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1.
PLoS ONE Vol 16(8), 2021, ArtID e0255294 ; 16(8), 2021.
Article in English | APA PsycInfo | ID: covidwho-1824375

ABSTRACT

The COVID-19 pandemic has introduced novel stressors into the lives of youth. Identifying factors that protect against the onset of psychopathology in the face of these stressors is critical. We examine a wide range of factors that may protect youth from developing psychopathology during the pandemic. We assessed pandemic-related stressors, internalizing and externalizing psychopathology, and potential protective factors by combining two longitudinal samples of children and adolescents (N = 224, 7-10 and 13-15 years) assessed prior to the pandemic, during the stay-at-home orders, and six months later. We evaluated how family behaviors during the stay-at-home orders were related to changes in psychopathology during the pandemic, identified factors that moderate the association of pandemic-related stressors with psychopathology, and determined whether associations varied by age. Internalizing and externalizing psychopathology increased substantially during the pandemic. Higher exposure to pandemic-related stressors was associated with increases in internalizing and externalizing symptoms early in the pandemic and six months later. Having a structured routine, less passive screen time, lower exposure to news media about the pandemic, and to a lesser extent more time in nature and getting adequate sleep were associated with reduced psychopathology. The association between pandemic-related stressors and psychopathology was reduced for youths with limited passive screen time and was absent for children, but not adolescents, with lower news media consumption related to the pandemic. We provide insight into simple, practical steps families can take to promote resilience against mental health problems in youth during the COVID-19 pandemic and protect against psychopathology following pandemic-related stressors. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

2.
Dissertation Abstracts International Section A: Humanities and Social Sciences ; 83(7-A):No Pagination Specified, 2022.
Article in English | APA PsycInfo | ID: covidwho-1824134

ABSTRACT

This qualitative study analyzes the effects that RENEW, a person-centered goal planning model, has on students with disabilities that are in an alternative school setting. Students in sixth through twelfth grade participated in this study to determine if RENEW can affect students' awareness of post-secondary options and assist with post-high school planning. In analyzing students' progress, the researcher utilized results of the AIR Self-Determination Scale, DIBELS assessments, and school-wide behavior data during students' participation in the RENEW initiative. In addition, the researcher used results of a Likert scale survey given to school personnel in order to examine how RENEW was implemented at the school. RENEW assisted students with completing post-high school plans by illuminating goals, correlating achievable steps towards those goals, and developing support systems to aid in reaching these goals. Although this research was implemented during the COVID-19 Pandemic, the alternative school implemented the RENEW intervention with fidelity and produced positive changes within the youth that participated in the initiative. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

3.
Dusunen Adam: Journal of Psychiatry and Neurological Sciences ; 34(1):32-40, 2021.
Article in English | APA PsycInfo | ID: covidwho-1823974

ABSTRACT

Objective: The number of publications reporting anxiety and fear about the ongoing outbreak of coronavirus 2019 (COVID-19) continues to grow;however, the psychometric tools available to assess a Turkish population are insufficient to measure the relevant mental health outcomes. The purpose of this study was to examine the psychometric properties of the Turkish version of the Fear of COVID-19 Scale (FCV-19S) and to analyze the validity and reliability in children and adolescents. Method: The study sample consisted of 381 children aged 10-18 years. Cronbach's alpha internal consistency analysis was used to evaluate the scale's reliability, and the criterion validity was assessed with the Revised Child Anxiety and Depression Scale- Child (RCADS-C) subscale scores. The construct validity of the scale was examined using exploratory and confirmatory factor analysis. Results: The Cronbach's alpha internal consistency coefficient calculated to determine the scale's reliability was alpha=0.88. The corrected total item test correlation values of the items varied between 0.63 and 0.68. Exploratory factor analysis determined that the factor load of the scale items was 0.73-0.77 and that there was only one factor with an eigenvalue >1. Confirmatory factor analysis indicated that the fit indices were acceptable. Conclusion: These findings show that the Turkish version of the FCV-19S is a valid and reliable measurement tool for use with children and adolescents. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

