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Introduction: COVID-19 is associated with higher morbimortality in pregnant people compared with non-pregnant people. At present, the benefits of maternal immunisation are considered to outweigh the risks, and therefore, vaccination is recommended during pregnancy. However, additional information is needed on the safety of the vaccines in this population., Methods and Analysis: This a retrospective cohort nested case-control study in pregnant people who attended maternity hospitals from eight Latin American and Caribbean countries. A perinatal electronic clinical history database with neonatal and obstetric information will be used. The proportion of pregnant people immunised with COVID-19 vaccines of the following maternal and neonatal events will be described: preterm infant, small for gestational age, low birth weight, stillbirth, neonatal death, congenital malformations, maternal near miss and maternal death. Moreover, the risk of prematurity, small for gestational age and low birth weight associated with exposure to COVID-19 vaccines will be estimated. Each case will be matched with two groups of three randomly selected controls. Controls will be matched by hospital and mother's age (±3 years) with an additional matching by delivery date and conception time in the first and second control groups, respectively. The estimated required sample size for the main analysis (exposure to any vaccine) concerning 'non-use' is at least 1009 cases (3027 controls) to detect an increased probability of vaccine-associated event risk of 30% and at least 650 cases (1950 controls) to detect 30% protection. Sensitivity and secondary analyses considering country, type of vaccine, exposure windows and completeness of immunisation will be reported., Ethics: The study protocol was reviewed by the Ethical Review Committee on Research of the Pan American Health Organization. Patient informed consent was waived due to the retrospective design and the utilisation of anonymised data (Ref. No: PAHOERC.0546.01). Results will be disseminated in open access journals., Competing Interests: Competing interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© World Health Organization 2024. Licensee BMJ.)

Objective: This study aimed to describe the results of inspection of clinical trials (CTs) and the feasibility of conducting inspections virtually in Peruvian Social Security hospitals during the pandemic of COVID-19., Methods: This study described 25 CTs that were inspected during August 2021-November 2021. The data for the variables were obtained from the CT inspection database of the Social Security Sub-directorate of Regulation and Management of Health Research which includes minutes and inspection reports. We describe the characteristics of the CT included and findings during the inspections using relative and absolute frequencies. Likewise, we evaluated the feasibility of virtual inspection through a self-administered questionnaire., Results: According to the findings of the inspection, 60% of CTs were on biological products, and 60% were focused on infectiology. Additionally, 64% of CTs were implemented in Lima, 52% were conducted in level IV health facilities, and 72% were funded by the pharmaceutical sector. The lack of submission of requested documents (16/25) and inadequate access to the internet (9/15) and source documents (4/15) were the primary observations during the inspection. Regarding the feasibility of virtual supervisions, most interviewees rated their understanding of instruction form as "normal" and its content as "adequate." Similarly, in the virtual self-assessment matrix, a large proportion of interviewees rated comprehension as "normal" (7/15) and its content as "adequate" (13/15). The quality of the virtual supervision process was 8.6 ± 1.1 on a scale of 1-10., Conclusion: Discrepancies in records and failure to submit requested documents were the main observations. Most interviewees considered the material to be adequate and gave an overall good rating to the virtual inspection process., (© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Objective: To estimate the prevalence of post-vaccination seropositivity against SARS-CoV-2 and identify its predictors in Peruvian Social Health Insurance (EsSalud) personnel in 2021., Methods: We conducted a cross-sectional study in a representative simple stratified sample of EsSalud workers. We evaluated IgG anti-SARS-CoV-2 antibodies response (seropositivity) by passive (previous infection) and active immunization (vaccination), and epidemiological and occupational variables obtained by direct interview and a data collection form. Descriptive and inferential statistics were used with correction of sample weights adjusted for non-response rate, and crude and adjusted odds ratio (OR) and geometric mean ratio (GMR) with their respective 95% confidence intervals (95%CI) were estimated., Results: We enrolled 1077 subjects. Seropositivity was 67.4% (95%CI: 63.4-71.1). Predictors of seropositivity were age (negative relation; p < 0.001), previous infection (aOR = 11.7; 95%CI: 7.81-17.5), working in COVID-19 area (aOR = 1.47; 95%CI: 1.02-2.11) and time since the second dose. In relation to antibody levels measured by geometric means, there was an association between male sex (aGMR = 0.77; 95%CI: 0.74-0.80), age (negative relation; p < 0.001), previous infection (aGMR = 13.1; 95%CI:4.99-34.40), non-face-to-face/licensed work modality (aGMR = 0.78; 95%CI: 0.73-0.84), being a nursing technician (aGMR = 1.30; 95%CI: 1.20-1.41), working in administrative areas (aGMR = 1.17; 95%CI: 1.10-1.25), diagnostic support (aGMR = 1.07; 95%CI: 1.01-1.15), critical care (aGMR = 0.85; 95%CI: 0.79-0.93), and in a COVID-19 area (aGMR = 1.30; 95%CI: 1.24-1.36) and time since receiving the second dose (negative relation; p < 0.001)., Conclusions: Seropositivity and antibody levels decrease as the time since receiving the second dose increases. Older age and no history of previous infection were associated with lower seropositivity and antibody values. These findings may be useful for sentinel antibody surveillance and the design of booster dose strategies., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objectives.: To evaluate the association between allergic rhinitis and the degree of pulmonary involvement in patients with COVID-19 and to determine the frequencies of the main variables., Materials and Methods.: An observational, cross-sectional and analytical study was carried out by reviewing the medical records of patients diagnosed with COVID-19 from the Cayetano Heredia National Hospital between 2020 and 2021. We obtained information regarding the history of allergic rhinitis; pulmonary involvement was assessed by non-contrast tomography results using the chest computed tomography (CT) score. Data regarding sociodemographic and clinical variables was also obtained. Both crude (PR) and adjusted (aPR) prevalence ratios with their respective 95% confidence intervals (CI) were estimated. We also used a generalized linear Poisson family model with log link function and robust variances., Results.: We evaluated 434 patients, who were mostly male, older than 60 years and had no relevant medical history. Of these, 56.2% had a history of allergic rhinitis and 43.1% had moderate to severe pulmonary involvement. The adjusted regression model showed that the history of allergic rhinitis reduced the severity of COVID-19 according to the pulmonary involvement assessed by the CT score (aPR: 0.70; 95%CI: 0.56-0.88; p=0.002)., Conclusions.: The history of allergic rhinitis resulted in a 30.0% decrease in COVID-19 severity according to the CT score in hospitalized patients.

