Sociodemographic Inequalities in COVID-19 Booster Dose Vaccination Coverage: a Retrospective Study of 196 Provinces in Peru.

BACKGROUND: The COVID-19 vaccination coverage shows variability in booster doses between residency areas or ethnicity. The aim of this study was to evaluate how sociodemographic conditions influence unequal vaccination coverage with booster doses against COVID-19 in Peru. METHODS: A retrospective, ecological study with an evaluation of 196 provinces in Peru. The sociodemographic conditions were evaluated as sources of inequality (sex, age group, educational level, residence area, and ethnic group). The inequality measure used was the GINI, an index that show the inequal vaccination coverage with third and fourth booster doses against COVID-19 in Peruvians provinces. The index allow determinate a higher inequality when the value is near to 1, and a lower inequality when the value is near to 0. Also, the impact of each sociodemographic condition in the general inequality was evaluate with a decomposition analysis of GINI coefficient into Sk (composition effect), Gk (redistribution effect), Rk (differential effect). RESULTS: In provinces evaluated the mean vaccine coverage for the third and fourth booster doses was 57.00% and 22.19%, respectively at twelve months since the beginning of vaccination campaign. The GINI coefficient was 0.33 and 0.31, for the third and fourth booster doses coverage, respectively. In the decomposition analysis, twelve months after the start of the third and fourth dose vaccination campaign, revealed higher Sk values for people living in rural areas (Sk = 0.94 vs. Sk = 2.39, respectively for third and fourth dose), while higher Gk values for Aymara (Gk = 0.92 vs. Gk = 0.92, respectively), Quechua (Gk = 0.53 vs. Gk = 0.53, respectively), and Afro-Peruvians (Gk = 0.61 vs. Gk = 0.61, respectively). Also, higher negative correlation in Rk values for people with elementary education (Rk=-0.43 vs. Rk=-0.33, respectively), aged between 15 and 19 years (Rk=-0.49 vs. Rk=-0.37, respectively), and Aymara (Rk=-0.51 vs. Rk=-0.66, respectively). CONCLUSION: The rural residency area, lower education and Quechua, Aymara or Afro-Peruvians ethnicity determinated inequalities in vaccination coverage with booster doses against COVID-19 in Peruvian provinces.

[Immunogenicity and adverse events of SARS-CoV-2 vaccine in health workers]. / Inmunogenicidad y efectos adversos de vacuna SARS-CoV-2 en trabajadores de salud.

INTRODUCTION: The aim of this study was to evaluate the adverse effects and immune response associated with IgG anti S1 SAEA-CoV-2 antibodies among healthcare workers at Señor del Milagro Hospital in Salta city, after receiving two doses of COVID-19 vaccine. METHODS: A prospective cohort study was carried out from March 2021 to April 2022. Demographic, clinical data, adverse events supposedly attributed to vaccination (AEFIs) were collected and two samples were taken to measure serum antibody levels. RESULTS: 408 volunteers participated, 401 (98%) were vaccinated with Sputnik-V. The average age was 45.5 years with a predominance of the female sex (71%). AEFIs were reported in 188 (46.1%) and 121 (29.7%) after the first and second doses respectively (p<0.001). These events were mostly mild and transient, more frequent after the first dose. The first antibody test was positive in 99% with a mean titer of 9.7 (SD 3.7). The second dosage was positive in 88% with a mean titer of 6.4 (SD 4.4). Participants with a history of infection and previous positive testing showed significantly higher antibody titers (p<0.001). CONCLUSION: The AEFIs reported were mostly mild and transient. Mass vaccination and administration of the recommended dose are essential to achieve effective herd immunity. The majority of vaccinated healthcare workers developed antibodies and those who had the disease prior to vaccination had significant antibody titers.

