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Introduction: Preventive approach via vaccination remains one of the most effective ways of controlling the COVID-19 pandemic. Safety concerns especially among children and teenagers is a concern. The aim of the study was to determine the adverse effects of COVID -19 vaccine among teenagers in Klang Valley. Method(s): A retrospective study involved 12 to less than 18 years old received COVID-19 Pfizer-BioNTech (BNT162b2) mRNA vaccine from 1st September 2021 until 15th November 2021 in Hospital Tunku Azizah. They were interviewed via telephone on the adverse effects of COVID -19 vaccination after available parental consent and assents. Result(s): A total of 300 teenagers recruited. There were 166 (55.3%) males and their mean age was 13.8 +/- 1.7 years. During first vaccination, 267 (87.0%) experienced local adverse effects (injection site pain, swelling and redness), 58 (18.0%) had systemic adverse effects and 77 (25.0%) had general symptoms (fever, lethargy, giddiness, chills and flush) during first 48 hours. About 5% had symptoms by second to seven days post-vaccination. Almost all adverse effects resolved by second week. For second vaccination, 251 (83.0%) had local adverse effects, 39 (13.0%) had systemic adverse effects and 71 (24.6%) had general symptoms within first 48 hours. Less than 6.0% had side effects between second to seventh day and almost all resolved by second week of vaccination. Adverse side effects were not related to their underlying medical problems, age and gender. Conclusion(s): Common adverse effects following COVID-19 vaccination among teenagers were localised to injection within the first 48 hours.
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Regular flushing and locking of totally implantable venous access devices (TIVADs) is recommended to maintain their patency when not in use. In this case report, a 73-year-old male patient received radical resection for rectal carcinoma in January 2010. A TIVAD was implanted in 2014 and a total of 12 rounds of chemotherapy of FOLFIRI was completed in 2015. During the period from 2015 to 2020, the patient never used or conducted the monthly infusion port flushing because of the inconvenience, the COVID-19 pandemic, and so on. On 18th April 2020, the patient was admitted to the radiotherapy department of Yiwu Central Hospital. The nurse evaluated the TIVAD upon admission, finding that the skin around the reservoir was normal without any sign of infection as erythema or induration of the skin overlying the implantable port but there was intraluminal occlusion of the devices. In order to re-access the catheter, discussion of a MDT was performed and several days of unremitting efforts were tried. Gratifyingly, the patient's port was re-accessed successfully without any adverse reactions. This is a rare infusion port that has not been used and maintained for 5 years. For the port that has not been used and maintained for a long time up to 5 years, the medical staff should not give up easily. During the COVID-19 pandemic, prolonging the flushing interval of TIVADs can be an optimal clinical strategy without negative outcomes.
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Toilet flushing generates and spread fecal aerosols, potentially leading to infection transmission risk. Squat toilets are widely used in public restrooms in some Asian countries including China and India, and remain to be studied. Aerosol dispersion while flushing squat toilet in cubicle was visualized, while the aerosol concentrations were measured on different surfaces by monitoring fluorescence intensity through seeding simulated fluorescence feces. Flushing-generated fecal aerosols could spread to the breathing zone, deposit on floor, and partitions in squat toilet cubicles, and spread even beyond to the restroom lobby. A total of 0.24 % and 0.17 % of seeded fecal waste deposits on the floor and partition (lower than 0.20 m) for each flush. Aerosol concentration decays rapidly, with 86.8 ± 2.2 % reduction in the second minute after a previous flush compared to that in the first minute. Public toilet users are recommended to wait for 2 min after the early flush before entering the cubicle.
