{"id":3093,"date":"2020-09-17T12:54:00","date_gmt":"2020-09-17T16:54:00","guid":{"rendered":"https:\/\/www.merkley.senate.gov\/merkley-colleagues-to-fda-maintain-public-trust-in-covid-19-vaccine-decisions-by-making-reviews-transparent-2020\/"},"modified":"2023-07-24T11:06:20","modified_gmt":"2023-07-24T15:06:20","slug":"merkley-colleagues-to-fda-maintain-public-trust-in-covid-19-vaccine-decisions-by-making-reviews-transparent-2020","status":"publish","type":"post","link":"https:\/\/www.merkley.senate.gov\/es\/merkley-colleagues-to-fda-maintain-public-trust-in-covid-19-vaccine-decisions-by-making-reviews-transparent-2020\/","title":{"rendered":"Merkley y colegas de la FDA: Mantengan la confianza del p\u00fablico en las decisiones sobre la vacuna COVID-19 haciendo que las revisiones sean transparentes"},"content":{"rendered":"

WASHINGTON, DC \u2013 El senador estadounidense de Oreg\u00f3n, Jeff Merkley, junto con 14 de sus colegas del Senado, insta a la Administraci\u00f3n de Alimentos y Medicamentos de los EE. UU. (FDA) a comprometerse con la total transparencia en el proceso de revisi\u00f3n de la vacuna COVID-19 en medio de la creciente presi\u00f3n pol\u00edtica del presidente para aprobar una vacuna antes del d\u00eda de las elecciones.<\/p>\n

En una carta al comisionado de la FDA, Dr. Stephen Hahn, los legisladores expresaron su preocupaci\u00f3n de que la administraci\u00f3n Trump haya anulado a los cient\u00edficos y haya presionado a las agencias federales para que aprueben productos bas\u00e1ndose en evidencia d\u00e9bil. Y los senadores instaron a la FDA a garantizar la transparencia en los esfuerzos de revisi\u00f3n de vacunas para mantener la confianza del p\u00fablico. <\/p>\n

\n

"Le escribimos para solicitar su compromiso de que el proceso de revisi\u00f3n de la Administraci\u00f3n de Alimentos y Medicamentos (FDA) para posibles vacunas contra la enfermedad del coronavirus 2019 (COVID-19) sea totalmente transparente y responsable". escribieron los senadores<\/b>. \u201cNos sentimos alentados por el desarrollo<\/a> de una serie de vacunas candidatas, y compartimos el objetivo de la FDA de facilitar "el desarrollo oportuno de vacunas seguras y eficaces para prevenir el COVID-19". Sin embargo, nos preocupa que el calendario acelerado y la intensa presi\u00f3n pol\u00edtica en torno al proceso de desarrollo de la vacuna puedan tener la consecuencia no deseada de socavar la confianza del p\u00fablico en la seguridad y la calidad de una eventual vacuna\u201d.<\/p>\n

\u201cPara lograr una amplia aceptaci\u00f3n entre el p\u00fablico, una futura vacuna contra el COVID-19 deber\u00e1 superar el escepticismo p\u00fablico sobre la velocidad del proceso, las dudas subyacentes sobre la seguridad de la vacuna y la desconfianza de larga data en el sistema m\u00e9dico entre las comunidades de color. y los efectos de la actual interferencia pol\u00edtica del presidente\u201d, continuaron los senadores.<\/b> <\/p>\n<\/blockquote>\n

Los senadores hicieron una serie de preguntas, incluyendo si las reuniones del Comit\u00e9 Asesor de Vacunas y Productos Biol\u00f3gicos Relacionados estar\u00edan abiertas al p\u00fablico, si los datos y detalles del dise\u00f1o de los ensayos cl\u00ednicos se pondr\u00edan a disposici\u00f3n del p\u00fablico y c\u00f3mo la FDA est\u00e1 involucrando a los representantes. de comunidades de color, personas con discapacidades, estadounidenses mayores y otros grupos con riesgo elevado de contraer COVID-19.<\/p>\n