Introducción: El objetivo de este estudio fue evaluar los efectos adversos y la respuesta inmune de anticuerpos IgG anti S1 SAEA-CoV-2 en el personal de Salud del Hospital del Milagro de la ciudad de Salta, posterior a recibir dos dosis de vacuna COVID-19. Métodos: Se realizó un estudio prospectivo de cohorte desde marzo de 2021 hasta abril 2022. Se recopilaron datos demográficos, clínicos, eventos adversos supuestamente atribuidos a la vacunación (ESAVI) y se tomaron dos muestras de sangre para medir los niveles de anticuerpos. Resultados: Participaron 408 voluntarios, 401 (98%) fueron vacunados con Sputnik- V. La edad promedio fue de 45.5 años con predominio del sexo femenino (71%). Los ESAVI fueron reportados en 188 (46.1%) y 121 (29.7%) luego de la primera y segunda dosis respectivamente (p<0.001). Estos eventos fueron mayormente de carácter leve y transitorios, más frecuentes luego de la primera dosis. El primer dosaje de anticuerpos fue positivo en 99% con una media de títulos de 9.7 (SD 3.7). El segundo dosaje fue positivo en 88% con una media de títulos de 6.4 (SD 4.4). Los participantes con antecedentes de infección y dosajes previos positivos mostraron títulos significativamente más altos de anticuerpos (p<0.001). Conclusión: Los ESAVI reportados fueron mayoritariamente leves y transitorios. La vacunación masiva y la administración de la dosis recomendada son esenciales para lograr una inmunidad colectiva efectiva. La mayoría de los trabajadores de la salud vacunados desarrollaron anticuerpos y aquellos que cursaron la enfermedad previa a la vacunación presentaron títulos significativos más elevados de anticuerpos.

Sociocultural Antecedents and Mechanisms of COVID-19 Vaccine Uptake among Mexican-Origin Youth.

Mexican-origin youth, as a large and growing population among U.S. youth, have been disproportionately affected by COVID-19. Understanding what, when, and how sociocultural factors may influence their COVID-19 vaccine uptake could inform current and future pandemic-response interventions promoting vaccination behaviors among Mexican-origin youth. The current study takes a developmental approach to reveal the long-term and short-term sociocultural antecedents of 198 Mexican-origin adolescents' COVID-19 vaccination uptake behaviors and explores the underlying mechanism of these associations based on the Knowledge-Attitude-Behavior model. The current study adopted Wave 1 (2012-2015) and Wave 4 (2021-2022) self-reported data from a larger study. Analyses were conducted to examine four mediation models for four sociocultural antecedents-daily discrimination, ethnic discrimination, foreigner stress, and family economic stress-separately. Consistent indirect effects of higher levels of concurrent sociocultural risk factors on a lower probability of COVID-19 vaccine uptake were observed to occur through less knowledge about the COVID-19 vaccines and less positive attitudes toward the COVID-19 vaccines at Wave 4. Significant direct effects, but in opposite directions, were found for the associations between Wave 1 ethnic discrimination/Wave 4 daily discrimination and the probability of COVID-19 vaccine uptake. The findings highlight the importance of considering prior and concurrent sociocultural antecedents and the Knowledge-Attitude-Behavior pathway leading to COVID-19 vaccination uptake among Mexican-origin youth and suggest that the impact of discrimination on COVID-19 vaccination uptake may depend on the type (e.g., daily or ethnic) and the context (e.g., during the COVID-19 pandemic or not) of discrimination experienced.

Factors associated with intention to be vaccinated with the COVID-19 booster dose: a cross-sectional study in Peru.

Introduction: The pandemic of COVID-19 continues to impact people worldwide, with more than 755 million confirmed cases and more than 6.8 million reported deaths. Although two types of treatment, antiviral and immunomodulatory therapy, have been approved to date, vaccination has been the best method to control the spread of the disease. Objective: To explore factors associated with the intention to be vaccinated with the COVID-19 booster dose in Peru. Material and Methods: Cross-sectional study, using virtual and physical surveys of adults with two or more doses of COVID-19 vaccine, where the dependent variable was the intention to be vaccinated (IBV) with the booster dose. We calculated prevalence ratios with 95% confidence intervals, using generalized linear models of the Poisson family with robust varying, determining associations between sociodemographic, clinical, and booster dose perception variables. Results: Data from 924 adults were analyzed. The IBV of the booster doses was 88.1%. A higher prevalence was associated with being male (aPR = 1.05; 95% CI [1.01-1.10]), having a good perception of efficacy and protective effect (PR = 3.69; 95% CI [2.57-5.30]) and belonging to the health sector (PR = 1.10; 95% CI [1.04-1.16]). There was greater acceptance of the recommendation of physicians and other health professionals (aPR = 1.40; 95% CI [1.27-1.55]). Conclusions: Factors associated with higher IBV with booster dose include male gender, health sciences, physician recommendation, and good perception of efficacy.

Self-reported side effects of COVID-19 vaccines among health professions students in India.

