The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study (original) (raw)
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Summary of safety and efficacy of COVID-19 vaccination in patients with multiple sclerosis
European Neurology, 2023
Background: The SARS-CoV-2 pandemic represents one of the most challenging issues that have recently influenced everyday life in countries all over the world. Understanding the risk of this disease is of high importance in patients with multiple sclerosis (MS) as they represent a vulnerable population through their treatment with disease-modifying therapies (DMTs). Infective episodes may trigger relapses and lead to deterioration of the health condition. Summary: Vaccination is an important preventive measure against infectious diseases. In MS patients, concerns have been raised about the effectiveness of vaccines in patients on various immunomodulatory drugs and about their possible adverse effects including impairment of neurological functions. The objectives of this article were to summarize the current knowledge on immune responses to the COVID-19 vaccines and their safety in MS patients and to provide practical guidance based on the data available to date. Key Messages: Although MS is not associated with a higher risk of COVID-19, this infection can trigger relapses or pseudo-relapses. Vaccines against SARS-CoV-2 are recommended for all MS patients who are not in the active phase of the disease, despite the fact that there is still a lack of long-term reliable data on the effectiveness and safety of vaccines against COVID-19. Some DMTs can reduce vaccine humoral responses, but might still provide some protection and adequate T-cell response. To optimize the effectiveness of vaccination, the ideal timing of vaccine application and DMTs dosing regimen is crucial.
COVID-19 vaccination in patients with multiple sclerosis: What we have learnt by February 2021
Multiple Sclerosis Journal, 2021
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, ...
Multiple Sclerosis and Related Disorders
Objectives and aims: Disease modifying therapies used in multiple sclerosis can decrease humoral response after COVID-19 vaccines. This problem must be adequately addressed because new variants evolve, and COVID-19 still poses a risk to patients with comorbidities and immunosuppression. We aimed to evaluate the antibody response after the third dose of the COVID-19 vaccine in people with multiple sclerosis on disease-modifying therapies. Methods: People with multiple sclerosis who received the third dose of either mRNA or inactivated vaccine after two doses of inactivated vaccine were recruited for the study. Blood samples were collected at least two weeks after the third dose. Results: Blood samples of 339 (female 72.5%) people with multiple sclerosis and 52 (female 71.2%) healthy controls were evaluated. Healthy controls (mean: 4.07 ± 0.66) have higher antibody titers than people with multiple sclerosis (mean: 2.79 ± 2.95). Seronegative cases were observed only in the fingolimod and ocrelizumab treatment groups. Patients on fingolimod who received mRNA as a third dose had significantly higher antibody titer than those who had inactivated vaccines. Longer disease duration, having inactivated vaccine as a third dose, and DMT use was associated with lower antibody response. Conclusions: The study shows that even after inactivated vaccine schedule, mRNA still offers more protection in people with multiple sclerosis on disease-modifying therapies.
2021
BackgroundPatients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to mRNA-based SARS-CoV-2 vaccines, while the degree of such responses is unimpaired and similar in pwMS treated with other disease modifying therapies (DMTs), or untreated. However, the nature of the SARS-CoV-2 vaccine-induced immune response is based also on cellular immunity and there is emerging evidence that anti-SARS-CoV-2 specific CD4 and CD8 T cell responses can be detected after vaccination also in patients with low antibody levels. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection and to identify correlates of reduced protection in frail vaccinated pwMS on different DMTs.MethodsWe designed a long term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis), a prospective multicenter cohort study enrolling pwMS scheduled for SARS-CoV-2 vaccination with mRNA vaccines and tested for SARS-CoV-2 antibodies befo...
Multiple Sclerosis and Related Disorders
Background: COVID-19 vaccines are recommended for people with multiple sclerosis (pwMS). Adequate humoral responses are obtained in pwMS receiving disease-modifying therapies (DMTs) after vaccination, with the exception of those receiving B-cell-depleting therapies and non-selective S1P modulators. However, most of the reported studies on the immunity of COVID-19 vaccinations have included mRNA vaccines, and information on inactivated virus vaccine responses, long-term protectivity, and comparative studies with mRNA vaccines are very limited. Here, we aimed to investigate the association between humoral vaccine responses and COVID-19 infection outcomes following mRNA and inactivated virus vaccines in a large national cohort of pwMS receiving DMTs. Methods: This is a cross-sectional and prospective multicenter study on COVID-19-vaccinated pwMS. Blood samples of pwMS with or without DMTs and healthy controls were collected after two doses of inactivated virus (Sinovac) or mRNA (Pfizer-BioNTech) vaccines. PwMS were sub-grouped according to the mode of action of the DMTs that they were receiving. SARS-CoV-2 IgG titers were evaluated by chemiluminescent microparticle immunoassay. A representative sample of this study cohort was followed up for a year. COVID-19 infection status
Multiple Sclerosis Journal - Experimental, Translational and Clinical
Background Several studies have demonstrated reduced serological response to vaccines in patients treated with anti-CD20 agents. However, limited data exist surrounding the clinical effect of disease modifying therapy (DMT) use on vaccine efficacy. Objectives To investigate breakthrough coronavirus disease 2019 (COVID-19) in vaccinated people with multiple sclerosis (PwMS) on DMT. Methods PwMS on DMT diagnosed with COVID-19 after full vaccination were identified from an existing Cleveland Clinic COVID-19 registry, supplemented by provider-identified cases. Demographics, disease history, DMTs, comorbidities, exposures, vaccination status, and COVID-19 outcomes were confirmed by review of the electronic medical record. Results Thirteen (3.8%) of 344 fully vaccinated people with multiple sclerosis on disease modifying therapy were diagnosed with COVID-19 after vaccination. Ten patients (76.9%) were on an anti-CD20 therapy, the remaining 3 (23.1%) on fingolimod. Only 2 patients (15.4%),...
Multiple Sclerosis Treatment in the COVID-19 Era: A Risk-Benefit Approach
Neurology International
The COVID-19 pandemic poses an ongoing global challenge, and several risk factors make people with multiple sclerosis (pwMS) particularly susceptible to running a severe disease course. Although the literature does report numerous articles on the risk factors for severe COVID-19 and vaccination response in pwMS, there is a scarcity of reviews integrating both these aspects into strategies aimed at minimizing risks. The aim of this review is to describe the risk of vulnerable pwMS exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the issues related to the SARS-CoV-2 vaccine and to evidence possible future strategies in the clinical management of pwMS. The authors searched for papers on severe COVID-19 risk factors, SARS-CoV-2 vaccination and people with multiple sclerosis in support of this narrative literature review. We propose a multilevel strategy aimed at: the evaluation of risk factors for severe COVID-19 in people with multiple sclerosis, identifying the...