ABSTRACT
Introduction: Knowledge regarding the development of protective immunity after COVID-19 vaccines is needed to guide medical, political and public health measures against the current and future pandemics. Objectives and Aims: To characterise and compare the safety, immunogenicity and efficacy of mRNA-COVID-19 vaccines in people with multiple sclerosis (pwMS) and healthy controls (HCs). Method(s): All pwMS vaccinated against COVID-19 in Norway were invited to participate in an ongoing observational cohort study (NevroVAX) from March 2021. Demographic-, immunisation-and disease-specific data were acquired from patient journals, web-questionnaires, the Norwegian Immunization Registry and Surveillance System for Communicable Diseases. Antibodies to full length spike protein and the receptor-binding domain (RBD) from SARS-CoV-2 were measured using a bead-based flow cytometric assay, while cellular immunity was investigated using high dimensional multiparameter analyses. Results and Conclusion(s): To date, 5545 pwMS were included with results available regarding humoral responses in 3021 (mean follow-up time 257 days), cellular responses in 140, and clinical efficacy in 900 pwMS. Those treated with anti-CD20 therapy or sphingosine-1-phosphate receptor modulators (S1PM) had weak humoral immune responses after two doses of mRNA-COVID-19 vaccines (80% and 91% <200 BAU/ml, respectively). Additional vaccine doses were safe and associated with a modest increase of anti-SARS-CoV-2 spike RBD IgG antibodies (72% and 83% <200 BAU/ml after three, 74% and 89% <200 BAU/ml after four doses). Humoral responses were weaker after all vaccine doses in pwMS (also in those without treatment) compared to HCs. Cellular responses were significantly attenuated in pwMS treated with S1PM. An elevated rate of non-omicron breakthrough infections was observed in the anti-CD20 (19%), S1PM (18%), and HSCT (14%) group, compared to pwMS on other high-or low-efficacy DMTs or without treatment (13%, 10%, and 7%, respectively). Among 900 pwMS treated at the same hospital, 12 (1%) were hospitalized due to COVID-19, one requiring intensive care. Our results show that antibody responses correlated with the rate of breakthrough infections but is not necessarily indicative of a failed cellular or clinical response to vaccination, and that pwMS have weaker humoral responses than HCs regardless of treatment status. Updated, real-world data from NevroVAX will be presented at ECTRIMS 2022.
ABSTRACT
Background and goals: The goal of this study was to assess the rate of self-reported side effects, need for medical assistance and hospitalizations after a third COVID-19 vaccination in people with multiple sclerosis (pwMS) with or without disease-modifying treatments. We also wanted to investigate if SARS-CoV2 antibody levels correlate with side effects. Method(s): Participants enrolled in the vaccination trial Nevrovax were invited to complete a questionnaire on side effects after the third dose of SARS-CoV-2 vaccination. SARS-CoV2 antibodies were measured in BAU/mL after 3 weeks or longer after vaccination. The results were linked to data from the Norwegian Immunization Registry. Statistical analyses were performed using SPSS Stastistics version 26. Group comparisons were analyzed using independent samples t-tests and chi-square tests with a significance level of 0.05. Result(s): In total 606 pwMS (77.4% female, mean age 48.3 years) were included in this study. At the time of immunization, 61.7% of all pwMS were treated with anti-CD20 monoclonal antibodies and 19%with sphingosine 1-phosphate receptor modulators. Mean time to follow up from third dose to answering the questionnaire was 29.9 days.586 patients received an mRNAvaccine (257 BNT162b2 and 344 mRNA1273 as dose 3) while 20 received a viral vector vaccine-AZD1222 (One as dose 3). Data on vaccine type of dose 3 was missing in 4 patients. Side effects were reported by 66.2% of all pwMS. Mean age of patients with and without side effects were 47.0and 50.7 years, respectively (p < 0.01). We found a higher rate of side effects among women (68.8%) than men (59.1%) (p=0.047), and a higher rate among those using anti-CD20 therapy (73.3%) (p<0.05). Blood samples of SARS-CoV2 antibodies were obtained in 547 patients. There were no significant difference in antibody levels in patients with side effects (mean 1185 BAU/ mL) and patients without side effects (mean 1174 BAU/mL), p= 0.66. 16 pwMS (2.6%) sought medical help after vaccination. No pwMS needed hospitalization. Conclusion(s): Our results demonstrate that a third dose of SARSCov2 vaccines are safe in pwMS using different DMTs. Rate and severity of side effects vary with both treatment and demographic factors. SARS-CoV2 IgG levels did not correlate with side effects. There were no hospitalizations after vaccination with a 3rd dose.
