{"id":5525,"date":"2022-01-14T16:20:39","date_gmt":"2022-01-14T13:20:39","guid":{"rendered":"https:\/\/www.klimik.org.tr\/koronavirus\/?p=5525"},"modified":"2022-01-14T16:27:32","modified_gmt":"2022-01-14T13:27:32","slug":"turk-toraks-dernegi-ttd-turk-klinik-mikrobiyoloji-ve-infeksiyon-hastaliklari-dernegi-klimik-ve-halk-sagligi-uzmanlari-dernegi-hasuder-ortak-basin-aciklamasi-ii","status":"publish","type":"post","link":"https:\/\/www.klimik.org.tr\/koronavirus\/turk-toraks-dernegi-ttd-turk-klinik-mikrobiyoloji-ve-infeksiyon-hastaliklari-dernegi-klimik-ve-halk-sagligi-uzmanlari-dernegi-hasuder-ortak-basin-aciklamasi-ii\/","title":{"rendered":"T\u00fcrk Toraks Derne\u011fi (TTD), T\u00fcrk Klinik Mikrobiyoloji ve \u0130nfeksiyon Hastal\u0131klar\u0131 Derne\u011fi (KL\u0130M\u0130K) ve Halk Sa\u011fl\u0131\u011f\u0131 Uzmanlar\u0131 Derne\u011fi (HASUDER) Ortak Bas\u0131n A\u00e7\u0131klamas\u0131 (II)"},"content":{"rendered":"<div class=\"section section-post-header\">\n<div class=\"section_wrapper clearfix\">\n<div class=\"column one post-header\">\n<div class=\"title_wrapper\">\n<p>\u00dc\u00e7 uzmanl\u0131k derne\u011fi olarak, 13 Aral\u0131k 2021 tarihinde \u00fclkemizin a\u015f\u0131 politikas\u0131 ve bu \u00e7er\u00e7evede Turkovac a\u015f\u0131s\u0131na dair izlenmesi gereken bilimsel yakla\u015f\u0131m konusunda \u00f6nerilerimizi kamuoyuyla payla\u015fm\u0131\u015ft\u0131k.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<p>Gerek s\u00f6z konusu a\u00e7\u0131klamam\u0131zda yer alan, gerekse pek \u00e7ok kesim taraf\u0131ndan yap\u0131lan benzer \u00e7a\u011fr\u0131lara yan\u0131t olarak 12 Ocak 2022 tarihinde Hacettepe \u00dcniversitesi\u2019nde Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 Bilimsel Dan\u0131\u015fma Kurulu \u00dcyesi Prof. Dr. Serhat \u00dcnal ve ayn\u0131 \u00fcniversitenin \u00f6\u011fretim \u00fcyesi Prof. Dr. Mine Durusu Tanr\u0131\u00f6ver\u2019in Turkovac konusunda kamuoyuna yap\u0131lan bilgilendirme hakk\u0131nda g\u00f6r\u00fc\u015flerimizi kamuoyuna aktarma gere\u011fi do\u011fmu\u015ftur.<\/p>\n<ol type=\"1\">\n<li>Turkovac a\u015f\u0131s\u0131na ait verilerin k\u0131smen ve gecikmeli de olsa a\u00e7\u0131klanm\u0131\u015f olmas\u0131 a\u015f\u0131ya kar\u015f\u0131 olu\u015fan teredd\u00fctleri gidermek a\u00e7\u0131s\u0131ndan \u00f6nemli bir ad\u0131md\u0131r.<\/li>\n<li>Genel olarak tart\u0131\u015fmaya a\u00e7\u0131k y\u00f6nleri olmakla birlikte Turkovac\u2019\u0131n belirli bir koruyucu etkinli\u011finin g\u00f6zlenmesi sevindiricidir. Bu ba\u011flamda \u00fclkemizin tarihsel ge\u00e7mi\u015fine yak\u0131\u015f\u0131r bi\u00e7imde yeniden a\u015f\u0131 \u00fcretimine y\u00f6nelmemiz hepimiz a\u00e7\u0131s\u0131ndan sevindirici olman\u0131n yan\u0131 s\u0131ra birey ve toplum sa\u011fl\u0131\u011f\u0131 a\u00e7\u0131s\u0131ndan kritik \u00f6neme haizdir. Dile\u011fimiz a\u015f\u0131lar ba\u015fta olmak \u00fczere sa\u011fl\u0131k hizmet