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Background: Nirmatrelvir–ritonavir was granted emergency use authorization in Israel in January 2022 to treat high-risk patients with mild-to-moderate COVID-19. The aim of the study was to assess the association between nirmatrelvir–ritonavir treatment and COVID-19-related hospitalization and healthcare resource utilization (HCRU) in a country with a high level of vaccinations compared to patients who were offered treatment and declined. Methods: The Maccabi Healthcare Services dataset was used to identify high-risk SARS-CoV-2-positive adults from January to February 2022 who received nirmatrelvir–ritonavir within 5 days of symptom onset (treatment group) or who were offered nirmatrelvir–ritonavir treatment and declined it (reference group). COVID-19-related hospitalizations and all-cause mortality and HCRU within 30 days were compared between treatment and reference groups using inverse probability of treatment weighting. Results: Treatment and reference groups included 3460 (median age, 68.4 years) and 1654 (70.2 years) patients, respectively. Patients with ≥1 dose of COVID-19 vaccine accounted for 89.5% (treatment group) and 72.1% (reference group) of the total. Treatment was associated with a lower risk of COVID-19-related hospitalization (adjusted OR, 0.59 [95% CI, 0.41,0.83]). Results were similar by age group (18–64/≥65 years) and among patients with/without vaccination in the prior 180 days. There were 11 (0.3%) versus 11 (0.7%) deaths in the treatment and reference groups, respectively. Treated patients had lower inpatient HCRU and greater less intensive outpatient HCRU (e.g., telemedicine and emergency room visits). Conclusions: Nirmatrelvir–ritonavir treatment was associated with a reduced risk of COVID-19-related hospitalization and a shift to less intensive outpatient HCRU. Comparison with a reference group of nirmatrelvir–ritonavir-eligible patients who declined treatment enabled an unbiased outcome assessment. Real-world data gathered during the Omicron BA.1 variant wave of COVID-19 in Israel support the continued use of nirmatrelvir–ritonavir for high-risk adults of all ages, regardless of previous vaccinations. [ABSTRACT FROM AUTHOR]

Background: The trophoblast is a significant source of vitamin D synthesis during pregnancy, with the literature suggesting its role in fetal growth. We aim to underline a possible mechanism that would explain negative fetal outcomes in COVID-19-positive mothers by examining the relationship between altered placental structure and function and throphoblast cells' vitamin D receptor levels. Methods: The study included 170 placental samples collected from women who gave birth at term without complications, divided into three groups: COVID-19-positive and unvaccinated, COVID-19-negative and vaccinated, and COVID-19-negative and unvaccinated, with exclusion criteria for any other medical complications. Immunohistochemistry (IHC) was performed to detect vitamin D receptor (VDR) expression, and immediate fetal outcomes (weight and Apgar score) were assessed. Results: We found lower gestational age at birth, lower birth weight, and reduced placental VDR (vitamin D receptor) levels in COVID-19-positive women compared to COVID-19-vaccinated and COVID-19-negative women. Conclusions: The presence of the vitamin D receptor in the placenta is related to fetal and placental growth. Its deficiency may contribute to negative fetal outcomes in COVID-19-positive cases. [ABSTRACT FROM AUTHOR]

Background: Celiac disease (CD) is the most common multisystemic autoimmune disorder affecting the pediatric population. However, little data is available regarding SARS-CoV-2 vaccination coverage in pediatric patients with CD. This study aims to evaluate the adherence to national recommendations for SARS-CoV-2 vaccination in children and adolescents with CD and its variation over time. Methods: We retrospectively analyzed medical charts and electronic registry records of SARS-CoV-2 vaccination of patients aged 0–19 years diagnosed with CD in a tertiary center. The vaccination coverage was evaluated according to age groups (young children, children, and adolescents), considering the patients' eligibility for vaccination at different times. Results: Among the 172 patients enrolled, 44.8% received at least one dose of the SARS-CoV-2 vaccine, showing no significant differences compared to the Italian population of similar age. Vaccination coverage demonstrated a progressive reduction after an initial peak (up to 65.5% in December 2021) concomitant with a gradual extension of vaccinable eligibility and falling SARS-CoV-2 infections. Histological diagnosis and the presence of other associated autoimmune diseases were associated with higher levels of adherence to vaccination. Conclusions: Adherence to the SARS-CoV-2 vaccination in young Italian children with CD was very low, while it was better in adolescents and patients with other associated autoimmune diseases. Vaccine hesitancy remains a concern, particularly among those diagnosed using the biopsy-sparing approach. Hesitancy increased during the pandemic period, suggesting the need for ongoing efforts to improve adherence to SARS-CoV-2 vaccination recommendations. [ABSTRACT FROM AUTHOR]

Background: We investigated the expression of inflammation, placental development, and function markers, including cluster of differentiation 44 (CD44), osteopontin (OPN), and cyclooxygenase-2 (COX-2), to shed light on the controversy regarding the impact of the COVID-19 epidemic on fetal development and pregnancy outcomes. Methods: We immunohistochemically analyzed placental tissue from 170 patients (65 COVID-positive and unvaccinated women; 35 Pfeizer-vaccinated and COVID-negative women; and 70 COVID-negative and unvaccinated women, without any other associated pathology) for particularities in the expression of these three molecules. Results: CD44 expression was highest in COVID-negative and unvaccinated women, moderate in COVID-positive cases, and lowest in vaccinated and COVID-negative women. OPN expression was highest in COVID-negative and Pfeizer-vaccinated cases, moderate in COVID-negative and unvaccinated cases, and lowest in COVID-positive cases. COX-2 expression was increased in COVID-negative and unvaccinated women, modestly elevated in COVID-positive and unvaccinated cases, and lowest in vaccinated cases. Conclusions: These findings reflected an alteration in the placental structure and consequent function due to altered expression of the three studied molecules. [ABSTRACT FROM AUTHOR]

Background: With limited pharmacological interventions, post-COVID-19 condition is a clinical challenge, and supplementary therapies are essential for symptom relief and enhancing quality of life (QoL). In our prospective observational study, we aimed to evaluate the impact of Salus per aquam (Spa) therapy on post-COVID-19 symptoms and QoL in individuals who suffer from chronic joint, musculoskeletal, skin, and/or respiratory conditions. Methods: A total of 159 individuals undergoing Spa therapy were enrolled, and 78 of them had post-COVID-19 symptoms, assessed using Visual Analogue Scale (VAS) and modified British Medical Research Council Questionnaire (mMRC-DS scales), as well as the Short Form 36 Health Status Survey (SF-36) questionnaire for QoL. Results: Spa therapy significantly reduced most post-COVID-19 symptoms, especially chronic fatigue, pain, brain fog, and persistent cough (all p < 0.05), as well as physical (+72%) and emotional (+66%) limitations. When stratified by sex, males showed a greater improvement from baseline, while females consistently displayed a higher amelioration in all QoL dimensions. Moreover, full vaccination with 3–4 doses significantly protected against SARS-CoV-2 re-infections and post-COVID-19 development (p < 0.05). Conclusions: Spa therapy demonstrated effectiveness in mitigating post-COVID-19 symptoms and enhancing QoL in patients suffering from chronic diseases. [ABSTRACT FROM AUTHOR]