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Background: Mast cell disorders (MCDs) are characterized by the proliferation and accumulation of mast cells in different tissues and their inappropriate release of mediators. Primary MCDs include systemic and cutaneous mastocytosis and monoclonal MC activation syndrome. They manifest with symptoms ranging from rash to anaphylaxis, idiopathic or elicited by heterogeneous factors, including vaccines. Vaccines are useful to prevent severe lung disease and mortality in COVID-19. Early reports of allergic reactions to COVID-19 vaccines emerged;however, their frequency is low. There are limited data on the safety of COVID-19 vaccine for immediate allergic reactions in high-risk patients like those with MCDs. To date, data concerning both the type of premedication and its need in these patients undergoing COVID-19 vaccines are limited. The objective of this study is to evaluate the safety of COVID-19 vaccine in patients with MCDs. Method(s): We included retrospectively patients with primary MCDs, according to WHO criteria, attending the Clinical Immunology and Allergy Unit at AO Mauriziano from June 2000 to December 2021, who underwent COVID-19 vaccination. We reported demographic and clinical data and noted -by phone call -vaccine type, premedication scheme, and contingent reactions. Result(s): We enrolled 44 patients (22 female, 50%), with a median age at diagnosis of 43.4 yrs. 25 patients had ISM, 8 CM, and 11 MMCAS. Median tryptase level was 44.3 ng/ml. 17 patients had history of anaphylaxis, none after vaccination. 37 patients (84.1%) underwent COVID-19 vaccination, 7 refused it. 32 completed the vaccination course, and 5 received two doses only. 25 patients were fully vaccinated with mRNA vaccine. The PEG-allergic one underwent Ad26.COV2.S vaccine, another one had first ChAdOx1, then mRNA-1273. All patients were vaccinated in hospital setting and observed for one hour. Most patients continued the daily antihistamine;9 started it few days before the injection;4 patients underwent vaccination without premedication. None showed anaphylaxis. One patient had immediate flushing;another had a delayed asthma exacerbation. A non-premedicated patient had immediate urticaria at first dose, while he tolerated others with AH The small cohort and the retrospective design limit this study. Nonetheless, the absence of severe hypersensitivity reactions to COVID-19 vaccines in our patients with MCDs, is an important finding. Conclusion(s): Our results confirm that patients with MCDs may be safely vaccinated to COVID-19.
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Introduction: Pulmonary transit time (PTT), the time taken for contrast to travel from the left to right ventricle, can be used as a surrogate marker for cardiac output. There have been previous studies evaluating the prognostic significance of Magnetic Resonance (MR) and Computed Tomography (CT) PTT in heart failure patients. This study used dynamic CT images to determine the PTT and study its correlation with left and right ventricular ejection fraction and left and right cardiac output in COVID patients, with a known range of cardiac outputs. Method(s): 123 COVID-19 patients were retrospectively studied. A single contrast bolus timing scan was acquired with a 320-detector CT (Acquilion ONE, Canon). A single 2 mm slice was placed axially where left and right ventricle and descending aorta were visualised. Contrast administration and scan acquisition began at the same with 20 ml of Omnipaque with 40 ml saline flush at 5 ml/s. One image was acquired every second and the total scan time was 26 seconds. A circular ROI was placed in the centre left and right ventricle, the signal intensity was plotted over time for each of these regions. Matlab software was used to extract the peak contrast time between the right and left ventricles. MR cardiac images were acquired on a 3 T Prisma, which determined MR PTT, left and right ejection fraction (LVEF, RVEF) and left and right ventricle cardiac output (LVCO, RVCO). These values were already computed from a previous study where this data was taken from. Correlations were studied using the Pearson correlation method using Minitab software. Result(s): There was correlation between MR PTT and LVEF and RVEF, r = - 0.433 p<0.05 and r=-0.358 p<0.05 respectively. A correlation was also seen with CT PTT and LVEF (figure 1) and RVEF, r=-0.-345 p<0.05 and r=-0.2 p=0.029 respectively. A correlation was seen for MR PTT and LVCO and RVCO, r=-0.322 p<0.05 and r=-0.295 p<0.05 but not for CT PTT and LVCO and RVCO, r=-0.1 p=0.297 and r=-0.04 p=0.668 respectively. Conclusion(s): A correlation was seen between MR PTT and CT PTT for both LVEF and RVEF, but this was not seen for CT PTT and LVCO and RVCO. Further work is required to understand the limitations of the CT PTT and why it fails to correlate with these parameters. Limitations may include dynamic CT temporal resolution or due to poor image quality due to motion from breathing. Compared to previous studies there is agreement between the MR PTT and MR cardiac parameters. At this stage there is an indication that CT PTT could be a potential tool to estimate LVEF and RVEF. [Formula presented]Copyright © 2023
