{"id":6984,"date":"2020-12-01T21:07:11","date_gmt":"2020-12-01T21:07:11","guid":{"rendered":"https:\/\/by-tv.co.uk\/?p=6984"},"modified":"2020-12-01T21:07:11","modified_gmt":"2020-12-01T21:07:11","slug":"biontech-kovid-19-asisi-icin-avrupa-ilac-ajansina-kosullu-onay-basvurusu-yapti","status":"publish","type":"post","link":"https:\/\/by-tv.co.uk\/en\/biontech-kovid-19-asisi-icin-avrupa-ilac-ajansina-kosullu-onay-basvurusu-yapti\/","title":{"rendered":"BioNTech, Kovid-19 a\u015f\u0131s\u0131 i\u00e7in Avrupa \u0130la\u00e7 Ajans\u0131na ‘ko\u015fullu onay’ ba\u015fvurusu yapt\u0131"},"content":{"rendered":"

BERL\u0130N (AA) – Amerikan ila\u00e7 \u015firketi Pfizer ile T\u00fcrk bilim insan\u0131 Prof. Dr. U\u011fur \u015eahin’in kurucu orta\u011f\u0131 oldu\u011fu Alman biyoteknoloji firmas\u0131 BioNTech’in, yeni tip koronavir\u00fcse (Kovid-19) kar\u015f\u0131 geli\u015ftirmekte oldu\u011fu potansiyel a\u015f\u0131 i\u00e7in d\u00fcn, Avrupa \u0130la\u00e7 Ajans\u0131na (EMA) ko\u015fullu piyasa onay\u0131 verilmesi konusunda ba\u015fvuru yapt\u0131\u011f\u0131 bildirildi.<\/p>\n

BioNTech’ten yap\u0131lan a\u00e7\u0131klamada, d\u00fcnk\u00fc ba\u015fvuruyla EMA taraf\u0131ndan 6 Ekim\u2019de Kovid-19’a kar\u015f\u0131 “BNT162b2” adl\u0131 a\u015f\u0131 aday\u0131na ruhsat verilmesi i\u00e7in ba\u015flat\u0131lan s\u00fcrecin tamamland\u0131\u011f\u0131 belirtildi.<\/p>\n

A\u015f\u0131n\u0131n daha \u00f6nce SARS-Cov-2 enfeksiyonu g\u00f6r\u00fclmeyen hastalarda y\u00fczde 95 etkili oldu\u011funun belirtildi\u011fi a\u00e7\u0131klamada, a\u015f\u0131n\u0131n etkinli\u011finin t\u00fcm ya\u015f ve cinsiyet gruplar\u0131nda tutarl\u0131 oldu\u011fu vurguland\u0131.<\/p>

\"\"<\/a><\/div>\n

A\u00e7\u0131klamada, “EMA, a\u015f\u0131 aday\u0131n\u0131n Kovid-19’a kar\u015f\u0131 koruma i\u00e7in faydalar\u0131n\u0131n, olas\u0131 risklerden daha a\u011f\u0131r bast\u0131\u011f\u0131 sonucuna var\u0131rsa ajans \u015fartl\u0131 piyasa onay\u0131n\u0131n verilmesini \u00f6nerecektir. Bu, BNT162b2’nin 2020’nin sonundan \u00f6nce Avrupa’da kullan\u0131lmas\u0131n\u0131 sa\u011flayabilir.” ifadelerine yer verildi.<\/p>\n

“A\u015f\u0131m\u0131z\u0131n h\u0131zl\u0131 k\u00fcresel da\u011f\u0131t\u0131m\u0131n\u0131 sa\u011flamak i\u00e7in \u00e7al\u0131\u015faca\u011f\u0131z”<\/h4>\n

A\u00e7\u0131klamada g\u00f6r\u00fc\u015flerine yer verilen Biontech \u00dcst Y\u00f6neticisi (CEO) ve Kurucu Orta\u011f\u0131 Prof. Dr. U\u011fur \u015eahin, ba\u015fvuruyu Kovid-19’a kar\u015f\u0131 a\u015f\u0131 \u00e7al\u0131\u015fmalar\u0131nda \u00f6nemli bir ad\u0131m olarak de\u011ferlendirdi.<\/p>\n

\u015eahin, “Onaylan\u0131rsa a\u015f\u0131m\u0131z\u0131n h\u0131zl\u0131 k\u00fcresel da\u011f\u0131t\u0131m\u0131n\u0131 sa\u011flamak i\u00e7in d\u00fcnya genelinde d\u00fczenleyici kurumlarla \u00e7al\u0131\u015fmaya devam etmek istiyoruz. Normale d\u00f6nebilmek i\u00e7in vir\u00fcsle m\u00fccadeleye y\u00f6nelik k\u00fcresel \u00e7abalara katk\u0131da bulunmak istiyoruz.” ifadelerini kulland\u0131.<\/p>\n