M\u00e1s que 100 vacunas<\/a> contra el COVID-19 se encuentran actualmente en desarrollo en todo el mundo, con 40<\/a> en ensayos cl\u00ednicos en humanos que avanzan a un ritmo sin precedentes. Para abordar las preocupaciones del p\u00fablico de que la r\u00e1pida velocidad del desarrollo de la vacuna podr\u00eda comprometer la integridad del proceso de revisi\u00f3n, la FDA directrices emitidas<\/a> en junio de 2020 para ayudar en el desarrollo cl\u00ednico y la licencia de vacunas para COVID-19. Sin embargo, el presidente Trump y su administraci\u00f3n han aplicado continuamente presi\u00f3n pol\u00edtica sobre la agencia, incluyendo prometedor<\/a> que se aprobar\u00e1 una vacuna a finales de 2020.<\/p>\n

Los Centros para el Control y la Prevenci\u00f3n de Enfermedades (CDC) tambi\u00e9n anunciaron recientemente que los estados deber\u00edan ser preparado<\/a> distribuir una vacuna antes del 1 de noviembre, lo que genera a\u00fan m\u00e1s preocupaciones de que el proceso de aprobaci\u00f3n se acelere. Estas declaraciones recientes hechas por la administraci\u00f3n Trump pueden correr el riesgo de socavar la confianza del p\u00fablico en la FDA a menos que la agencia se comprometa a ampliar a\u00fan m\u00e1s la transparencia.<\/p>\n

Encuestas recientes muestran un importante escepticismo p\u00fablico sobre una futura vacuna, incluida una encuesta reciente<\/a> que encontr\u00f3 que solo 49% de adultos estadounidenses planean aceptar una vacuna contra el coronavirus, 20% no planean vacunarse y 31% no est\u00e1n seguros. El misma encuesta<\/a> encontr\u00f3 que solo 25% de afroamericanos y 37% de hispanoamericanos planean vacunarse. La desconfianza p\u00fablica en una vacuna segura y eficaz podr\u00eda tener ramificaciones generalizadas, peligrosas y da\u00f1inas, prolongando innecesariamente la pandemia y costando potencialmente miles de vidas estadounidenses m\u00e1s.<\/p>\n

La carta tambi\u00e9n fue firmada por los senadores estadounidenses Elizabeth Warren (D-MA), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY), Richard Blumenthal (D-CT), Tina Smith (D-MN), Angus S. King, Jr. (I-ME), Jack Reed (D-RI), Christopher S. Murphy (D-CT), Mazie K. Hirono (D-HI), Tammy Baldwin (D-WI), Bernard Sanders ( D-VT), Michael F. Bennet (D-CO) y Sherrod Brown (D-OH). <\/p>\n

Los senadores solicitaron una respuesta a su carta a m\u00e1s tardar el 28 de septiembre de 2020.<\/p>\n

El texto completo de la carta est\u00e1 disponible. aqu\u00ed<\/a>.<\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

WASHINGTON, D.C. – Oregon’s U.S. Senator Jeff Merkley, along with 14 of his Senate colleagues, is urging the U.S. Food and Drug Administration (FDA) to commit to full transparency in the COVID-19 vaccine review process amidst mounting political pressure from the President to approve a vaccine before Election Day. In a letter to FDA Commissioner […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[24],"tags":[37],"class_list":["post-3093","post","type-post","status-publish","format-standard","hentry","category-press-releases","tag-health-care"],"acf":[],"yoast_head":"\nMerkley, Colleagues to FDA: Maintain Public Trust in COVID-19 Vaccine Decisions by Making Reviews Transparent - Merkley<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.merkley.senate.gov\/es\/merkley-colleagues-to-fda-maintain-public-trust-in-covid-19-vaccine-decisions-by-making-reviews-transparent-2020\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merkley, Colleagues to FDA: Maintain Public Trust in COVID-19 Vaccine Decisions by Making Reviews Transparent - Merkley\" \/>\n<meta property=\"og:description\" content=\"WASHINGTON, D.C. – Oregon’s U.S. Senator Jeff Merkley, along with 14 of his Senate colleagues, is urging the U.S. Food and Drug Administration (FDA) to commit to full transparency in the COVID-19 vaccine review process amidst mounting political pressure from the President to approve a vaccine before Election Day. 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