{"id":13473,"date":"2021-09-18T12:20:34","date_gmt":"2021-09-18T10:20:34","guid":{"rendered":"https:\/\/informatialibera.ro\/?p=13473"},"modified":"2021-09-18T12:20:34","modified_gmt":"2021-09-18T10:20:34","slug":"fda-a-respins-vineri-solicitarea-depusa-de-compania-pfizer-privind-adaugarea-unei-a-treia-doze-asta-e-medicina-sau-comert","status":"publish","type":"post","link":"https:\/\/informatialibera.ro\/fda-a-respins-vineri-solicitarea-depusa-de-compania-pfizer-privind-adaugarea-unei-a-treia-doze-asta-e-medicina-sau-comert\/","title":{"rendered":"FDA, a respins vineri solicitarea depus\u0103 de compania Pfizer, privind ad\u0103ugarea unei a treia doze – Asta e medicin\u0103 sau comer\u0163?"},"content":{"rendered":"

Adep\u0163ii celei de-a treia doze de vaccin anti-Covid au primit o lovitur\u0103 de la autorit\u0103\u0163ile americane, spre exemplu. Autoritatea federal\u0103 american\u0103 \u00een domeniul medicamentelor, FDA, a respins vineri solicitarea depus\u0103 de compania Pfizer, privind ad\u0103ugarea unei a treia doze suplimentare la schema complet\u0103 de vaccinare.<\/strong><\/h2>\n
<\/div>\n

Membrii Comitetului FDA au votat asupra urm\u0103toarei formul\u0103ri: \u201eSus\u021bin datele din studiul clinic aprobarea unei doze suplimentare<\/a>\u00a0administrate persoanelor de cel pu\u021bin 16 ani, la cel pu\u021bin \u0219ase luni de la finalizarea schemei ini\u021biale?\u201d<\/strong><\/em>. Respingerea a fost votat\u0103 cu 16 la 2.<\/p>\n

<\/div>\n

De ce a fost respins\u0103 cererea Pfizer?<\/h2>\n

Speciali\u015ftii de la FDA nu sunt siguri c\u0103 a 3-a doz\u0103 ar fi benefic\u0103 pentru to\u0163i pacien\u0163ii. Ei au \u00eendoilei \u00een leg\u0103tur\u0103 cu siguran\u021ba unei doze suplimentare la adul\u021bii tineri \u0219i la adolescen\u021bi \u0219i s-au pl\u00e2ns de lipsa datelor privind siguran\u021ba \u0219i eficien\u021ba pe termen lung \u00een cazul celei de-a treia doze.<\/p>\n

Exist\u0103 totu\u015fi \u015fi un compromis:\u00a0FDA a aprobat recomandarea ca doza suplimentar\u0103\u00a0s\u0103 fie administrat\u0103 persoanelor cu v\u00e2rste de cel pu\u021bin 65 de ani \u0219i celor expu\u0219i riscului de a face forma grav\u0103 a infec\u021biei cu COVID.<\/p>\n

<\/div>\n

\u00cen SUA, 54,4% din popula\u021bie a fost complet vaccinat\u0103 iar ritmul de vaccinare este de circa 342.000 de persoane imunizate \u00een fiecare zi.<\/p>\n

FDA vrea s\u0103-\u015fi fac\u0103 propriile teste<\/h2>\n

Angaja\u0163ii Administra\u0163iei pentru Medicamente \u015fi Alimente (FDA) din Statele Unite au refuzat s\u0103 exprime o pozi\u0163ie privind\u00a0autorizarea rapelului vaccinului pentru Covid-19 al Pfizer, afirm\u00e2nd c\u0103 nu au evaluat \u00eenc\u0103 toate datele disponibile.<\/p>\n

\u201dEste posibil s\u0103 existe multe studii relevante, dar FDA nu a evaluat independent sau nu a verificat datele fundamentale sau concluziile lor. Unele dintre aceste studii, inclusiv date din programul de vaccinare din Israel, vor fi discutate \u00een timpul unei \u00eent\u00e2lniri din 17 septembrie\u201d<\/strong><\/em>, a anun\u0163at FDA.<\/p>\n

Oamenii de \u015ftiin\u0163\u0103 \u015fi al\u0163i exper\u0163i \u00een domeniul s\u0103n\u0103t\u0103\u0163ii au criticat \u00een mod repetat planul, afirm\u00e2nd c\u0103 datele citate de oficialii din domeniul s\u0103n\u0103t\u0103\u0163ii nu sunt conving\u0103toare, ei caracteriz\u00e2nd presiunea administra\u0163iei pentru rapeluri ca fiind prematur\u0103.<\/p>\n

 <\/p>\n

Sursa: national.ro\u00a0<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Adep\u0163ii celei de-a treia doze de vaccin anti-Covid au primit o lovitur\u0103 de la autorit\u0103\u0163ile americane, spre exemplu. Autoritatea federal\u0103 american\u0103 \u00een domeniul medicamentelor, FDA, a respins vineri solicitarea depus\u0103 de compania Pfizer, privind ad\u0103ugarea unei a treia doze suplimentare la schema complet\u0103 de vaccinare. Membrii Comitetului FDA au votat […]<\/p>\n","protected":false},"author":2,"featured_media":8559,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spay_email":""},"categories":[166],"tags":[],"yoast_head":"\nFDA, a respins vineri solicitarea depus\u0103 de compania Pfizer, privind ad\u0103ugarea unei a treia doze - Asta e medicin\u0103 sau comer\u0163? - 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\/fda-a-respins-vineri-solicitarea-depusa-de-compania-pfizer-privind-adaugarea-unei-a-treia-doze-asta-e-medicina-sau-comert\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA, a respins vineri solicitarea depus\u0103 de compania Pfizer, privind ad\u0103ugarea unei a treia doze - Asta e medicin\u0103 sau comer\u0163? - Informa\u021bia Liber\u0103\" \/>\n<meta property=\"og:description\" content=\"Adep\u0163ii celei de-a treia doze de vaccin anti-Covid au primit o lovitur\u0103 de la autorit\u0103\u0163ile americane, spre exemplu. 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