{"id":733484,"date":"2025-04-02T20:51:01","date_gmt":"2025-04-02T18:51:01","guid":{"rendered":"https:\/\/www.hashtag.al\/?p=733484"},"modified":"2025-04-02T20:54:13","modified_gmt":"2025-04-02T18:54:13","slug":"fda-ja-ne-shba-shtyn-vendimin-per-vaksinen-covid-19","status":"publish","type":"post","link":"https:\/\/www.hashtag.al\/index.php\/2025\/04\/02\/fda-ja-ne-shba-shtyn-vendimin-per-vaksinen-covid-19\/","title":{"rendered":"FDA-ja n\u00eb SHBA shtyn vendimin p\u00ebr vaksin\u00ebn Covid-19","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

\"\"<\/a><\/span><\/p>\n

Rregullator\u00ebt federal\u00eb t\u00eb barnave kan\u00eb humbur afatin p\u00ebr marrjen e nj\u00eb vendimi ky\u00e7 n\u00eb lidhje me nj\u00eb vaksin\u00eb Covid-19 nga Novavax, disa dit\u00eb pasi shefi i vaksinave t\u00eb FDA-s\u00eb u dor\u00ebhoq.<\/span><\/p>\n

Agjencia ishte vendosur t\u00eb jepte miratimin e plot\u00eb p\u00ebr vaksin\u00ebn e Novavax, por drejtuesit e lart\u00eb t\u00eb agjencis\u00eb tani jan\u00eb duke marr\u00eb vendimin dhe kan\u00eb th\u00ebn\u00eb se aplikacioni i Novavax kishte nevoj\u00eb p\u00ebr m\u00eb shum\u00eb t\u00eb dh\u00ebna dhe nuk kishte gjasa t\u00eb miratohej s\u00eb shpejti, than\u00eb njer\u00ebz t\u00eb njohur me k\u00ebt\u00eb \u00e7\u00ebshtje, shkruan WSJ<\/a><\/span>.<\/span><\/p>\n

FDA-ja ka lejuar p\u00ebrdorimin urgjent t\u00eb vaksin\u00ebs Covid-19 t\u00eb Novavax. Ajo caktoi nj\u00eb afat 1 prill p\u00ebr nj\u00eb vendim n\u00ebse do jepet nj\u00eb miratim normal dhe i plot\u00eb, than\u00eb njer\u00ebzit.<\/span><\/p>\n

Vendimi do kishte mund\u00ebesuar p\u00ebrdorimin e vijuesh\u00ebm t\u00eb vaksin\u00ebs edhe pse urgjenca pandemike ka kaluar. FDA-ja dha miratimin e plot\u00eb p\u00ebr vaksinat Covid-19 nga Pfizer dhe partneri i saj BioNTech dhe nga Moderna n\u00eb 2021 dhe 2022.<\/span><\/p>\n

Novavax tha se “po vijon t\u00eb komunikoj\u00eb me FDA-n\u00eb dhe t\u00eb dialogoj\u00eb p\u00ebr t\u00eb siguruar q\u00eb ata t\u00eb ken\u00eb t\u00eb gjith\u00eb informacionin e k\u00ebrkuar p\u00ebr t\u00eb plot\u00ebsuar aplikacionin ton\u00eb”.<\/span><\/p>\n

Nj\u00eb z\u00ebdh\u00ebn\u00ebs i Departamentit t\u00eb Sh\u00ebndet\u00ebsis\u00eb nuk pranoi t\u00eb komentoj\u00eb. FDA nuk iu p\u00ebrgjigj menj\u00ebher\u00eb k\u00ebrkesave p\u00ebr koment.<\/span><\/p>\n

Q\u00ebndrimi i qeveris\u00eb federale p\u00ebr vaksinat \u00ebsht\u00eb v\u00ebzhguar nga af\u00ebr q\u00eb kur skeptiku ndaj vaksinave Robert F. Kennedy Jr. u em\u00ebrua Sekretar iSh\u00ebndet\u00ebsis\u00eb, institucion q\u00eb mbik\u00ebqyr FDA-n\u00eb. N\u00eb seancat e tij t\u00eb konfirmimit n\u00eb Senat, Kennedy i premtoi Senatorit Bill Cassidy se nuk do t\u00eb ndryshonte sistemet e miratimit t\u00eb vaksinave.<\/span><\/p>\n

FDA-ja tashm\u00eb kishte d\u00ebrguar komunikime n\u00eb lidhje me vendimin p\u00ebr dh\u00ebnien e miratimit t\u00eb plot\u00eb p\u00ebr vaksin\u00ebn Covid-19 t\u00eb Novavax drejtuesve n\u00eb HHS. Vendimi ishte gjithashtu p\u00ebr nj\u00eb parashikim t\u00eb veprimeve t\u00eb ardhshme p\u00ebr drejtuesit e FDA n\u00eb zyr\u00ebn e komisionerit t\u00eb agjencis\u00eb.<\/span><\/p>\n