Studies focusing on the safety and common side effects of vaccines play a crucial role in enhancing public acceptance of vaccination. Research is scarce regarding the usage of COVID-19 vaccines and the side effects experienced by health professions students in India and other countries. This study aimed to document self-reported side effects associated with COVID-19 vaccination among medical and dental students of six medical and dental colleges and teaching hospitals in four states (Tamil Nadu, Madhya Pradesh, Gujarat, and West Bengal) of India. A cross-sectional survey using purposive sampling of medical and dental students was conducted from 26 April to 26 May 2021. Data was collected using a Google Forms questionnaire capturing information regarding receiving COVID-19 vaccines, side effects and symptoms, onset and duration of symptoms, use of treatment to alleviate symptoms, awareness of haematologic risks associated with vaccination, and side effects from previous (non-COVID-19) vaccinations. The majority (94.5%) of participants received both doses of the Covishield/AstraZeneca COVID-19 vaccine. Among participants (n = 492), 45.3% (n = 223) reported one or more side effects. The most frequently reported side effects were soreness of the injected arm (80.3%), tiredness (78.5%), fever (71.3%), headache (64.1%), and hypersomnia (58.7%). The two most common severe symptoms were fever (14.8%) and headache (13%). Most side effects appeared on the day of vaccination: soreness of the injection site (57%), fever (43.1%), and tiredness (42.6%). Most reported symptoms persisted for one to three days-soreness of the injection site (53%), fever (47.1%), and headache (42.6%). Logistic regression showed that women were almost 85% less likely to report side effects. The study's findings corroborate the safety of the Covishield/AstraZeneca vaccine's first dose, evidenced by the relatively minor and transient nature of the side effects. However, the study underscores the necessity for ongoing research to assess the long-term impacts of COVID-19 vaccines, especially in the context of booster doses, thereby contributing to the global understanding of vaccine safety and efficacy.

An unexpected IgE anti-receptor binding domain response following natural infection and different types of SARS-CoV-2 vaccines

Humoral response to SARS-CoV-2 has been studied, predominantly the classical IgG and its subclasses. Although IgE antibodies are typically specifc to allergens or parasites, a few reports describe their production in response to SARS-CoV-2 and other viruses. Here, we investigated IgE specifc to receptor binding domain (RBD) of SARS-CoV-2 in a Brazilian cohort following natural infection and vaccination. Samples from 59 volunteers were assessed after infection (COVID-19), primary immunization with vectored (ChAdOx1) or inactivated (CoronaVac) vaccines, and booster immunization with mRNA (BNT162b2) vaccine. Natural COVID-19 induced IgE, but vaccination increased its levels. Subjects vaccinated with two doses of ChAdOx1 exhibited a more robust response than those immunized with two doses of CoronaVac; however, after boosting with BNT162b2, all groups presented similar IgE levels. IgE showed intermediate-to-high avidity, especially after the booster vaccine. We also found IgG4 antibodies, mainly after the booster, and they moderately correlated with IgE. ELISA results were confrmed by control assays, using IgG depletion by protein G and lack of reactivity with heterologous antigen. In our cohort, no clinical data could be associated with the IgE response. We advocate for further research on IgE and its role in viral immunity, extending beyond allergies and parasitic infections. (AU)

Distinctions between survivors and non-survivors with SARS-CoV-2 vaccine-induced thrombotic thrombocytopenia: A systematic review and meta-analysis.

Vaccine-inducing immune thrombocytopenia, thrombosis, and bleeding emerge as infrequent and potential complications with mortality risk in healthy subjects. However, differences between survivors and non-survivors with SARS-CoV-2 vaccine-induced thrombotic thrombocytopenia (VITT) are unclear. Methods: According to the PRISMA statement, we conducted a systematic review and meta-analysis, and the protocol was registered in PROSPERO. The main objective is to identify differences among survivors and non-survivors of SARS-CoV-2 VITT patients. We systematically searched through PubMed, Scopus, and Web of Science. We included cohorts, case series, and case reports. We classified bleeding complications according to the ISTH definition. Statistics: unpaired Student's t-test or one-way ANOVA, Wilcoxon, and Kruskal-Wallis. Results: We systematically searched from January 2021 to June 2021 and identified 51 studies that included 191 patients. Non-survivors had the most severe thrombocytopenia (p 0.02) and lower fibrinogen measurements (p 0.01). Subjects vaccinated with mRNA vaccines (BNT162b2 and mRNA-1273) had an earlier onset of adverse events following immunization (p 0.001). We identified a higher trend of overall thrombotic events (p 0.001) in recipients of viral mechanism-dependent vaccines (Table 2). Non-survivors with cerebral venous sinus thrombosis (CVST) had more severe thrombocytopenia (p 0.01) than survivors with CVST. Finally, 61 % of survivors and 50 % with thrombosis received heparin. Conclusion: We identified more severe thrombocytopenia, lower fibrinogen measurements, and a higher trend of overall thrombotic events, including CVST and thrombotic storm, particularly with viral mechanisms-dependent vaccines in non-survivors VITT patients.