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Introduction: Legionella pneumophila is an opportunistic pathogen that is a key contributor to drinking water-associated disease outbreaks in the United States. Prolonged water stagnation periods in building plumbing systems due to low occupancy, especially during building shutdowns, breaks, and holidays, can lead to water quality deterioration and (re)colonization of buildings with L. pneumophila. Water monitoring in buildings typically relies on grab samples with small datasets. Methods: In this study, a larger dataset was created by sampling a Leadership in Energy and Environmental Design (LEED)-certified data-rich commercial building for L. pneumophila and physical-chemical water quality during the COVID-19 pandemic after reduced building occupancy. A proxy for human occupancy rates using WIFI logins was recorded throughout the study period. Results: L. pneumophila was observed in grab samples taken throughout the building, where concentrations generally increased with greater distances from the building point of entry to locations throughout the building. Factors conducive to microbial growth were identified in the building including fluctuations in water temperatures, lack of chlorine residual, a low water heater setpoint, colonized water-saving fixtures, prolonged stagnation throughout the building;especially in an expansion tank designed to reduce pressure issues during demand fluctuations, and the presence of oversized softener tanks with ion exchange resin that contributed to chlorine residual removal as well as colonization of the resin with L. pneumophila. Discussion: Flushing and thermal disinfection alone did not resolve the problem, and replacement of the expansion tank ultimately resolved the L. pneumophila issue. As ad-hoc approaches are logistically- and time-intensive, more proactive approaches are needed for informing preventative and corrective actions for reducing the risk of exposure to opportunistic pathogens in the building plumbing. Copyright © 2023 Joshi, Richard, Levya, Harrison, Saetta, Sharma, Crane, Mushro, Dieter, Morgan, Heida, Welco, Boyer, Westerhoff and Hamilton.
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Purpose: Kidney transplant recipients are at high-risk for severe coronavirus disease 2019 (COVID-19). Studies suggest that intervention with monoclonal antibody (MAB) treatment may decrease hospitalization rates. Here we describe a single-center experience of the use of casirivimab-imdevimab, a currently approved MAB, for treatment of COVID-19 disease in kidney transplant recipients. Method(s): This is a retrospective single center study of adult kidney transplant patients who were diagnosed with mild to moderate COVID-19 and received casirivimab-imdevimab as an outpatient infusion between 12/29/20 to 10/20/21. All patients had at least 30 days of study follow-up from date of infusion. Result(s): 69 patients were included with the following characteristics: 65.2% male, 73.9% white, mean age 50+/-13 years, 33% diabetic. Median time from transplant to COVID-19 diagnosis was 80 (IQR 33-143) months. 49.3% of patients were not vaccinated for COVID-19 while 1.5%, 34.8%, and 14.5% had received 1, 2 and 3 doses, respectively. Median time from COVID-19 diagnosis to MAB treatment was 3 (range 0-9) days. Of the 69 patients, 3 (4.3%) required hospitalization within 30 days after MAB infusion (table). There were no emergency department-only visits within 30 days after MAB infusion. There were no deaths, graft losses, or acute rejection episodes recorded in the 30-day follow-up period. One infusion reaction of flushing and palpitations was reported. Conclusion(s): To our knowledge, this study describes the largest cohort of kidney transplant recipients treated with casirivimab-imdevimab and demonstrates that among high-risk, immunosuppressed patients with COVID-19, casirivimabimdevimab therapy is associated with low rates of hospitalization and a favorable safety profile.