Background: As the SARS-CoV-2 virus remains one of the main causes of severe respiratory system infections, the Food and Drug Administration strongly advises the continuation of current vaccination programs, including the distribution of updated boosters, especially in high-risk groups of patients. Therefore, there is an unceasing need for further research on the safety and, no less importantly, the clinical effectivity of the vaccines, with an extra focus on cohorts of patients with underlying health problems. This study aimed to assess the efficacy of the SARS-CoV-2 vaccine in possibly immunocompromised children with rheumatic disease while utilizing the interferon-gamma release assay (IGRA) as a marker for COVID-19 immunity in the study follow-up. Methods: This prospective study was performed in a group of 55 pediatric patients diagnosed with juvenile idiopathic arthritis. Eight participants were immunized with the Comirnaty mRNA vaccine before the research commenced, while the rest of the group (n = 47) had not been vaccinated against SARS-CoV-2. At the study baseline, the cellular response to the virus antigen was measured using a specific quantitative IGRA in whole blood; subsequently, the anti-SARS-CoV-2 test was performed, marking the antibodies' levels in serum. Around four months after the enrollment of the last patient in the study, a follow-up survey regarding the events of COVID-19 infection within the cohort was conducted. Results: The study confirmed that all the vaccinated children developed specific T-cell (p = 0.0016) and humoral (p = 0.001 for IgA antibodies, p = 0.008 for IgG antibodies) responses to the inoculation, including those receiving biological treatment and those on conventional disease-modifying anti-rheumatic drugs. The study also showed the different patterns of immunity elicited both after infection and post-vaccination, with higher levels of antibodies and T-cell response after inoculation than after natural exposure to the pathogen. According to the follow-up survey, six children developed PCR-confirmed SARS-CoV-2 infection, whereas the additional 10 patients admitted to having COVID-like symptoms with no laboratory verification. Conclusions: SARS-CoV-2 vaccinations elicit valid immune responses in pediatric rheumatic patients. Including the assessment of T-cell immunity in the evaluation of inoculation-induced immunization can enhance the accuracy of sole humoral response assays. [ABSTRACT FROM AUTHOR]

Background/Objectives: Molnupiravir (MOV), an oral antiviral COVID-19 treatment, was introduced in the Czech Republic in December 2021 for COVID-19 patients at a high risk of progression to severe disease requiring hospitalization. In this observational, retrospective study, we aimed to describe the characteristics and healthcare resource utilization in non-hospitalized, adult COVID-19 patients prescribed MOV in the Czech Republic between 1 January and 30 April 2022. Methods: A total of 621 patients were included and followed up with for 28 days. Results: The median age was 68.0 (20–99) years, 77.8% were overweight or obese, 14.1% smoked, and 85.7% were vaccinated. The overall cumulative incidence (95% CI) of all-cause hospitalization was 0.71 (0.37; 1.24) per 1000 person years or 1.9%, with similar rates across sexes, age groups, BMI category, multimorbidity category, polypharmacy category, and COVID-19 vaccination status. Among patients reported hospitalized, oxygen-based resources were not observed, and no deaths occurred. Conclusions: These data describe the characteristics and healthcare resource utilization in Czech MOV-treated patients whose clinical characteristics may put them at increased risk of severe disease. [ABSTRACT FROM AUTHOR]

Background: CA 19-9 is a commonly assessed tumor marker, considered characteristic of pancreatic ductal adenocarcinoma (PDAC) and biliary tract cancers; however, the positive predictive value of CA 19.9 is too low, and the usage of CA 19.9 as a screening tool in the healthy population remains controversial. Methods: The presented case illustrates a reversed diagnosis of highly elevated serum CA 19-9 levels in a 54-year-old female complaining of pain in the epigastric region, shortly after COVID-19 vaccination. Laboratory tests showed a significantly elevated level of the CA 19-9 marker (>12,000 U/mL, reference value: <37 U/mL) with normal pancreatic enzyme activity. The patient underwent imaging examination, which showed no abnormalities, except for increased pancreatic dimension and areas of fluid signal in the pancreas in magnetic resonance imaging (MRI), which may correspond to autoimmune pancreatitis (AIP). The patient remains asymptomatic with a recommendation for a follow-up MRI in 12 months. Results: A literature review conducted revealed multi-causal CA 19-9 increases above 1000 U/mL, including non-cancerous diseases of the lung, pancreas, liver, ovary, kidney, and others. The median concentration of CA 19-9 regardless of the cause of disease was 2810 U/mL (IQR ± 6895). The median CA 19-9 values in men and women were 3500 (IQR ± 10,050) and 2455 (IQR ± 3927), respectively, and differ significantly between the compared groups (p < 0.05). There was no difference between CA 19-9 values and the categorized cause of the increase. Conclusions: Conducting differential diagnosis, it should not be forgotten that most international guidelines recommend the use of CA 19-9 only in conjunction with pathology of pancreas in radiological imaging; however, even such a combination can point the diagnostic pathway in the wrong direction. A highly elevated CA 19-9 level, typically associated with PDAC, may be the result of benign disease including AIP related to COVID-19 vaccination. [ABSTRACT FROM AUTHOR]

COVID Vaccine Arm (CVA) is an adverse drug reaction from mRNA vaccine for SARS-CoV-2. CVA is characterized by erythema and edema on the vaccination site (usually deltoid area) that appears from 5 to 10 days after vaccination and is sometimes associated with itching or pain. The exact etiology of CVA is still unclear, but delayed hypersensitivity against an excipient seems to play an essential role in the pathogenesis of the disease. This work performs a systematic literature review on CVA using three different databases containing articles published until 10 November 2021. The literature review includes eight papers reporting single cases or case series of CVA. Moreover, it also addresses, other cutaneous reactions following COVID 19 vaccinations as well as possible differential diagnosis. CVA migrans-like erythema is characterized by a ring-shaped rash in the injection area, which appears some days after the injection and disappears in about 10 days. This reaction may appear more rapidly in subsequent doses. [ABSTRACT FROM AUTHOR]

Myasthenia gravis (MG) is the most common neuromuscular junction disorder. We evaluated the MG incidence rate in the province of Ferrara, Northern Italy, over two time frames (2008–2018 and 2019–2022, i.e., the COVID-19 pandemic) and considered early-onset (EOMG), late-onset (LOMG), and thymoma- and non-thymoma-associated MG. Moreover, in the second period, we assessed its possible relationship with SARS-CoV-2 infection or COVID-19 vaccination. We used a complete enumeration approach to estimate the MG incidence and its temporal trend. For the period of 2008–18, 106 new cases were identified (mean incidence rate 2.7/100,000 people). The highest rates were observed for the over-70 age group and in rural areas, with 17% of thymoma-associated MG. During the COVID-19 period, 29 new cases were identified (average incidence rate 2.1/100,000 people), showing a marked (though not statistically significant) decrease in the mean annual incidence compared to the previous period. Again, the highest rate was observed for the over-70 age group. The first period was in line with our previous observations for the period between 1985 and 2007, highlighting a rising incidence of LOMG and a marked decrease in EOMG. During the COVID-19 period, incidence rates were lower in the first years whereas, when the pandemic ended, the previous trend was confirmed. [ABSTRACT FROM AUTHOR]