COVID-19 vaccine confidence in the post-vaccination era: Perceptions among adults with immune-mediated inflammatory diseases.

Objective: Assess the perceived protection afforded by a range of COVID-19 vaccines in immune-mediated inflammatory diseases patients previously vaccinated against SARS-CoV-2. Study design: Survey. Methods: On-line cross-sectional survey aimed at evaluating the perceived protection (and its determinants) afforded by a range of COVID-19 vaccines among immune-mediated inflammatory diseases previously vaccinated for COVID-19. Results: Out of 493 eligible respondents who lived in Brazil, 397 (80.5%) were confident that their primary vaccination series would protect them against severe COVID-19. In multivariate analysis, only overlapping immune-mediated inflammatory diseases remained (negatively) associated with the perception of protection. Conclusions: No influence was found between COVID-19 vaccine types and the perception of protection after initial vaccinations.

Side Effects of COVID-19 Vaccines in Pregnant and Lactating Mexican Women and Breastfed Infants: A Survey-Based Study.

COVID-19 vaccines' safety has been extensively studied; however, further analysis is required in pregnant women, nursing mothers, and breastfed infants. Our aim was to compare the extension and severity of self-reported COVID-19 vaccine side effects in pregnant and breastfeeding women, and breastfed infants. In this cross-sectional study, COVID-19-vaccinated subjects were enrolled using an online survey in Mexico. Women were classified by pregnancy and breastfeeding status at the time of vaccination (n = 3167). After the first or only dose, there was a trend toward fewer systemic effects in pregnant women (p = 0.06). BNT162b2 (Pfizer-BioNTech) had a higher frequency of local symptoms in pregnancy. Lactating women experienced fewer local symptoms after the first or single dose (p = 0.04) and the opposite occurred after the second dose (p = 0.001). ChAdOx1 (AstraZeneca) increased the chances of developing both local and systemic symptoms after the first dose but decreased them after the second dose. The severity was similar across groups, although the result of lack of association in pregnancy requires studies with a larger sample size. Irritability was the most reported symptom in breastfed infants. This study contributes to the knowledge about the side effects in pregnant and lactating women, and breastfed babies.

Henoch-Schönlein purpura in a 6-year-old boy after initial COVID-19 vaccination.

The COVID-19 pandemic has significantly impacted global health, and the widespread immunization of adults against SARS-CoV-2 has played a pivotal role in altering the course of the disease. While COVID-19 vaccine adverse events are generally uncommon and mild, the recent vaccination of the pediatric population has emphasized the need for vigilance and reporting of potential side effects. In this case report, we present a 6-year-old boy who developed Henoch-Schönlein purpura following the administration of the first dose of Pfizer-BioNTech BNT16B2b2 mRNA COVID-19 vaccine, making it the earliest reported case of such an adverse event. Our report highlights the importance of continued monitoring and reporting of adverse events in pediatric patients receiving the COVID-19 vaccine, as well as the need for prompt diagnosis and management of potential vaccine-related complications.

Conocimiento, actitudes y prácticas de mujeres gestantes respecto a la vacunación / Knowledge, attitudes and practices of pregnant women regarding vaccination

INTRODUCCIÓN: La vacunación durante el embarazo ha demostrado ser una medida segura y efectiva que protege a la mujer gestante y al feto contra enfermedades inmunoprevenibles. OBJETIVO: Determinar los conocimientos, actitudes y prácticas de mujeres gestantes respecto a la vacunación en el marco de la pandemia por el virus SARS-CoV-2. MATERIALES Y MÉTODOS: Estudio observacional de corte transversal realizado en Instituciones Prestadoras de Servicios de Salud Públicas de los 19 municipios de Casanare, Colombia, entre enero y marzo de 2022. Los datos se recolectaron mediante un instrumento de medición documentado que incluyó 22 ítems agrupados en cuatro secciones: datos sociodemográficos, conocimiento, actitudes y prácticas sobre vacunación. RESULTADOS: La media de puntuación de conocimientos fue 5,9 (DE 1,9) de un máximo de 10. El 93,7% cree que la vacunación es realmente necesaria durante el embarazo. Los factores asociados al nivel adecuado de conocimiento incluyeron el grupo de edad entre 26-30 años (OR: 2,27; IC 95%: 1,21-4,25; p = 0,011), estar en el tercer trimestre de embarazo (OR: 2,37; IC 95%: 1,12-5,01; p = 0,024) y contar con un nivel educativo básico, medio o superior (OR: 10,45; IC 95%: 2,37-46,03; p = 0,002). CONCLUSIÓN: Es esencial fortalecer las estrategias de información, educación y comunicación, para promover la vacunación segura durante el embarazo.

