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

Mult Scler. 2021 May;27(6):864-870. doi: 10.1177/13524585211003476. Epub 2021 Apr 15.


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.

Keywords: COVID-19; Multiple sclerosis; acute relapse; adverse events; immune response; vaccination.

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Aged
  • BNT162 Vaccine
  • COVID-19 / complications
  • COVID-19 / epidemiology
  • COVID-19 Vaccines / adverse effects*
  • COVID-19 Vaccines / therapeutic use*
  • Cohort Studies
  • Disability Evaluation
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multiple Sclerosis / complications*
  • Patient Safety
  • Recurrence
  • Vaccination*
  • Young Adult


  • COVID-19 Vaccines
  • BNT162 Vaccine