alan\u0131nda kullan\u0131lan t\u0131bbi \u00fcr\u00fcnlerin geli\u015ftirilmesi ve \u00fcretilmesinin ulus\u00f6tesi \u015firketlerin inisiyatifine b\u0131rak\u0131lamayacak kadar hayati bir alan oldu\u011funun fark edilerek kamunun sa\u011fl\u0131k alan\u0131nda g\u00fc\u00e7l\u00fc bir akt\u00f6r olarak yetkinle\u015ftirilmesinin sa\u011flanmas\u0131d\u0131r. Refik Saydam H\u0131fz\u0131s\u0131hha Enstit\u00fcs\u00fc\u2019n\u00fcn \u00e7a\u011f\u0131n gereklerine uygun bi\u00e7imde yeniden faal konuma getirilmesi ise g\u00fc\u00e7l\u00fc kamu sa\u011fl\u0131k yap\u0131lanmas\u0131n\u0131n vazge\u00e7ilmez gere\u011fidir.<\/li>\n<li>Turkovac konusunda Hacettepe \u00dcniversitesi yerle\u015fkesinde a\u00e7\u0131klama yapan Prof. Dr. Serhat \u00dcnal\u2019\u0131n ifadelerinden kendilerinin de acil kullan\u0131m onay\u0131 (AKO) s\u00fcrecinin k\u0131smen d\u0131\u015f\u0131nda oldu\u011fu anla\u015f\u0131lmaktad\u0131r. Bu nedenle Turkovac a\u015f\u0131s\u0131 hakk\u0131nda yap\u0131lacak bilgilendirmenin, AKO onay\u0131 \u00f6ncesinde veT\u00fcrkiye Sa\u011fl\u0131k Enstit\u00fcleri Ba\u015fkanl\u0131\u011f\u0131 (T\u00dcSEB) ya da Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131\u2019n\u0131n da kat\u0131l\u0131m\u0131yla yap\u0131lmas\u0131 daha uygun olurdu. Kamuoyu AKO onay\u0131ndan sorumlu yap\u0131lara sorular\u0131n\u0131 y\u00f6neltebilme ve onlardan gerekli yan\u0131tlar\u0131 alabilme \u015fans\u0131na sahip olurdu.<\/li>\n<li>Bilindi\u011fi \u00fczere Comirnaty (Pfizer-BionNTech) ve di\u011fer a\u015f\u0131lar i\u00e7in gereken uluslararas\u0131 onay s\u00fcre\u00e7leri ayr\u0131nt\u0131l\u0131 olarak kamuoyu ile payla\u015f\u0131lmaktad\u0131r. Ku\u015fkusuz b\u00f6ylesi bir \u015feffafl\u0131k a\u015f\u0131lara kar\u015f\u0131 olu\u015fabilecek teredd\u00fcd\u00fc azaltan bir uygulamad\u0131r. Benzer uygulaman\u0131n Turkovac konusunda da hayata ge\u00e7irilmesini ve kamuoyuna yap\u0131lan k\u0131s\u0131tl\u0131 a\u00e7\u0131klaman\u0131n yan\u0131 s\u0131ra T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (T\u0130TCK)\u2019nun onay s\u00fcrecine ili\u015fkin bilgilerin ve rapor ve dok\u00fcmanlar\u0131n kamuoyu ile payla\u015f\u0131lmas\u0131n\u0131n yararl\u0131 olaca\u011f\u0131n\u0131 d\u00fc\u015f\u00fcn\u00fcyoruz.<\/li>\n<li>Turkovac konusunda a\u00e7\u0131klanan veriler ara\u015ft\u0131rman\u0131n randomize yap\u0131s\u0131, izlem s\u00fcreci, insidans\u0131n ki\u015fi-zaman olarak hesaplanm\u0131\u015f olmas\u0131, bridging (imm\u00fcnolojik yan\u0131tlarla klinik sonu\u00e7lar\u0131n birlikte de\u011ferlendirilmesi) yap\u0131lm\u0131\u015f olmas\u0131 gibi \u00e7e\u015fitli y\u00f6nleriyle belirli standartlara sahip oldu\u011funu g\u00f6stermesi bak\u0131m\u0131ndan sevindiricidir.<\/li>\n<li>Turkovac a\u015f\u0131s\u0131n\u0131n Coronavac\u2019tan \u201cnon-inferior\u201d oldu\u011fu yani en az onun kadar koruyucu oldu\u011funun g\u00f6zlenmi\u015f olmas\u0131 memnuniyet vericidir.