COVID-19 infections accelerate liver decompensation and serious liver-related co-morbidities. The aim is to evaluate the safety and impact of COVID vaccines on hepatic disease progression in patients with advanced liver disease and to identify parameters that predict the occurrence of complications. The study involved 70 patients with advanced liver disease who were vaccinated with different COVID vaccines from January 2021 to April 2022. They were evaluated clinically. The laboratory investigation included a complete blood count, liver and kidney function tests, calculation of CTP and MELD scores, plasma levels of ammonia, abdominal ultrasound, and upper GI endoscopy. Twenty patients had experienced complications 64 ± 12 days from the last dose of a vaccination. Twenty patients (28.6%) developed hepatic decompensation and hypothyroidism (n = 11, 15.7%), and five (7.14%) patients developed splanchnic thrombosis. There were no COVID-19 reinfections except for two patients who received Sinopharm and developed vaccine-associated enhanced disease (2.9%). Complications after COVID vaccinations were correlated with ALT (r = 0.279, p = 0.019), serum sodium (r = −0.30, p = 0.005), creatinine (r = 0.303, p = 0.011), liver volume (LV) (r = −0.640, p = 0.000), and MELD score (r = 0.439, p = 0.000). Multivariate logistic regression revealed that LV is the only independent predictor (p = 0.001). LV ≤ 682.3 has a sensitivity of 95.24% and a specificity of 85.71% in predicting complications with an AUC of 0.935, p < 0.001. In conclusion, the hepatic reserve and prognosis in liver cirrhosis should be evaluated prior to COVID vaccinations using the MELD score and liver volume as promising risk stratification criteria. In summary, the research proposes a novel triaging strategy that involves utilizing the MELD score and liver volume as risk stratification parameters of the hepatic reserve and prognosis of advanced liver cirrhosis prior to COVID immunization to determine who should not receive a COVID vaccination. [ABSTRACT FROM AUTHOR]

The potential role of the COVID-19 vaccine and infection to induce autoimmunity is currently underestimated despite the literature emphasizing arthralgia as a common adverse event. We aimed to study the impact of rheumatological complications post-COVID-19 (PC) and post-COVID-19 vaccine (PCV), comparing undifferentiated arthritis (UA) to Polymyalgia Rheumatica, Horton's Arteritis (PMR-HA) and isolated arthritis to UA with "connective-like" accompanying symptoms. We retrospectively included 109 patients with at least 6 months of follow-up, analyzing serum biomarkers, joint ultrasound (US), lung HRCT, DLCO, and HLA haplotypes. There were 87 UA patients showing increased gastrointestinal and lung involvement (p = 0.021 and p = 0.012), higher anti-spike protein IgG levels (p = 0.003), and anti-SARS-CoV-2 IgG positivity (p = 0.003). Among them, 66 cases progressed to ACR-EULAR 2010 early arthritis after 3 months, whereas PMR-HA patients were more commonly PCV (81.8%, p = 0.008), demonstrating higher CRP (p = 0.007) and ESR (p = 0.006) levels, a lower rate of ANA positivity (p = 0.005), and a higher remission rate after six months (p = 0.050). In UA patients, the prevalent HLA was DRB1*11 and C*07 (36.8% and 42.1%). Serum calprotectin, interleukin-6, and C*07 (p = 0.021, 0.041, 0.018) seemed more specific for isolated UA. Conversely, "connective-like" arthritis showed poorer DLCO (p = 0.041) and more frequent US synovitis (p = 0.041). In conclusion, UA is a frequent common PC and PCV complication and may persist over time when compared to PMR-HA. [ABSTRACT FROM AUTHOR]

Background: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs). Methods: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups. Results: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31–50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2–2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4–3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3–4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1–4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3–1.0; p = 0.036). Conclusion: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity. [ABSTRACT FROM AUTHOR]

The current challenge worldwide is the administration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Considering that the COVID-19 vaccination represents the best possibility to resolve this pandemic, this systematic review aims to clarify the major aspects of fatal adverse effects related to COVID-19 vaccines, with the goal of advancing our knowledge, supporting decisions, or suggesting changes in policies at local, regional, and global levels. Moreover, this review aims to provide key recommendations to improve awareness of vaccine safety. All studies published up to 2 December 2021 were searched using the following keywords: "COVID-19 Vaccine", "SARS-CoV-2 Vaccine", "COVID-19 Vaccination", "SARS-CoV-2 Vaccination", and "Autopsy" or "Post-mortem". We included 17 papers published with fatal cases with post-mortem investigations. A total of 38 cases were analyzed: 22 cases were related to ChAdOx1 nCoV-19 administration, 10 cases to BNT162b2, 4 cases to mRNA-1273, and 2 cases to Ad26.COV2.S. Based on these data, autopsy is very useful to define the main characteristics of the so-called vaccine-induced immune thrombotic thrombocytopenia (VITT) after ChAdOx1 nCoV-19 vaccination: recurrent findings were intracranial hemorrhage and diffused microthrombi located in multiple areas. Moreover, it is fundamental to provide evidence about myocarditis related to the BNT162B2 vaccine. Finally, based on the discussed data, we suggest several key recommendations to improve awareness of vaccine safety. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic, which affected the entire global population, had an impact on our health and quality of life. Many people had complications, were hospitalised or even died due to SARS-CoV-2 infection. The health systems of many countries had to radically change their way of functioning and scientists around the world worked intensively to develop a vaccine for the SARS-CoV-2 virus. Aim: The aim of this work is to assess the quality of life of patients who were hospitalised for COVID-19, using the SF-36 questionnaire. Methods: Between May and August 2022, we conducted a telephone assessment of quality of life in patients who were hospitalised for COVID-19 at the Temporary Hospital in Pyrzowice (Silesia, Poland), between November 2021 and January 2022. Results: Quality of life was significantly lower in women (p = 0.040), those with DM2 (p = 0.013), CKD (p = 0.041) and the vaccinated (p = 0.015). Conclusions: People with chronic kidney disease, diabetes mellitus and women had a lower quality of life after COVID-19 disease. However, people who were vaccinated for SARS-CoV-2 had a lower quality of life than non-vaccinated people did. This is possibly due to the higher mean age, and probably the higher disease burden, in the vaccinated group. [ABSTRACT FROM AUTHOR]

