ABSTRACT
Intro: With the first case of COVID-19 in Cuba on March 11, 2020, the Center for Genetic Engineering and Biotechnology in Havana began an extensive vaccine program. Two vaccines based on RBD recombinant protein were developed, one for systemic administration "Abdala" and one mucosal vaccine "Mambisa". Abdala received the EUA in July 2021 and "Mambisa" completed its clinical development as a booster dose for convalescent subjects. Method(s): Two doses (25 and 50 microg) and two schedules (0-14-28 and 1-28-56 days) were evaluated in phase I clinical trials with volunteers 19 to 54 years old. The phase II and III clinical trials were also double-blind, randomized, and placebo-controlled, and included respectively 660 and 48,000 volunteers from 19 to 80 years. The anti-RBD titers were evaluated using a quantitative ELISA system developed at the Center for Immunoassay, Havana Cuba, and ELECSYS system from Roche. The RBD to ACE2 plate-based binding competitive ELISA was performed to determine the inhibitory activity of the anti-RBD polyclonal sera on the binding of the hFc-ACE2 coated plates. The neutralization antibody titers were detected by a traditional virus microneutralization assay (MN50). Finding(s): The Abdala vaccine reached 92.28% efficacy. The epidemic was frankly under control in Cuba after the vaccine introduction having reached the highest levels of cases and mortality in July 2021 with the dominance of the Delta strain. The peak of the Omicron wave, unlike other countries, did not reach half of the cases of the Delta wave with a significant reduction in mortality. The mucosal vaccine candidate "Mambisa" completed its clinical development as a booster dose for convalescent subjects reaching the trial end-point. Conclusion(s): Vaccine composition based on RBD recombinant antigen alone is sufficient to achieve high vaccine efficacy comparable to mRNA and live vaccine platforms. The vaccine also protects against different viral variants including Delta and Omicron strains.Copyright © 2023
ABSTRACT
Resumen El COVID-19 ha visibilizado las inequidades sistémicas, multiplicado las condiciones de vulnerabilidad y descubierto la incapacidad de numerosas instituciones públicas para responder a la pandemia. El objetivo del presente trabajo fue analizar y contextualizar la gestión de la crisis sanitaria en Cuba, así como la atención a grupos vulnerables durante el primer año de la pandemia. La investigación se sustenta en un enfoque mixto que combina el análisis cualitativo de contenido con el de datos estadísticos procedentes de fuentes primarias y secundarias. Los hallazgos revelaron que más de la mitad de la población cubana es vulnerable ante COVID-19 por factores como edad, género, raza, salud física, condiciones del hogar y limitaciones para acceder a derechos básicos asociados a alimentación de calidad, vivienda digna y servicios de agua potable. Las estadísticas epidemiológicas recabadas entre marzo de 2020 y marzo de 2021 muestran una gestión de la crisis sanitaria adecuada a partir de la articulación gubernamental con la gestión científica y tecnológica y la infraestructura de salud pública y universal. Sin embargo, existen estrategias contradictorias en la atención a la población en riesgo, que profundizan desigualdades previamente existentes y dinamizan y amplían la condición de vulnerabilidad. COVID-19 constituye una ventana de oportunidad para pensar estrategias de desarrollo desde un modelo de política social integral.
Abstract COVID-19 has made visible systemic inequities, multiplied vulnerability conditions, and uncovered the lack of capacity of numerous public institutions to respond to the pandemic. The paper aims to analyze and contextualize the health crisis management, as well as vulnerable groups' care in Cuba during the first year of the pandemic. For this purpose, a mixed approach was selected, which combines qualitative content analysis with statistical data obtained from primary and secondary sources. Findings revealed that more than half of the Cuban population is vulnerable to COVID-19 due to factors such as age, gender, race, physical health, living conditions, and limitations to access to basic rights associated to quality food, dignified housing, and potable water rights. Epidemiological statistics collected between March 2020 and March 2021, show an adequate management of the sanitary contingency based on the coordination of governmental structures with scientific and technological sectors and public and universal health infrastructure. However, there are contradictory strategies in caring for vulnerable populations that deepen previously existing inequalities and dynamize and extend vulnerability conditions. COVID-19 constitutes a window of opportunity to rethink country development strategies from a comprehensive social policy model.