ABSTRACT
Background Due to current safety measures concerning the Corona pandemic, clinical staff in all sections are urged to wear surgical masks most of the time. Health care workers often perceive respiratory protection as uncomfortable and suspect a negative impact on their cognitive abilities. The current study investigated the impact of surgical masks on cognition and mental health as well as staff members' self-evaluations regarding potential impacts. Methods 29 clinical health care workers underwent 2 ± 90-minute sessions assessing their cognitive abilities and psychological health, one session wearing a surgical mask and one without. The assessments included neuropsychological diagnostics, questionnaires, recordings of partial pressure of oxygen (PO 2) and pulse as well as self-assessments regarding their cognitive abilities. Results Wearing surgical masks over 90-minutes had an impact neither on the subjects self-assessment, nor on the objective measures of cognitive functioning. However, self-assessments of cognitive abilities were influenced by apprehensions regarding the COVID-19 situation. Conclusions Neither subjective nor objective cognitive abilities are influenced by wearing surgical masks. Self-assessments were, however, predicted by perceptions of safety and worries. Hence, it is of paramount importance to acknowledge the individual fears of health care workers regarding the COVID-19 situation in a working environment. © 2021 Georg Thieme Verlag. All rights reserved.
ABSTRACT
Introduction: Expert organizations worldwide recommend that all patients with multiple sclerosis (MS) should be vaccinated against acute respiratory syndrome coronavirus 2 disease of 2019 (COVID- 19). However, the effect of disease-modifying therapies (DMTs) on the efficacy to mount an appropriate immune response is unknown. There is increasing evidence of altered protective humoral immunity after mRNA-COVID-19 vaccines among patients treated with fingolimod, rituximab and ocrelizumab. However, the role of cellular immunity is still unknown. Appropriate knowledge regarding the development of protective immunity is of paramount importance in respect to medical, political and public health measures to aid the fight against the COVID-19 pandemic. Objectives and Aims: We aimed to characterize humoral and cellular immunity after mRNA-COVID-19 vaccines in patients with MS treated with high-efficacy DMTs (NEVROVAX). Methods: All patients treated with alemtuzumab, natalizumab, fingolimod, rituximab or cladribine, and vaccinated with BNT162b2- or mRNA-1273-COVID-19 vaccine were invited. We assessed protective humoral immunity by measuring acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG response using anti-spike protein-based serology in all included patients before, and 3-6 weeks after full vaccination (NEVROVAX-HUMORAL). Cellular immunity was investigated using high dimensionality multiparameter analyses in 50 pre-selected individuals (10 patients in each treatment group;NEVROVAX-CELLULAR) and in all patients not developing protective humoral immunity in the former group (NEVROVAX-EXTENSION). Results and Conclusions: Over 900 patients were invited and, to date, more than 300 patients have been included in our study. Preliminary results show altered protective humoral immunity in MS patients treated with rituximab and fingolimod. Continuous analysis of cellular immunity is conducted in these patients. The percentage of vaccinated inhabitants in Norway is still under 10%. We expect to complete all analyses by September 2021 and will present our results during ECTRIMS 2021.