Pfizer \u00dcst Y\u00f6neticisi Albert Bourla, s\u00f6z konusu ba\u015fvuruyla Kovid-19 kriziyle m\u00fccadelede \u00e7abalar\u0131nda \u00f6nemli bir kilometre ta\u015f\u0131na daha ula\u015ft\u0131klar\u0131n\u0131 vurgulayarak “Bu yolculu\u011fun ba\u015flang\u0131c\u0131ndan beri insanlar\u0131n bir a\u015f\u0131 bekledi\u011fini biliyorduk ve olas\u0131 bir onay al\u0131r almaz, Kovid-19 a\u015f\u0131 dozlar\u0131n\u0131 da\u011f\u0131tmaya haz\u0131r olaca\u011f\u0131z.” de\u011ferlendirmesinde bulundu.<\/p>\n

S\u00f6z konusu a\u015f\u0131n\u0131n onay\u0131 i\u00e7in ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA) ile \u0130ngiltere \u0130la\u00e7 ve Sa\u011fl\u0131k \u00dcr\u00fcnleri D\u00fczenleme Kurumu (MHRA) ba\u015fta olmak \u00fczere Avustralya, Kanada ve Japonya\u2019da yetkili kurumlara ba\u015fvuruda bulunuldu\u011fu hat\u0131rlat\u0131ld\u0131.<\/p>\n

\u015eirketler, 6 Ekim\u2019de yapt\u0131klar\u0131 a\u00e7\u0131klamada, EMA\u2019n\u0131n “BNT162b2” adl\u0131 a\u015f\u0131 aday\u0131n\u0131, “Rolling Review” ad\u0131 verilen bir s\u00fcre\u00e7le inceleyece\u011fini a\u00e7\u0131klam\u0131\u015ft\u0131.<\/p>\n

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

BERL\u0130N (AA) – Amerikan ila\u00e7 \u015firketi Pfizer ile T\u00fcrk bilim insan\u0131 Prof. Dr. U\u011fur \u015eahin’in kurucu orta\u011f\u0131 oldu\u011fu Alman biyoteknoloji firmas\u0131 BioNTech’in, yeni tip koronavir\u00fcse (Kovid-19) kar\u015f\u0131 geli\u015ftirmekte oldu\u011fu potansiyel a\u015f\u0131 i\u00e7in d\u00fcn, Avrupa \u0130la\u00e7 Ajans\u0131na (EMA) ko\u015fullu piyasa onay\u0131 verilmesi konusunda ba\u015fvuru yapt\u0131\u011f\u0131 bildirildi. BioNTech’ten yap\u0131lan a\u00e7\u0131klamada, d\u00fcnk\u00fc ba\u015fvuruyla EMA taraf\u0131ndan 6 Ekim\u2019de Kovid-19’a kar\u015f\u0131 “BNT162b2” adl\u0131 a\u015f\u0131 aday\u0131na ruhsat verilmesi i\u00e7in ba\u015flat\u0131lan s\u00fcrecin tamamland\u0131\u011f\u0131 belirtildi. A\u015f\u0131n\u0131n daha \u00f6nce SARS-Cov-2 enfeksiyonu g\u00f6r\u00fclmeyen hastalarda y\u00fczde 95 etkili oldu\u011funun belirtildi\u011fi a\u00e7\u0131klamada, a\u015f\u0131n\u0131n etkinli\u011finin t\u00fcm ya\u015f ve cinsiyet gruplar\u0131nda tutarl\u0131 oldu\u011fu vurguland\u0131. A\u00e7\u0131klamada, “EMA, a\u015f\u0131 aday\u0131n\u0131n Kovid-19’a kar\u015f\u0131 koruma i\u00e7in faydalar\u0131n\u0131n, olas\u0131 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[13],"tags":[2382,2380,1834,2381,2317,1509,2383,2219],"class_list":["post-6984","post","type-post","status-publish","format-standard","hentry","category-saglik","tag-albert-bourla","tag-avrupa-ilac-ajansi","tag-biontech","tag-ema","tag-fda","tag-kovid-19","tag-mhra","tag-prof-dr-ugur-sahin"],"_links":{"self":[{"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/posts\/6984","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/comments?post=6984"}],"version-history":[{"count":0,"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/posts\/6984\/revisions"}],"wp:attachment":[{"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/media?parent=6984"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/categories?post=6984"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/by-tv.co.uk\/en\/wp-json\/wp\/v2\/tags?post=6984"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}