Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients’ subgroups

Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53–1203) vs 825 (451–1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals

POS1246 COVID-19 IN ITALIAN PATIENTS WITH RHEUMATIC AUTOIMMUNE SYSTEMIC DISEASES: RESULTS OF A NATIONWIDE SURVEY STUDY

Background: SARS-CoV-2 infection poses a serious challenge for patients with rheumatic autoimmune systemic diseases (ASD), characterized by marked immune-system dysregulation and frequent visceral organ involvement. Objectives: To evaluate the impact of Covid-19 pandemic in a large series of Italian patients with ASD. Methods: Our multicenter telephone survey (8-week period, March-April 2020) included a large series of 2,994 patients (584 M, 2,410 F, mean age 58.9±13.4SD years) with ASD followed at 34 tertiary referral centers of 14 regions of northern, central, and southern Italian macro areas, characterized by different prevalence of SARS-CoV-2 infection. According to currently used criteria, Covid-19 was classified as definite Covid-19 (signs or symptoms of Covid-19 confirmed by positive oral/nasopharyngeal swabs at PCR testing) or highly suspected Covid-19 (signs or symptoms highly

The Corevent 2020: An Open-source, Rapid Design-build-Test Emergency Ventilator Developed for Covid-19

In the first quarter of 2020, SARs-CoV-2 (COVID-19) infections began to grow at an alarming rate despite drastic measures to reduce infection rates. Severe COVID-19 cases required mechanical ventilation, resulting in ventilator shortages worldwide. To address the ventilator shortages, the authors developed the CoreVent 2020, an emergency-use ventilator for adult patients that was designed, built, and tested in ten days. The CoreVent 2020 is a pressure-cycled, time-limited ventilator with a breath-assist mode that operates on standard pressurized oxygen and medical air. It provides adjustable peak inspiratory pressure (PIP) and positive end-expiratory pressure (PEEP). A medical-grade commercially available breathing circuit is used to minimize non-medical component requirements. The CoreVent 2020 was fabricated in-house at Stony Brook University Hospital and tested on three mechanical lung simulators in which the operating modes and alarm features were demonstrated. Animal studies were also performed in both normal breathing mode and breath-assisted modes. Arterial blood gas measurements confirmed that the ventilator provided satisfactory ventilation for the test subjects. The COVID-19 pandemic presented unique constraints on the design and innovation process not normally encountered in typical practice. Design decisions such as component choice, delivery time, and ease of high-volume, rapid manufacturing influenced all aspects of the design process. This aspect of the design/innovation process is also discussed, as well as an introductory discussion on how training and simulations can be developed so that innovation can occur efficiently in future crises situations.</jats:p