关键词： Basophil activation test   polyethylene glycol allergy   PEGylated lipid nanoparticles   CD63  

摘要： Basophil activation test (BAT) with COVID-19 mRNA vaccine seems particularly suitable for detecting sensitization to polyethylene glycol (PEG) in patients with PEG allergy. It was the aim of this study to determine the cutoffs for BAT using BNT162B2 (Comirnaty (R)) in a larger group of PEG allergic patients and controls. 10 PEG allergic patients and 10 controls were studied. BAT was performed using anti-CCR3 for basophil identification and anti-CD63 to assess basophil activation. Incubations with BNT162B2 at four different concentrations were performed. Basophil activation was significantly higher in PEG allergic patients compared to controls at the higher concentrations used. ROC curves showed best results with a sensitivity of 60% and specificity of 100% with a cutoff of 5% CD63+ basophils at a concentration of 4.5 mu g/ml. Controls showed no positive results. In our group of PEG allergic patients, a concentration of 4.5 mu g/ml BNT162B2 with a cutoff of 5% CD63+ basophils was the most suitable condition for identifying patients with a sensitization to PEG. Allergological work-up of PEG allergic patients including BAT with PEGylated lipid nanoparticles might play a role in the future when these substances will be used for other vaccines and cancer immunotherapies.

关键词： SARS-CoV-2   safety   reactogenicity   vaccine development   post-marketing surveillance   real-world studies   MYOCARDITIS  

摘要： The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.

关键词： Pertussis   sero-epidemiology   vaccine   factors  

关键词： Influenza   COVID-19   SARS-CoV-2   Green-Pass   vaccination   vaccine-hesitancy  

摘要： To investigate the dynamic evolution of vaccine hesitancy toward both COVID-19 and influenza in a context characterized by the compresence of SARS-CoV-2 pandemic and seasonal flu epidemics, a two times repeated cross-sectional exploratory design was performed at Udine Hospital (Italy) following a cohort of 479 adult patients with a previous history of SARS-CoV-2 infection in 2020. Vaccine attitude was assessed through standardized telephone interviews performed at 12 and 18 months after the acute illness. The first interview reported the success of the 2020/21 seasonal influenza immunization with 46.8% (224/479) of the participants showing a positive attitude, especially the elderly and people with comorbidities (p < .001), but the investigation conducted at 18 months showed a drastic drop in flu shot acceptance (30/166, 18.1%). On the other hand, a great increase in vaccinations against SARS-CoV-2 occurred after the introduction of Green Pass (26.7% vs 72.9%). The major drivers of flu vaccine skepticism were represented by the feeling of protection regardless of prevention and by concerns regarding vaccines safety and efficacy; conversely compulsory strategies seemed to play a secondary role, since only a minority of the participants identified in the restrictions induced by the certification the major incentive to get immunized against SARS-CoV-2. The focus on this peculiar historical period helps to take a step forward in the comprehension of the complexity and dynamicity of the vaccine hesitancy phenomenon. Future vaccination campaigns will need to consider the role of personal opinions and emotions, interpreted according to the social and political context.

关键词： CME online learning   other learning   continuing professional development   PHYSICIAN PERFORMANCE   HEALTH-SCIENCES   PATIENT HEALTH   CARE   CME  

摘要： BackgroundIn Ireland and internationally, small-group learning (SGL) has been shown to be an effective way of delivering continuing medical education (CME) and changing clinical *** QuestionThis study sought to determine the benefits and limitations, as reported by Irish GPs, of the change of CME-SGL from face-to-face to online learning during *** were invited to participate via email through their respective CME tutors. The first of three rounds of a survey using the Delphi method gathered demographic information and asked GPs about the benefits and/or limitations of learning online in their established small groups. Subsequent rounds obtained a consensus ***-eight GPs across Ireland agreed to participate. Response rates varied from 62.5% to 72% in different rounds. These GPs reported that attending their established CME-SGL groups allowed them to discuss the practical implications of applying guidelines in COVID care into practice (92.7% consensus), reviewing new local services and comparing their practice with others (94% consensus); helping them feel less isolated (98% consensus). They reported that online meetings were less social (60% consensus), and informal learning that occurs before and after meetings did not take place (70% consensus). GPs would not like online learning to replace face-to face-CME-SGL after COVID (89% consensus).ConclusionGPs in established CME-SGL groups benefited from online learning as they could discuss how to adapt to rapidly changing guidelines while feeling supported and less isolated. They report that face-to-face meetings offer more opportunities for informal learning.