4.
International Journal of Developmental Disabilities ; 67(6):458-459, 2021.
Article in English | APA PsycInfo | ID: covidwho-1823912

ABSTRACT

Reports an error in "Parents' perceptions on physical activity for their children with autism spectrum disorders during the novel Coronavirus outbreak" by Oguz Kaan Esenturk (International Journal of Developmental Disabilities, 2021[Dec], Vol 67[6], 446-457). When this issue of the journal was first published online, the papers appeared in the wrong order. The order has been amended and the page numbering subsequently corrected. (The following of the original article appeared in record 2020-39934-001). Considering that parents are one of the key figures in their child's participation in physical activity, it is extremely important to examine parents' perceptions and experiences of physical activity in order to protect children with Autism Spectrum Disorders (ASD) from the inactive life during the novel Coronavirus (COVID-19) outbreak and to include them in physical activities in the home environment. Although it is still a new subject, there is no research that addresses parents' physical activity knowledge, needs and recommendations for the physical activity experiences of children with ASD during the COVID-19 outbreak, and offers solutions accordingly. Considering this gap in the literature, the aim of this qualitative study is to explore parents' perceptions on physical activity for their children with ASD. Participants of the study were 10 parents with children with ASD, who participated in one-to-one semi-structured phone calls. Interview data were analyzed thematically. The analysis of the data revealed three main themes: 1) Possible benefits of physical activity during the COVID-19 outbreak, 2) Physical activity barriers during the COVID-19 outbreak, and 3) Recommendations for physical activity during the COVID-19 outbreak. The results revealed that parents thought that physical activities had a positive effect on the development areas of their children with ASD. It was determined that parents want to involve their children in physical activities in the home environment, but they have barriers that they need to overcome. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

5.
Cefai, Carmel [Ed]|Regester, Dominic [Ed]|Akoury Dirani, Leyla [Ed] (2020) Social and emotional learning in the Mediterranean: Cross cultural perspectives and approaches ; : 3-10, 2020.
Article in English | APA PsycInfo | ID: covidwho-1823819

ABSTRACT

The rapid social, economic and technological changes taking place in the world today, have led to the rise of social and emotional processes as an essential requirement in positive human development and meaningful education. Children and young people need to grow and develop as autonomous, productive and healthy citizens in a fast-changing world. The term 'social and emotional learning' (SEL) captures both the intra and interpersonal core competences, namely self-awareness, self-management and regulation, social awareness and empathy, relationships and responsible decision making. There is consistent evidence that SEL has a positive impact on both cognitive and social and emotional outcomes in children and young people. The worldwide anxiety created by the recent COVID-19 pandemic, both amongst children and adults alike, underlined the need for such 'life competences' to help overcome our fears, manage our anxiety, maintain a sense of control and build our resilience to cope effectively with the psychological impact of the crisis. This introductory chapter describes the concept of SEL and provides a brief overview of the following chapters. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

6.
Dissertation Abstracts International Section A: Humanities and Social Sciences ; 83(7-A):No Pagination Specified, 2022.
Article in English | APA PsycInfo | ID: covidwho-1823641

ABSTRACT

As a result of the COVID-19 pandemic, many students had their educational experiences disrupted as schools became shuttered and for some students virtual schooling began. When school facilities closed and online began, families had increased responsibilities for their children's education. Subsequently, there is an increase in attention to understanding how families support the academic development of their school-aged children.Informed by Bronfenbrenner's ecological and bioecological models, as well as, cultural capital theory, I used the READS for Summer Learning longitudinal dataset and conducted various statistical analyses-univariate, bivariate, and regression (logistic, ordinal, and multiple)-to explain the nature of family involvement in promoting learning during the summer for rising fourth graders, and examine the relationship between family involvement and learning experiences of rising fourth-graders during the summer and later reading achievement. I also examined to what extent summer activities varied by gender, race/ethnicity, free and reduced lunch status, and previous reading abilities.The findings showed that gender, previous reading achievement, and FRL status explain variations in fall reading achievement scores. Of particular importance was the lack of difference in summer activities across different racial/ethnic groups. Drawing on the findings, I make recommendations related to teaching phonics, scaffolding summertime learning experiences based on children's needs for family involvement to support reading achievement, and using better measures to predict reading achievement were outlined. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

