mRNA COVID-19 vaccines do not increase the short-term risk of clinical relapses in multiple sclerosis

Filippo, Massimiliano Di; Cordioli, Cinzia; Malucchi, Simona; Annovazzi, Pietro; Cavalla, Paola; Clerici, Valentina Torri; Ragonese, Paolo; Romozzi, Marina; Radaelli, Marta; Laroni, Alice; Buttari, Fabio; Lorefice, Lorena; Ferraro, Diana; Gajofatto, Alberto; Prosperini, Luca; Fantozzi, Roberta; Boffa, Laura; Lanzillo, Roberta; Moccia, Marcello; Clerico, Marinella; Luca, Giovanna De; Tomassini, Valentina; Calabrese, Massimiliano; Borrelli, Antonio; Paolicelli, Damiano; Maniscalco, Giorgia Teresa; Gazzola, Paola; Gallo, Antonio; Solaro, Claudio; Cocco, Eleonora; Gasperini, Claudio; Tortorella, Carla

doi:10.1136/jnnp-2021-327200

Cited by 58 publications

(69 citation statements)

References 5 publications

(4 reference statements)

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“…In the present emergency due to the SARS-CoV-2 pandemic, there still appear to be some vaccine hesitancies the reasons for which derive from the fear both of possible side effects of vaccines and of possible effects that a vaccine might have on MS disease course. Actually, available data for Pfizer/BioN-Tech BNT162b2 vaccine in the MS population and results did not support evidence for an association between vaccination and risk for MS onset or relapses [16,17]. Conversely, the present report confirms the risk, after SARS-Cov-2 infection, of demyelinating events including MS onset and relapse.…”

Section: Discussioncontrasting

confidence: 88%

“…Recently, a study evaluated the relapse rate in the MS population who underwent COVID-19 vaccination, compared to a cohort of non-vaccinated patients, showing no increased risk of relapses [16]. Similarly, an Italian prospective, self-controlled, multicentric observational study conducted in 25 Italian MS centers, concluded that Pfizer/BioNTech BNT162b2 vaccine did not increase the short-term risk of clinical reactivation in MS patients [17].…”

Section: Discussionmentioning

confidence: 99%

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Clinical Onset and Multiple Sclerosis Relapse after SARS-CoV-2 Infection

Pignolo

Aprile

Gagliardo

et al. 2021

Neurology International

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been associated with several neurological disorders including headache, facial palsy, encephalitis, stroke, demyelinating disorders. The present report will discuss cases of multiple sclerosis (MS) onset and relapse both beginning early after SARS-CoV-2 infection. In both cases, magnetic resonance imaging (MRI) showed widespread bilateral subcortical and periventricular active lesions. Serum IgG against SARS-CoV-2 Spike antigens confirmed seroconversion with titers that are considered not definitely protective against possible reinfection. We hypothesize that SARS-CoV-2 infection, as previously reported for other viruses, could drive an active inflammatory response that can contribute either to the onset of MS or its relapse. The presented data further support the importance of vaccination in individuals with MS.

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Section: Discussioncontrasting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Clinical Onset and Multiple Sclerosis Relapse after SARS-CoV-2 Infection

Pignolo

Aprile

Gagliardo

et al. 2021

Neurology International

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“…The vaccinated group consisted mostly of patients enrolled online (299, 71.9%), the majority being women (339/416, 81.5%), with a median age of 50 years (21,88). The non-vaccinated group included mostly patients enrolled during hospital evaluations, mostly women (183/207, 88.4%), with a median age of 48 years (19,73).…”

Section: Resultsmentioning

confidence: 99%

“…In addition, various studies including the preliminary data from the EULAR COVID-19 Vaccination Registry [15] showed an acceptable safety profile for COVID-19 vaccines, showing no evidence of significant disease flare-ups across different AID-IMD [16][17][18][19].…”

Section: Discussionmentioning

confidence: 99%

COVID-19 Vaccine Does Not Increase the Risk of Disease Flare-Ups among Patients with Autoimmune and Immune-Mediated Diseases

Pinte

Negoi

et al. 2021

JPM

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Background: Reports describing post-vaccine autoimmune phenomena, in previously healthy individuals, increased the concerns regarding the risk of disease flare-ups in patients with immune diseases. We aimed to assess the potential risk of disease flare-up, after receiving the COVID-19 (Coronavirus disease 2019) vaccine, during a follow-up period of 6 months. Methods: We performed a prospective cohort study, enrolling the patients with autoimmune- and immune-mediated diseases who voluntarily completed our questionnaire, both online and during hospital evaluations. Based on their decision to receive the vaccine, the patients were divided into two groups (vaccinated and non-vaccinated). Participants who chose not to receive the vaccine served as a control group in terms of flare-ups. Results: A total of 623 patients, 416 vaccinated and 207 non-vaccinated, were included in the study during hospital evaluations (222/623) and after online (401/623) enrolment. There was no difference concerning the risk of flare-up between vaccinated and non-vaccinated patients (1.16, versus 1.72 flare-ups/100 patients-months, p = 0.245). The flare-ups were associated with having more than one immune disease, and with a previous flare-up during the past year. Conclusions: We did not find an increased risk of flare-up following COVID-19 vaccination in patients with autoimmune-/immune-mediated diseases, after a median follow-up of 5.9 months. According to our results, there should not be an obvious reason for vaccine hesitancy among this category of patients.

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“…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.…”

Section: Introductionmentioning

confidence: 99%