ABSTRACT
As the healthcare response to the COVID-19 pandemic continues, providing enhanced protection to frontline healthcare personnel exposed to aerosolized infectious material is essential. The rapid spread of the COVID-19 virus across the globe in early 2020 generated an overwhelming surge in demand for effective personal protective equipment (PPE), in particular, passive personal respirators (PPR). Global manufacturing of PPR was limited, and research and development of improved respirators were restricted by the availability of accredited laboratories for timely testing at the peak of the pandemic. The authors have described a clinical method of safety and efficacy testing of a new PPR, the TopBioShield, using portable capnography for the measurement of end-tidal pCO2 (ETCO2) and bedside pulse oximetry to measure oxygen saturation (SpO2), respiratory rate (RR), and heart rate (HR) in healthy volunteers to overcome shortages of clinical testing capabilities during the height of the pandemic. Twenty-eight volunteers with a median age of 41 years (range 16–71) representing all 10 subgroups of head/face size were included. Only one participant asked to withdraw due to a feeling of claustrophobia after 30 min. Clinical monitoring while wearing TopBioShield revealed ETCO2, SpO2, respiratory rate, and heart rate measurements were within normal limits in all the subjects throughout the experiment. Bedside clinical monitoring is effective in demonstrating the physiological safety of PPR and is an important alternative to conventional mannequin testing. In this study all measured values over a 90-min experiment period were within normal limits, demonstrating the effectiveness of TopBioShield in preventing CO2 retention. Clinical testing methods must adhere to the highest standards and are essential during times of shortage. © 2023, The Institution of Engineers (India).
ABSTRACT
Introduction: The National multiple sclerosis (MS) Society and other expert organizations recommended that all MS patients should be vaccinated against COVID-19. The impact of diseasemodifying therapies on the efficacy to mount appropriate immune responses is currently under investigation. Objective(s): To characterize humoral and cellular immunity in mRNA-COVID-19 MS vaccinees treated with Teriflunomide. Method(s): We prospectively measured (1) SARS-COV-2 IgG response using a quantitative anti-spike protein-based immunoassay (Euroimmun, Lubeck, Germany, cut-off IgG level >35.2 BAU/ml), (2) memory B-cells specific for SARS-CoV-2 RBD, and (3) memory T-cells secreting IFN-g and/or IL-2, in response to SARS-CoV-2 peptides by ELISpot/Fluorospot assays, in MS patients vaccinated with BNT162b2-COVID-19 vaccine before, one and three months after the second vaccine dose. Patients were either untreated (N=31, 21 females) or under treatment with Teriflunomide (N=30, 23 females, median treatment duration 3.7 years, range 1.5-7.0 years). The percent of subjects that developed protective antibodies, the antibody titer, and the cellular B and T cell responses were evaluated. Result(s): None of the patients had clinical SARS-CoV-2 or immune evidence for prior infection. Spike IgG titers were similar between untreated and Teriflunomide treated MS patients both at 1 month (median 1320.7, 25-75 IQR 850.9-3152.8 vs. median 901.7, 25-75 IQR 618.5-1495.8, BAU/ml, respectively), and at 3 months (median 1388.8, 25-75 1064.6-2347.6 vs. median 1164.3 25-75 IQR 726.4-1399.6, BAU/ml, respectively), after the second vaccine dose. In untreated and Teriflunomide-treated MS patients specific SARS-COV-2 memory B cells were detected in 41.9% and 40.0% of subjects at 1 month, and in 32.3% and 43.3% and at 3 months following vaccination, respectively. Specific SARS-COV-2 memory T cells were found in 48.4% and 46.7% of untreated and Teriflunomide-treated MS patients at 1 month, and in 41.9% and 56.7% in untreated and Teriflunomide-treated MS patients at 3 months, respectively. Conclusion(s): Teriflunomide treatment enabled effective humoral and cellular immune responses to COVID-19 vaccination.