7.
Revista Publicaciones ; 51(2):133-159, 2021.
Article in Spanish | Web of Science | ID: covidwho-1822728

ABSTRACT

There is a growing need in schools for counsellors with an increasingly wide range of competences, amongst which socio-emotional competencies occupy a preferential place. Undoubtedly these competences have an enormous potential for dealing with various, unforeseen educational situations, especially in times of Covid-19. As a result of this, a study was undertaken with a quantitative methodological design (Likert-type rating scale) with the aim of specifically finding out the evaluations of secondary school counsellors within the Autonomous Community of Galicia on the socio-emotional competences and thus contribute to the effectiveness of their educational work particularly in the complex scenarios like the ones we are live in. This study offers valuable information that may likely be implemented, including the fostering of the most relevant social-emotional competences.

8.
Vaccines ; 10(4):9, 2022.
Article in English | Web of Science | ID: covidwho-1822455

ABSTRACT

COVID-19 has impacted children's immunization rates, putting the lives of children at risk. The present study assesses the impact of phone-call counseling, on immunization uptake during the pandemic. Families of babies discharged from the SNCUs in six government centers in three South Indian states were recruited. Calls were made 10 days after the immunization due date. Missed vaccinees were counseled and followed up on 7 and 15 days. Of 2313 contacted, 2097 completed the survey. Respondents were mostly mothers (88.2%), poor (67.5%), and had secondary level education (37.4%). Vaccinations were missed due to the baby's poor health (64.1%), COVID-19 related concerns (32.6%), and lack of awareness (16.8%). At the end of the intervention, the immunization uptake increased from 65.2% to 88.2%. Phone-call intervention can safely support immunization and lower the burden on health workers.

9.
Frontiers in Pediatrics ; 10, 2022.
Article in English | EMBASE | ID: covidwho-1822393

ABSTRACT

Objectives: The COVID-19 virus is highly contagious primarily via aerosol transmission and has a high mortality rate. On March 13, 2020, the United States declared a national emergency in response to the COVID-19 pandemic. This study aims to enumerate the effect of the pandemic on vaccination rates during the COVID-19 lockdown and the aftermath in pediatric patients aged 6weeks-6 years. Study Design: A retrospective review of medical records was performed of missed well childcare visits at MetroHealth from March 1, 2020 to June 30, 2020. The sample size of 400 children aged 6 weeks to 6 years were randomly selected. Demographic data, number of calls made to attempt, scheduled WCC, no show rates for clinic appointments, number of missed WCC, location of MH facility, insurance type, vaccination status prior to the pandemic were collected. Statistical analysis was performed with SPSS software (IBM Corp. Released 2020. IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp). Results: From this descriptive study, we found that 43.5% of patients were not up to date on their childhood vaccination. The mean age was 24.38 months (SD 20.15). There were slightly more males (52.8%) in the study than females (47.3%) and most children were of African American descent. More than 50% of patients missed a scheduled well child appointment and 27% had a missed at least two consecutive appointments. Conclusion: The COVID-19 pandemic has no doubt made a significant mark on health care;the effects would be both immediate and delayed, with vulnerable population being the most impacted. There is an urgent need to prevent a large-scale health disaster of catastrophic potential that could occur if an effective vaccination strategy is not implemented rapidly.

