{"id":3605,"date":"2021-01-13T17:32:35","date_gmt":"2021-01-13T14:32:35","guid":{"rendered":"https:\/\/www.klimik.org.tr\/koronavirus\/?p=3605"},"modified":"2021-01-13T19:36:27","modified_gmt":"2021-01-13T16:36:27","slug":"koronavirus-asilari-hakkinda-klimik-dernegi-gorusu","status":"publish","type":"post","link":"https:\/\/www.klimik.org.tr\/koronavirus\/koronavirus-asilari-hakkinda-klimik-dernegi-gorusu\/","title":{"rendered":"Koronavirus A\u015f\u0131lar\u0131 Hakk\u0131nda KL\u0130M\u0130K Derne\u011fi G\u00f6r\u00fc\u015f\u00fc"},"content":{"rendered":"

Son haftalarda pe\u015f pe\u015fe acil kullan\u0131m onay\u0131 alarak d\u00fcnyada kullan\u0131ma giren a\u015f\u0131lar ve \u00fclkemizde, Brezilya ve Endonezya\u2019da Faz III \u00e7al\u0131\u015fmas\u0131 y\u00fcr\u00fct\u00fclen inaktive a\u015f\u0131 (Coronavac\u2122<\/sup>) ile ilgili olarak kamuoyunda \u00e7ok tart\u0131\u015fma ya\u015fanmaktad\u0131r. Coronavac\u2122 <\/sup>a\u015f\u0131s\u0131n\u0131n farkl\u0131 \u00fclkelerden a\u00e7\u0131klanan sonu\u00e7lar\u0131n\u0131n etkililik a\u00e7\u0131s\u0131ndan farkl\u0131 olmas\u0131 ve \u00fclkemizde bu a\u015f\u0131n\u0131n uygulanacak olmas\u0131 tart\u0131\u015fmalar\u0131 daha da alevlendirmi\u015ftir.<\/p>\n

\u00d6ncelikle bu a\u015f\u0131lar\u0131n hi\u00e7birinin Faz III \u00e7al\u0131\u015fmalar\u0131n\u0131n sonu\u00e7lanmad\u0131\u011f\u0131, etkililik ve k\u0131sa s\u00fcreli g\u00fcvenlik ara sonu\u00e7lar\u0131na g\u00f6re pandemi ko\u015fullar\u0131 nedeniyle acil kullan\u0131m onay\u0131 verilerek insanlarda yayg\u0131n \u015fekilde kullan\u0131lmaya ba\u015fland\u0131\u011f\u0131 unutulmamal\u0131d\u0131r. A\u015f\u0131lar\u0131n uzun d\u00f6nem g\u00fcvenlik ve etkililik sonu\u00e7lar\u0131 takip edilmektedir ve tam ruhsatland\u0131r\u0131lmalar\u0131 bu s\u00fcre\u00e7 sonucunda elde edilecek verilere g\u00f6re yap\u0131labilecektir. Bu a\u015f\u0131lar\u0131n tamam\u0131n\u0131n Faz I ve II \u00e7al\u0131\u015fma sonu\u00e7lar\u0131 bilimsel dergilerde yay\u0131mlanm\u0131\u015f olup mRNA a\u015f\u0131lar\u0131n\u0131n (Pfizer-Biontech\u2122<\/sup> ve Moderna\u2122<\/sup>) ve viral vekt\u00f6r a\u015f\u0131s\u0131n\u0131n (Oxford-AstraZeneca\u2122<\/sup>) Faz III \u00e7al\u0131\u015fmas\u0131na ait veriler bilimsel dergilerde yay\u0131mlanm\u0131\u015f, inaktive a\u015f\u0131n\u0131n Brezilya, Endonezya ve T\u00fcrkiye\u2019deki Faz III \u00e7al\u0131\u015fma verileri ise \u00e7al\u0131\u015fmalar\u0131 y\u00fcr\u00fctenler ve\/veya sa\u011fl\u0131k otoriteleri taraf\u0131ndan kamuoyuyla payla\u015f\u0131lm\u0131\u015ft\u0131r.<\/p>\n