(1) Background: Periodic resurgences in COVID-19 due to more contagious variants highlight the need to increase coverage of booster doses. (2) Methods: Our September 2022 nationally representative survey of US adults measured COVID-19 vaccination status, intentions, attitudes, values, and confidence in information sources. (3) Findings: Although 85% of the weighted sample reported receiving at least one dose of a COVID-19 vaccine, only 63% reported being up-to-date on COVID-19 vaccines (e.g., received a booster dose). Only 12% of those not yet up-to-date indicated they were likely to get up-to-date as soon as possible, whereas 42% were unlikely to ever get up-to-date, and 46% were still uncertain. Most of those not up-to-date on their COVID-19 vaccines were under 45 years of age (58%), without a bachelor's degree (76%), making under $75,000 annually (53%), and Republican or Independent (82%). Prevalent concerns about COVID-19 vaccines among those uncertain about getting up-to-date included: potential side effects that have not been figured out yet (88%), speed of development (77%), newness (75%), ingredients (69%), drug companies making money (67%), allergic reactions (65%), and experimenting on people (63%). (4) Conclusions: Nearly half of adults not yet up-to-date on COVID-19 vaccines were uncertain about doing so, indicating an opportunity to support their decision-making. [ABSTRACT FROM AUTHOR]

Background: Vaccination is a known trigger for the appearance of immune-mediated glomerulopathies (IMG). The appearance of IMG after SARS-CoV-2 vaccination with suspected causality has been described. Our aim is to analyze the incidence of IMG flares before and after SARS-CoV-2 vaccination in our center. Methods: All persons with native kidney biopsy (KB) from January 2019 to March 2022 in our center were included in the study. We compared the incidence of IMG before and after the start of vaccination. We also collected information about whether the patients had received a SARS-CoV-2 vaccine or have suffered from COVID in the six weeks before the IMG. We also evaluated the analytical characteristics of the outbreaks. Results: A total of 386 KB were studied. Of them, 86/218 (39.4%) were IMG performed pre- and 85/168 (50.6%) post-SV (029). The incidence of idiopathic nephrotic syndrome (INS), studied separately, was also significantly increased post-vaccination (n = 18 (10.7%)) compared to pre-vaccination (n = 11 (5%)) (p = 0.036). There were no differences in the incidence of vasculitis or IgA nephropathy. Up to 17 (20%) flares occurred 6 weeks before SARS-CoV-2 vaccination and only 2 (2.4%) within the first 6 weeks after SARS-CoV-2 infection. Within those 17 flares, the most common diagnosis was IgAN (n = 5 (29.4%)); a total of 14 (82.4%) received an mRNA vaccine and 9 (52.9%) took place after the 1st vaccine dose. There were 13 cases of minimal change disease (MCD) with debut/recurrence pre-SV and 20 MCD with debut/recurrence post-SV (p = 0.002). Conclusions: The incidence of IMG, INS and MCD flares in our center increased significantly after SARS-CoV-2 vaccination. Importantly, 20% of IMG flares took place within the first 6 weeks after receiving a vaccine dose, with the first dose being the riskiest one and IgAN the most frequent diagnosis. [ABSTRACT FROM AUTHOR]

Background: Myocarditis, diagnosed by symptoms and troponin elevation, has been well-described with COVID-19 infection, as well as shortly after COVID-19 vaccination. The literature has characterized the outcomes of myocarditis following COVID-19 infection and vaccination, but clinicopathologic, hemodynamic, and pathologic features following fulminant myocarditis have not been well-characterized. We aimed to compare clinical and pathological features of fulminant myocarditis requiring hemodynamic support with vasopressors/inotropes and mechanical circulatory support (MCS), in these two conditions. Methods: We analyzed the literature on fulminant myocarditis and cardiogenic shock associated with COVID-19 and COVID-19 vaccination and systematically reviewed all cases and case series where individual patient data were presented. We searched PubMed, EMBASE, and Google Scholar for "COVID", "COVID-19", and "coronavirus" in combination with "vaccine", "fulminant myocarditis", "acute heart failure", and "cardiogenic shock". The Student's t-test was used for continuous variables and the χ2 statistic was used for categorical variables. For non-normal data distributions, the Wilcoxon Rank Sum Test was used for statistical comparisons. Results: We identified 73 cases and 27 cases of fulminant myocarditis associated with COVID-19 infection (COVID-19 FM) and COVID-19 vaccination (COVID-19 vaccine FM), respectively. Fever, shortness of breath, and chest pain were common presentations, but shortness of breath and pulmonary infiltrates were more often present in COVID-19 FM. Tachycardia, hypotension, leukocytosis, and lactic acidosis were seen in both cohorts, but patients with COVID-19 FM were more tachycardic and hypotensive. Histologically, lymphocytic myocarditis dominated both subsets, with some cases of eosinophilic myocarditis in both cohorts. Cellular necrosis was seen in 44.0% and 47.8% of COVID-19 FM and COVID-19 vaccine FM, respectively. Vasopressors and inotropes were used in 69.9% of COVID-19 FM and in 63.0% of the COVID-19 vaccine FM. Cardiac arrest was observed more in COVID-19 FM (p = 0.008). Venoarterial extracorporeal membrane oxygenation (VA-ECMO) support for cardiogenic shock was also used more commonly in the COVID-19 fulminant myocarditis group (p = 0.0293). Reported mortality was similar (27.7%) and 27.8%, respectively) but was likely worse for COVID-19 FM as the outcome was still unknown in 11% of cases. Conclusions: In the first series to retrospectively assess fulminant myocarditis associated with COVID-19 infection versus COVID-19 vaccination, we found that both conditions had a similarly high mortality rate, while COVID-19 FM had a more malignant course with more symptoms on presentation, more profound hemodynamic decompensation (higher heart rate, lower blood pressure), more cardiac arrests, and higher temporary MCS requirements including VA-ECMO. In terms of pathology, there was no difference in most biopsies/autopsies that demonstrated lymphocytic infiltrates and some eosinophilic or mixed infiltrates. There was no predominance of young males in COVID-19 vaccine FM cases, with male patients representing only 40.9% of the cohort. [ABSTRACT FROM AUTHOR]

Beneficial off-target effects of the Bacillus Calmette-Guérin (BCG) vaccination might offer general protection from respiratory tract infections. We conducted a systematic review and meta-analysis of published randomized controlled trials (RCTs) to ascertain BCG vaccination effectiveness against COVID-19. We looked up English RCTs from 1 January 2019 to 15 November 2022 in Embase, the Cochrane Library, and the Web of Science in this systematic review and meta-analysis. Nine RCTs, including 7963 participants, were included. The infection rate of COVID-19 was not decreased in people who were vaccinated with BCG (OR, 0.96; 95% CI, 0.82–1.13; I2 = 4%), and the BCG vaccination group did not have decreased COVID-19 related-hospitalization (OR, 0.66; 95% CI, 0.37–1.18; I2 = 42%), admission to the ICU (OR, 0.25; 95% CI, 0.05–1.18; I2 = 0%), and mortality (OR, 0.64; 95% CI, 0.17–2.44; I2 = 0%) compared with the control group. There is not sufficient evidence to support the use of BCG vaccination in the prevention of COVID-19 infection and severe COVID-19 and avoid overstating the role of BCG vaccination leading to its misuse. [ABSTRACT FROM AUTHOR]