10.
Frontiers in Pediatrics ; 10, 2022.
Article in English | EMBASE | ID: covidwho-1822390

ABSTRACT

Background: With the outbreak of the COVID-19 pandemic, non-pharmaceutical interventions such as social distancing have been implemented worldwide, and a decrease in other infectious diseases has been reported as an unexpected benefit. However, to date, studies are lacking regarding the effects of the COVID-19 pandemic on neuroinfectious diseases;therefore, we aimed to determine the effects of the COVID-19 pandemic on the incidence of meningitis, which is the most common infectious disease in children. Methods: This retrospective study used electronic medical record data from five university hospitals located in the metropolitan cities in Korea. This study included patients aged <18 years who were diagnosed with meningitis between January 2017 and December 2020. We analyzed the clinical characteristics of patients with meningitis and changes in the incidence and causative pathogens of meningitis before and after the COVID-19 outbreak. Results: The study included 677 patients with meningitis. Following the outbreak of COVID-19 in Korea in January 2020, the incidence of childhood meningitis significantly decreased and seasonal changes noted yearly disappeared. There was a difference in the age distribution of patients with meningitis. The incidence of meningitis decreased significantly in children aged >5 years, and the incidence in children <5 years of age relatively increased (p < 0.001). In addition, there was a notable decrease in the cases of suspected meningitis (p < 0.001). The incidence of enteroviral meningitis, the most common cause of meningitis, significantly decreased. Conclusion: After the COVID-19 outbreak, the incidence of childhood meningitis significantly decreased with the implementation of non-pharmaceutical interventions. Absence of enteroviral meningitis and decrease in the proportion of patients aged ≥5 years with meningitis having mild symptoms were noted. Consequently, it can be concluded that the non-pharmaceutical interventions (NPIs) instituted to prevent the spread of COVID-19 had some effect on reducing the incidence of meningitis.

11.
Etnoantropoloski Problemi-Issues in Ethnology and Anthropology ; 17(1):259-283, 2022.
Article in Serbian | Web of Science | ID: covidwho-1820518

ABSTRACT

At the beginning of 2020 a children's game called "Corona" spontaneously appeared among the lower grade pupils of the primary school "Saint Sava" in Belgrade's municipality of Vraoar. Typologically it belongs to the games of chasing and the rules of the first detected variant resemble very much the playground game known as tag with the exception that the player who chases is called "Corona". During April and May of 2021 a field research was conducted in order to collect information about the ways the game was played in the schoolyard during the months of February and March 2020 (on the 17th of March the schools in Serbia were closed due to the Covid-19 pandemic and were not opened until the beginning of the following school year on the 1st of September 2020) and during the school year 2020/2021. An analysis of the collected data showed that there are two basic groups of variants: the first one practiced during the school year 2019/2020 and the second one during the school year 2020/2021 (in which the role of Doctor appears). Both groups are described through the ideal types of their respective variants. The ideal type models of all variants have been observed in relation to the series of elements from the sociocultural context within which the game "Corona" originated, pointing towards a direct correlation between the game elements and its structure on the one hand, and, on the other, the changes that occurred in the micro and macro sociocultural environment of the interviewed children immediately before and after the proclamation of the pandemic of Covid-19. Some of the factors which were triggers in the inner dynamics of the process of shaping the variants of the game "Corona" as a sociocultural construct have been discussed: the internal ones (coming from the children's community itself - those concerning their specific needs and their pre-existing idioculture) and the external ones, concerning a dense network of regulatory and informational factors imposing onto the children a new emerging pandemic reality. This new reality resulted in changes of daily routines, reactions to highly restrictive school regulations and exposure to fear- and confusion-inducing information which reached children through various information channels. The new schoolyard game called "Corona" gave the participants possibility to project their inner psychological tension and express it through a recreational activity (running) and through a frame of a complex communication achieved on a symbolic level.

12.
Children & Society ; n/a(n/a), 2022.
Article in English | Wiley | ID: covidwho-1819881

ABSTRACT

Based on in-depth interviews with 24 middle-class Indian child participants, this is the first exploratory qualitative study, in India, to demonstrate the ways in which children as reflexive social actors re-negotiated everyday schedules, drew on classed resources at their disposal and made sense of the impact of the pandemic on their educational pathways and future aspirations. These narratives offer a unique lens on the politics of middle-classness and its constitutive relation to constructions of normative childhoods in contemporary India. Study findings contribute to the sociology of Indian childhood and more generally help enrich our understanding of southern childhoods and the reproduction of inequalities in contemporary India.