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Background: The COVID-19 pandemic has disrupted healthcare delivery and education of physicians, including rheumatology trainees. Objectives: To assess the impact of the COVID-19 pandemic on the clinical experiences, research opportunities, and well-being of rheumatology trainees. Methods: A voluntary, anonymous, web-based survey was administered in English, Spanish, or French from 19/08/2020 to 05/10/2020. Adult and paediatric rheumatology trainees worldwide in training in 2020 were invited to participate via social media and email. Using multiple choice questions, Likert scales, and free text answers, we assessed trainee patient care activities, redeployment, research, and well-being. Results: The 302 respondents were from 33 countries, with most (83%, 252/302) in adult rheumatology training. Many trainees (45%, 135/300) reported an increase in non-rheumatology clinical work (e.g. care of COVID-19 patients), with 52% of these (70/135) also continuing rheumatology clinical work. COVID-19 redeployment was not optional for 68% (91/134). Trainees reported a negative impact of the pandemic in their growth in rheumatology (Figure 1). They also reported a substantial impact on several training areas: outpatient clinics (79%, 238/302), inpatient consultations (59%, 177/302), formal teaching (55%, 167/302), procedures (53%, 147/302), teaching opportunities (52%, 157/302), and ultrasonography (36%, 110/302), with 87-96% perceiving a negative impact on these areas. Only 54% (159/294) reported feeling comfortable with their level of clinical supervision during the pandemic (Figure 1). Many trainees (46%, 128/280) reported changes in research experiences during the pandemic;39% (110/285) reported that COVID-19 negatively affected their ability to continue their pre-pandemic research and 50% (142/285) reported difficulty maintaining research goals (Figure 1). Some rheumatology trainees reported having health condition(s) putting them at high risk for COVID-19 (10%, 30/302) and 14% of trainees (41/302) reported having had COVID-19 (Table 1). Only 53% (160/302) reported feeling physically safe in the workplace while 25% (76/302) reported not feeling physically safe;reasons included lack of training about COVID-19, lack of comfort in the clinical setting, insufficient personal protective equipment, immunocompromised state, and pregnancy. Half (151/302) reported burnout and 68% (204/302) an increase in stress from work during the pandemic (Figure 1), whilst 25% (75/302) reported that changes to their training programme negatively impacted their physical health. Conclusion: The COVID-19 pandemic has negatively impacted the experience of rheumatology training as well as the well-being of trainees globally. Our data highlight concerns for rheumatology trainees including research opportunities and clinical care which should be a focus for curriculum planning.
ABSTRACT
Background: The COVID-19 pandemic led to a rapid increase in remote consultations in rheumatology care. Due to the potential impact of this change on rheumatology clinical training, we investigated trainees' experiences with telemedicine. Objectives: To assess the impact of telemedicine use during the COVID-19 pandemic on rheumatology training, including supervision. Methods: A voluntary, anonymous web-based survey was administered in English, Spanish, or French from 19/08/2020 to 05/10/2020. Adult and paediatric rheumatology trainees worldwide in training in 2020 were invited to participate via social media and email. Using multiple choice questions, Likert scales, and free text answers, we collected data regarding prior and current telemedicine use, training, and supervision. Results: 302 respondents from 33 countries completed the survey, with most (83%, 252/302) in adult rheumatology training. Reported use of telemedicine increased from 13% (39/302) pre-pandemic to 82% (247/302) (Table 1). European trainees predominantly utilised audio-only compared to trainees from the rest of the world (ROW) who predominantly utilised audio-video telemedicine. Most trainees continued to evaluate new patients using telemedicine (65%, 161/247). A larger proportion of trainees were comfortable using telemedicine to evaluate follow-up (69% 170/247) versus new patients (25%, 41/161) (Figure 1). Only 32% (97/302) were trained in telemedicine, with the highest proportion among United States (US) trainees (59%, 69/116);subjects included software, clinical skills, and billing. The majority of trainees found this helpful (92%, 89/97). Supervision was most frequently in the form of verbal discussion after the consultation (Table 1);24% (59/247) had no telemedicine supervision during the pandemic. In general, trainees found telemedicine negatively impacted their supervision (51%, 123/242) and clinical teaching quality (70%, 171/244);only 9% reported a positive impact on these areas. Conclusion: Adoption of telemedicine during the COVID-19 pandemic has led to areas of concern for rheumatology trainees including inadequate supervision and clinical teaching. Our results suggest a need for education on evaluation of new patients using telemedicine, increasing telemedicine training, and ensuring adequate supervisory arrangements.