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Drinking water stagnation can lead to degradation of chlorine residual, bacterial growth (including of opportunistic pathogens and nitrifiers), and metals release from plumbing materials;however, few studies have characterized building water quality and bacterial communities during the extended stagnation periods that occurred during COVID-19 pandemic-related building closures. Additionally, despite a lack of evidence-based guidance, flushing fixtures has been recommended to restore building water quality. We aimed to evaluate the impacts of reduced building occupancy (>2 months) and weekly restorative flushing on drinking water quality, bacterial communities, and the occurrence of undesirable microorganisms in three university buildings. Reduced occupancy led to diminished chloramine and elevated intact cell counts, but values remained stable after additional weeks of limited water use. Flushing temporarily improved water quality, with chlorine and cell counts remaining stable for at least 1 day but returning to levels measured prior to flushing within 1 week. Alpha diversity was lower under more stagnant conditions, and fixture identity, not flushing, was the most influential factor on bacterial community composition, suggesting a strong influence from local biofilm. Although Mycobacterium, Legionella, Pseudomonas, Nitrosomonas, and Nitrospira were detected in samples via amplicon sequencing, concentrations measured via qPCR of M. avium complex, L. pneumophila, P. aeruginosa, and ammonia-oxidizing bacteria were very low or were undetected, supporting that stagnation alone did not lead to high occurrence of undesirable microorganisms. Findings from this study contribute to our understanding of the effects of stagnation on building water microbiomes and the efficacy of flushing to improve water quality. Under the conditions of this case study, repeated flushing on a weekly timescale during low occupancy periods was not sufficient to maintain chlorine residual and prevent bacterial growth in fixtures. Building managers need to weigh the temporary water quality benefits of flushing against the labor and water resources required considering local context.
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During the COVID-19 pandemic, building owners and operators sought to protect their occupants by following ASHRAE and CDC guidance for HVAC and water system risk mitigation. This paper presents the results of building readiness assessments conducted for 95 commercial office buildings across the United States. In these assessments, the authors evaluated buildings for initial alignment with ASHRAE Epidemic Task Force (ETF) guidance and recommended action where additional risk mitigation measures were warranted. The engineering assessments focused on outdoor air ventilation rates, filtration efficiency levels, flushing spaces during unoccupied periods, and Eegonella water management practices. Primary challenges to implementing ETF guidance included resistance to operational changes with potential adverse energy impacts, concerns regarding existing system limitations, and in a limited number of cases, ventilation system design constraints. The assessments showed that most of the office buildings could modify their HVAC and water system operatingpractices to minimize the spread of harmful pathogens without major upgrades to equipment or significant increases in energy use. Almost all subject buildings had the capacity to meet or exceed minimum ventilation rates, upgrade to at least MERV-13 filters, implement appropriate flushing periods to achieve target clean air changes, and manage their water systems to minimize Legionella risk.
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Introduction & Objectives: Residential aged care facility (RACF) patients require complex care, with many needing urinary catheters. As part of Aged Care Quality Standards, facilities are expected to provide appropriate catheter management. Hospital transfers for simple catheter management burdens both Patients and health care systems. Additionally, during the COVID 19 pandemic, transfers to ED for simple catheter issues unnecessarily stresses an already strained healthcare system. Visiting geriatric services provide an alternative for RACF patients. We assessed the trends of ED presentations and referrals to visiting geriatric services for catheter related concerns before and during 2020. Methods: We assessed the electronic medical records of a tertiary teaching hospital for RACF patients with catheter related issues who were transferred to ED and those who were referred to the visiting geriatric services from 2018 to 2020. Exclusion criteria included patients who received a urinary catheter for indications other than a primary urinary tract pathology or where further assessment was required. Flushing, repositioning, or changing of a catheter was deemed suitable as management by nursing staff at RACF. Non-urgent medical assessment was deemed suitable for visiting geriatric services. Results: A total of 399 catheter related issues were managed over the included timeframe, with 129 in 2018, 126 in 2019 and 144 in 2020. Presentations to the ED accounted for 70 (54.3%), 61 (48.4%), and 56 (38.9%) of all presentations in 2018, 2019, and 2020 respectively. The remainder were managed by visiting geriatric services. Out of all catheters related issues, visiting geriatric services managed proportionately more presentations over each sequential year. Subgroup analysis of patients presenting to the ED (total 188) showed that, 115 (61.2%) were suitable for management by RACF staff. A further 34 (18.1%) were deemed suitable for visiting geriatric services. Across all three years, 79.3% of presentations were deemed safe to manage outside of the ED. Furthermore, a total of 211 were patients referred to visiting geriatric services. Of these, 25 (11.8%) were ultimate referred to hospital. Conclusions: During the COVID-19 pandemic in 2020, ED presentations for simple catheter issues reduced with subsequent increase in referrals to visiting geriatric services. This reduces not only financial costs or risks of delirium and falls, but also use of ED resources. However, given 79.3% of ED presentations were deemed safe to manage in the community with or without visiting geriatric services, and only 11.8% of those managed by visiting geriatric services were referred to the ED, there is ongoing unnecessary expenditure for these cases. Further collaboration between ED, urology and geriatric medicine can further streamline this process to identify appropriate residents to be managed in RACF.