13.
Pediatric Pulmonology ; n/a(n/a), 2022.
Article in English | Wiley | ID: covidwho-1819388

ABSTRACT

IntroductionIt is not clear whether asthma, the most frequent chronic disease in childhood, is a risk for severe SARS-CoV-2 infection in the pediatric population and how SARS-CoV-2 infection affects the lung functions in these patients.PurposeWe aimed to investigate the course and the consequences of SARS-CoV-2 infection among children with asthma and determine the risk factors for the decline in lung function testsMethodsIn this retrospective study, asthmatic children with Coronavirus disease 2019 (COVID-19) were compared with a random control group of asthmatic patients without COVID-19. In addition, the clinical course and the effect on lung function tests of COVID-19 among children with asthma were also evaluated.ResultsOne hundred eighty-nine patients who had COVID-19, and 792 who did not were included in the study. Fever, fatigue, and cough were the most frequent symptoms during COVID-19. Regarding the severity of COVID-19, 163 patients (87.6%) had a mild clinical condition, 13 (7%) had moderate disease, one (0.5%) had severe disease and two had (1.1%) critically ill disease. Two patients were diagnosed with multisystem inflammatory syndrome in children (MIS-C), one patient suffered from pneumothorax. Lung function tests of the patients before and after COVID-19 infection were analyzed;no significant differences were found in FEV1 % (91.7% vs 90.9%, p=0.513), FVC% (89.8% vs 90.8%, p=0.502) and FEV1/FVC (103.1% vs 100.6%, p=0.056), while FEF25-75% values (107.6% vs 98.4%, p<0.001) were significantly lower after the COVID-19 infection. Obesity [OR: 3.785, 95%CI: 1.152-12.429, P =0.028] and having a family history of atopy [OR:3.359, 95%CI:1.168-9.657, P = 0.025] were found to be the independent risk factors for ≥25% decrease in FEF25-75 after COVID-19 infection.ConclusionCOVID-19 infection leads to dysfunction of the small airways in asthmatic children and obesity is an independent risk factor for ≥25% decrease in FEF25-75. The long-term effects of COVID-19 infection especially on small airways require close monitoring in children with asthma.This article is protected by copyright. All rights reserved.

14.
Open Access Macedonian Journal of Medical Sciences ; 10:570-575, 2022.
Article in English | EMBASE | ID: covidwho-1818255

ABSTRACT

BACKGROUND: Child mortality rate in Indonesia is now fluctuating. The Province of the Special Region of Yogyakarta (DIY) had fluctuated infant mortality rate in the recent years. As a result, guidelines of Integrated Management of Childhood Illness (IMCI) are still required to improve the health of Indonesian children. AIM: This study aimed to explore the implementation of IMCI in DIY Province in terms of input, process, and output components. METHODS: A case study approach with a qualitative method was conducted among implementers of IMCI in the DIY Province. The data were obtained from secondary sources, such as the reports, attendance lists, and focus group discussion video recordings. RESULTS: The results were differentiated by input, process, and output components. Most IMCI implementers have not received special training (input);there were no specific guidelines for sick children during the COVID-19 pandemic (process);and the IMCI implementation target has not been achieved with the percentage below 60–70% (output). CONCLUSION: The implementation of IMCI in Yogyakarta Province is still required to improve the quality of services provided to sick children.

