has been reported with the BNT162b2 vaccine in pwMS [8]. Whilst data in that study were collected during consultations in clinic, we relied on the return of multiple-choice questionnaires, which inevitably affects the denominator since patients having an adverse experience are more likely to voice their MSARD-S-21-00644-R1 -Allen-Philbey K, et al SARS-CoV2 vaccination in multiple sclerosis 6 grievances and, thus, return their questionnaire, than people without, or only minor, side effects.…”

Adverse events after first COVID-19 vaccination in patients with autoimmune diseases

“…8 , 9 However, a limitation of our study is that data on disease activity were based on self-report rather than validated disease activity measures, and we did not assess the duration and severity of disease flares. Known pathophysiological effects of mRNA on the innate immune system could be both immunostimulatory and immunosuppressive, 10 , 11 thus as COVID-19 vaccines are the first mRNA vaccines to be widely applied, prospective controlled studies with adequate follow-up are required to draw robust conclusions about long-term effects of COVID-19 vaccines on autoimmune disease activity. Another limitation of our study was that control participants were not a random sample of the general population, nor were they an exact match for patients with autoimmune diseases with regard to age and sex distribution.…”

Acute bilateral optic/chiasm neuritis with longitudinal extensive transverse myelitis in longstanding stable multiple sclerosis following vector-based vaccination against the SARS-CoV-2

“…A recent meta-analysis of adverse events across different vaccines against COVID-19 revealed a very low risk (1/10,000) of TM in the general population [ 5 ]. TM has not been reported in MS patients treated with BNT162b2 vaccine (Pfizer-BioNTech COVID-19) injections [ 1 ] but there were 3 patients in the safety register of the approval study of the vector-based COVID-19 Vaccine ® [ 7 , 9 ]. One of them turned out to suffer from a previously unrecognized MS.…”