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Background: Allergic reactions to COVID-19 vaccines have raised concerns, particularly as repeated doses are required. Skin tests with vaccines excipient were found to be of low value whereas the utility of skin tests with the whole vaccine is yet to be determined. Objective(s): we set to evaluate a panel of skin tests and outcomes of subsequent doses of immunization among subjects that suffered an immediate allergic reaction to the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Method(s): In a prospective cohort study during December 27th-2020 to February 22nd-2021 Individuals with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center in israel, underwent risk assessment using an algorithm that included a detailed questionnaire department. Patients were considered to be at high risk for allergic reactions if thery either had: (1) prior anaphylactic reaction to any drug or vaccine, (2) multiple drug allergies, (3) multiplemallergies, or (4) mast cell disorders, as were patients who were deferred by their GP or local allergist or the immunization team from vaccination in the regular setting because of concerns about allergic. reactions. This high-risk group was referred to be immunized with 2 hours of observation by a dedicated allergy team. Result(s): Of the 429/8102 individuals who applied to the COVID-19 referral center and were defined as "highly allergic", 304 (70.8%) were female, mean age was 52 +/- 16 years. This "highly allergic" group was referred to immunization under medical supervision. Following the 1st dose of the BNT162b2, 420/429 (98%) had no immediate allergic event, 6/429 (1.4%) developed minor responses and 3/429 (0.7%) had anaphylactic reactions. During the study period, 218/429 "highly allergic" patients received the 2nd dose, of which 214/218 (98.1%) had no allergic reactions while 4 patients had minor allergic reactions. Other immediate and late reactions were comparable to the general population except for delayed itch and rash that were more common among allergic patients. Conclusion(s): The rate of allergic reactions to BNT162b2 vaccine, is higher among allergic patients, particularly in a sub-group with high-risk history. In this study we showed that the vast majority of patients with a history of allergic diseases and particularly "highly allergic" patients can be safely immunized. Utilizing an algorithm that can be implemented in different medical facilities and include a referral center, a risk assessment questionnaire and a setting for immunization under medical supervision of "highly allergic" patients. Further studies are required to define more specific risk factors for allergic reactions to BNT162b2 vaccine.
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IntroductionIn the era of COVID-19 pandemic, data on safety and efficacy of anti-COVID vaccines in SLE patients is needed and scarce. Belimumab is a monoclonal antibody directed at BAFF, an essential cytokine in B cell survival, though it does not impair efficacy of some traditional vaccines. Thus, the aim of our study was to assess immunogenicity and safety of BNT162b2 Pfizer mRNA vaccine in SLE patients treated with Belimumab.MethodsSLE patients treated with Belimumab for at least 6 months in the Sheba Medical Center were included in this study. All were recommended to receive the BNT162b2 COVID-19 mRNA vaccine according to Ministry of Health recommendations, and thereafter to perform a serologic test for CoV-2 IgG 2–6 weeks after receiving the 2nd or 3rd doses. Clinical data included demographics, SLE treatments, adverse effects to the vaccine as well as SLEDAI scores performed 2 weeks before receiving 1st dose and 6 to 8 weeks after receiving 2nd and 3rd doses of the vaccine.ResultsOur cohort included 17 patients, 15(88.2%) were females, median age was 50±14.2 years, and disease duration was 12±10.57 years. Median Belimumab treatment time was 6±2.5 years. In our cohort 2/17 received only 2 vaccine doses as thereafter the suffered mild COVID-19 infection, while 15/17 patients received 3-doses. Serologic assessment was performed for 10 patients, 7/10(70%) became seropositive following the second dose, while 2/3 patients seroconverted only after the 3rd dose. Vaccination was well tolerated with minimal adverse events and no disease flares (e,g. SLEDAI 7.7±5.19 and 7.82±5.2 before vaccination and post 3rd dose respectively).ConclusionsImmunization with 3 doses of BNT vaccine is safe and efficacious for SLE patients treated with Belimumab. Only following the 3rd dose immunogenicity of SLE patients in this cohort mounted to 90%, thereby approximating the general healthy population. Assessment of seroconversion and consideration of subsequent boosters’ vaccine should be considered for SLE patients treated with Belimumab.
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BACKGROUND: In October 2020, the Royal Melbourne Hospital implemented a Respiratory Protection Program (RPP), which was initiated by the Victorian Government. This study was to evaluate the effectiveness of the program. METHODS: A cohort of 158 employees, who were identified as high risk to respiratory biohazard exposure, were invited to participate in the RPP. We provided a bundle of interventions, which included an online training package, and mandatory quantitative fit testing. The main outcomes included the participants' knowledge and attitude toward respiratory protection equipment (RPE), which were assessed via an online survey. Their donning and doffing skills, and user seal check techniques on four different types of N95 respirators were also assessed by an observer using a pre-determined marking sheet. We compared these outcomes before and after participation in the program. RESULTS: There was a total of 125 participants, all of whom completed the knowledge and attitude assessment, and 69 completed the skill assessment before and after the program. There was a statistically significant improvement in their knowledge scores, donning and doffing skills, and user seal check techniques after participation in the RPP. Participants also reported significant increased level of confidence in their RPE knowledge, training and skills; and workplace safety. CONCLUSION: This initial report of the implementation of a novel RPP in a Victorian major tertiary hospital provides guidance on the benefits to respiratory protection, staff knowledge, skills, confidence and morale that can be acquired from a scalable online training package combined with mandatory quantitative fit testing.
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Respiratory Protective Devices , Hospitals, Public , Humans , WorkplaceABSTRACT
Biological systems are complex and highly interconnected. Despite increasing amounts of information collected, it is not always clear how to use these data to make conclusions and predictions. Mathematical models are powerful tools in biology because they allow us to abstract the biological system in order to frame questions, explore patterns and synthesize information. Indeed, we are writing these remarks during the COVID-19 Pandemic which has illustrated in a staggering way the importance of quantitative modeling in aiding our understanding of complex biological processes. This volume contains the scientific and collaborative work from the Collaborative Workshop for Women in Mathematical Biology. The workshop brought together forty-five researchers to collaborate on seven problems each of which used mathematics to understand complex biological systems. The workshop was held at the Institute of Pure and Applied Mathematics on the campus of University of California, Los Angeles from June 17-21, 2019 in Los Angeles, CA and was organized by Rebecca Segal, Blerta Shtylla, and Suzanne Sindi. The articles contained in this volume were initiated during the intensive one-week workshop and continued through follow-up collaborations afterwards. © 2021, The Association for Women in Mathematics and the Author(s).