Objective: To evaluate humoral and T-cell cellular-mediated immune response after three doses of SARS-CoV-2 mRNA vaccines in patients with systemic lupus erythematosus (SLE) under Belimumab. Patients and methods: 12 patients on Belimumab and 13 age-matched healthy volunteers were recruited. Patients were in remission or in low disease activity, and they were taking no corticosteroids or only low doses. None of the patients and controls had detectable anti-SARS-CoV-2 antibodies due to previous exposure to the virus. All the patients received three doses of mRNA anti-SARS-CoV-2 vaccines and the humoral and cellular-mediated response were tested 4 weeks after the second dose (T0), 6 months after the second dose (T1) and 4 weeks after the third dose (T2). Comparison with the control group was performed at time T0 (i.e., 4 weeks after the second dose). Total anti-SARS-CoV-2 RBD antibodies were analyzed using a diagnostic assay, while cellular-mediated response was evaluated using the interferon-gamma release assay (IGRA). Results: A humoral response was documented in all the patients at T0 (median 459; IQR 225.25–758.5), but the antibody titer significantly declined from T0 to T1 (median 44.7; IQR: 30.3–202; p = 0.0066). At T2, the antibody titer significantly increased from T1 (median 2500; IQR: 2500–2500), and it was not different from T0 (respectively p < 0.0001, p = 0.66). Cellular-mediated response significantly declined from T0 to T1 (p = 0.003) but not from T0 to T2 (p = 0.3). No differences were found between patients and controls at T0 as regards both humoral and cellular responses (p = 1.0 and p = 0.09 for humoral and cellular responses, respectively). Conclusion: The third dose of mRNA COVID-19 vaccine can restore both humoral and cellular immune response in SLE patients on Belimumab. [ABSTRACT FROM AUTHOR]

Pregnant women were excluded from vaccination against Coronavirus 2019 (COVID-19) until September 2021 in South Korea. Although vaccination for pregnant women started in October 2021, vaccine acceptance in pregnant women is yet unknown. This cross-sectional study aimed to investigate COVID-19 vaccine acceptance during pregnancy and influencing factors. An anonymous survey was distributed in obstetrics departments to all pregnant or postpartum women, during the prenatal or postpartum visit. The proportion of self-reported COVID-19 vaccination during pregnancy among 436 women was 26.6%. Pregnancy-related independent factors influencing maternal COVID-19 vaccination were "received vaccine information about from obstetrics and gynecology (OBGYN) doctors" (OR 3.41, 95% CI 2.05–5.65), "cohabitant COVID-19 vaccination" (OR 2.43, 95% CI 1.06–5.59), and "second trimester" (OR 7.35, 95% CI 1.54–35.15). In women who did not want to get vaccinated, the most common reason for COVID-19 vaccination hesitancy was concern that COVID-19 vaccine might affect the fetus (91.7%, 243/266), followed by distrust in COVID-19 vaccine effectiveness (42.6%, 113/266). This study showed that providing information about maternal COVID-19 vaccination, especially by OBGYN doctors, is crucial for increasing vaccination coverage in pregnant women. Providing updated evidence of COVID-19 vaccine efficacy and safety in pregnant women may be also helpful for increasing vaccine acceptance. [ABSTRACT FROM AUTHOR]

Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty®, Spikevax®, Vaxzevria® and Jcovden®. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Background and Objectives: The need for, and ideal frequency of, the vaccination against coronavirus disease 2019 (COVID-19) of previously infected individuals have not yet been sufficiently evaluated. The aim of this study was to examine the anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody status and adverse reactions after vaccination among medical staff with or without a history of COVID-19. Materials and Methods: A single-center prospective study was performed at Fukuoka University Chikushi Hospital. We investigated the presence of the anti-SARS-CoV-2 antibody titer among medical staff before and after mRNA vaccination with the BNT162b2. The levels of immunoglobulin G antibody were quantitatively measured at six points—before vaccination, after the first vaccination, at three points after the second vaccination, and finally, after the third vaccination—and the levels were then compared based on the COVID-19 infection history. Results: The previously infected (before the first vaccination) subjects (n = 17) showed a marked increase in antibody titers two weeks after the first vaccination and four weeks after the second vaccination. Although they were able to maintain a certain level of antibody titers until 30 weeks after the second vaccination, the titers fell in the same way as observed in the non-infected subjects. The subjects who did not receive the third vaccination due to adverse reactions to previous vaccines (n = 1) or who were positive for COVID-19 prior to the third vaccination (n = 2) were excluded from the subsequent analyses. Among non-infected subjects (n = 36), smokers had lower peak antibody titers than the others. The previously infected subjects had a significantly higher incidence of adverse reactions after the first vaccination but had a similar incidence of adverse reactions after the second and third vaccinations compared to the non-infected subjects. Conclusions: A history of COVID-19 may influence only the initial increase in anti-SARS-CoV-2 antibody titers and the occurrence of adverse reactions after the first vaccination. [ABSTRACT FROM AUTHOR]

COVID-19 mRNA vaccinations have recently been implicated in causing myocarditis. Therefore, the primary aim of this systematic review and meta-analysis was to investigate the clinical characteristics of patients with myocarditis following mRNA vaccination. The secondary aims were to report common imaging and laboratory findings, as well as treatment regimes, in these patients. A literature search was performed from December 2019 to June 2022. Eligible studies reported patients older than 18 years vaccinated with mRNA, a diagnosis of myocarditis, and subsequent outcomes. Pooled mean or proportion were analyzed using a random-effects model. Seventy-five unique studies (patient n = 188, 89.4% male, mean age 18–67 years) were included. Eighty-six patients had Moderna vaccines while one hundred and two patients had Pfizer-BioNTech vaccines. The most common presenting symptoms were chest pain (34.5%), fever (17.1%), myalgia (12.4%), and chills (12.1%). The most common radiologic findings were ST-related changes on an electrocardiogram (58.7%) and hypokinesia on cardiac magnetic resonance imaging or echocardiography (50.7%). Laboratory findings included elevated Troponin I levels (81.7%) and elevated C-reactive protein (71.5%). Seven patients were admitted to the intensive care unit. The most common treatment modality was non-steroid anti-inflammatory drugs (36.6%) followed by colchicine (28.5%). This meta-analysis presents novel evidence to suggest possible myocarditis post mRNA vaccination in certain individuals, especially young male patients. Clinical practice must therefore take appropriate pre-cautionary measures when administrating COVID-19 mRNA vaccinations. [ABSTRACT FROM AUTHOR]

