País está en lista para recibir vacunas de Pfizer y Moderna

Santo Domingo, RD.- Ante el inicio ya de la apli­cación en varios países de las vacunas contra el Covid-19 de Pfizer y Moderna, las dos primeras aprobadas de emergencia, la Organi­zación Mundial de la Salud (OMS) y la Alianza Mun­dial de Vacunas (GAVI) ini­ciaron negociaciones pa­ra su inclusión a través del COVAX, que es el mecanis­mo al que la organización se ha adherido y en cuya lista de países inscritos fi­gura República Dominica­na.

Los detalles fueron da­dos por el doctor Marcos Espinal, di­rector del Departamento de enfermedades transmi­sibles y determinantes am­bientales de OPS/OMS, quien dijo además que pro­bable en las próximas se­manas Astra Zeneca sea aprobada en algunos paí­ses, y que es en la que el país hizo un aporte econó­mico inicial para estar en la lista de los primeros en reci­birla una vez sea aprobada.

No obstante Espinal, no especificó el avance de las negociaciones con las dos vacunas aprobadas para emergencia ni para qué fe­cha se podría estar distribu­yendo a los países inscritos en el COVAX.

Recordó que las agencias internacionales no son regu­ladoras de los países y que la función de aprobar definiti­vamente una vacuna o para uso de emergencia corres­ponde a las agencias regu­ladoras de cada país (FDA en USA, ANVISA en Brasil, MHRA en Uk, COFEPRIS en México, etc.).

Explicó que la OMS pre­califica las vacunas y desa­rrolla normas y estándares internacionales, de modo que los países de todo el mundo puedan regular los productos y tecnologías sanitarias de forma coherente.

Cadena de frío
“Estamos en negociacio­nes para ver cómo se inclu­ye a través del COVAX que es el mecanismo al que nos hemos adherido. Recuerda que el problema de esa va­cuna (Pfizer) es que la ma­yoría de nuestros países no tienen disponibilidad de la cadena de frío que necesita esa vacuna y se deben bus­car soluciones al respecto”, señaló.

Sobre la vacuna que ela­bora la empresa Astra Ze­neca en colaboración con la universidad de Oxford, Espinal señaló que parece ser que tiene una eficacia de al­rededor 70% lo que es acep­table para su uso, pero to­davía no ha sido aprobada ya que hay algunas cosas que aclarar con respecto a la misma.

No obstante, agregó que se está trabajando para tra­tar de aumentar la eficacia de la misma un poco más y que es probable que en las próximas semanas Astra Ze­neca sea aprobada en algu­nos países.

Sean seguras
Espinal explicó que las agencias internacionales precalifican las vacunas y las agencias reguladoras nacionales aprueban pa­ra uso.

Destacó que la preca­lificación de la OMS ga­rantiza que las vacunas utilizadas en los progra­mas de inmunización sean seguras y eficaces, y además proporciona a los Estados miembros y otros socios la información ne­cesaria para comprar va­cunas que satisfagan las necesidades específicas del programa.

La OMS, agregó Espi­nal, también examina y comparte datos de vacu­nas sobre eficacia, poten­cia, termoestabilidad, pre­sentación, etiquetado y condiciones de envío.

Agregó que para que una vacuna ingrese al proceso de precalificación de la OMS, la Autoridad (Agencia) Nacional Regu­ladora debe ser determi­nada como “funcional” de acuerdo con los indicado­res del organismo.

El portafolio de COVAX.
El portafolio actual de COVAX incluye 10 va­cunas que son Astra­Zeneca/ University of Oxford (Phase 3); Clo­ver Biopharmaceuticals, China (Phase 1);

CureVac, Germany (Phase 2B/3); Inovio, USA (Phase 2); Insti­tut Pasteur/Merck/The­mis, France/USA/Aus­tria (Phase 1); Moderna, USA (Phase 3); Nova­vax, USA (Phase 3); SK bioscience, South Korea (Preclinical); Universi­ty of Hong Kong, Hong Kong (Preclinical) y Uni­versity of Queensland/ CSL, Australia (Phase 1, programme disconti­nued).


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