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Sağlık Bakanlığı Koronavirüs Bilim Kurulu Üyesi Prof. Dr. Ateş Kara , elde edilen ön verilere göre, TURKOVAC uygulanan kişiler arasında Kovid-19'u ağır geçiren olmadığını, ayrıca yerli aşının hatırlatma dozunda da antikor seviyelerini hızla yükselttiğini bildirdi.
Aynı zamanda TÜSEB'e bağlı Türkiye Aşı Enstitüsü Başkanı olan Kara, AA muhabirine, acil kullanım onayı başvurusu yapılan yerli inaktif Kovid-19 aşısı TURKOVAC'la ilgili yürütülen klinik çalışmalarda elde edilen ön sonuçları değerlendirdi.
TURKOVAC aşısının klinik çalışmalardaki verilerinin oldukça olumlu olduğunu, inaktif aşı Sinovac'la yürütülen karşılaştırmalı verilerden de olumlu sonuçlar alındığını belirten Kara, TURKOVAC'la ilgili iki grup veri üzerinden değerlendirme yapıldığını anlattı.
Kara, bu kapsamda ilk olarak yerli aşının etkinliğinin saptanmasına için bir gruba TURKOVAC , diğer gruba da mevcut kullanılan aşının uygulandığını ifade ederek, şu bilgileri paylaştı: "Şu ana kadar elde ettiğimiz verilerde, TURKOVAC uygulanan kişiler arasında ağır hastalanan, hastaneye veya yoğun bakıma yatan olmadığını gördük. Ayrıca diğer aşının uygulandığı grupta da çok ağır hastalanan olmadı. Kovid-19 pozitif olanların sayılarını karşılaştırdığımızda da TURKOVAC'da avantajlı olduğumuzu görüyoruz. Bu, aşının etkinliğini, koruyuculuğunu gösterme yönünden bir avantaj. Bu noktada ilk verilerimiz çok olumlu. Bu verilerin hepsi, detaylarıyla acil kullanım onayını değerlendiren komisyonlara sunuldu. Çok titiz değerlendiriliyor."
AŞININ YAN ETKİLERİYLE İLGİLİ İLK SONUÇLAR DA OLUMLU Aşının yan etkilerinin ele alındığı, güvenlik yönüyle ilgili ikinci grup çalışmada ise yaklaşık 3-4 bin kişiye ulaşılmasının amaçlandığına dikkati çeken Kara, "Bu noktada başlangıca göre bir avantajımız var; inaktif aşılar genel anlamda kullanıldığı ve dünya genelinde yaklaşık 3,5 milyar kişiye uygulandığı için olası istenmeyen etkilerinin neler ve hangi sıklıkta olduğunu biliyoruz. TURKOVAC'ta da bu etkilerin görülüp görülmediğine bakıyoruz. O verilerin de olumlu olduğunu gördük." dedi.
Kara, bu iki grup verinin acil kullanım onayı sürecinde avantaj sağlayan sonuçlardan olduğuna dikkati çekti.
AŞININ ÜRETİM AŞAMASINA YÖNELİK ÇOK SAYIDA TEST UYGULANIYOR Bilim Kurulu Üyesi Prof. Dr. Kara, aşının üretim aşamasına yönelik de çok sayıda test uygulandığının altını çizerek, TURKOVAC 'ın üretilebilir olduğunun saptandığını söyledi.
Ayrıca üretim sürecinde aşının antijen miktarının vücut açısından yeterli olup olmadığı ve son kullanma tarihinin belirlenmesine ilişkin, "stabilite" testlerinin yapıldığını anlatan Kara, TURKOVAC'ın onay alması durumunda üzerine "3 aylık kullanım süresi vardır" diye yazılabileceğini ifade etti.
Bu kullanım süresinin periyodik olarak yapılacak stabilite testlerinden elde edilen sonuçlara göre 6 aya çıkabileceğini aktaran Kara, birkaç yıl sürecek testler sonucunda da kullanım süresinin 1 veya 2 yıl olarak belirlenebileceğini dile getirdi.
Kara, aşılarla ilgili bu testlerin çok titiz, "kişiyi en fazla nasıl korurum" yaklaşımıyla gerçekleştirildiğinin altını çizdi.
"VERİLER, AŞININ HATIRLATMA DOZU OLARAK KULLANILABİLİR OLACAĞINI GÖSTERİYOR" Kara, TURKOVAC 'ın hatırlatma dozu olarak uygulanmasına yönelik yürütülen klinik çalışmanın bulgularına ilişkin de şu bilgileri paylaştı: "İnaktif ve mRNA aşılarında ilk iki dozdan sonra uygulanan hatırlatma dozuyla, antikor seviyesinde hızlı bir zıplama görülüyor. TURKOVAC'ın hatırlatma dozu olarak uygulandığı çalışmalarda da böyle bir zıplamayı görüyoruz. Bu da bizim en büyük avantajlarımızdan bir tanesi. Veriler, aşının hatırlatma dozu olarak kullanılabilir olacağını gösteriyor."
Kara, bu sonuçları bir araştırmacı olarak yorumladığına dikkati çekerek, esas çok yönlü değerlendirmenin TURKOVAC'ın acil kullanım sürecini inceleyen bağımsız ve tarafsız komisyondaki hocalar tarafından yapılacağını ve bunun sonucunda bir karara varılacağını vurguladı.
TURKOVAC'IN ACİL KULLANIM ONAYI ALMASI GÜVENİLİR OLDUĞUNU KANITLAYACAK Komisyonun bu kapsamlı değerlendirmeleri sonucunda TURKOVAC 'a acil kullanım onayı verilmesinin aşının her yönüyle güvenilir olduğu anlamına geleceğine işaret eden Kara, şunları kaydetti: "Yapılan incelemelerde üretiminin, istenmeyen etkilerinin, etkinliğinin 'uygun' şeklinde değerlendirilmesi durumunda, şu an nasıl ülkemizde istenirse mRNA, istenirse inaktif Sinovac aşısı olunabiliyor, üçüncü bir aşı olarak TURKOVAC da rahatlıkla kullanılabilir olacak. İsteyen herkes TURKOVAC'ı da aşı dozu olarak tercih edebilecek."