15.
Frontiers in Endocrinology ; 13, 2022.
Article in English | EMBASE | ID: covidwho-1817935

ABSTRACT

Prader–Willi syndrome (PWS) is a genetic disorder caused by the lack of expression of genes on the paternally inherited chromosome region 15q11.2-q13. It is a multisystem disorder that is characterized by severe hypotonia with poor suck and feeding difficulties in early infancy, followed in early childhood by excessive eating and gradual development of morbid obesity. The incidence of type 2 diabetes mellitus is high, particularly in obese patients. Non-alcoholic fatty liver disease has also been reported in some patients with PWS. Liver adenomatosis is a benign vascular lesion of the liver, defined by the presence of >10 adenomas, in the otherwise healthy liver parenchyma. We report the first case of a patient with PWS with severe obesity, type 2 diabetes mellitus, and non-alcoholic fatty liver who also developed liver adenomatosis, review the pediatric literature on liver adenomatosis, and discuss the potential underlying mechanisms.

16.
Rivista Sperimentale di Freniatria: La Rivista della Salute Mentale ; 145(2):37-52, 2021.
Article in English | APA PsycInfo | ID: covidwho-1817910

ABSTRACT

The Covid-19 pandemic crisis has caused, in addition to the serious effects on the health systems, a sharp slowdown in the Italian and European economy, mainly weighing on the weakest sections of the population with a worrying increase in economic and social inequalities. Using a multidisciplinary approach, this study focuses on the link between socio-economic fragility and epidemic exposure to Covid-19 in Italy and Europe, with a triple objective: to monitor the main dimensions of increased inequalities within the economy and society through an academic literature review;to empirically understand the reasons for national differences in the spread and lethality of the Covid-19 virus at European level;to provide, on the basis of the results obtained in pursuing the previous two objectives, a key to understanding the main public policies for a healthier, more inclusive and sustainable Italy and Europe. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Italian) La crisi pandemica da Covid-19 ha determinato, oltre ai gravi effetti sul piano sanitario, un forte rallentamento dell'economia italiana ed europea, pesando principalmente sulle fasce piu deboli della popolazione con un preoccupante aumento delle disuguaglianze economico-sociali. Mediante un approccio multidisciplinare, questo studio si concentra sul collegamento tra la fragilita socio-economica e l'esposizione epidemica al Covid-19 in Italia ed Europa, con un triplice obiettivo: monitorare le principali dimensioni delle accresciute disuguaglianze all'interno dell'economia e della societa mediante un'analisi della letteratura scientifica;comprendere empiricamente le ragioni delle differenze nazionali nella diffusione e letalita del virus da Covid-19 a livello europeo;fornire, sulla base dei risultati ottenuti nel perseguimento dei precedenti due obiettivi, una chiave di lettura delle principali politiche pubbliche per un'Italia ed un'Europa piu sane, inclusive e sostenibili. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

17.
Respirology ; 27(SUPPL 1):137, 2022.
Article in English | EMBASE | ID: covidwho-1816638

ABSTRACT

Introduction/Aim: To determine (1) the influenza vaccine uptake of children with cystic fibrosis from 2016 to 2020 and (2) the impact of the COVID pandemic of 2020 and increased uptake of Telehealth outpatient appointments on vaccination rates. Methods: A retrospective audit of children with cystic fibrosis aged 6 months to 18 years who reside in South Australia was performed using the Women's and Children's Respiratory Department cystic fibrosis database from 2016 to 2020. The Australian Childhood Immunization Record (ACIR) was used to determine vaccination status during this period. Results: One hundred eighty-two children with cystic fibrosis were identified, 172 of whom vaccination records were available on the ACIR. Proportion of eligible patients who were vaccinated ranged from 66% to 88% over the 5 year period. There was nil significant decrease in uptake during the COVID pandemic in 2020 (75%). Despite the introduction of Telehealth reviews in 2020 majority (66%) of patients continued to have exclusive face-to-face appointments, of which 73% received the vaccination. Vaccination coverage of those who received combination of Telehealth and faceto- face was 81%. Conclusion: The high influenza vaccination rate of South Australian children with cystic fibrosis is consistent with rates seen in other tertiary centres globally. This audit demonstrated that the COVID pandemic and introduction of Telehealth appointments did not have any measurable uptake of the influenza vaccination our South Australian population.

