Patient-reported safety and tolerability of the COVID-19 vaccines in persons with rare neuroimmunological diseases

Abstract

Background : The COVID-19 vaccines are currently recommended for people with rare neuroimmunological diseases such as Neuromyelitis optica spectrum disorder (NMOSD), MOG-antibody disease (MOGAD), and transverse myelitis. However, the safety profile of the vaccines in this population is uncertain. Objective : To report real-world safety data of the COVID-19 vaccines in persons with rare neuroimmunological diseases. Methods : An anonymous survey was distributed to patients recruited on social media. Participants answered general demographic and disease-related questions, and specific questions about their experiences with the COVID-19 vaccines. Results : 438 participants completed the questionnaire. The median age was 51 (range 18-82 years); 366 were female (83.6%); 102 (23.3%) had associated comorbidities, and 354 (80.1%) were treated with immunotherapies. 242 participants (55.3%) reported a diagnosis of NMOSD; 99 (22.6%) had MOGAD; 79 (18%) had transverse myelitis. 239 participants (66.2%) were younger than 55 years of age. 138 participants (31.5%) reported immediate adverse events. Of these, 93 (67.4%) were < 55 years old, and 45 (32.6%) were > 55 years old (p=0.0086). The most common adverse events were local reactions, including pain, redness, and swelling at the injection site, reported by 155 participants (35.4%). 73 participants (16.7%) reported new or worsening neurological symptoms following the vaccination. Most symptoms occurred within the first week after vaccination and resolved within three days. Conclusions : This survey indicates an overall favorable safety and tolerability profile of the COVID-19 vaccines among persons with rare neuroimmunological diseases. Longer-term studies are warranted to confirm these data.

Risk of disease relapse following COVID-19 vaccination in patients with AQP4-IgG-positive NMOSD and MOGAD

“…Similarly, no attacks were reported among 9 NMOSD patients that received the Beijing/Sinopharm-BBIBP-CorV (n=8) or BNT162b2-Pfizer-BioNTech vaccines (n=1) ( Jovicevic et al, 2021 ). These data are in line with our findings, although we observed a higher frequency of minor side effects, particularly pain at vaccine injection site ( Lotan et al, 2021 , Jovicevic et al, 2021 ).…”

“…Of note, distinction of relapses vs pseudo-relapses is mandatory and often challenging, since infection or vaccination side effects (as fever) can per se cause transient worsening of Similarly, no attacks were reported among 9 NMOSD patients that received the Beijing/Sinopharm-BBIBP-CorV (n = 8) or BNT162b2-Pfizer-BioNTech vaccines (n = 1) (Jovicevic et al, 2021). These data are in line with our findings, although we observed a higher frequency of minor side effects, particularly pain at vaccine injection site (Lotan et al, 2021;Jovicevic et al, 2021).…”

“…An increased risk of post-vaccination relapses has been reported for AQP4-IgG+NMOSD, particularly in untreated patients ( Mealy et al, 2018 ) and several studies have reported MOGAD attacks following vaccinations ( Kumar et al, 2020 ). In a large web-based study on SARS-CoV-2 vaccination in patients with neuroimmunological disorders, including MOGAD and AQP4-IgG+NMOSD, no post-vaccination relapses were detected, although 17.8% of patients reported new or worsening of previous symptoms requiring in some cases specific treatment ( Lotan et al, 2021 ). Of note, distinction of relapses vs pseudo-relapses is mandatory and often challenging, since infection or vaccination side effects (as fever) can per se cause transient worsening of symptoms.…”

“…In particular, the urgent need for mass vaccination has raised the question whether SARS-CoV-2 vaccines may increase the risk of disease relapse in these patients. While several studies have assessed the safety of SARS-CoV-2 vaccines in patients with multiple sclerosis, ( Di Flippo et al, 2021 ) there are limited data available on patients with aquaporin-4-IgG neuromyelitis optica spectrum disorder -AQP4-IgG+NMOSD- or myelin oligodendrocyte glycoprotein associated disease -MOGAD- ( Lotan et al, 2021 ). This topic is of relevance since a post-vaccination onset or worsening has been reported in both conditions.…”

New diagnosis of multiple sclerosis in the setting of mRNA COVID-19 vaccine exposure

“…This association warrants further systematic investigation, as COVID-19 vaccination, and in our cases mRNA vaccination, appears to be associated with inflammatory MS disease activity. In real-world safety reports based on MS, MOG antibody disease, neuromyelitis optica spectrum disorder, and transverse myelitis populations (963 patients), exposure to Pfizer-BioNTech COVID-19 vaccine has been associated with new or worsening neurological symptoms in less than ~15% of patients, commonly occurring early in the post-vaccination period (<7 days), and mostly self-resolving within 2 weeks ( Lotan et al, 2021a ; Lotan et al, 2021b ), Although there is evidence of immune activation with vaccines leading to other neuroimmunological disorders such as Guillain-Barré Syndrome, acute disseminated encephalomyelitis, or transverse myelitis, this has not been the case for MS. ( Stone et al, 2019 ; Agmon-Levin et al, 2009 ) Despite broad use of mRNA COVID-19 vaccines, there have been few reports of MS flares in the short-term post-vaccination period as well as optic neuritis and transverse myelitis ( Maniscalco et al, 2021 ; Kaulen et al, 2021 ). A cohort of 555 MS patients receiving at least one dose of Pfizer-BioNTech mRNA COVID-19 vaccine did not experience an increase in relapse rate as compared to the unvaccinated population ( Achiron et al, 2021 ).…”