<\/li>\n<li>12 Ocak 2022 g\u00fcn\u00fc kamuoyuna yap\u0131lan a\u00e7\u0131klama baz\u0131 k\u0131s\u0131tl\u0131l\u0131klar i\u00e7ermektedir.\n<ul>\n<li>\u00c7al\u0131\u015fman\u0131n planlanan birincil tamamlama tarihinin de\u011fi\u015ftirilmesi ve bunun sonu\u00e7lara etkisi konusu yeterince a\u00e7\u0131klanmam\u0131\u015ft\u0131r.<\/li>\n<li>G\u00f6n\u00fcll\u00fclerin genel demografik yap\u0131s\u0131na dair bilgiler verilmi\u015f olmakla birlikte ara\u015ft\u0131rman\u0131n iki kolundaki ya\u015f ve cinsiyet da\u011f\u0131l\u0131m\u0131n\u0131n e\u015fit olup olmad\u0131\u011f\u0131 a\u00e7\u0131klanmam\u0131\u015ft\u0131r.<\/li>\n<li>Ara\u015ft\u0131rma kapsam\u0131nda bridging yap\u0131ld\u0131\u011f\u0131 anla\u015f\u0131lmakla birlikte yap\u0131lan bas\u0131n a\u00e7\u0131klamas\u0131nda buna dair sonu\u00e7lara yer verilmemi\u015ftir.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>Bilimsel ara\u015ft\u0131rma metodolojisi y\u00f6n\u00fcnden bu \u00fc\u00e7 konu, Turkovac ile Coronavac aras\u0131nda saptanan fark\u0131n yorumlanabilmesi a\u00e7\u0131s\u0131ndan vazge\u00e7ilmezdir. Ara\u015ft\u0131rman\u0131n protokol\u00fcndeki de\u011fi\u015fikliklerin etkisinin tart\u0131\u015f\u0131lmas\u0131 gerekir. Ayr\u0131ca, \u00f6l\u00fc vir\u00fcs a\u015f\u0131s\u0131 olmas\u0131 y\u00f6n\u00fcnden ayn\u0131 yap\u0131da iki a\u015f\u0131 aras\u0131nda Turkovac lehine bir farkl\u0131l\u0131\u011f\u0131n olmas\u0131n\u0131 a\u00e7\u0131klamak gereklili\u011fi vard\u0131r. \u0130mm\u00fcnolojik kar\u015f\u0131la\u015ft\u0131rmalar\u0131n iki a\u015f\u0131 aras\u0131ndaki fark\u0131 do\u011furup do\u011furmad\u0131\u011f\u0131n\u0131n ortaya konmas\u0131 gereklidir.<\/p>\n<ol start=\"8\">\n<li>Turkovac ara\u015ft\u0131rmas\u0131n\u0131n metodolojik olarak \u201czay\u0131f\u201d olan y\u00f6n\u00fc Turkovac\u2019\u0131n kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131 i\u00e7in Coronavac\u2019\u0131n referans olarak se\u00e7ilmi\u015f olmas\u0131d\u0131r. Etik ilkeler uyar\u0131nca plasebo kontroll\u00fc bir \u00e7al\u0131\u015fman\u0131n yap\u0131lmam\u0131\u015f olmas\u0131 do\u011fald\u0131r. Ancak \u201cnon-inferiority\u201d \u00e7al\u0131\u015fmalar\u0131nda kar\u015f\u0131la\u015ft\u0131r\u0131lmak istenen yeni ila\u00e7 ya da a\u015f\u0131n\u0131n, o g\u00fcn itibariyle var olan ila\u00e7 ya da a\u015f\u0131 se\u00e7eneklerinin en iyisi ile kar\u015f\u0131la\u015ft\u0131r\u0131lmas\u0131 tercih edilmektedir. Konumuz itibariyle \u201cTurkovac\u2019\u0131n etkinli\u011finin \u201cen az Coronava kadar iyi\u201d oldu\u011funu bulmak bize ne kazand\u0131r\u0131r? sorgulamas\u0131 yap\u0131lmal\u0131d\u0131r. Kendisi \u00e7ok da y\u00fcksek etkilili\u011fe sahip olmayan ve kendisinden daha iyi se\u00e7eneklerin a\u00e7\u0131k\u00e7a bulundu\u011fu bir a\u015f\u0131 referans al\u0131nmak yerine \u00fclkemizde kullan\u0131mda olan mRNA