Do ishte l\u00ebvizja e par\u00eb e madhe e FDA-s\u00eb p\u00ebr vaksinat q\u00eb kur Dr. Peter Marks, kreu i divizionit q\u00eb shqyrton aplikimet e vaksinave dhe arkitekt kryesor i \u201cOperacionit Warp Speed\u201d \u200b\u200bgjat\u00eb administrat\u00ebs s\u00eb par\u00eb t\u00eb Trump, paraqiti dor\u00ebheqjen t\u00eb premten.<\/span><\/p>\n

Largimi i tij rr\u00ebzoi aksionet e kompanive bioteknike dhe prodhuesve t\u00eb vaksinave, duke p\u00ebrfshir\u00eb Novavax, me analist\u00ebt dhe investitor\u00ebt q\u00eb pyesin n\u00ebse FDA-ja do vijoj\u00eb t\u00eb miratoj\u00eb vaksinat.<\/span><\/p>\n

HHS jav\u00ebt e fundit i ka k\u00ebrkuar agjencis\u00eb t\u00eb pastroj\u00eb t\u00eb gjitha komunikimet p\u00ebrmes departamentit, than\u00eb njer\u00ebz t\u00eb njohur me k\u00ebt\u00eb \u00e7\u00ebshtje. Stefanie Spear, nj\u00eb ndihm\u00ebse e gjat\u00eb e Kenedit, i \u00ebsht\u00eb dashur t\u00eb n\u00ebnshkruaj\u00eb t\u00eb gjitha komunikimet e lidhura me vaksin\u00ebn, tha nj\u00eb nga njer\u00ebzit.<\/span><\/p>\n

N\u00eb pritje t\u00eb miratimit, draft komunikimet p\u00ebr t\u00eb shpallur vendimin u d\u00ebrguan n\u00eb HHS p\u00ebr shqyrtim jav\u00ebn e kaluar, por nuk jan\u00eb miratuar, tha nj\u00eb person tjet\u00ebr i njohur me k\u00ebt\u00eb \u00e7\u00ebshtje.<\/span><\/p>\n

Vaksina e Novavax p\u00ebrdor nj\u00eb teknologji m\u00eb t\u00eb vjet\u00ebr t\u00eb proteinave dhe p\u00eblqehej nga njer\u00ebzit q\u00eb preferonin t\u00eb shmangnin teknologjin\u00eb e ARN-s\u00eb t\u00eb p\u00ebrdorur n\u00eb imunizimet Pfizer-BioNTech dhe Moderna.<\/span><\/p>\n

K\u00ebrkesa e Novavax p\u00ebr miratim t\u00eb plot\u00eb \u00ebsht\u00eb ende nj\u00eb aplikim n\u00eb pritje dhe mund t\u00eb miratohet nga FDA n\u00eb \u00e7do koh\u00eb, than\u00eb njer\u00ebz t\u00eb njohur me k\u00ebt\u00eb \u00e7\u00ebshtje.<\/span><\/p>\n

Njer\u00ebzit mund t\u00eb vazhdojn\u00eb t\u00eb marrin vaksin\u00ebn e Novavax n\u00ebn autorizimin e saj p\u00ebr p\u00ebrdorim urgjent. N\u00eb vitin 2021, Kennedy i k\u00ebrkoi FDA-s\u00eb t\u00eb revokonte autorizimet e p\u00ebrdorimit urgjent t\u00eb vaksinave Covid-19. Tani q\u00eb ai \u00ebsht\u00eb Sekretar i Sh\u00ebndet\u00ebsis\u00eb, ai mund t\u00eb l\u00ebviz\u00eb p\u00ebr t\u00eb anuluar autorizimin e urgjenc\u00ebs t\u00eb Novavax, si dhe autorizimet e urgjenc\u00ebs q\u00eb mbeten n\u00eb fuqi p\u00ebr vaksinat Covid-19 p\u00ebr f\u00ebmij\u00ebt, than\u00eb ekspert\u00ebt e politikave sh\u00ebndet\u00ebsore.<\/span><\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"

Rregullator\u00ebt federal\u00eb t\u00eb barnave kan\u00eb humbur afatin p\u00ebr marrjen e nj\u00eb vendimi ky\u00e7 n\u00eb lidhje me nj\u00eb vaksin\u00eb Covid-19 nga Novavax, disa dit\u00eb pasi shefi i vaksinave t\u00eb FDA-s\u00eb u dor\u00ebhoq. Agjencia ishte vendosur t\u00eb jepte miratimin e plot\u00eb p\u00ebr vaksin\u00ebn e Novavax, por drejtuesit e lart\u00eb t\u00eb agjencis\u00eb tani jan\u00eb duke marr\u00eb vendimin dhe […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":51,"featured_media":733485,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-733484","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fast-foodi"],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/posts\/733484","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/users\/51"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/comments?post=733484"}],"version-history":[{"count":99999,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/posts\/733484\/revisions"}],"predecessor-version":[{"id":733489,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/posts\/733484\/revisions\/733489"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/media\/733485"}],"wp:attachment":[{"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/media?parent=733484"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/categories?post=733484"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hashtag.al\/index.php\/wp-json\/wp\/v2\/tags?post=733484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}