Faz I ve II sonu\u00e7lar\u0131na g\u00f6re etkili ve g\u00fcvenli olduklar\u0131 g\u00f6zlenen ve bu sayede Faz III \u00e7al\u0131\u015fmaya ge\u00e7ebilen bu a\u015f\u0131lardan Pfizer-Biontech\u2122<\/sup> ve Moderna\u2122 <\/sup>a\u015f\u0131lar\u0131n\u0131n Faz III sonu\u00e7lar\u0131 farkl\u0131 \u00fclkelerde veya merkezlerde y\u00fcr\u00fct\u00fclmelerine ra\u011fmen ayn\u0131 protokole ba\u011fl\u0131 kal\u0131narak yap\u0131ld\u0131\u011f\u0131 i\u00e7in daha geni\u015f ve daha kolay yorumlanabilir veri sunmaktad\u0131r. Buna kar\u015f\u0131l\u0131k, Oxford-AstraZeneca\u2122<\/sup> ve Coronavac\u2122<\/sup> a\u015f\u0131lar\u0131nda farkl\u0131 \u00fclkelerde farkl\u0131 \u00e7al\u0131\u015fma protokolleri uyguland\u0131\u011f\u0131 i\u00e7in, elde edilen veriler ayr\u0131 ayr\u0131 de\u011ferlendirilerek bir sonuca ula\u015fmak gerekmektedir.<\/p>\n

S\u00f6z\u00fc edilen a\u015f\u0131lara ait \u00e7al\u0131\u015fmalar bu bak\u0131\u015f a\u00e7\u0131s\u0131yla de\u011ferlendirildi\u011finde \u00f6zet olarak;<\/p>\n

1.<\/strong> A\u015f\u0131lanan ki\u015fide hastal\u0131k geli\u015fmesini \u00f6nleme konusundaki etkilili\u011fin;<\/p>\n

Pfizer-Biontech\u2122<\/sup> a\u015f\u0131s\u0131 i\u00e7in %95 (%95 G\u00fcven Aral\u0131\u011f\u0131-GA:90,3-97,6),<\/p>\n

Moderna\u2122 <\/sup>a\u015f\u0131s\u0131 i\u00e7in %94.1 (%95 GA:89.3-96.8),<\/p>\n

Oxford-AstraZeneca\u2122<\/sup> a\u015f\u0131s\u0131 i\u00e7in \u0130ngiltere \u00e7al\u0131\u015fmas\u0131 ilk a\u015f\u0131n\u0131n yar\u0131m doz 28 g\u00fcn sonra yap\u0131lan ikinci a\u015f\u0131n\u0131n ise tam doz uyguland\u0131\u011f\u0131 grupta %90,0 (%95 GA:67.4-97.0), \u0130ngiltere \u00e7al\u0131\u015fmas\u0131 her iki a\u015f\u0131n\u0131n tam doz uyguland\u0131\u011f\u0131 grupta %60,3 (%95 GA: 28,0-78,2), Brezilya \u00e7al\u0131\u015fmas\u0131 her iki a\u015f\u0131n\u0131n tam doz uyguland\u0131\u011f\u0131 grupta %64.2 (%95 GA:30.7-81.5),<\/p>\n

Coronavac\u2122<\/sup> a\u015f\u0131s\u0131 i\u00e7in: T\u00fcrkiye\u2019de %91.25 (%95 GA: 71-97), Brezilya\u2019da %50.38 (\u00e7ok hafif hastal\u0131k i\u00e7in) ve %77.96 (hafif hastal\u0131k i\u00e7in) oldu\u011fu,<\/p>\n

2.<\/strong> A\u015f\u0131lanan ki\u015fide a\u011f\u0131r hastal\u0131k ve \u00f6l\u00fcm\u00fc \u00f6nleme konusundaki etkilili\u011fin t\u00fcm a\u015f\u0131lar i\u00e7in %100\u2019e yak\u0131n oldu\u011fu,<\/p>\n

3.<\/strong> A\u015f\u0131lar\u0131n hi\u00e7birinde k\u0131sa d\u00f6nem (1-2 ay) ciddi yan etki olu\u015fma s\u0131kl\u0131\u011f\u0131n\u0131n plasebodan y\u00fcksek olmad\u0131\u011f\u0131,<\/p>\n