a\u015f\u0131s\u0131 ile kar\u015f\u0131la\u015ft\u0131rma yap\u0131lsayd\u0131 bug\u00fcn itibariyle \u00e7ok de\u011ferli bir bilgiye sahip olurduk. Omicron dalgas\u0131n\u0131n etkili oldu\u011fu \u015fu g\u00fcnlerde SARS-CoV-2\u2019ye kar\u015f\u0131 zaten k\u0131s\u0131tl\u0131 olan etkilili\u011fi yeni varyantlarla daha da azalm\u0131\u015f bir a\u015f\u0131dan \u201cnon-inferior\u201d oldu\u011fu g\u00f6sterilmi\u015f bir a\u015f\u0131ya sahip oldu\u011fumuz g\u00f6r\u00fclmektedir. Bu durum Turkovac a\u015f\u0131s\u0131n\u0131n ak\u0131lc\u0131 kullan\u0131m politikas\u0131n\u0131 belirlerken dikkate al\u0131nmas\u0131 gereken hayati bir konudur.<\/li>\n<li>Yap\u0131lan a\u00e7\u0131klama Faz 3 ara\u015ft\u0131rmas\u0131n\u0131n olduk\u00e7a s\u0131n\u0131rl\u0131 say\u0131da g\u00f6n\u00fcll\u00fc ile ula\u015f\u0131lan ara sonlan\u0131m noktas\u0131 verilerine dayal\u0131d\u0131r.\u00a0 AKO s\u00fcrecinde sadece bu ara\u015ft\u0131rman\u0131n de\u011fil, ba\u015fka ara\u015ft\u0131rma sonu\u00e7lar\u0131n\u0131n, ba\u015fka verilerin ve \u00fcretim ko\u015fullar\u0131na ili\u015fkin bilgilerin de birlikte de\u011ferlendirildi\u011fi ifade edilmi\u015ftir. Bilimsel ara\u015ft\u0131rma ve onay s\u00fcre\u00e7lerinin zorunlu bir gere\u011fi olarak belirtilen bu di\u011fer ara\u015ft\u0131rmalar\u0131n, di\u011fer verilerin ve \u00f6zellikle \u00fcretim ko\u015fullar\u0131na ili\u015fkin di\u011fer raporlar\u0131n a\u00e7\u0131klanmas\u0131n\u0131 bekliyoruz.<\/li>\n<li>Turkovac\u2019\u0131n D\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc taraf\u0131ndan onaylanmak \u00fczere ba\u015fvurusunun yap\u0131l\u0131p yap\u0131lmayaca\u011f\u0131 da \u00f6nemli bir husustur. B\u00f6yle bir ba\u015fvuru yap\u0131l\u0131rsa, yan\u0131t\u0131n\u0131 arad\u0131\u011f\u0131m\u0131z sorular ve a\u015f\u0131 \u00fcretim ko\u015fullar\u0131na ili\u015fkin aranan standartlar DS\u00d6 onay\u0131 a\u00e7\u0131s\u0131ndan da \u00f6nemli konular olacakt\u0131r. Dile\u011fimiz Turkovac\u2019\u0131n bu uluslararas\u0131 standartlara sahip oldu\u011funun da g\u00f6sterilebilmesidir.<\/li>\n<\/ol>\n<p>Son olarak Turkovac\u2019\u0131 geli\u015ftirmek i\u00e7in emek veren, Faz \u00e7al\u0131\u015fmalar\u0131n\u0131 ger\u00e7ekle\u015ftiren t\u00fcm bilim insanlar\u0131na te\u015fekk\u00fcr\u00fc bir bor\u00e7 biliyoruz. \u00dc\u00e7 uzmanl\u0131k derne\u011fi olarak hassasiyet g\u00f6sterdi\u011fimiz konu bu eme\u011fe ve \u00f6zveriye lay\u0131k bir kamusal \u00f6zeni ve \u015feffafl\u0131\u011f\u0131 sa\u011flayabilmektir.