18.
Experimental Dermatology ; 31(2):e80-e81, 2022.
Article in English | EMBASE | ID: covidwho-1816549

ABSTRACT

COVID-19 still has a big impact on health care and economics all over the world. The major task is to protect the most vulnerable persons from being infected. Skin lesions have been reported since the beginning of the pandemic more or less systematically. Data to their general prevalence differ a lot. A wide variety of lesions have been described: early appearing popular or pustular rash, maculopapulous or urticarial rash during the course of the disease and late appearing perniosis like acral lesions. The latter are associated with childhood, a mild course of the disease and appear around 4 weeks after the onset of COVID-19 symptoms. Here we report histologic results of perniosis like acral lesions and the comparison of immune histochemic results in these cases. Skin biopsies were formalin fixed and paraffin embedded sections were stained with hematoxylin/eosine and immune histochemically with antibodies against lymphocytic antigens. Kryosections were analysed by immunofluorescence for pathologic deposits of immunglobulins or complement. We could confirm association of perniosis like lesions with mild COVID-19. The inflammatory differs a lot in the specimens of different patients with being nearly absent in some cases whereas showing dense dermal lymphocytic infiltrates with a pronouncement around adnexial structures in others. IgG deposits in small blood vessels could be detected in one patient. In general our data are in line with others that perniosis like lesions are more common in young patients, after mild disease and that there are no specific histologic signs for the diagnosis, hence histology must be interpreted in the context of anamnestic data.

19.
The New England Journal of Medicine ; 386(17):1638-1645, 2022.
Article in English | ProQuest Central | ID: covidwho-1815683

ABSTRACT

Understanding Vaccine SafetyDevelopment and public acceptance of vaccines are crucial for disease control. This review covers the process of evaluating vaccines for safety and efficacy, authorization pathways, and factors that advisory bodies consider when establishing vaccine recommendations.

20.
The New England Journal of Medicine ; 386(17):1615-1626, 2022.
Article in English | ProQuest Central | ID: covidwho-1815678

ABSTRACT

BackgroundRespiratory syncytial virus (RSV), a major cause of illness and death in infants worldwide, could be prevented by vaccination during pregnancy. The efficacy, immunogenicity, and safety of a bivalent RSV prefusion F protein–based (RSVpreF) vaccine in pregnant women and their infants are uncertain.MethodsIn a phase 2b trial, we randomly assigned pregnant women, at 24 through 36 weeks’ gestation, to receive either 120 or 240 μg of RSVpreF vaccine (with or without aluminum hydroxide) or placebo. The trial included safety end points and immunogenicity end points that, in this interim analysis, included 50% titers of RSV A, B, and combined A/B neutralizing antibodies in maternal serum at delivery and in umbilical-cord blood, as well as maternal-to-infant transplacental transfer ratios.ResultsThis planned interim analysis included 406 women and 403 infants;327 women (80.5%) received RSVpreF vaccine. Most postvaccination reactions were mild to moderate;the incidence of local reactions was higher among women who received RSVpreF vaccine containing aluminum hydroxide than among those who received RSVpreF vaccine without aluminum hydroxide. The incidences of adverse events in the women and infants were similar in the vaccine and placebo groups;the type and frequency of these events were consistent with the background incidences among pregnant women and infants. The geometric mean ratios of 50% neutralizing titers between the infants of vaccine recipients and those of placebo recipients ranged from 9.7 to 11.7 among those with RSV A neutralizing antibodies and from 13.6 to 16.8 among those with RSV B neutralizing antibodies. Transplacental neutralizing antibody transfer ratios ranged from 1.41 to 2.10 and were higher with nonaluminum formulations than with aluminum formulations. Across the range of assessed gestational ages, infants of women who were immunized had similar titers in umbilical-cord blood and similar transplacental transfer ratios.ConclusionsRSVpreF vaccine elicited neutralizing antibody responses with efficient transplacental transfer and without evident safety concerns. (Funded by Pfizer;ClinicalTrials.gov number, NCT04032093.)

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