关键词： Vaccine hesitancy   COVID-19   public   interviews   booster   bivalent   DRIVERS   REFUSAL   TRUST  

摘要： We sought in-depth understanding on the evolution of factors influencing COVID-19 booster dose and bivalent vaccine hesitancy in a longitudinal semi-structured interview-based qualitative study. Serial interviews were conducted between July 25th and September 1st, 2022 (Phase I: univalent booster dose availability), and between November 21st, 2022 and January 11th, 2023 (Phase II: bivalent vaccine availability). Adults (>= 18 years) in Canada who had received an initial primary series and had not received a COVID-19 booster dose were eligible for Phase I, and subsequently invited to participate in Phase II. Twenty-two of twenty-three (96%) participants completed interviews for both phases (45 interviews). Nearly half of participants identified as a woman (n = 11), the median age was 37 years (interquartile range: 32-48), and most participants were employed full-time (n = 12); no participant reported needing to vaccinate (with a primary series) for their workplace. No participant reported having received a COVID-19 booster dose at the time of their interview in Phase II. Three themes relating to the development of hesitancy toward continued vaccination against COVID-19 were identified: 1) effectiveness (frequency concerns; infection despite vaccination); 2) necessity (less threatening, low urgency, alternate protective measures); and 3) information (need for data, contradiction and confusion, lack of trust, decreased motivation). The data from interviews with individuals who had not received a COVID-19 booster dose or bivalent vaccine despite having received a primary series of COVID-19 vaccines highlights actionable targets to address vaccine hesitancy and improve public health literacy.

关键词： Acute disseminated encephalomyelitis (ADEM)   self-controlled case-series   COVID-19 vaccine safety  

摘要： Acute disseminated encephalomyelitis (ADEM) has been identified as an Adverse Event of Special Interest in the COVID-19 vaccine programme due to its long-standing temporal association with a wide range of other vaccines. Case reports of ADEM shortly following COVID-19 vaccination have now been documented. There were 217 ADEM admissions in 215 individuals in the period 8th December 2020 to 31st March 2023. An increased risk of ADEM following the first dose of ChAdOx1 vaccine was observed (relative incidence (RI) = 3.13, 95% Confidence Interval (CI) [1.56-6.25]) with a vaccine attributable risk of 0.39 per million doses. When doses 1 and 2 were combined this increased risk remained just significant (1.96 [95%CI 1.01-3.82]). No significant increased risk was observed with any other vaccine or dose. This small, elevated risk after the first dose of ChAdOx1-S vaccine demonstrates how large national electronic datasets can be used to identify very rare risks and provides reassurance that any risk of ADEM following the ChAdOx1-S COVID-19 vaccination is extremely small. Given the rarity of this risk, further studies in settings with access to data on large populations should be carried out to verify these findings.

关键词： SARS-COV-2   COVID-19   psoriasis   biologics   remote care   TELEDERMATOLOGY  

摘要： BackgroundDuring the COVID-19 pandemic, psoriasis care underwent significant changes in consultation methods and treatment management. However, comprehensive data on these changes and patient perceptions are *** evaluate the pandemic's implications on psoriasis patients, focusing on access to information, consultation methods, patient satisfaction, disease control assessment, and treatment management *** multicenter cross-sectional survey was performed in psoriasis patients from 4 dutch hospitals during the second wave of the *** 551 respondents, approximately 55% received information their treatment in relation to COVID-19 from their treating physician, while 16.3% sought information online. Consultation methods were shifted to remote formats for 43.6% of patients, primarily via phone and the shift was often initiated by physicians. Overall patient satisfaction during the pandemic scored high (8.0), with remote consultations scoring between 8.0-9.0. Patients on biological treatment reported better disease control (8.0), compared to those on topical (6.0) or conventional systemic treatments (7.0). However, within the systemic treatment group and biologics group, a notable percentage interrupted (16.3% resp. 12.9%) or discontinued treatment (14.1 resp. 10.6%) during the pandemic. Disease control was moderate-to-good assessed by 75% of patients receiving face-to-face and 68% receiving remote *** care appears to be a viable alternative to face-to-face consultations, with potential benefits in enhancing access to information provided by treating physicians.

