{"id":13669,"date":"2021-09-23T11:21:57","date_gmt":"2021-09-23T09:21:57","guid":{"rendered":"https:\/\/informatialibera.ro\/?p=13669"},"modified":"2021-09-23T11:22:29","modified_gmt":"2021-09-23T09:22:29","slug":"doi-cercetatori-de-top-si-au-dat-demisia-din-fda-inainte-de-anuntarea-celei-de-a-treia-doze-dovezile-stiintifice-arata-nu-este-nevoie-de-o-amplificare-a-vaccinului","status":"publish","type":"post","link":"https:\/\/informatialibera.ro\/doi-cercetatori-de-top-si-au-dat-demisia-din-fda-inainte-de-anuntarea-celei-de-a-treia-doze-dovezile-stiintifice-arata-nu-este-nevoie-de-o-amplificare-a-vaccinului\/","title":{"rendered":"Dovezile \u0219tiin\u021bifice arat\u0103 : NU este nevoie de o amplificare a vaccinului – Doi cercet\u0103tori de top \u0219i-au dat demisia din FDA \u00eenainte de anun\u021barea celei de-a treia doze"},"content":{"rendered":"

Doi oameni de \u0219tiin\u021b\u0103 de top care \u0219i-au anun\u021bat recent retragerea din cadrul autorit\u0103\u021bii americane de supraveghere a medicamentelor au criticat politica de a administra celor mai mul\u021bi oameni vaccinuri de rapel Covid-19, cu doar c\u00e2teva zile \u00eenainte ca administra\u021bia Biden s\u0103 planifice s\u0103 \u00eenceap\u0103 s\u0103 fac\u0103 acest lucru, scrie\u00a0Financial Times.<\/a><\/h3>\n

Philip Krause \u0219i Marion Gruber, care au demisionat de la Food and Drug Administration \u00een urm\u0103 cu dou\u0103 s\u0103pt\u0103m\u00e2ni, se num\u0103r\u0103 printre autorii unei critici dure la adresa vaccinurilor de rapel larg r\u0103sp\u00e2ndite, care a fost publicat\u0103 luni \u00een The Lancet.<\/h3>\n

<\/h3>\n
Articolul, care sus\u021bine c\u0103 dovezile \u0219tiin\u021bifice nu justific\u0103 \u00eenc\u0103 administrarea pentru majoritatea oamenilor a treia injec\u021bie de vaccinuri cu ARN mesager, ofer\u0103 o perspectiv\u0103 asupra tensiunilor interne din administra\u021bia Biden, care au fost declan\u0219ate de decizia brusc\u0103 a Casei Albe de a sus\u021bine planul de rapel.<\/div>\n
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Articolul avertizeaz\u0103:\u00a0„Dovezile actuale nu par s\u0103 demonstreze necesitatea unei amplific\u0103ri \u00een r\u00e2ndul popula\u021biei generale, \u00een care eficacitatea \u00eempotriva bolilor grave r\u0103m\u00e2ne ridicat\u0103”.<\/div>\n
<\/div>\n
Acesta adaug\u0103: „Rezerva limitat\u0103 a acestor vaccinuri va salva cele mai multe vie\u021bi dac\u0103 va fi pus\u0103 la dispozi\u021bia persoanelor care prezint\u0103 un risc apreciabil de \u00eemboln\u0103vire grav\u0103 \u0219i care nu au primit \u00eenc\u0103 niciun vaccin”. Chiar dac\u0103, \u00een cele din urm\u0103, se poate ob\u021bine un anumit c\u00e2\u0219tig din stimularea vaccin\u0103rii, acesta nu va fi mai mare dec\u00e2t beneficiile asigur\u0103rii unei protec\u021bii ini\u021biale pentru persoanele nevaccinate.”<\/div>\n
<\/div>\n
Administra\u021bia Biden a anun\u021bat luna trecut\u0103 c\u0103 inten\u021bioneaz\u0103 s\u0103 \u00eenceap\u0103 s\u0103 le ofere americanilor o nou\u0103 doz\u0103 de vaccin Covid cu ARNm produs de BioNTech\/Pfizer \u0219i Moderna \u00eencep\u00e2nd cu 20 septembrie, dup\u0103 ce s-a demonstrat c\u0103 eficacitatea a sc\u0103zut la c\u00e2teva luni dup\u0103 a doua doz\u0103.<\/div>\n