4.<\/strong> mRNA a\u015f\u0131lar\u0131n\u0131n ciddi olmayan lokal ve sistemik yan etkilerinin \u00f6zellikle gen\u00e7 ya\u015f grubunda belirgin olarak fazla oldu\u011fu,<\/p>\n

5.<\/strong> \u0130leri ya\u015ftaki ki\u015filerde mRNA a\u015f\u0131lar\u0131n\u0131n etkilili\u011finin gen\u00e7 ya\u015flardakine benzer \u015fekilde y\u00fcksek oldu\u011fu,<\/p>\n

6.<\/strong> Oxford-AstraZeneca\u2122<\/sup> a\u015f\u0131s\u0131nda 55 ya\u015f \u00fczerinde etkilili\u011finin biraz daha d\u00fc\u015f\u00fck oldu\u011fu,<\/p>\n

7.<\/strong> Coronavac\u2122 <\/sup>a\u015f\u0131s\u0131nda Brezilya\u2019daki \u00e7al\u0131\u015fman\u0131n 60 ya\u015f \u00fcst\u00fcndeki ki\u015fileri de kapsamas\u0131yla birlikte bunlara ait verinin hen\u00fcz yay\u0131mlanmad\u0131\u011f\u0131 g\u00f6r\u00fclmektedir.<\/p>\n

Sonu\u00e7 olarak, g\u00fcndemdeki d\u00f6rt a\u015f\u0131n\u0131n hastal\u0131\u011f\u0131 \u00f6nleme konusundaki etkililikleri farkl\u0131 olmakla birlikte a\u011f\u0131r hastal\u0131k ve \u00f6l\u00fcmleri \u00f6nleme konusunda etkililiklerinin %100\u2019e yak\u0131n oldu\u011fu, farkl\u0131 ya\u015f ve risk gruplar\u0131nda etkililik ve yan etki a\u00e7\u0131s\u0131ndan birbirlerine \u00fcst\u00fcnl\u00fckleri olabildi\u011fi, bug\u00fcne kadarki veriler \u0131\u015f\u0131\u011f\u0131nda hi\u00e7birinin ciddi yan etki olu\u015fturmad\u0131\u011f\u0131 s\u00f6ylenebilir.<\/p>\n

Bu a\u015f\u0131lardan mRNA a\u015f\u0131lar\u0131 (Pfizer-Biontech\u2122<\/sup> ve Moderna\u2122<\/sup>) ve viral vekt\u00f6r a\u015f\u0131s\u0131 (Oxford-AstraZeneca\u2122<\/sup>) d\u00fcnyada pek \u00e7ok \u00fclkede acil kullan\u0131m onay\u0131 alm\u0131\u015f ve kitlesel a\u015f\u0131lama programlar\u0131nda kullan\u0131lmaya ba\u015flam\u0131\u015ft\u0131r.\u00a0 \u00dclkemiz i\u00e7in kullan\u0131m\u0131 s\u00f6z konusu olacak olan Coronavac\u2122 <\/sup>a\u015f\u0131s\u0131n\u0131n \u00c7in d\u0131\u015f\u0131nda acil kullan\u0131m onay\u0131 bulunmay\u0131p T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (T\u0130TCK) b\u00fcnyesinde olu\u015fturulan bir bilimsel komisyonda Brezilya, Endonezya ve T\u00fcrkiye Faz III \u00e7al\u0131\u015fmalar\u0131n\u0131n de\u011ferlendirilmesi ile karar verilece\u011fi bildirilmektedir. Bir yandan da acil kullan\u0131m onay\u0131 alma olas\u0131l\u0131\u011f\u0131na kar\u015f\u0131 sahada a\u015f\u0131lama haz\u0131rl\u0131klar\u0131 devam etmektedir.<\/p>\n

Pandeminin etkilerinin hafifletilebilmesi ve insanlar\u0131m\u0131z\u0131n sa\u011fl\u0131\u011f\u0131 i\u00e7in son derece \u00f6nemli ve vazge\u00e7ilmez olan a\u015f\u0131yla ilgili s\u00fcre\u00e7lerin nas\u0131l y\u00fcr\u00fct\u00fcld\u00fc\u011f\u00fc yukar\u0131da \u00f6zetlenen verilerden bile daha \u00f6nemlidir. Bu nedenle toplumda Coronavac\u2122 <\/sup>a\u015f\u0131s\u0131na kar\u015f\u0131 teredd\u00fct olu\u015fmas\u0131n\u0131 engellemek i\u00e7in;<\/p>\n