BACKGROUND: Vaccination during pregnancy has proven to be a safe and effective measure that protects pregnant woman and the fetus against immuno-preventable diseases. AIM: To determine the knowledge, attitudes and practices of pregnant women regarding vaccination in the context of the SARS-CoV-2 pandemic. METHODS: A cross-sectional observational study was conducted at public health care institutions in the 19 municipalities of Casanare, Colombia, from January to March 2022. Data were collected using a documented measurement instrument that included 22 items grouped into four sections: sociodemographic data, knowledge, attitudes and practices about vaccination. RESULTS: The mean knowledge score was 5.9 (SD: 1.9) of a maximun of 10; 93.7% believed that vaccination was really necessary during pregnancy. Factors associated with adequate level of knowledge included age group 26-30 years (OR: 2.27; 95% CI: 1.21-4.25; p = 0.011), being in the third trimester of pregnancy (OR: 2.37; 95% CI: 1.12-5.01; p = 0.024) and having basic, intermediate or higher education (OR: 10.45; 95% CI: 2.37-46.03; p = 0.002). CONCLUSIONS: It is essential to strengthen information, education and communication strategies to promote safe vaccination during pregnancy.

The COVID-19 epidemic curve and vaccine acceptance among patients with rheumatic diseases: an ecological study.

The attitudes toward emerging COVID-19 vaccines have been of great interest worldwide, especially among vulnerable populations such as patients with rheumatic and musculoskeletal diseases (RMDs). The aim of this study was to analyze the relationship between the nationwide number of COVID-19 cases and deaths, and vaccine acceptance or hesitancy of patients with RMDs from four patient care centers in Mexico. Furthermore, we explored differences in acceptance according to specific diagnoses: rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). This ecological study was a secondary analysis of a cross-sectional study using a validated questionnaire to measure vaccine acceptance. We generated a global Likert scale to evaluate overall attitudes toward the COVID-19 vaccine. We analyzed data from 1336 patients from March to September 2021: 85.13% (1169) were women, with a mean age of 47.87 (SD 14.14) years. The most frequent diagnoses were RA (42.85%, 559) and SLE (27.08%, 393). 635(47.52%) patients were unvaccinated, 253(18.93%) had one dose and 478(35.77%) had two doses. Of all participating patients, 94% were accepting toward the COVID-19 vaccine. Vaccine acceptance remained consistently high throughout the study. However, differences in vaccine acceptance are identified when comparing diagnoses. The peak of the national epidemic curve coincided with an increase in hesitancy among patients with RA. Contrastingly, patients with SLE became more accepting as the epidemic curve peaked. Mexican patients show high acceptance of the COVID-19 vaccine, influenced in part by a patient's specific diagnosis. Furthermore, vaccine acceptance increased mirroring the curve of COVID-19 cases and deaths in the country. This should be taken into consideration when updating recommendations for clinical practice.

Antibody response dynamics to CoronaVac vaccine and booster immunization in adults and the elderly: A long-term, longitudinal prospective study.

Background: The long-term humoral immune response after vaccination varies between vaccines and is dependent on the accuracy of the antibody test. A better understanding of the vaccine immune response may help to define vaccination strategies against coronavirus disease 2019 (COVID-19). Objective: To investigate the long-term immunological response to CoronaVac vaccine and determinants of breakthrough COVID-19 infection. Methods: A long-term, prospective cohort study involving vaccinated adult and elderly subjects was conducted to investigate the presence of anti-RBD-specific immunoglobulin (Ig)G, anti-nucleocapsid IgG and anti-spike trimeric protein IgG. Antibody level dynamics and risk factors associated with breakthrough COVID-19 infection were investigated. Results: In total, 3902 participants were included in this study. Vaccination with two doses of CoronaVac and a booster dose increased the levels of anti-RBD-specific IgG, anti-nucleocapsid IgG and anti-spike trimeric IgG significantly. In adults, anti-nucleocapsid IgG and anti-spike trimeric IgG levels decreased significantly 7 months after the second dose. In adults and the elderly, the levels of anti-spike trimeric IgG and anti-RBD IgG decreased significantly 4 and 6 months after the booster dose, respectively. Previous exposure to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and anti-spike trimeric IgG titres was independently associated with a lower probability of post-vaccination infection. Conclusions: A significant increase in antibody levels was found after two doses of CoronaVac and a booster dose. Antibody titres declined significantly 7 months post-vaccination in participants who did not receive a booster dose. Higher levels of antibodies and previous SARS-CoV-2 infection were associated with protection against breakthrough COVID-19.