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Objective: The systemic anti-cancer therapy (SACT) work stream of the East of England Cancer alliance identified variation in SACT administration times as a potential area to counter the impact of Covid-19 capacity restrictions within chemotherapy day units. The aim is to assess the impact of reducing post infusion observation time of pertuzumab-trastuzumab on efficiency and safety. Methods: The recommendation from East of England Cancer Alliance was to adopt one hour observation post pertuzumab and one hour post trastuzumab for cycle 1, 30 min after each infusion for cycle 2 and 3 and a zero observation time thereafter for patients who have had no reaction. All patients administered IV pertuzumab-trastuzumab between October 2020 and May 2021 were identified. The number of patients experiencing hypersensitivity reactions with the original and reduced observation time was compared. The impact of reduced observation time on chair capacity was also calculated. Results: Of the 26 patients treated with the original observation time between October 2020 to January 2021, two patients reacted and received Hydrocortisone IV 100 mg and Chorphenamine IV 10 mg. Patients continued treatmnet at a slower rate. No patients discontinued treatment due to the reaction. Reactions included flushing, stomach pain, uncontrolled bladder and face swelling. Between February and May 2021,18 patients were treated with reduced observation times and 3 patients reacted. Reactions included hypertension, chills, vomiting and shivering. The total number of patients between the cohorts differs due to the conversion of some patients to Phesgo from April 2021. These patients were managed similarly to the previous cohort with added IV ondansetron and IV metoclopramide. No patient discontinued treatment following the reaction. Chair times savings were 5 h for cycle 1, 2 h for cycle 2 and 3, and 3 h from cycle 4 onwards. In total, 53 chair hours in the chemotherapy day unit were released between February to May 2021. Conclusion: The pressure on chemotherapy units has been exacerbated by staff absence, reduced capacity due to social distancing and use of PPE. Whilst the SPC for trastuzumab states patients should be observed for 6 h post first infusion and for 2 h post subsequent infusions, the implementation of reduced observation times post infusion of pertuzumab-trastuzumab did not impact on patient safety and encouragingly increased the capacity of the day unit by 53 h in four months.
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Purpose of Study Acute appendicitis (AA) is the most common abdominal surgical emergency in pediatrics. There was a precipitous drop in pediatric visits to hospitals, including the emergency department, since the US declared COVID-19 a national emergency. Managing AA during the pandemic remains a challenge as fear of COVID exposure can lead to delays in presentation and surgery, as well as a shift to conservative management. Alvarado score (AS) is a ten-point clinical scoring system to identify AA and the American Association for the Surgery of Trauma (AAST) grading system (I-V) are validated tools for AA diagnosis and severity. There are no studies on prevalence and severity of AA during the COVID- 19 pandemic in an urban multiethnic community. Objective To compare prevalence and severity of AA before and during the COVID-19 pandemic. Methods Used This was a retrospective chart review of patients admitted to Flushing Hospital Medical Center and Jamaica Hospital Medical Center with the diagnosis of AA from March 2018 to March 2021. Charts were reviewed for demographics, clinical, imaging and surgical data to determine AS and AAST. AS grouped from 1-6 (less likely to require surgery) and 7-10 (more likely to require surgery). AAST scoring was based on most severe criteria if grading discrepancies were found between pathology, surgical and computed tomography findings. Leukocytosis was defined as white blood cell count >10. G1 identified AA cases March 2018 - February 2020 and G2 March 2020 - March 2021. Data was analyzed using SPSS software, p<0.05 considered significant. Summary of Results Of 239 patients with AA over 3 years, G1 totaled 184 (77%) in 2 years pre-pandemic and G2 had 55 (23%) during first year pandemic. Mean age, gender and ethnicity were similar for G1 and G2. AS and AAST were compared for G1 and G2, table 1. G2 had significantly greater overall AS of >7 (p=0.038) and higher AAST (p=0.016). Only three patients tested positive for SARS-CoV-2 and 9 (16%) of G2 were transferred to a tertiary care center. Conclusions Although there was a decline in number of AA evaluated in our emergency department, the severity of AA was heightened during the pandemic. Healthcare providers need to have a high index of suspicion of increased severity with complications of AA. (Table Presented).
