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Colaboración, factor clave para desarrollo de vacuna contra COVID-19 y su acceso a la población.

Los esfuerzos en investigación y desarrollo biofarmacéutico para encontrar una vacuna buscan obtener en meses lo que tomaría hasta 15 años. Una vacuna es la mejor alternativa para mitigar la pandemia por COVID-19. Hasta 4.2 años puede tomar el proceso para tener disponible una futura vacuna en el sistema de salud mexicano.

 

 

Redacción / Revista GM5

editor@gm5.com.mx

La Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF) reunió a especialistas de Sanofi, Pfizer, Janssen y GSK, para conversar sobre las investigaciones y desarrollos que cada una de estas compañías realiza para encontrar una posible vacuna contra el coronavirus SARS-CoV-2, la trascendencia de este esfuerzo como solución clave para la pandemia, así como los retos en desarrollo, producción y la regulación sanitaria aplicable en México.

La investigación y desarrollo biofarmacéutico son actividades clave para atender y solucionar la pandemia que causa la enfermedad COVID-19, por lo que en este contexto se han creado alianzas globales sin precedentes entre el sector público, el sector privado, la academia y organizaciones civiles, quienes trabajan a contrarreloj para que un desarrollo, que en situaciones normales tomaría de 10 a 15 años, se pueda llevar a cabo entre 12 y 18 meses.

Con la participación de la Dra. Alejandrina Malacara, Directora médica de la unidad de Vacunas de Sanofi-Sanofi Pasteur; el Dr. Alejandro Cané, Líder de asuntos científicos y médicos para América del Norte de la división de vacunas de Pfizer; el Dr. Eduardo Franco, Director Médico en Janssen; y la Dra. María Yolanda Cervantes Apolinar, Directora de investigación y desarrollo clínico y asuntos médicos de vacunas, GSK México; se analizaron los estatus de cada investigación, la tecnología utilizada, las fases que implican y las expectativas en esfuerzos y tiempos.

En tanto, el Dr. Fernando Fon, Director Médico y de Asuntos Regulatorios de AMIIF, señaló que entre la investigación y desarrollo de una vacuna y su producción y distribución está el proceso regulatorio que realiza la Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris): “Una vez que exista una o varias vacunas contra la pandemia, al igual que toda innovación biofarmacéutica, deberá seguir el proceso de aprobación y regulación por parte de las autoridades mexicanas”.

El descubrimiento de una vacuna por sí solo no resuelve la pandemia, es necesario lograr que llegue a todas las personas a través de los sistemas de salud pública, además de garantizar, mediante procesos técnicos y científicos, que la futura vacuna sea un producto de calidad, seguro y eficaz para lo cual se requiere la intervención de las autoridades regulatorias, como la Cofepris en el caso mexicano.

“Tenemos análisis del proceso regulatorio y de aprobación para una molécula nueva en México, que sería el caso de una potencial vacuna para la enfermedad COVID- 19, que indican que, desde el inicio de los trámites de solicitud de registro ante Cofepris, hasta su disponibilidad en el sistema de salud pública, puede tomar 4.2 años”, apuntó Fernando Fon. La estimación se basó en días hábiles y la suma del tiempo que en los hechos ocupa cada fase del proceso.

La pandemia representa un reto para el ecosistema de investigación y desarrollo biofarmacéutico a fin de reducir dramáticamente los tiempos de desarrollo para alcanzar una posible vacuna contra COVID-19, pero también abre la oportunidad para revisar los procesos regulatorios que permiten que esta y otro tipo de nuevas opciones terapéuticas lleguen a los mexicanos con mayor celeridad.

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  172. Awesome blog! Do you have any hints for aspiring writers? I’m hoping to start my own blog soon but I’m a little lost on everything. Would you propose starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m completely confused .. Any ideas? Thanks!|

  173. I do believe all of the concepts you have introduced on your post. They’re very convincing and will definitely work. Nonetheless, the posts are very short for starters. May just you please lengthen them a bit from subsequent time? Thanks for the post.|

  174. Awesome blog! Is your theme custom made or did you download it from somewhere? A theme like yours with a few simple adjustements would really make my blog jump out. Please let me know where you got your theme. Thank you|

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