(1) Background: The development of effective COVID-19 vaccines has reduced the impact of COVID-19 on the general population. Our study aims to analyze how vaccination modifies the likelihood of death and length of stay in hospitalized patients with COVID-19; (2) Methods: A retrospective cohort study of 1927 hospitalized patients infected with COVID-19 was conducted. Information was gathered on vaccination status, hospitalization episode, and clinical profile of the patients. The effect of vaccination on mortality was analyzed using a multiple logistic regression model, and length of stay was analyzed using linear regression. The performance and fit of the models were evaluated; (3) Results: In hospitalized patients with COVID-19, the risk of dying during admission in vaccinated patients was half that of non-vaccinated (OR: 0.45; CI 95%: 0.25 to 0.84). In patients who were discharged due to improvement, the reduction in hospital stay in vaccinated patients was 3.17 days (CI 95%: 5.88 to 0.47); (4) Conclusions: Patients who, despite having been vaccinated, acquire the infection by SARS-CoV-2, have a significant reduction of the risk of death during admission and a reduction of hospital stay compared with unvaccinated patients. [ABSTRACT FROM AUTHOR]

Background: The Delta COVID-19 variant caused a resurgence in cases and deaths during the summer of 2021, particularly among the unvaccinated, highlighting the need to increase vaccine coverage. We describe a survey conducted in September 2021, in the midst of the Delta variant surge, after the FDA fully approved Pfizer-BioNTech's vaccine for ages 16+ and issued an emergency use authorization for ages 12–15. Methods and Findings: US adults were surveyed to measure COVID-19 vaccination status, intentions, attitudes, values, and trust in public health authorities. More than three-quarters (77%) reported receiving at least one dose of COVID-19 vaccination. Of the unvaccinated, 6% intended to vaccinate, 40% were unlikely to ever vaccinate, and 55% remained uncertain. Most of the unvaccinated were <45 years old (62%), without a bachelor's degree (83%), earning less than $85,000 annually (74%), and Republican/Independent (66%). Concerns among the unvaccinated-yet-still-uncertain included the vaccines' safety (86%), speed of development (86%), and suspicion of government (79%) and pharmaceutical companies (69%). Most (86%) of the unvaccinated reported they would not vaccinate if mandated by their employer. About one third (34%) of the unvaccinated reported facing at least one barrier to vaccination. Conclusion: More than half of unvaccinated adults remained uncertain about COVID-19 vaccination, indicating an opportunity to support their decision making. Public health must increase easy and equitable access to vaccination and renew efforts to provide unvaccinated populations access to information from trusted sources. [ABSTRACT FROM AUTHOR]

Vaccines against SARS-CoV-2 are believed to play a key role in the suppression of the COVID-19 pandemic. However, patients suffering from inflammatory bowel diseases (IBD) were excluded from SARS-CoV-2 vaccines trials. Therefore, concerns regarding vaccination efficacy and safety among those patients were raised. Overall, vaccination is well tolerated in the IBD population, and different gastroenterological societies recommend vaccinating patients with IBD at the earliest opportunity to do so. Nevertheless, very little is known about the safety of COVID-19 vaccines in special IBD populations such as pregnant and breastfeeding women or pediatric patients, and further research on this matter is crucial. The available data on vaccine efficacy are promising and show high seroconversion rates in IBD patients on different immune-modifying therapies. However, patients treated with high doses of systemic corticosteroids, infliximab or infliximab and immunomodulators may have a blunted response to the vaccination. The data on COVID-19 vaccination willingness among patients with IBD are conflicting. Nevertheless, vaccine effectiveness and safety are reported to be the most common reasons for hesitancy. This review examines the effectiveness and safety of COVID-19 vaccines and describes vaccination willingness and the reasons for potential hesitancy among patients with IBD. [ABSTRACT FROM AUTHOR]

Background: Patients affected by pre-existing chronic spontaneous/Inducible urticaria (CSU/CIU) still feel unsafe due to the potential risk of an Adverse Event Following Immunization (AEFI) and Cutaneous Adverse Reactions (CARs) of COVID-19 vaccines. The appropriate management in this field remains debated and evidence is still lacking. Methods: We considered 160 CSU/CIU patients in Omalizumab/antihistamine therapy who received two doses of Comirnaty/Moderna mRNA vaccines; 20 of them also received a booster dose. Urticaria Activity Score-7 (UAS7) was used to assess the severity of the disease. Demographics, medical history, AEFI and CARs outcome after vaccination were collected by administering a web-based questionnaire completed by phone interview. Results: In total, 147 patients did not show urticaria relapse (91.88%). Worsening cutaneous symptoms were experienced by 13 of our patients (8.12%). Exacerbation had a mean duration of 2 days and 11 h and mostly occurred after the first dose (69.23%). Systemic mild side effects were experienced by 9 patients (5.62%). No severe reactions were observed. Conclusions: Omalizumab can potentially prevent CARs and AEFI; however, major problems were registered during the 2-month stop period scheduled in the treatment. We suggest patients should not undergo vaccination during this period. CSU/CIU exacerbations appear to be transient and can be managed by antihistamines. [ABSTRACT FROM AUTHOR]

Clinical trials for COVID-19 vaccines initially excluded pregnant women due to safety concerns, and when the vaccines were authorized for emergency use, they were not recommended for this population. However, observational studies discovered that pregnant women infected with COVID-19 have higher risks of negative pregnancy and delivery outcomes compared to non-pregnant women, raising the question of the risks–benefits of administering COVID-19 vaccines to pregnant women. By mid-2021, there was general consensus on the relative safety of COVID-19 vaccination during pregnancy; therefore, it is critical to investigate the safety issues related to these vaccines, considering the increasing acceptance among pregnant women. To address these concerns, we developed a research project to study the short-term effects and outcomes of COVID-19 vaccination during the first trimester of pregnancy. Our research followed an observational retrospective design for 12 months from the beginning of the vaccination campaign, and included 124 cases of spontaneous abortions and 927 ongoing pregnancies. The odds of spontaneous abortion were non-significant for both versions of the mRNA vaccine (Pfizer BNT162b2 AOR = 1.04, CI = 0.91–1.12; Moderna mRNA-1273 AOR = 1.02, CI = 0.89–1.08). Overall, our data indicated that the risk of spontaneous abortion after mRNA COVID-19 immunization during the first trimester of pregnancy is commensurate with the predicted risk in non-vaccinated pregnant women. These findings contribute to the growing body of information regarding the safety of mRNA COVID-19 vaccination during pregnancy. [ABSTRACT FROM AUTHOR]

