Safety and tolerability of SARS‐Cov‐2 vaccination in patients with myasthenia gravis: A multicenter experience

Abstract

Background and purpose During the COVID‐19 pandemic, myasthenia gravis (MG) patients have been identified as subjects at high risk of developing severe COVID‐19, and thus were offered vaccination with priority. The lack of direct data on the safety and tolerability of SARS‐CoV‐2 vaccines in MG have contributed to vaccine hesitancy. To address this issue, the safety and tolerability of SARS‐CoV‐2 vaccines were assessed in a large cohort of MG patients from two referral centers. Methods Patients with confirmed MG diagnosis, consecutively seen between October and December 2021 at two MG centers, were enrolled. Demographics, clinical characteristics, and information regarding SARS‐CoV‐2 infection/vaccination were extracted from medical reports and/or collected throughout telephonic or in‐person interviews. Results Ninety‐eight (94.2%) of 104 patients included were administered at least two vaccine doses 4 weeks before the interview or earlier, and among them, 63 of 98 (64.2%) have already received the “booster” dose. The most frequently used vaccines were BNT162b2‐Pfizer‐BioNTech and mRNA‐1273‐Moderna. Overall, only minor side effects were reported, most commonly local pain and fever. MG worsening after vaccination was observed in eight of 104 (7.7%) cases. The frequency of worsening among muscle‐specific tyrosine kinase MG cases (3/9, 33.3%) was significantly higher compared to other serological subgroups. Spontaneous symptom regression was observed in six of eight cases. Twelve of 104 (11.5%) patients had SARS‐CoV‐2 infection, and none of the SARS‐CoV‐2‐infected MG patients worsened after vaccination. Conclusions Our data support the safety and tolerability of mRNA COVID‐19 vaccines, which should be strongly recommended in MG patients, who could be at higher risk of complications if exposed to SARS‐CoV‐2 infection.

Vaccines and myasthenia gravis: a comprehensive review and retrospective study of SARS-CoV-2 vaccination in a large cohort of myasthenic patients

“…In line with Patone et al [ 46 ], we did not find cases of myasthenic exacerbations between the first and second dose, as only three of patients included received ChAdOx1 nCoV-19 vaccine. Our results are very similar to a recent paper by Farina et al that found myasthenic worsening cases in 7.7% of a large group of vaccinated Italian MG patients [ 47 ].…”

“…A recent Italian study investigating the safety of anti-SARS-CoV-2 vaccines in 104 myasthenic patients, found MG worsening cases after vaccination in 8/104 (7.7%, 7 after Pfizer BNT162b2 vaccine and 1 after Moderna mRNA-1273 vaccine), most of which were mild events. Remarkably, the frequency of disease exacerbation in anti-MuSK seropositive patients was much higher than other MG categories [ 47 ].…”

BNT162b2 mRNA COVID-19 vaccine three-dose safety and risk of COVID-19 in patients with myasthenia gravis during the alpha, delta, and omicron waves

“…A small-scale, questionnaire-based study was conducted to assess the early safety of these vaccines, and although reassuring, has not included boosters [ 22 ]. As far as we are aware, only one study has examined the safety of “booster” vaccinations, albeit with a small sample [ 23 ] and without addressing new-onset cases. To the best of our knowledge, no study has been conducted regarding the effect of the Omicron wave on this susceptible population.…”

SARS-CoV-2 vaccination and new-onset myasthenia gravis: A report of 7 cases and review of the literature

“…The literature so far suggests there may be a 1-15% risk of exacerbation of pre-existing MG following SARS-CoV-2 vaccination, mostly mild and responding well to standard treatment, with the exception of one published case of a patient who suffered a myasthenic crisis one week after the second dose of the Moderna vaccine [ 18 , [39] , [40] , [41] , [42] ].…”