Background: Vaccination is an important public health strategy; however, many neurological adverse effects are associated with COVID-19 vaccination, being encephalitis a rare manifestation., Case Presentation: We present the case of a 33-year-old woman who received the first dose of the BBIBP-CorV vaccine against COVID-19 on April 4 and the second dose on April 28, 2021. Three days after receiving the second dose, she experienced a subacute episode of headache, fever, insomnia, and transient episodes of environment disconnection. We obtained negative results for infectious, systemic, and oncological causes. Brain magnetic resonance imaging showed lesions in the bilateral caudate nucleus and nonspecific demyelinating lesions at the supratentorial and infratentorial compartments. The results of the neuronal autoantibodies panel were negative. She had an adequate response to immunoglobulin and methylprednisolone; however, she experienced an early clinical relapse and received a new cycle of immunosuppressive treatment followed by a satisfactory clinical evolution., Conclusions: We report the first case of severe encephalitis associated with BBIBP-CorV (Sinopharm) vaccination in Latin America. The patient had atypical imaging patterns, with early clinical relapse and a favorable response to corticosteroid therapy., (© 2022. The Author(s).)

Background: Booster doses have been described as effective in reducing hospitalizations and deaths from the new variants. However, its coverage is heterogeneous in Latin America and the Caribbean (LAC), one of the regions most affected by the pandemic. We aimed to assess the factors associated with not receiving a coronavirus disease 2019 (COVID-19) vaccine booster dose in adults from LAC., Methods: We analyzed a secondary database compiled by the University of Maryland and Facebook assessing the global impact of COVID-19. We included Facebook users over 18 years of age who resided in LAC and responded to the survey between February 13, 2022, and March 14, 2022. We evaluated sociodemographic characteristics, comorbidities, food, and economic insecurity, mental health, and vaccination-related practices. We calculated crude (cPR) and adjusted (aPR) prevalence ratios with their respective 95% confidence intervals (95%CI)., Results: The sample included 154,841 adults from 20 LAC countries. 33.7% (n = 46,459) reported not receiving the COVID-19 booster vaccine. Being under 75 years old, having a college, high school, pre-university, primary, or lower education, having no or 1 to 2 comorbidities, living in a town, having food insecurity, depressive symptoms, and having had COVID-19, were associated with a higher prevalence of not receiving the booster dose. In contrast, being female or non-binary and having anxiety symptoms were associated with a lower prevalence of not receiving the booster dose., Conclusions: Approximately three out of 10 adults surveyed in LAC reported not having received the booster vaccine. Authorities must design campaigns that promote receiving a booster dose considering the factors found., Competing Interests: Declaration of competing interest The authors declare that they have no competing interests., (Copyright © 2022. Published by Elsevier Ltd.)