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\u00cens\u0103 anun\u021bul a fost f\u0103cut \u00eenainte ca oricare dintre companii s\u0103 fi depus o cerere la FDA pentru a autoriza o a treia doz\u0103.<\/div>\n
<\/div>\n
Ambele companii au depus acum cererile pentru injec\u021bia de rapel, iar un grup de exper\u021bi se va reuni vineri pentru a oferi FDA o recomandare oficial\u0103 privind autorizarea sau nu a cererii Pfizer. Cererea Moderna va fi discutat\u0103 probabil \u00een urm\u0103toarele s\u0103pt\u0103m\u00e2ni.<\/div>\n
<\/div>\n
Modul \u00een care a fost gestionat anun\u021bul a provocat iure\u0219 \u00een cadrul administra\u021biei. Krause \u0219i Gruber \u0219i-au dat demisia de la departamentul de vaccinuri al FDA \u00een urm\u0103 cu dou\u0103 s\u0103pt\u0103m\u00e2ni, alia\u021bii lor spun\u00e2nd c\u0103 au fost frustra\u021bi de modul \u00een care autoritatea de reglementare a fost subminat\u0103 \u00een aceast\u0103 decizie \u0219i \u00een alte c\u00e2teva decizii cheie. Ei vor p\u0103r\u0103si agen\u021bia \u00een urm\u0103toarele s\u0103pt\u0103m\u00e2ni.<\/div>\n
<\/div>\n
FDA a precizat \u00eentr-o declara\u021bie: „Dup\u0103 cum se men\u021bioneaz\u0103 \u00een articol, opiniile autorilor nu reprezint\u0103 punctul de vedere al agen\u021biei”.<\/div>\n
<\/div>\n
Aceasta a ad\u0103ugat: „Ne afl\u0103m \u00een mijlocul unui proces deliberativ de revizuire a cererii de aprobare suplimentar\u0103 a vaccinului de rapel a Pfizer, iar FDA, ca o chestiune de practic\u0103, nu comenteaz\u0103 cu privire la problemele \u00een curs de solu\u021bionare \u00een fa\u021ba agen\u021biei. A\u0219tept\u0103m cu ner\u0103bdare o discu\u021bie robust\u0103 \u0219i transparent\u0103 vineri cu privire la aceast\u0103 cerere.”<\/div>\n
<\/div>\n
a declarat Pfizer: „R\u0103m\u00e2nem angaja\u021bi s\u0103 \u00eemp\u0103rt\u0103\u0219im toate datele disponibile cu FDA \u0219i CDC prin intermediul proceselor lor de revizuire bine stabilite, riguroase \u0219i transparente, inclusiv \u00een cadrul reuniunii de vineri a Comitetului consultativ pentru vaccinuri \u0219i produse biologice conexe”.<\/div>\n
<\/div>\n
\n

Sursa: C\u0103t\u0103lin Vu\u0219can\/ ActiveNews<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Doi oameni de \u0219tiin\u021b\u0103 de top care \u0219i-au anun\u021bat recent retragerea din cadrul autorit\u0103\u021bii americane de supraveghere a medicamentelor au criticat politica de a administra celor mai mul\u021bi oameni vaccinuri de rapel Covid-19, cu doar c\u00e2teva zile \u00eenainte ca administra\u021bia Biden s\u0103 planifice s\u0103 \u00eenceap\u0103 s\u0103 fac\u0103 acest lucru, scrie\u00a0Financial […]<\/p>\n","protected":false},"author":2,"featured_media":13670,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spay_email":""},"categories":[166],"tags":[],"yoast_head":"\nDovezile \u0219tiin\u021bifice arat\u0103 : NU este nevoie de o amplificare a vaccinului - Doi cercet\u0103tori de top \u0219i-au dat demisia