Vaccines represent the best tool to prevent the severity course and fatal consequences of the pandemic by the new Coronavirus 2019 infection (SARS-CoV-2). Considering the limited data on vaccination of pediatric oncohematological patients, we developed a Consensus document to support the Italian pediatric hematological oncological (AIEOP) centers in a scientifically correct communication with families and patients and to promote vaccination. The topics of the Consensus were: SARS-CoV-2 infection and disease (COVID-19) in the pediatric subjects; COVID-19 vaccines (type, schedule); who and when to vaccinate; contraindications and risk of serious adverse events; rare adverse events; third dose and vaccination after COVID-19; and other general prevention measures. Using the Delphi methodology for Consensus, 21 statements and their corresponding rationale were elaborated and discussed with the representatives of 31 centers, followed by voting. A high grade of Consensus was obtained on topics such as the potential risk of severe COVID-19 outcome in pediatric oncohematological patients, the need for vaccination as a preventative measure, the type, schedule and booster dose of vaccine, the eligibility of the patients for vaccination, and the timing, definition, and management of contraindications and serious adverse events, and other general prevention measures. All 21 of the statements were approved. This consensus document highlights that children and adolescents affected by hematological and oncological diseases are a fragile category. Vaccination plays an important role to prevent COVID-19, to permit the regular administration of chemotherapy or other treatments, to perform control visits and hospital admissions, and to prevent treatment delays. [ABSTRACT FROM AUTHOR]

This study attempted to draw the present and future perspective of the COVID-19 vaccine by identifying the most important scientists and their scientific contexts, trends of research topics, and relationships between different entities. Methods: To achieve this purpose, bibliometric and scientometric techniques were used to analyze 6288 scientific documents contributing to COVID-19 vaccines from the beginning of 2019 to 13 December 2021, indexed in the Web of Science. Results: The United States (US) had the greatest impact by publishing 2104 documents and receiving 32,958 citations. The US and the UK countries had the highest level of scientific collaborations with 192 collaborative studies. The University of Oxford and the Harvard Medical School were the most active institutions, and the University of Oxford and Emory University were the most influential institutions. Pollard AJ and Lambe T had the most publications and the highest citations and h-index. T Lambe, SC Gilbert, M Voysey, and AJ Pollard from the University of Oxford had the highest number of co-authorships. More than 19% of the research was conducted in the field of immunology. The Vaccines journal had the most publications, with 425 articles. The US Department of Health & Human Services granted the most research. In 2019, studies were focused on the topics of COVID-19 virus identification and ways to deal with it; in 2020, studies focused on the topics of COVID-19 and vaccines, whereas in 2021, they focused on the topics of COVID-19 vaccines and their effects, vaccines hesitancy, the role of healthcare workers in COVID-19, as well as discussions about these vaccines in the social media. Conclusions: Recognition of the most important actors (countries, institutes, researchers, and channels for the release of COVID-19 vaccine studies), research trends, and fields of study on the COVID-19 vaccine can be useful for researchers, countries, and policy makers in the field of science and health to make decisions and better understand these vaccines. [ABSTRACT FROM AUTHOR]

We aimed to evaluate the safety and immunogenicity of the BNT162b2 vaccine in young people with Down syndrome (DS), and to compare their humoral immune response with those of the healthy controls (HC). Individuals with DS and HC received the BNT162b2 vaccine. Longitudinal blood samples were collected on the day of vaccination, twenty-one days after the first dose, seven days after the second dose, and six months after the first dose. Both the local and systemic adverse events reported by participants were mild. Pain at the injection site was the most reported local adverse event, while fever was the systemic adverse event. Humoral responses showed a significant increase of anti-S and anti-S trimeric antibody (Ab) levels after both doses of vaccine in both groups. In comparison with HC, Ab levels in individuals with DS were similar at T21, but significantly lower, both in terms anti-S and anti-S trimeric, at T28 (respectively p = 0.0003 and p = 0.0001). At T180 both groups showed a significant reduction of anti-S trimeric Ab levels compared to T28 (p = 0.0004 and p < 0.0001 for DS and HC, respectively). Individuals with DS exhibit a good humoral response to the BNT162b2 vaccine; however, similarly to in HC, the immune response wanes over time. [ABSTRACT FROM AUTHOR]

Many patients are receiving SARS-CoV-2 vaccinations, which have been associated with a variety of adverse effects. Cutaneous adverse reactions to SARS-CoV-2 vaccinations have been progressively reported, but they have not been reviewed according to their morphological clinical patterns. The objective of this review was to summarize the existing data concerning the cutaneous adverse reactions following SARS-CoV-2 vaccines and group them according to common morphological and pathogenetic patterns. We reviewed the English language literature up to 15 August 2021, using predefined keywords to identify the relevant studies evaluating cutaneous adverse reactions associated with SARS-CoV-2 vaccines. We search for recurrent morphological patterns sharing clinical signs and symptoms and physio-pathological mechanisms. Timing to onset following the first or booster dose of the vaccine, predisposing conditions, therapeutic management, and outcome were also collected. Among the dermatological manifestations associated with SARS-CoV-2 vaccinations, we distinguished: (1) new onset reactions and (2) flares of preexisting dermatoses. The most common were injection site reactions, affecting 30–70% and generally mild or moderate. Small case series or single case reports included filler reactions, exanthemas, vascular lesions, urticaria, eczematous dermatitis, autoimmune bullous reactions, and severe cutaneous adverse reactions. In addition, the exacerbation of chronic immuno-mediated dermatoses (mainly psoriasis and atopic dermatitis) and reactivations of herpes infection were reported. The cutaneous reactions were generally mild, self-limiting, and resembled common cutaneous drug eruptions and/or COVID-19 skin manifestations. [ABSTRACT FROM AUTHOR]

Introduction: Belatacept is a common immunosuppressive therapy used after kidney transplantation (KT) to avoid calcineurin-inhibitor (CNI) use and its related toxicities. It is unclear whether its use exposes KT recipients (KTx) to a greater risk of infection or a poorer response to vaccines. Areas covered: We reviewed PubMed and the Cochrane database. We then summarized the mechanisms and impacts of belatacept use on the risk of infection, particularly opportunistic, in two settings, i.e., de novo KTx and conversion from CNIs. We also focused on COVID-19 infection risk and response to SARS-CoV-2 vaccination in patients whose maintenance immunosuppression relies on belatacept. Expert opinion: When belatacept is used de novo, or after drug conversion the safety profile regarding the risk of infection remains good. However, there is an increased risk of opportunistic infections, mainly CMV disease and Pneumocystis pneumonia, particularly in those with a low eGFR, in older people, in those receiving steroid-based therapy, or those that have an early conversion from CNI to belatacept (i.e.,