Background: The prognostic value of the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) in patients with COVID-19 is rarely described in older adults. We aimed to estimate the prognostic value of NLR and PLR, determining the mortality of adults over 60 years of age hospitalized for COVID-19 in three hospitals in Peru from March to May 2020., Methods: We performed a secondary analysis of data from a retrospective cohort carried out in Lambayeque, Peru, from March 18 to May 13, 2020. Older adults hospitalized for COVID-19 were included. The outcome variable was in-hospital mortality by all causes, while the exposure variable was the NLR and PLR (categorized in tertiles and numerically, performing a logarithmic transformation). We included sociodemographic variables, comorbidities, vital functions, laboratory markers, and treatment received during hospital stay. We evaluated the association between NLR and PLR using the hazard ratio (HR) in a Cox regression model. We estimated HR with their respective 95% confidence intervals (95% CI). We estimated cumulative/dynamic time-dependent ROC curves and reported area under the curve ROC (AUC-ROC) for 15-, 30-, and 60-day mortality with their respective simultaneous confidence intervals (confidence bands (CB)). Also, we estimated an optimal cut-off point based on the maximally selected rank statistics., Results: A total of 262 hospitalized older adults were analyzed, 71.8% ( n = 188) of whom were male with a median age of 70 years (interquartile range: 65-78). The mean NLR and PLR were 16.8 (95% CI: 14.9-18.7; SD: 15.5) and 50.3 (95% CI: 44.6-55.9; SD: 46.3), respectively. The mortality rate was 68.7% (95% CI: 62.7-74.3). The adjusted Cox regression analysis showed that the high NLR (adjusted HR (aHR) = 2.12; 95% CI: 1.43-3.14) and PLR (aHR = 1.90; 95% CI: 1.30-2.79) tertiles were associated with a higher risk of mortality. The maximum AUC-ROC values at 60 days of follow-up for NLR and PLR were 0.713 (95%CB: 0.627-0.800) and 0.697 (95%CB: 0.583-0.754), respectively., Conclusions: The NLR and PLR are predictors of higher risk of mortality, and these results suggest that both could be reliable and practical markers for the identification of older adults at high risk of mortality by COVID-19. NLR and PLR have prognostic value, with an AUC greater than 0.5; however, by themselves, they are weak prognostic markers. It is important to carry out future studies incorporating these two markers into preexisting models or designing new ones considering them., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Solangel Ortega-Rojas et al.)

During the COVID-19 pandemic, the Pan American Health Organization (PAHO) promoted several activities to strengthen the countries' emergency response. Vaccines represented a breakthrough in the pandemic evolution, even though they have not been equitably distributed. As most vaccines have received emergency authorizations for their timely delivery, vaccine safety surveillance has been highlighted for detecting early signals of potential adverse events following immunization (AEFI, also known as ESAVI). The objective of this article is to share the different steps, methodologies, and preliminary results of a regional policy to strengthen the ESAVI surveillance system in the Americas, including the adoption of HL7 FHIR for health information exchange between countries and PAHO.