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The aim of the overview was to synthesize existing systematic reviews (SRs) of flushing interval for patients who inserted totally implanted venous catheter devices (TIVAD). Regular flushing is indispensable for catheter patency, the recommended flushing interval of TIVAD is 4 weeks, however, there is an argument for prolonging the maintenance interval, which has been proved by many SRs. However, the flushing interval range from 4-week to 3-month. The discrepancy in maintenance period could puzzle health professionals and hinder best practice into the clinic. So, we performed the overview by following the PRISMA statement. The PubMed, Ovid, Wan Fang database, Web of Science, CINAHL, CNKI, EMBASE, Cochrane Library were searched from inception to November 2021. The AMSTAR-2, the PRISMA statement, and ROBIS tool were used to assess SRs' method, report quality, and risk of bias, respectively. Then all results were synthesized, the quality of SRs' results was evaluated with GRADE. Finally, five SRs were included. However, non-randomized and small sample size of original studies result in the limitation of SRs. The evidence grade of conclusions is low, bias of mixed factors in included studies, further large sample sizes, RCTs need to be conducted in the future. Prolonged flushing interval was feasible based on the recent evidence, especially during the COVID-19 pandemic because the overwhelming healthcare system and inconvenience of transportation made maintenance not as easy as it used to be. There is no difference of complication between prolonged flushing interval (⩾4-week) and 4-week period, and it can also reduce healthcare cost with no harm to patients.
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Background:In the wake of Covid-19 pandemic, there has been a growing concern over the various modes of spread of virus. While airborne droplet transmission must be considered, and is a critical component to the safety of healthcare workers, it is also important to consider the role of surfaces. Knowing the extent of environmental -contamination of SARS-CoV-2 will play a significant role in improving the safety practices in hospital-settings as well as in answering ques- tions about virus-transmission among the public. Methods: Swab samples were collected from surfaces in Covid-19 wards and laboratory. Sterile premoistened swabs were used to collect samples from high-contact surfaces like door-handles, light-switches, faucet-handles, flushing- buttons, slabs, biosafety-cabinets etc. A total of 48 samples were tested with an RT-PCR test kit, targeting the envelope (E) and RNA dependent RNA polymerase (RdRp) of SARS-CoV-2. A cycle threshold (Ct) ≤36 was considered as positive for SARS-CoV-2 RNA and Ct >36 was considered as negative. Results:Among the 48 samples, RT-PCR analysis showed SARS-Cov2 RNA (E-gene positive, RdRp positive) in three sites (6.25%), while six samples (12.5%) were screen-positive (E-gene positive, RdRp negative) despite routine decontamina- tion of the surfaces. SARS-CoV-2 RNA was detected in samples collected from the electric-switches and door-handles in the Covid-19 ward and testing-area. Conclusions:The routine decontamination protocol must include previous mapped high touch surfaces in the area. De- spite decontamination standard precautions must be followed in healthcare settings.
