MS and COVID-19 vaccination: Hesitancy and early safety/tolerability data

ABSTRACT

Introduction: Vaccine hesitancy is a major barrier to achieving herd immunity against COVID-19. This is especially apparent in patients with autoimmune diseases, such as multiple sclerosis (MS), who were largely excluded from seminal vaccine trials. Objectives/Aims: To assess COVID-19 vaccine hesitancy and early safety/tolerability in patients with MS and related disorders. Methods: Participants were recruited from multiple academic centers as part of the MS Resilience to COVID-19 (MSReCOV) Study Consortium. Statistical analysis was performed on responses to vaccine-specific questionnaires completed between February 24th and April 28th, 2021. Results: 1761 participants completed the vaccine questionnaire, including 1081(62%) with MS or another neuroinflammatory disease (NID), and 657(38%) controls. By survey completion, 1150(65%) participants had been vaccinated against SARS-CoV-2 with Pfizer(n=526, 54%), Moderna(n=415, 43%), Johnson & Johnson(n=22, 2%), AstraZeneca(n=2, 0.2%), or unknown(n=3, 0.3%). 82%(n=568) of MS/NID were on disease modifying therapy at the time of vaccination. Hesitancy rates were similar between MS/NID and controls(p=0.39), with 32% of unvaccinated participants(n=597, 34%) either unsure or not planning to be vaccinated. The most common reasons for hesitancy in patients with MS/NID pertained to vaccines being understudied in the autoimmune population(n=35, 54%), triggering a demyelinating event(n=30, 46%), or being too new(n=24, 37%). Of the MS/NID participants vaccinated with mRNA vaccines, 42%(n=240) and 45%(n=178) reported side effects(SE) after the first and second doses, respectively. Higher rates of SEs were noted in the MS/NID group after the second dose (67% vs. 45%;p<0.0001;RR 1.5, 95%CI1.3 - 1.7). Most common SEs in the MS/NID groups were arm soreness(n=278, 85%), flu-like symptoms(n=139, 42%), and headache(n=23, 7%). Only 1 MS/ NID patient (vs. 3 controls) reported a neurologic SE other than headache, described as transient numbness. When comparing vaccinated and unvaccinated MS/NID patients, there was no difference in rates of recurrent neurologic symptoms(p=0.45), new neurologic symptoms(p=0.65) or new/ active lesions detected on MRI(p=0.35). Conclusions: Reasons for vaccine hesitancy in MS/NID population include lack of study in autoimmune population and fear of relapse. In this early analysis we found a higher rate of expected SEs after second mRNA dose but no evidence of worsening neurologic disease.