Clinical Characteristics and Outcomes among Vaccinated and Unvaccinated Patients with Cardiovascular Disease Who Were Hospitalized for COVID-19 in Brazil: Retrospective Cohort.

INTRODUCTION: COVID-19 in Brazil has already caused, and it still causes, several impacts on health, economy, and education. The risk factors for death involved those with cardiovascular diseases (CVD), which were prioritized for the vaccination of COVID-19. OBJECTIVE: To investigate the clinical characteristics and outcomes between vaccinated and unvaccinated patients with cardiovascular diseases hospitalized for COVID-19 in Brazil in the year 2022. METHODS: A retrospective cohort was analyzed from the year 2022, with cases being hospitalized by COVID-19 being drawn from SIVEP-GRIPE surveillance. We compared clinical characteristics, comorbidities, and outcomes between CVD carriers and non-carriers, and we also compared vaccinated with two doses vs. those that are unvaccinated in CVD carriers. We performed chi-square, odds ratio, logistic regression, and survival analysis. RESULTS: We included, in the cohort, 112,459 hospital inpatients. An amount of 71,661 (63.72%) of the hospitalized patients had CVD. Regarding deaths, 37,888 (33.69%) died. Regarding vaccination against COVID-19, 20,855 (18.54%) people were not vaccinated with any dose among those with CVD. Death p- < 0.001 (OR 1.307-CI 1.235-1.383) and fever p- < 0.001 (OR 1.156-CI 1.098-1.218) were associated with the unvaccinated CVD carriers, and diarrhea p-0.015 (OR 1.116-CI 1.022-1.218), dyspnea p-0.022 (OR 1.074-CI 1.011-1.142), and respiratory distress p-0.021 (OR 1.070-CI 1.011-1.134) were also recorded. Those patients who possessed predictors of death, including invasive ventilation (p- < 0.001 (OR 8.816-CI 8.313-9.350)), were admitted to the ICU p- < 0.001 (OR 1.754-CI 1.684-1.827), and some had respiratory distress p- < 0.001 (OR 1.367-CI 1.312-1.423), dyspnea p < 0.001 (OR 1.341-CI 1.284-1.400), O2 saturation < 95% p- < 0. 001 (OR 1.307-CI 1.254-1.363), they were unvaccinated against COVID-19 p- < 0.001 (OR 1.258-CI 1.200-1.319), they were of male sex p- < 0.001 (OR 1.179-CI 1.138-1.221), they had diarrhea p-0.018 (OR 1.081-CI 1.013-1.154), and they may have been old p < 0.001 (OR 1.034-CI 1.033-1.035). Survival was shorter for the unvaccinated p-0.003, and p- <0.001. CONCLUSIONS: We highlight the predictors of death for those unvaccinated against COVID-19 in this research, and we evidenced the benefits of the COVID-19 vaccine in reducing deaths in hospitalized CVD patients.

Facial fat necrosis after autologous fat transfer possibly associated with SARS-CoV-2 vaccine.

A 52-year-old female patient developed facial fat necrosis presenting with cutaneous induration three weeks after minimal access cranial suspension (MACS) lift with autologous fat grafting from the abdomen. Given that the patient received the Moderna SARS-CoV-2 vaccine one week after surgery, we hypothesize that the former predisposed her to tissue ischemia leading to fat necrosis. Histological findings after biopsy were consistent with fat necrosis, which included marked dermal fibrosis with areas of focal fat necrosis, lipophages, multinucleated giant cells, and siderophages. It is our hope that documenting this rare development in literature may serve as encouragement for adverse effect reporting after the SARS-CoV-2 vaccine administration and may boost inspection and monitoring of other health consequences by regulating agencies.

Effect of religious fatalism and concern about new variants on the acceptance of COVID-19 vaccines.