Testing for SARS-CoV-2 antibodies is commonly used to determine prior COVID-19 infections and to gauge levels of infection- or vaccine-induced immunity. Michigan Medicine, a primary regional health center, provided an ideal setting to understand serologic testing patterns over time. Between 27 April 2020 and 3 May 2021, characteristics for 10,416 individuals presenting for SARS-CoV-2 antibody tests (10,932 tests in total) were collected. Relative to the COVID-19 vaccine roll-out date, 14 December 2020, the data were split into a pre- (8026 individuals) and post-vaccine launch (2587 individuals) period and contrasted with untested individuals to identify factors associated with tested individuals and seropositivity. Exploratory analysis of vaccine-mediated seropositivity was performed in 347 fully vaccinated individuals. Predictors of tested individuals included age, sex, smoking, neighborhood variables, and pre-existing conditions. Seropositivity in the pre-vaccine launch period was 9.2% and increased to 46.7% in the post-vaccine launch period. In the pre-vaccine launch period, seropositivity was significantly associated with age (10 year; OR = 0.80 (0.73, 0.89)), ever-smoker status (0.49 (0.35, 0.67)), respiratory disease (4.38 (3.13, 6.12)), circulatory disease (2.09 (1.48, 2.96)), liver disease (2.06 (1.11, 3.84)), non-Hispanic Black race/ethnicity (2.18 (1.33, 3.58)), and population density (1.10 (1.03, 1.18)). Except for the latter two, these associations remained statistically significant in the post-vaccine launch period. The positivity rate of fully vaccinated individual was 296/347(85.3% (81.0%, 88.8%)). [ABSTRACT FROM AUTHOR]

The Pfizer/BioNtech Comirnaty vaccine (BNT162b2 mRNA COVID-19) against SARS-CoV-2 is currently in use in Italy. Antibodies to evaluate SARS-CoV-2 infection prior to administration are not routinely tested; therefore, two doses may be administered to asymptomatic previously exposed subjects. The aim of this study is to assess if any difference in antibody concentration between subjects exposed and not exposed to SARS-CoV-2 prior to BNT162b2 was present after the first dose and after the second dose of vaccine. Data were retrospectively collected from the clinical documentation of 337 healthcare workers who underwent SARS-CoV-2 testing before and after BNT162b2. Total anti RBD (receptor-binding domain) antibodies against SARS-CoV-2′s spike protein were measured before and 21 days after the first dose, and 12 days after the second dose of BNT162b2. Twenty-one days after the first dose, there was a statistically significant difference in antibody concentration between the two groups, which was also maintained twelve days after the second dose. In conclusion, antibody response after receiving BNT162b2 is greater in subjects who have been previously exposed to SARS-CoV-2 than in subjects who have not been previously exposed to the virus, both after 21 days after the first dose and after 12 days from the second dose. Antibody levels, 21 days after the first dose, reached a titer considered positive by the test manufacturer in the majority of subjects who have been previously infected with SARS-CoV-2. Evaluating previous infection prior to vaccination in order to give the least effective number of doses should be considered. [ABSTRACT FROM AUTHOR]

Introduction. Sars-CoV-2 infection poses particular problems in pregnancy, as the infection more frequently causes severe complications than in unaffected pregnant women or nonpregnant women with SARS-CoV-2 infection. Now that vaccination is available and rapidly being implemented worldwide, the question arises whether pregnant women should be vaccinated, and if so, whether they should receive priority. Methods. Available scientific data and available guidelines about vaccination against SARS-CoV-2 were collected by the Guideline Committee of the International Society of Infectious Diseases in Obstetrics and Gynecology (ISIDOG) and were analyzed, discussed and summarized as guidelines for healthcare workers caring for pregnant women. Concluding statements were graded according to the Oxford evidence-based medicine grading system. Results. There is evidence to consider pregnancy as a risk factor for serious complications of COVID-19 infection, even in the absence of additional risk factors, such as hypertension, diabetes and obesity which increase these risks even more in pregnancy. Currently available data slightly favor mRNA-based vaccines above vector-based vaccines during pregnancy and breastfeeding, until more safety data become available. Conclusion. ISIDOG advises policy makers and societies to prioritize pregnant women to receive vaccination against SARS-CoV-2 and favor the mRNA vaccines until further safety information becomes available. [ABSTRACT FROM AUTHOR]

Background: As of 8 April 2021, a total of 2.9 million people have died with or from the coronavirus infection causing COVID-19 (Corona Virus Disease 2019). On 29 January 2021, the European Medicines Agency (EMA) approved a COVID-19 vaccine developed by Oxford University and AstraZeneca (AZD1222, ChAdOx1 nCoV-19, COVID-19 vaccine AstraZeneca, Vaxzevria, Covishield). While the vaccine prevents severe course of and death from COVID-19, the observation of pulmonary, abdominal, and intracranial venous thromboembolic events has raised concerns. Objective: To describe the clinical manifestations and the concerning management of patients with cranial venous sinus thrombosis following first exposure to the "COVID-19 vaccine AstraZeneca". Methods: Patient files, laboratory findings, and diagnostic imaging results, and endovascular interventions of three concerning patients were evaluated in retrospect. Results: Three women with intracranial venous sinus thrombosis after their first vaccination with "COVID-19 vaccine AstraZeneca" were encountered. Patient #1 was 22 years old and developed headaches four days after the vaccination. On day 7, she experienced a generalized epileptic seizure. Patient #2 was 46 years old. She presented with severe headaches, hemianopia to the right, and mild aphasia 13 days after the vaccination. MRI showed a left occipital intracerebral hemorrhage. Patient #3 was 36 years old and presented 17 days after the vaccination with acute somnolence and right-hand hemiparesis. The three patients were diagnosed with extensive venous sinus thrombosis. They were managed by heparinization and endovascular recanalization of their venous sinuses. They shared similar findings: elevated levels of D-dimers, platelet factor 4 antiplatelet antibodies, corona spike protein antibodies, combined with thrombocytopenia. Under treatment with low-molecular-weight heparin, platelet counts normalized within several days. Conclusion: Early observations insinuate that the exposure to the "COVID-19 vaccine AstraZeneca" might trigger the expression of antiplatelet antibodies, resulting in a condition with thrombocytopenia and venous thrombotic events (e.g., intracranial venous sinus thrombosis). These patients' treatment should address the thrombo-embolic manifestations, the coagulation disorder, and the underlying immunological phenomena. [ABSTRACT FROM AUTHOR]

Precision medicine approaches based on pharmacogenomics are now being successfully implemented to enable physicians to predict more efficient treatments and prevention strategies for a given disease based on the genetic background of the patient. This approach has already been proposed for vaccines, but research is lagging behind the needs of society, and precision medicine is far from being implemented here. While vaccinomics concerns the effectiveness of vaccines, adversomics concerns their side effects. This area has great potential to address public concerns about vaccine safety and to promote increased public confidence, higher vaccination rates, and fewer serious adverse events in genetically predisposed individuals. The aim here is to explore the contemporary scientific literature related to the vaccinomic and adversomic aspects of the three most-controversial vaccines: those against hepatitis B, against measles, mumps, and rubella, and against human Papilloma virus. We provide detailed information on the genes that encode human leukocyte antigen, cytokines and their receptors, and transcription factors and regulators associated with the efficacy and safety of the Hepatitis B and Measles, Mumps and Rubella virus vaccines. We also investigate the future prospects of vaccinomics and adversomics of a COVID-19 vaccine, which might represent the fastest development of a vaccine ever. [ABSTRACT FROM AUTHOR]