din FDA \u00eenainte de anun\u021barea celei de-a treia doze - Informa\u021bia Liber\u0103<\/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:\/\/informatialibera.ro\/doi-cercetatori-de-top-si-au-dat-demisia-din-fda-inainte-de-anuntarea-celei-de-a-treia-doze-dovezile-stiintifice-arata-nu-este-nevoie-de-o-amplificare-a-vaccinului\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dovezile \u0219tiin\u021bifice arat\u0103 : NU este nevoie de o amplificare a vaccinului - Doi cercet\u0103tori de top \u0219i-au dat demisia din FDA \u00eenainte de anun\u021barea celei de-a treia doze - Informa\u021bia Liber\u0103\" \/>\n<meta property=\"og:description\" content=\"Doi oameni de \u0219tiin\u021b\u0103 de top care \u0219i-au anun\u021bat recent retragerea din cadrul autorit\u0103\u021bii americane de supraveghere a medicamentelor au criticat politica de a administra celor mai mul\u021bi oameni vaccinuri de rapel Covid-19, cu doar c\u00e2teva zile \u00eenainte ca administra\u021bia Biden s\u0103 planifice s\u0103 \u00eenceap\u0103 s\u0103 fac\u0103 acest lucru, scrie\u00a0Financial […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/informatialibera.ro\/doi-cercetatori-de-top-si-au-dat-demisia-din-fda-inainte-de-anuntarea-celei-de-a-treia-doze-dovezile-stiintifice-arata-nu-este-nevoie-de-o-amplificare-a-vaccinului\/\" \/>\n<meta property=\"og:site_name\" content=\"Informa\u021bia Liber\u0103\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/Informa%c8%9bia-Liber%c4%83-100151015423577\" \/>\n<meta property=\"article:published_time\" content=\"2021-09-23T09:21:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-09-23T09:22:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/i2.wp.com\/informatialibera.ro\/wp-content\/uploads\/2021\/09\/fda496532228.jpg?fit=645%2C363&ssl=1\" \/>\n\t<meta property=\"og:image:width\" content=\"645\" \/>\n\t<meta property=\"og:image:height\" content=\"363\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Scris de\" \/>\n\t<meta name=\"twitter:data1\" content=\"Informa\u021bia Liber\u0103\" \/>\n\t<meta name=\"twitter:label2\" content=\"Timp estimat pentru citire\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"https:\/\/informatialibera.ro\/#organization\",\"name\":\"Informa\u021bia Liber\u0103\",\"url\":\"https:\/\/informatialibera.ro\/\",\"sameAs\":[\"https:\/\/www.facebook.com\/Informa\u021bia-Liber\u0103-100151015423577\"],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/informatialibera.ro\/#logo\",\"inLanguage\":\"ro-RO\",\"url\":\"https:\/\/i2.wp.com\/informatialibera.ro\/wp-content\/uploads\/2021\/01\/logo.png?fit=1073%2C199&ssl=1\",\"contentUrl\":\"https:\/\/i2.wp.com\/informatialibera.ro\/wp-content\/uploads\/2021\/01\/logo.png?fit=1073%2C199&ssl=1\",\"width\":1073,\"height\":199,\"caption\":\"Informa\u021bia Liber\u0103\"},\"image\":{\"@id\":\"https:\/\/informatialibera.ro\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/informatialibera.ro\/#website\",\"url\":\"https:\/\/informatialibera.ro\/\",\"name\":\"Informa\u021bia Liber\u0103\",\"description\":\"G\u00e2nde\u0219te liber. 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