RESUMEN
Background COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern. Methods We conducted a global Phase 3, multi-stage efficacy study (NCT04904549) among adults aged [≥]18 years. Participants were randomized 1:1 to receive two intramuscular injections 21 days apart of a bivalent SARS-CoV-2 recombinant protein vaccine with AS03-adjuvant (5 g of ancestral (D614) and 5 g of B.1.351 [beta] variant spike protein) or placebo. Symptomatic COVID-19 was defined as laboratory-confirmed COVID-19 with COVID-19-like illness (CLI) symptoms. The primary efficacy endpoint was the prevention of symptomatic COVID-19 [≥]14 days after the second injection. Results Between 19 Oct 2021 and 15 Feb 2022, 12,924 participants received [≥]1 study injection. 75% of participants were SARS-CoV-2 non-naive. 11,416 participants received both study injections (efficacy-evaluable population [vaccine, n=5,736; placebo, n=5,680]). Up to 15 March 2022, 121 symptomatic COVID-19 cases were reported (32 in the vaccine group and 89 in the placebo group) [≥]14 days after the second injection with a vaccine efficacy (VE) of 64.7% (95% confidence interval [CI] 46.6; 77.2%). VE was 75.1% (95% CI 56.3; 86.6%) in non-naive and 30.9% (95% CI -39.3; 66.7%) in naive participants. Viral genome sequencing identified the infecting strain in 68 cases (Omicron [BA.1 and BA.2 subvariants]: 63; Delta: 4; Omicron and Delta: 1). The vaccine was well-tolerated and had an acceptable safety profile. Conclusions A bivalent vaccine conferred heterologous protection against symptomatic infection with newly emergent Omicron (BA.1 and BA.2) in non-naive adults 18-59 years of age. ClinicalTrials.gov: NCT04904549
RESUMEN
ABSTRACT Introduction: Osteoporosis is a public health problem. However, there is still a lack of data in Colombia on the characteristics of patients with osteoporosis. Objectives: This study aims to characterize the population with osteoporosis without previous diagnosis. Materials and methods: Observational, retrospective, descriptive study in patients with osteoporosis. Patients diagnosed between 2014 and 2017 were included. The information was obtained from the patient medical records and the densitometry results. Results: Most (92.2%) of the patients came from Medellín, and the rest from Cali. The mean age of the population was 65.1 years (SD: 9.97). As regards the history of fracture, it was reported that 12.0% had suffered from vertebral fractures, 2.3% had a history of fracture in the distal radius, 2.8% in the femoral neck, and 1.4% had had femoral shaft fracture. Bone densitometry showed a mean T-score of -2.90 in the femoral neck; -3.02 in total hip; -3.03 in the lumbar spine, and -3.42 in the 33% radius. In the 602 patients who had a control bone densitometry, an average BMD gain was seen in all the evaluated regions. Conclusions: The present study has enabled the characterizing of patients from 2 Colombian cities with a diagnosis of osteoporosis. The 2 most frequently reported locations for the diagnosis of osteoporosis were lumbar spine and femoral neck. An average BMD gain was also observed.
RESUMEN Introducción: La osteoporosis es un problema de salud pública, sin embargo, en Colombia en la actualidad faltan datos sobre las características de los pacientes con esta enfermedad. Objetivos: Este estudio pretende caracterizar la población con osteoporosis sin diagnóstico previo. Materiales y métodos: Estudio observacional, retrospectivo, descriptivo en pacientes con osteoporosis. Incluyó a pacientes diagnosticados entre el 2014 y el 2017. La información fue obtenida a partir de las historias clínicas de los pacientes y el resultado de la densitometría. Resultados: El 92,2% de los pacientes provenía de Medellín y los restantes de Cali. La edad promedio ± desviación estándar de la población fue 65,1 ± 9,97 arios. En cuanto al antecedente de fractura, se reportó que el 12,0% había presentado fracturas vertebrales, el 2,3% tenía antecedente de fractura en radio distal, el 2,8% en cuello femoral y el 1,4% había tenido fractura de diáfisis femoral. La densitometría ósea (DMO) mostró un T-score promedio de -2,90 en cuello femoral, -3,02 en cadera total, -3,03 en columna lumbar y-3,42 en radio 33%. En los 602 pacientes que contaban con DMO de control se vio una ganancia de la DMO promedio en todas las regiones evaluadas. Conclusiones: El presente estudio permitió caracterizar a pacientes con diagnóstico de osteoporosis en 2 ciudades de Colombia. Las 2 localizaciones más reportadas para el diagnóstico de osteoporosis fueron columna lumbar y cuello femoral; adicionalmente, se observó una ganancia de la DMO promedio.