Objectives: To estimate the prevalence and factors associated with the intention to be vaccinated (ITV) against COVID-19 in Peru., Materials and Methods: Analytical cross-sectional study using the survey conducted by the University of Maryland, USA, on Facebook. The dependent variable is the ITV. Crude and adjusted prevalence ratios (PR) were calculated, with their 95% confidence intervals (95% CI) using generalized linear models of the Poisson family, in order to evaluate the association of sociodemographic variables, compliance with community mitigation strategies, symptoms of COVID-19, mental health and acceptance of vaccination before the recommendation (AVR) by various actors and health authorities, with the ITV., Results: Data from 17,162 adults were analyzed. The overall prevalence of the ITV was 74.9%. A lower prevalence of the ITV was associated with the female sex (PR=0.95; 95% CI: 0.94-0.97), living in a town (PR=0.95; 95% CI: 0.91-0.99) or village or other rural area (PR=0.90; 95% CI: 0.86-0.93) and the AVR of politicians (PR=0.89; 95% CI: 0.87-0.92). Conversely, having COVID-19 symptoms (PR=1.06; 95% CI: 1.03-1.09), economic insecurity (PR=1.04; 95% CI: 1.01-1.06), fears of becoming seriously ill or that a family member becomes seriously ill from COVID-19 (PR=1.49; 95% CI: 1.36-1.64) and the AVR of family and friends (PR=1.10; 95% CI: 1.08-1.12), healthcare workers (PR=1.29; 95% CI: 1.26-1.32), World Health Organization (PR=1.34; 95% CI: 1.29-1.40) and government officials (PR=1.18; 95% CI: 1.15-1.22) was associated with a higher prevalence of the ITV., Conclusions: Three-quarters of the respondents had the ITV. There are potentially modifiable factors that could improve vaccine acceptance.

Background: Determinants of vaccine acceptance are multifactorial, complex, and in most cases, context-dependent. We determined the prevalence of COVID-19 vaccination intention (VI) and fear of its adverse effects (FAE) as well as their associated factors in Latin America and the Caribbean (LAC)., Methods: We conducted a secondary cross-sectional analysis of a database collected by the University of Maryland and Facebook. We included participants aged 18 and over from LAC surveyed, January 15 to February 1, 2021. We evaluated VI, FAE, sociodemographic characteristics, COVID-19 symptomatology, compliance with community mitigation strategies, food and economic insecurity, mental health evaluation and the influence in VI when recommended by different stakeholders. We calculated crude and adjusted prevalence ratios with their 95%CIs., Results: We analyzed 472,521 responses by Latin American adults, finding a VI and FAE prevalence of 80.0% and 81.2%, respectively. We found that female and non-binary genders were associated with a lower probability of VI and a higher probability of FAE. Besides, living in a town, village or rural area and economic insecurity was associated with a higher FAE probability. The fears of becoming seriously ill, a family member becoming seriously ill from COVID-19 and having depressive symptoms were associated with a higher probability of VI and FAE., Conclusion: Eight out of 10 adults in LAC have VI and FAE. The factors identified are useful for the development of communication strategies to reduce FAE frequency. It is necessary to guarantee mass vaccination and support the return of economic activities., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Peru was one of the countries with the highest COVID-19 mortality worldwide during the first stage of the pandemic. It is then relevant to evaluate the risk factors for mortality in patients hospitalized for COVID-19 in three hospitals in Peru in 2020, from March to May, 2020.  Methods: We carried out a retrospective cohort study. The population consisted of patients from three Peruvian hospitals hospitalized for a diagnosis of COVID-19 during the March-May 2020 period. Independent sociodemographic variables, medical history, symptoms, vital functions, laboratory parameters and medical treatment were evaluated. In-hospital mortality was assessed as the outcome. We performed Cox regression models (crude and adjusted) to evaluate risk factors for in-hospital mortality. Hazard ratios (HR) with their respective 95% confidence intervals (95% CI) were calculated.  Results: We analyzed 493 hospitalized adults; 72.8% (n=359) were male and the mean age was 63.3 ± 14.4 years. COVID-19 symptoms appeared on average 7.9 ± 4.0 days before admission to the hospital, and the mean oxygen saturation on admission was 82.6 ± 13.8. While 67.6% (n=333) required intensive care unit admission, only 3.3% (n=16) were admitted to this unit, and 60.2% (n=297) of the sample died. In the adjusted regression analysis, it was found that being 60 years old or older (HR=1.57; 95% CI: 1.14-2.15), having two or more comorbidities (HR=1.53; 95% CI: 1.10-2.14), oxygen saturation between 85-80% (HR=2.52; 95% CI: 1.58-4.02), less than 80% (HR=4.59; 95% CI: 3.01-7.00), and being in the middle (HR=1.65; 95% CI: 1.15-2.39) and higher tertile (HR=2.18; 95% CI: 1.51-3.15) of the neutrophil-to-lymphocyte ratio, increased the risk of mortality.  Conclusions: The risk factors found agree with what has been described in the literature and allow the identification of vulnerable groups in whom monitoring and early identification of symptoms should be prioritized in order to reduce mortality., Competing Interests: No competing interests were disclosed., (Copyright: © 2021 Díaz-Vélez C et al.)