<\/p>\n<div>\n<div>\n<p><strong>Prof. Dr. Oya \u0130til<br \/>\n<\/strong><strong>TTD Ba\u015fkan\u0131<\/strong><\/p>\n<p><strong style=\"font-size: 1.21429rem;\">Prof. Dr. Serap \u015eim\u015fek-Yavuz<br \/>\n<\/strong><strong style=\"font-size: 1.21429rem;\">KL\u0130M\u0130K Ba\u015fkan\u0131<\/strong><\/p>\n<p><strong style=\"font-size: 1.21429rem;\">Prof. Dr. B\u00fclent K\u0131l\u0131\u00e7<br \/>\n<\/strong><strong style=\"font-size: 1.21429rem;\">HASUDER Ba\u015fkan\u0131<\/strong><\/p>\n<p><strong style=\"font-size: 1.21429rem;\"><a href=\"https:\/\/www.klimik.org.tr\/?p=109175\">\u0130lk Bas\u0131n A\u00e7\u0131klamas\u0131 \u0130\u00e7in T\u0131klay\u0131n\u0131z<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"section section-post-related\">\n<div class=\"section_wrapper clearfix\">\n<div class=\"section-related-adjustment simple\">\n<div class=\"section-related-ul col-4\">\n<div>\n<div>\n<div>\n<div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div class=\"column post-related post-3721 post type-post status-publish format-standard has-post-thumbnail hentry category-basin-bildirileri tag-covid-19 tag-halk-sagligi tag-hasuder tag-yeni-koronavirus\">\n<div class=\"single-photo-wrapper image\">\n<div class=\"image_frame scale-with-grid\">\n<div class=\"image_wrapper\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u00dc\u00e7 uzmanl\u0131k derne\u011fi olarak, 13 Aral\u0131k 2021 tarihinde \u00fclkemizin a\u015f\u0131 politikas\u0131 ve bu \u00e7er\u00e7evede Turkovac a\u015f\u0131s\u0131na dair izlenmesi gereken bilimsel yakla\u015f\u0131m konusunda \u00f6nerilerimizi kamuoyuyla payla\u015fm\u0131\u015ft\u0131k. Gerek s\u00f6z konusu a\u00e7\u0131klamam\u0131zda yer alan, gerekse pek \u00e7ok kesim taraf\u0131ndan yap\u0131lan benzer \u00e7a\u011fr\u0131lara yan\u0131t olarak 12 Ocak 2022 tarihinde Hacettepe \u00dcniversitesi\u2019nde Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 Bilimsel Dan\u0131\u015fma Kurulu \u00dcyesi Prof. Dr. Serhat \u00dcnal ve ayn\u0131 \u00fcniversitenin \u00f6\u011fretim \u00fcyesi Prof. Dr. Mine Durusu Tanr\u0131\u00f6ver\u2019in Turkovac konusunda kamuoyuna yap\u0131lan bilgilendirme hakk\u0131nda g\u00f6r\u00fc\u015flerimizi kamuoyuna aktarma gere\u011fi do\u011fmu\u015ftur. Turkovac a\u015f\u0131s\u0131na ait verilerin k\u0131smen ve gecikmeli de olsa a\u00e7\u0131klanm\u0131\u015f olmas\u0131 a\u015f\u0131ya kar\u015f\u0131 olu\u015fan teredd\u00fctleri gidermek a\u00e7\u0131s\u0131ndan \u00f6nemli bir ad\u0131md\u0131r. Genel olarak [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5306,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts\/5525"}],"collection":[{"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/comments?post=5525"}],"version-history":[{"count":3,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts\/5525\/revisions"}],"predecessor-version":[{"id":5528,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts\/5525\/revisions\/5528"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/media\/5306"}],"wp:attachment":[{"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/media?parent=5525"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/categories?post=5525"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/tags?post=5525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}