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When stay-at-home orders were issued to slow the spread of COVID-19, building occupancy (and water demand) was drastically decreased in many buildings. There was concern that widespread low water demand may cause unprecedented Legionella occurrence and Legionnaires' disease incidence. In lieu of evidenced-based guidance, many people flushed their water systems as a preventative measure, using highly variable practices. Here, we present field-scale research from a building before, during, and after periods of low occupancy, and controlled stagnation experiments. We document no change, a > 4-log increase, and a > 1.5-log decrease of L. pneumophila during 3- to 7-week periods of low water demand. L. pneumophila increased by > 1-log after precautionary flushing prior to reoccupancy, which was repeated in controlled boiler flushing experiments. These results demonstrate that the impact of low water demand (colloquially called stagnation) is not as straight forward as is generally assumed, and that some flushing practices have potential unintended consequences. In particular, stagnation must be considered in context with other Legionella growth factors like temperature and flow profiles. Boiler flushing practices that dramatically increase the flow rate and rapidly deplete boiler temperature may mobilize Legionella present in biofilms and sediment.
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WATERLIT : Flushing a toilet can generate large quantities of microbe-containing aerosols depending on the design, water pressure or flushing power of the toilet. A variety of pathogens are usually found in stagnant water as well as in urine, feces and vomit. When dispersed widely through aerosolization, these pathogens can cause Ebola, norovirus that results in violent food poisoning, as well as COVID-19 caused by SARS-CoV-2
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Background: Prader-Willi syndrome (PWS) is a rare genetic disorder associated with multiple neuroendocrine abnormalities including decreased hypothalamic oxytocin, resulting in severe hyperphagia and neuropsychiatric and behavioral issues. The CARE-PWS Phase 3 study evaluated safety and efficacy of intranasal carbetocin, a selective oxytocin receptor agonist, in participants with PWS. Methods: Subjects with genetically confirmed PWS aged 7-18 were randomized to carbetocin 9.6mg or 3.2mg or placebo (given TID by nasal spray) for an initial 8-week period. The primary endpoint assessed change through week 8 in hyperphagia (HQ-CT) or obsessive-compulsive (CY-BOCS) scores for the 9.6mg arm vs placebo, and the first secondary endpoint assessed change through week 8 in HQ-CT or CY-BOCS for the 3.2mg arm vs placebo. Secondary endpoints included assessments of behavioral distress (PADQ) and Clinical Global Impression of Change (CGI-C). Results: Due to COVID-19, enrollment was closed early with 119 subjects in the primary analysis. In the carbetocin 9.6mg arm, trends toward improvements in HQ-CT and CGI-C vs placebo were observed but did not reach statistical significance;however, the carbetocin 3.2mg arm showed a significant improvement in HQ-CT scores vs placebo (-3.14, p = 0.016). In the 3.2 mg arm, improvements vs placebo were also seen in multiple secondary endpoints including CGI-C (p = 0.027) and PADQ (p = 0.027). Trends for improvement in CY-BOCS were observed in each dose arm, but did not reach statistical significance. Recent data from the subsequent long-term follow-up period has demonstrated continued numeric improvements from baseline across multiple endpoints in each active treatment arm. Intranasal carbetocin was generally well-tolerated;the most frequently reported adverse event was flushing, which was generally mild and transient. Conclusions: In conclusion, results of the CARE-PWS Phase 3 study support that intranasal carbetocin appears to be safe and well tolerated, and reduces hyperphagia and behavioral distress in PWS.