1.<\/strong> T\u0130TCK b\u00fcnyesinde olu\u015fturulan bilimsel komisyon acil kullan\u0131m onay\u0131 i\u00e7in yapt\u0131\u011f\u0131 de\u011ferlendirmeyi ayr\u0131nt\u0131l\u0131 ve \u015feffaf bir \u015fekilde bilimsel kamuoyu (konuyla ilgili bilim insanlar\u0131, uzmanl\u0131k dernekleri ve \u00fcniversiteler) ile payla\u015fmal\u0131d\u0131r.<\/p>\n

2.<\/strong> Acil Kullan\u0131m Onay\u0131 verilme veya verilmeme gerek\u00e7eleri Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131nca de\u011fil T\u0130TCK b\u00fcnyesindeki komisyon taraf\u0131ndan genel kamuoyuna duyurulmal\u0131d\u0131r.<\/p>\n

3.<\/strong> A\u015f\u0131lar\u0131n de\u011fi\u015fik ya\u015f ve risk gruplar\u0131nda yukar\u0131da \u00f6zetlenen birbirlerine g\u00f6re farkl\u0131 avantaj ve dezavantajlar\u0131 oldu\u011fundan T\u00fcrkiye\u2019deki a\u015f\u0131 \u00e7e\u015fitlili\u011fi art\u0131r\u0131lmal\u0131 ve a\u015f\u0131 temininin s\u00fcreklili\u011fi sa\u011flanmal\u0131d\u0131r.<\/p>\n

\"\"<\/p>\n

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Son haftalarda pe\u015f pe\u015fe acil kullan\u0131m onay\u0131 alarak d\u00fcnyada kullan\u0131ma giren a\u015f\u0131lar ve \u00fclkemizde, Brezilya ve Endonezya\u2019da Faz III \u00e7al\u0131\u015fmas\u0131 y\u00fcr\u00fct\u00fclen inaktive a\u015f\u0131 (Coronavac\u2122) ile ilgili olarak kamuoyunda \u00e7ok tart\u0131\u015fma ya\u015fanmaktad\u0131r. Coronavac\u2122 a\u015f\u0131s\u0131n\u0131n farkl\u0131 \u00fclkelerden a\u00e7\u0131klanan sonu\u00e7lar\u0131n\u0131n etkililik a\u00e7\u0131s\u0131ndan farkl\u0131 olmas\u0131 ve \u00fclkemizde bu a\u015f\u0131n\u0131n uygulanacak olmas\u0131 tart\u0131\u015fmalar\u0131 daha da alevlendirmi\u015ftir. \u00d6ncelikle bu a\u015f\u0131lar\u0131n hi\u00e7birinin Faz III \u00e7al\u0131\u015fmalar\u0131n\u0131n sonu\u00e7lanmad\u0131\u011f\u0131, etkililik ve k\u0131sa s\u00fcreli g\u00fcvenlik ara sonu\u00e7lar\u0131na g\u00f6re pandemi ko\u015fullar\u0131 nedeniyle acil kullan\u0131m onay\u0131 verilerek insanlarda yayg\u0131n \u015fekilde kullan\u0131lmaya ba\u015fland\u0131\u011f\u0131 unutulmamal\u0131d\u0131r. A\u015f\u0131lar\u0131n uzun d\u00f6nem g\u00fcvenlik ve etkililik sonu\u00e7lar\u0131 takip edilmektedir ve tam ruhsatland\u0131r\u0131lmalar\u0131 bu s\u00fcre\u00e7 sonucunda elde edilecek verilere g\u00f6re yap\u0131labilecektir. […]<\/p>\n","protected":false},"author":4,"featured_media":3253,"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\/3605"}],"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=3605"}],"version-history":[{"count":5,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts\/3605\/revisions"}],"predecessor-version":[{"id":3610,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/posts\/3605\/revisions\/3610"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/media\/3253"}],"wp:attachment":[{"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/media?parent=3605"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/categories?post=3605"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.klimik.org.tr\/koronavirus\/wp-json\/wp\/v2\/tags?post=3605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}