La farmacéutica rusa buscará también combinar su dosis con AstraZeneca para una mayor eficacia
Ciudad de México.- Los fabricantes rusos de la vacuna Sputnik V contra el coronavirus han presentado la solicitud y documentación necesaria a la Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) para realizar estudios clínicos en México, según informó este lunes el canciller Marcelo Ebrard.
En un mensaje en su cuenta oficial de Twitter, el secretario de Relaciones Exteriores detalló que esta solicitud ocurre luego de que México extendió una invitación a Rusia para llevar a cabo los ensayos.
“Les comparto que a invitación de México, los fabricantes rusos de la vacuna Sputnik V han presentado solicitud y documentación necesaria a la Cofepris para realizar estudios clínicos en nuestro país y obtener la autorización correspondiente”, afirmó el canciller.
La vacuna Sputnik V, que ya se encuentra en la fase tres de ensayos clínicos en otras naciones, ha mostrado una eficacia del 91,4 % y ahora Rusia procederá a registrarla en otros países, según informó este lunes en un comunicado el Centro Gamaleya y el Fondo de Inversiones Directas de Rusia (FIDR).
Este es el resultado de los análisis realizados entre 22.714 voluntarios después de 21 días desde el momento de la inoculación de la primera dosis de la vacuna o de placebo.
Según el director del Centro Gamaleya, Alexandr Gintsburg, estos datos “permiten afirmar con seguridad que (Sputnik V) es altamente eficaz y totalmente segura para la salud”.
A su vez, los especialistas rusos registraron 20 casos graves entre aquellos que fueron tratados con placebo y ninguno en el grupo de vacuna.
Actualmente, los ensayos clínicos de fase III están aprobados y en curso en Bielorrusia, los Emiratos Árabes Unidos, Venezuela y otros países, así como la fase II-III en la India.
Hasta ahora no se han identificado eventos adversos inesperados durante la investigación. Algunos de los vacunados experimentaron eventos adversos menores de corta duración, como dolor en el punto de inyección y síntomas pseudogripales, como fiebre, debilidad, fatiga y dolor de cabeza.
Actualmente, México forma parte de los ensayos clínicos en fase tres de la vacuna CanSino Biologics, que empezó sus primeras pruebas en voluntarios en noviembre pasado, además de la farmacéutica Janssen, de Johnson & Johnson, que inició sus ensayos a principios de diciembre en el país.
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