Brasil, uno de los países más azotados por la pandemia del nuevo coronavirus, autorizó este lunes los ensayos clínicos de la potencial vacuna contra la COVID-19 SCB-2019, financiada por la empresa china Sichuan Clover Biopharmaceuticals.
La Agencia Nacional de Vigilancia Sanitaria (Anvisa) informó en un comunicado que en el país se llevará a cabo la tercera y última etapa de las pruebas del antígeno, el sexto que se experimentará en Brasil desde el inicio de la emergencia sanitaria global.
La vacuna de Sichuan Clover es producida a partir de una combinación de proteínas con adyuvantes sintéticos, que sirven para potenciar la respuesta inmunológica del organismo.
Asimismo, debe ser administrada en dos dosis con un intervalo de 22 días entre ellas y será probada en cerca de 12 100 brasileños de 18 o más años de edad, distribuidos en los estados de Río Grande del Sur, Río Grande del Norte y Río de Janeiro.
A nivel mundial, las pruebas deberán incluir a 22 mil voluntarios de varios países de América Latina, así como de Sudáfrica, Bélgica, China, España, Polonia y Reino Unido.
Para conceder su aval, la agencia reguladora analizó los datos de las etapas anteriores de los estudios, entre ellos los resultados preliminares de los ensayos clínicos que ya están en marcha.
«Los resultados obtenidos hasta el momento demostraron un perfil de seguridad aceptable de la vacuna candidata», señaló.
Se trata del sexto estudio de fase tres de potenciales vacunas contra la COVID-19 autorizado por las autoridades de Brasil, el segundo país con el mayor número de muertos a causa de la enfermedad, detrás de Estados Unidos, y donde la pandemia sigue descontrolada.
A lo largo del año pasado, se experimentaron en el país las fórmulas del laboratorio chino Sinovac y de la farmacéutica estadounidense Pfizer, además de los antígenos de AstraZeneca, desarrollada en conjunto con la Universidad de Oxford, y de Janssen, el brazo farmacéutico de Johnson & Johnson.
Asimismo, el pasado 8 de abril Anvisa dio luz verde a los ensayos clínicos de fase 3 de la fórmula desarrollada por la farmacéutica canadiense Medicago, que deberán incluir a unos 3.500 participantes.
Con una población superior a 210 millones de habitantes, Brasil atraviesa la peor fase de la pandemia y ya acumula casi 375 mil muertos y unos 14 millones de infectados por la COVID-19.
Por: Agencia
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