ABSTRACT
Introduction: As the vaccination against coronavirus disease 2019 (COVID-19) becomes available worldwide, 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 young MS patients up to 30 years of age. Methods: We assessed the safety of BNT162b2-COVID-19 vaccination in young MS patients. Patients were contacted by phone, email, WhatsApp, or face-to-face encounters. Follow-up was conducted in the MS Center to record any occurrence of acute relapses Results: The safety profile of COVID-19 vaccination was compared between 21 very young and 71 young MS patients, median (25-75 IQR) age 18.7 (18.1 - 19.8) vs. 26.5 (24.2 - 28.3) years, p<0.001. One patient (4.8%) in the very young age group was infected with SARS-COV-2 following the first vaccine dose;no cases of COVID-19 infection were noted during the follow-up, median (range) 85 (7 - 116) days after the second vaccine dose. The percent of patients with any adverse event was higher in the very young age group, after the first and the second vaccine doses, 76.2% and 80.9% vs. 52.1% and 59.1%, respectively. Adverse events profile was characterized by increased rates of pain at the injection site fatigue, and headache in the very young age group, after the first and after the second vaccine doses. No events of face tingling or facial palsy were recorded in either age group. No increased risk of relapse activity was noted in both groups. Conclusions: The COVID-19-BNT162b2 vaccine is safe for young MS patients. The frequency of adverse events was higher in the very young age group, and more so after the second vaccine dose.
ABSTRACT
Introduction: We have previously reported (Achiron A, et al. Mult Scler. 2021. PMID: 33856242) that the BNT162b2 vaccine against coronavirus disease 2019 (COVID-19) proved safe for multiple sclerosis (MS) patients, with no increased risk of relapse activity. Since our previous report, further data has accumulated, and the follow-up period was extended. Objectives: Revalidate 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. Patients were questioned regarding adverse events via phone, WhatsApp, email, or face-to-face encounters. Follow-up was conducted in the MS Center to record any occurrence of acute relapses. Results: Between December 2020 and April 2021, 911 MS patients received the first vaccine dose and 888 completed the second dose. Four cases of COVID-19 infection were encountered after the first dose. The adverse event profile of COVID-19 vaccine was mainly characterized by pain at the injection site (23.1% and 15.6% of patients following first and second dose, respectively), fatigue (10.3%, 19.4%), and headache (5.5%, 8.1%). An acute relapse was noted in 1.5% of patients adjacent to the first dose. Within a follow-up period of up to 4 months from second vaccine dose, 3.1% of patients experienced an acute relapse, median 41 days from second dose. The rate of acute relapses during the follow-up period was similar between vaccinated and nonvaccinated MS patients (4.6%). Younger age (18-55 years), lower disability (Expanded Disability Status Scale ≤3.0), and treatment with immunomodulatory medication were associated with a higher frequency of adverse events. Conclusions: COVID-19 BNT162b2 vaccine is safe for MS patients. No increased risk of acute relapse activity was noted following vaccination.
ABSTRACT
Background: During the coronavirus disease-2019 (COVID-19) pandemic outbreak our blood bank developed protocols to guarantee accurate blood components to COVID-19 patients. Objectives: To provide convalescent whole blood donor screening strategies for patients recovering from COVID-19. Methods: We recruited COVID-19 recovering patients who met our defined inclusion criteria for whole blood donation. All blood units were screened for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) RNA by real time reverse transcription polymerase chain reaction (RT-PCR) and SARS-COV-2 immunoglobutin G (IgG) antibodies against the S1 domain. Results: We screened 180 blood units from patients recovering from COVID-19. All results were negative for SARS-CoV-2 RNA and 87.2% were positive for SARS-COV-2 IgG antibodies in the plasma. Conclusions: Blood component units from recovering COVID-19 patients are safe. Plasma units with positive IgG antibodies could serve as an efficient passive immunization for COVID-19 patients. Moreover, in the face of increased transfusion demand for treatment of anemia and coagulation dysfunction in critical ill COVID-19 patients, red blood cells units and random platelets units from convalescent donors can be safely transfused.