关键词： Worry   rumination   COVID-19   purchasing   compliance   coping   Daryl O'Connor, University of Leeds, United Kingdom   Introductory Psychology   General Psychology   Cognitive Psychology   Environmental Psychology   Health Psychology   Social Psychology   Psychological Science   PSYCHOLOGICAL IMPACT   DEPRESSIVE SYMPTOMS   WORRY   RUMINATION   ASSOCIATIONS   SUBTYPES   ANXIETY   STRESS  

摘要： ObjectiveThe onset of the COVID-19 pandemic engendered a host of different behavioral responses in key areas such as resource purchasing and compliance with COVID regulations. This study explores why participation in these behaviors may have varied by examining the role of perseverative cognition (i.e., worry, rumination).MethodA representative sample of U.S. adults (N = 230, Mage = 45.4, 50% female) was recruited online early in the COVID-19 pandemic (June 2020), approximately three months into safety-related school and business shutdowns. Participants completed a series of questionnaires on COVID-19-related worry, non-specific rumination, and a range of behaviors observed during the early stages of the pandemic (e.g., excessive shopping, purchasing guns, following isolation guidelines). Exploratory principal axis factoring and reliability studies of the newly created COVID-19 worry and behavior scales were performed, followed by an examination of the associations between worrying, ruminating and COVID-19-related early ***-related worry and reflective rumination were positively associated with purchasing behavior (i.e., purchasing household items, items for security, and items for entertainment). COVID-related worry was also positively associated with compliance behavior (i.e., watching the news, following government directives strictly, and staying home but contacting family and friends remotely). Brooding rumination was not significantly associated with either type of *** cognition can help explain patterns in COVID-related behaviors, what motivated differences in these behaviors and, thereby, help explain how people coped during this trying time.

关键词： COVID-19   APACHE II   SOFA   NEWS   CCEDRRN COVID-19 mortality score   NLR   PLR   prognosis   severity   EARLY WARNING SCORE   CLINICAL CHARACTERISTICS   MORTALITY  

摘要： AimsThis study aimed to re-evaluate whether the scoring systems, neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were effective in predicting prognosis and severity of COVID-19 patients in the emergency department (ED).MethodsCOVID-19 patients enrolled in this retrospective study divided into the death (DEA) and survival (SUR) groups, the severe/critical (SC) and non-severe/critical (non-SC) groups. The Acute Physiology and Chronic Health Evaluation (APACHE) II, Sequential Organ Failure Assessment (SOFA), National Early Warning Score (NEWS) and CCEDRRN COVID-19 Mortality Score were calculated. The neutrophil, lymphocyte and platelet counts were extracted from the first routine blood examination, and NLR and PLR were calculated accordingly. Receiver Operating Characteristic (ROC) curve and logistic regression were *** the scoring systems, as well as NLR and PLR, significantly increased in both the DEA and SC groups. The ROC curve showed that the CCEDRRN COVID-19 Mortality Score had the highest predictive value for mortality and severity (AUC 0.779, 0.850, respectively), which outperformed the APACHE II, SOFA and NEWS. NLR presented better predictive ability for severity (AUC 0.741) than death (AUC 0.702). The APACHE II, NEWS and CCEDRRN COVID-19 Mortality Score were positively correlated with both prognosis and severity, whereas NLR only with *** NEWS and CCEDRRN COVID-19 Mortality Score were reconfirmed for early and rapid predicting the poor prognosis and severity of COVID-19 patients in ED, especially the CCEDRRN COVID-19 Mortality Score with the highest discrimination capacity, and NLR was more appropriate for predicting the severity.