RESUMO
La vacunación es una forma de contribuir a la protección de la población al reducir el riesgo de efectos graves de la enfermedad COVID-19. Para marzo de 2021, en tiempo récord, la industria biotecnológica cubana contaba con cinco candidatos vacunales. Se realizó una intervención sanitaria con un esquema heterólogo: dos dosis de SOBERANA®02 más una dosis de SOBERANA®Plus, en trabajadores durante el período de marzo a junio de 2021, en el Instituto Finlay de Vacunas, en La Habana, Cuba. Se evaluaron los efectos directos e indirectos de la vacunación con SOBERANA®02 y SOBERANA®Plus en una cohorte de riesgo de infección, enfermedad y diseminación de la COVID-19. La cohorte se estableció en marzo de 2021 en trabajadores con alta exposición al coronavirus de tipo 2 causante del síndrome respiratorio agudo severo, en el área de consulta médica de Instituto Finlay de Vacunas, establecida como sitio clínico. Entre el 22 de marzo de 2021 y el 11 de junio de 2021, se inscribieron un total de 1.776 participantes; de ellos, 1.719 cumplieron los criterios de inclusión con un porcentaje de 96,79 por ciento para la primera dosis, 1.675 recibieron la segunda dosis y 1.653 se vacunaron SOBERANA®Plus como tercera dosis para un 97,87por ciento. Mil cuatrocientos cincuenta y siete tenían entre 19 y 59 años, con predominio del sexo femenino. De los participantes, 175 tuvieron acontecimientos adversos y se observaron, predominantemente, una hora después de la administración de cada dosis. La reacción local más referida fue el dolor en el lugar de la inyección. Se registraron pocos acontecimientos adversos no solicitados. No se notificó ningún evento adverso grave o severo asociado a la vacuna. La distribución de casos de COVID-19 fue de 30, 16 y 6 posterior a cada dosis recibida. No se notificaron muertes asociadas a COVID-19. Las vacunas SOBERANA®02 y SOBERANA®Plus tuvieron un buen perfil de seguridad y fueron capaces de reducir la enfermedad grave por COVID-19 y la muerte, ayudando a revertir la situación epidemiológica causada por el coronavirus de tipo 2 causante del síndrome respiratorio agudo severo en Cuba(AU)
Vaccination is a way to help protect people by reducing the risk of serious effects from COVID-19 illness. By March of 2021, in record time, Cuba's biotech industry had five vaccine candidates. A sanitary intervention with a heterologous scheme, two doses of SOBERANA®02 and one dose of SOBERANA®Plus, was carried out in workers during the period of March to June 2021 at Finlay Vaccine Institute, in Havana, Cuba. We evaluated the direct and indirect effects of vaccination with SOBERANA®02 and SOBERANA®Plus, in a cohort at risk of infection, disease and spread of the epidemic COVID-19. The cohort was established in March 2021, among workers with high exposure to SARS-CoV-2, at the area of medical consultation at Finlay Vaccine Institute, established as clinical site. Between March 22, 2021 and June 11, 2021, were enrolled a total of 1,776 participants and, of them, 1,719 met the inclusion criteria with a percentage of 96.79percent for first dose, of which 1,675 received the second dose and 1,653 received SOBERANA®Plus as third dose for 97.87percent. The majority of participants were aged 19-59 years (1,457), being female, the predominant sex. Among the participants, 175 had adverse events, predominantly observed one hour after the administration of each dose. The most common local reaction was injection site pain. Few unsolicited adverse events were recorded. No vaccine-associated severe or serious adverse events were reported. The distribution of COVID-19 case was 30 post first dose, 16 post second dose and 6 post last dose. No deaths associated with COVID-19 were reported. SOBERANA®02 and SOBERANA®Plus vaccines had a good safety profile and were capable of a reduction of severe COVID-19 illness and death helping to reverse the epidemiological situation caused by the SARS-COV-2 in Cuba(AU)
Assuntos
Humanos , Masculino , Feminino , Vacinas contra COVID-19/uso terapêutico , COVID-19/epidemiologia , Categorias de TrabalhadoresRESUMO
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.
RESUMO
Se realizó un estudio descriptivo retrospectivo, para mostrar el comportamiento epidemiológico de las lesiones por mordeduras de animales en la población e Identificar los factores de riesgo que inciden en las mismas; el universo de trabajo lo componen todos los pacientes lesionados por mordeduras de animales en el Municipio Especial Isla de la Juventud, en el período comprendido de enero del 1998 a diciembre de 1999. La fuente primaria de información fueron las Historias Clínicas de Tratamiento Antirrábico del Dpto. de Estadística de las áreas de salud correspondientes. Se estudiaron las siguientes variables: área de salud, edad, sexo, tipo de lesión, lugar de ocurrencia, especie lesionadora, región anatómica afectada y época del año de ocurrencia. Resultados: predominaron los lesionados en el área No. 3, siendo el perro la especie lesionadora que más casos aportó, no existió diferencia significativa en cuanto al sexo de los lesionados pero si en la edad, donde el número de lesiones graves ocurrieron en niños, fundamentalmente de 5 a 9 años debido a su baja estatura, predominando lesiones múltiples en ambas edades, en verano; el mayor número de lesionados ocurre dentro de las viviendas (74.9 porciento) y no en la calle. La falta de medidas, en cuanto a crianza y tenencia de animales por sus propietarios, aumentan los riegos hacia la mayor presentación de los casos. Se recomienda cumplir con las medidas establecidas en el Programa Nacional de Prevención y Control de la Rabia e identificar las viviendas donde existen perros(AU)
A Retrospective Descriptive study is carry out, to show the epidemic behaviour of the animal bites lesions in the population and to Identify the risk factors that impact on them. The work universe was all the patients injured by animal bites in the Isle of Youth in the period of January, 1998 to December, 1999. The primary source of information was the clinical Histories Antirabic Treatment of the Stadistics Department of the corresponding health areas. The following variables were studied: health area, age, sex, type of lesion, occurrence place, lesioned species, affected anatomical region and time of the year occurrence. Results: most of the lesioned people come from area number 3, being the dog the lesioned species with more contribution cases, there was not significant difference about the people sex, but there was in the age, where the number of serious injured happened in children, mainly from 5 to 9 years due to its low stature, prevailing multiple lesions in both ages, in summer, the biggest number of injured people happens at home (74.9 percent) and not in the street. The lack measures as for upbringing and holding animal for its proprietors increase the cases. It is recommended to fulfill the measures settled down in the National Prevention Program of the Rage and to identify the houses where a dog exists(AU)