Introduction: To protect public health, it is important that the population be vaccinated against COVID-19; however, certain factors can affect vaccine acceptance. Objective: The objective of this study was to determine whether religious fatalism and concern about new variants have a significant effect on the acceptance of COVID-19 vaccines. Methodology: An explanatory study was conducted with 403 adults of legal age captured through non-probabilistic convenience sampling in vaccination centers in the 13 health networks of the Regional Health Directorate of Puno, Peru. Data were collected through a brief scale of religious fatalism, a scale of acceptance of vaccines against COVID-19 and a scale of concern about a new variant of COVID-19. Results: The proposed model obtained an adequate fit. There was a negative effect of religious fatalism on vaccine acceptance, a positive effect of fatalism on vaccine rejection, a positive effect of concern about new variants on the acceptance of vaccines, and a positive effect of concern about new variants on vaccine rejection. Conclusion: These findings provide evidence for the usefulness of considering both religious fatalism and concern about new variants affect the intention to receive the COVID-19 vaccine in adults in southern Peru.

Determinants of the Attitude to COVID-19 Vaccine in Lima-Peru: Path Analysis and Structural Regression.

Introduction: Research on the effects of COVID-19 has shown that a favorable attitude toward the COVID-19 vaccine would help reduce the pandemic's sequelae and avoid lethal variants. Objective: A theoretical model was tested through the strategy of path analysis and structural equation modeling, seeking to evaluate the direct effect of neuroticism and the indirect effects of risk-avoidance and rule-following behaviors, mediated by attitudes toward science. Methods: A total of 459 adults, mostly women (61%), mean age 28.51 (SD = 10.36), living in Lima (Peru), participated. The scales of neuroticism, risk avoidance behavior (RAB), norm following (NF), attitudes toward science, and attitudes toward vaccination were administered. Results: The path analysis explained 36% of the variance in vaccine attitude, whereas the latent structural regression model achieved a 54% explanation; according to this model attitude toward science (ß=.70, p < .01) and neuroticism (ß=-.16, p < .01) are significant predictors of vaccine attitude. Likewise, risk avoidance behavior and rule-following have indirect effects on attitudes toward vaccination. Conclusion: Low neuroticism and a positive attitude toward the science that mediates the effects of RAB and NF directly condition the possibility of vaccination against COVID-19 in the adult population.

Lipschütz acute vulvar ulcer related to COVID-19 vaccination: First case report in South America.

Lipschütz ulcer is a non-sexually transmitted genital lesion of unknown etiology, which presents as a painful vulvar ulcer. Lipschütz ulcers have been described in most continents. This is the first case reported in Peru and South America. We present the case of a 33-year-old female patient with a Lipschütz ulcer after being vaccinated with the second dose of the AstraZeneca COVID-19 vaccine. She reported having had only one sexual partner in her lifetime. Laboratory results were negative for herpes simplex 2, Cytomegalovirus, Toxoplasma gondii, Epstein-Barr virus, and syphilis. The patient received symptomatic treatment. Ten days after the onset, the patient was significantly better during follow-up. This case report displays a potential adverse effect of the AstraZeneca COVID-19 vaccine as a Lipschütz ulcer triggered by the host humoral immune response. However, further research is needed to establish the causal relationship between these two.

La úlcera de Lipschütz es una lesión genital no transmitidas por vía sexual de etiología desconocida, se presenta como una úlcera vulvar muy dolorosa. Las úlceras de Lipschütz se han descrito en la mayoría de los continentes. Este es el primer caso que se reporta en Perú y Sudamérica. En este reporte de caso se presentauna paciente de 33 años con una úlcera de Lipschütz luego de haber sido vacunada con la segunda dosis de la vacuna AstraZeneca COVID-19. Refirió haber tenido una sola pareja sexual a lo largo de su vida. Los resultados de laboratorio fueron negativos para herpes simplex 2, Citomegalovirus, Toxoplasma gondii, virus de Epstein-Barr y sífilis. La paciente recibió tratamiento sintomático. Diez días después, durante el seguimiento, la paciente estaba significativamente mejor. Este reporte de caso expone un potencial efecto adverso de la vacuna AstraZeneca COVID-19, en forma de úlcera de Lipschütz, desencadenado por la respuesta inmune humoral del huésped. Sin embargo, es necesario realizar más investigación para establecer la relación causal entre ambos.