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Background: With the launch of COVID-19 vaccination, cases of allergic reactions to tozinameran were soon reported, with excipient polyethylene glycol (PEG) 2000 becoming the principal suspect. We present the immediate reactions recorded in our Vaccination Center, the allergological workup performed and the outcome of the second dose whenever administered. Method: This is a prospective study among people working in public health care facilities and armed and security forces who received the first dose between 27/12/2020 and 17/01/2021. Reactions with at least one objective sign observed within 6 hours after vaccination were recorded. Allergological investigation was carried out 14-20 days later as follows: 1/ skin prick tests to tozinameran 100%, PEG 6000 (100mg/ml) 10% and 100%, polysorbate 80 (50mg/ml) 10% and 100%, intradermal tests with PEG 6000 up to 1% and polysorbate 80 up to 0.1% both in three consecutive 10-fold dilutions, 2/ serum tryptase (reaction's and basal), 3/ basophil activation test (BAT) to PEG 2000. The same work-up was followed for patients who had received their shot in other vaccination centers but were referred for investigation. Results: From a total of 1755 immunizations, 14 reactions (0.8%) were recorded in our unit and extra 8 referred reactions were included in the work-up. Median age was 43.5 years (range 28-59) and 72.7% were female. Mean time of onset was 14 min (range 3-40) with a broad duration frame (1-72h). Hypertension and tachycardia were the most prevalent symptoms (86.4% and 77.3% respectively);flushing (63.6%), nausea/eructation or intestinal hyperperistalsis (36.4%), tremor (22.7%) were also recorded. Reaction's serum tryptase was measured in 8/20 patients;elevated compared to baseline was detected only in a 32ys old female treated with IM adrenaline. Skin tests were performed in 17/22 patients, none turned positive. BAT results were positive in 1/5 reactors. Finally, 13/22 already received the second dose, with 10/13 (77%) not reacting at all, while the rest experienced a much milder similar reaction. Conclusion: Female predominated and a special pattern of reaction with elevated blood pressure/ heart rate along with flushing and/ or increase in gastrointestinal motility, resembling the acute stress response (“fight-or-flight”) was observed. PEG does not seem to be the offending “allergic” agent. Polysorbate 80 can be tested before administration of other SARS-CoV-2 vaccine in case of suspended PEG allergy. (Table Presented).
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Background: COVID-19 vaccines are being administered all over the world, but information is lacking about the frequency and type of allergic reactions associated to these new vaccines. Method: Retrospective study of health care professionals (HCP) from our hospital who received COVID 19 vaccine Comirnaty, between 29/12/2020 and 20/2/2021. We reviewed clinical data, particularly the immediate reactions after the administration (<6h), skin tests (ST) and graded vaccine administration. Following national guidelines, all HCP with previous history of food, drug or hymenoptera venom allergy or idiopathic anaphylaxis (IA) were first evaluated by an allergist. Vaccination was postponed if HCP had previous history of IA and/or recurrent anaphylaxis (RA), severe allergic reactions to vaccines and mast cell activation syndromes. ST to the vaccine (prick and intradermal) were performed in HCP with IA and/ or RA, severe allergic reactions to vaccines and HCP with immediate reactions to the 1st dose. Graded administration of the vaccine (0.1+0.2cc after 30') was performed in the postponed HCP and the ones with immediate reactions to the 1st dose. Results: From 3073 HCP who received the vaccine, 74.2% were female, mean age 40.2 years-old ± 13.4, 316 (10.3%) were evaluated by an allergist and 4 (1.3%) postponed the administration and performed allergy investigation. 2955 HCP (97%) were able to receive the 2 doses of the vaccine. 118 employees received only one dose: 98 had COVID-19 meanwhile, 7 got pregnant, 13 due to other conditions. Adverse reactions to the vaccine with possible hypersensitivity mechanisms, occurred in 17 (0.6%) HCP, 12 on the 1st dose and 5 on the 2nd dose. Observed reactions were 6 (0.2%) urticaria, 5 (0.16%) pruritus with or without flushing, 2 (0.07%) anaphylaxis (mild), 2 (0.07%) flushing and hoarseness, 1 (0.03%) flushing and nausea and 1 (0.03%) asthma exacerbation. ST with the vaccine were performed in 4 HCP, all negative in the immediate reading and 1 positive in non-immediate reading. 7 HCP undertook the graded administration with the vaccine: 6 tolerated, but one reproduced the immediate urticaria with 0.1cc of the vaccine (0.03% vaccine allergy). Conclusion: In the evaluated sample, suspicious allergic reactions to COVID19 vaccine Commirnaty were rare and allergy was only confirmed in one HCP. The allergist initial evaluation was essential for a safe risk stratification and permitted the non-exclusion of a considerable number of HCP from the vaccination program.