Lipschütz acute vulvar ulcer related to COVID-19 vaccination: first case report in South America / Úlcera vulvar aguda de Lipschütz relacionada con la vacunación por COVID-19: primer caso notificado en Sudamérica

Lipschütz ulcer is a non-sexually transmitted genital lesion of unknown etiology, which presents as a painful vulvar ulcer. Lipschütz ulcers have been described in most continents. This is the first case reported in Peru and South America. We present the case of a 33-year-old female patient with a Lipschütz ulcer after being vaccinated with the second dose of the AstraZeneca COVID-19 vaccine. She reported having had only one sexual partner in her lifetime. Laboratory results were negative for herpes simplex 2, Cytomegalovirus, Toxoplasma gondii, Epstein-Barr virus, and syphilis. The patient received symptomatic treatment. Ten days after the onset, the patient was significantly better during follow-up. This case report displays a potential adverse effect of the AstraZeneca COVID-19 vaccine as a Lipschütz ulcer triggered by the host humoral immune response. However, further research is needed to establish the causal relationship between these two.

La úlcera de Lipschütz es una lesión genital no transmitidas por vía sexual de etiología desconocida, se presenta como una úlcera vulvar muy dolorosa. Las úlceras de Lipschütz se han descrito en la mayoría de los continentes. Este es el primer caso que se reporta en Perú y Sudamérica. En este reporte de caso se presentauna paciente de 33 años con una úlcera de Lipschütz luego de haber sido vacunada con la segunda dosis de la vacuna AstraZeneca COVID-19. Refirió haber tenido una sola pareja sexual a lo largo de su vida. Los resultados de laboratorio fueron negativos para herpes simplex 2, Citomegalovirus, Toxoplasma gondii, virus de Epstein-Barr y sífilis. La paciente recibió tratamiento sintomático. Diez días después, durante el seguimiento, la paciente estaba significativamente mejor. Este reporte de caso expone un potencial efecto adverso de la vacuna AstraZeneca COVID-19, en forma de úlcera de Lipschütz, desencadenado por la respuesta inmune humoral del huésped. Sin embargo, es necesario realizar más investigación para establecer la relación causal entre ambos.

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial.

Background: SOBERANA-02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phases 1/2 clinical trials demonstrated high immunogenicity, promoting neutralising IgG and specific T-cell response. A third heterologous dose of SOBERANA-Plus (RBD-dimer) further increased neutralising antibodies. The aim of this study is to evaluate the safety and efficacy of two immunisation regimes: two doses of SOBERANA-02 and a heterologous three-dose combination with SOBERANA-Plus added to it. Methods: From March 8th to June 24th, 2021 we conducted in Havana, Cuba a multicentre randomised, double-blind, placebo-controlled, phase-3 trial evaluating a two doses SOBERANA-02 scheme and a heterologous scheme with one dose SOBERANA-Plus added to it (RPCEC00000354). Participants 19-80 years were randomly assigned to receiving 28 days apart either the two or three dose scheme or placebo. The main endpoint was vaccine efficacy in preventing the occurrence of RT-PCR confirmed symptomatic COVID-19 at least 14 days after the second or third dose in the per-protocol population. We also assessed efficacy against severe disease and, in all participants receiving at least one vaccine/placebo dose, safety for 28 days after each dose. Findings: We included 44,031 participants (52.0% female, 48.0% male; median age 50 years, range 19-80 years; 7.0% black, 24.0% mixed-race, 59.0% white) in a context of initial Beta VOC predominance, with this variant being partially replaced by Delta near the trial's end. Vaccine efficacy in the heterologous combination was 92.0% (95%CI 80.4-96.7) against symptomatic disease. There were no severe COVID-19 cases in the vaccine group against 6 in the placebo group. Two doses of SOBERANA-02 was 69.7% (95%CI 56.5-78.9) and 74.9% (95%CI 33.7-90.5) efficacious against symptomatic and severe COVID-19, respectively. The occurrence of serious and severe adverse events (AE) was very rare and equally distributed between placebo and vaccine groups. Solicited AEs were slightly more frequent in the vaccine group but predominantly local and mostly mild and transient. Interpretation: Our results indicate that the straightforward to manufacture SOBERANA vaccines are efficacious in a context of Beta and Delta VOC circulation, have a favourable safety profile, and may represent an attractive option for use in COVID-19 vaccination programmes. Funding: This study received funds from the National Fund for Science and Technology (FONCI-CITMA-Cuba, contract 2020-20) of the Ministry of Science, Technology and Environment of Cuba.