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Sanayi ve Teknoloji Bakanı Mustafa Varank , Prof. Dr. Mayda Gürsel ile Prof. Dr. İhsan Gürsel tarafından geliştirilen ve Ankara Onkoloji Hastanesinde TÜBİTAK COVID-19 Türkiye Platformu çatısı altında çalışmaları süren yerli VLP aşı adayının Faz-2 çalışmalarının tamamlandığını duyurdu.
Aşının Faz-2 çalışmalarına ilişkin değerlendirmelerde bulunan Prof. Dr. Fevzi Altuntaş, VLP aşısı nın, varyantlara karşı hızla dizayn edilebilmesi ve virüsün 4 önemli antijenini de kapsaması nedeniyle inovatif, yenilikçi bir aşı olduğunu söyledi.
Faz-1 aşamasında aşının dozunu ve güvenliği test ettiklerini, güvenliği konusunda olumlu gelişmeler kaydedildiğini anımsatan Altuntaş, şöyle konuştu:
"26 Haziran itibarıyla Faz-2 aşamasına geçmiştik. Faz-2 aşaması daha çok aşının ve ilaçlarının aktivitesinin test edilmesi, yine güvenilirliğinin daha fazla sayıda gönüllü üzerinde test edilmesi demektir. 330 gönüllü ile üç merkezde gerçekleştirdik. 8 Ağustos itibarıyla yerli VLP aşımızın ikinci doz aşılamaları da bitti. Bu arada 35. gün kontrolleri ve 49. gün kontrolleri de devam etmekte. Yani yerli VLP aşımızın aşılamaları bitmiş olup klinik takipleri ve immünolojik değerlendirmeleri devam ediyor. Ağustosun sonu itibarıyla da laboratuvar verilerinin klinik verilerle beraber sonlandırılmış olmasını ve Faz-3 dosyasının hazırlanmasını bekliyoruz. Yani yerli VLP aşımızın Faz-3 aşamasına geçmesi çok yakın, eylül içerisinde geçmesi mümkün. Planımız, beklentimiz eylül içerisinde Faz-3 aşamasına geçmek."
Faz-1'in 10'lu, Faz-2'nin 100'lü sayılarda gönüllü üzerinde denendiğini ancak Faz-3 ün daha fazla gönüllüyle gerçekleştirileceğini belirten Altuntaş, "Yerli VLP aşımız TURKOVAC'tan sonra ikinci aşımız da yolda. Bu da VLP aşısı. VLP aşısının inovatif yönüyle beraber bir an önce klinik kullanıma, yaygın kullanıma sunmak, ticari ürün haline dönüştürmek istiyorsak Faz-3'ün de belli bir aşamada tamamlanmış olması ve bunun sonuçlarıyla birlikte etkinliğinin gösterilmiş olması, bununla birlikte erken kullanım izni alması gerekiyor." dedi.
"GÖNÜLLÜ OLMAYA DAVET EDİYORUZ"
Altuntaş, Faz-1 ve Faz-3'den çıkan sonuçlara ilişkin de şu değerlendirmelerde bulundu:
"Gerek Faz-1'den ve gerek Faz-2'den çıkardığımız deneyimler, aşının güvenli olduğu yönünde. Yerli VLP aşısında ciddi bir yan etkiyle karşılaşmadık. Çok hafif düzeyde lokal yan etkiler tabii ki oldu. Etkinliği konusunda, yani aşının çalışıp çalışmadığı konusunda kendi klinik gözlemlerimize baktığımız zaman da aşının aktif olduğunu, çalıştığını söyleyebiliriz ancak etkin olup olmadığını söylemek için Faz-3 çalışmasının sonuçları beklenmeli. Önemli sayıda vatandaşımız aşı oldu, yerli aşı bekleyen vatandaşlarımız var, onları yerli VLP veya TURKOVAC aşısına gönüllü olmaya davet ediyoruz ve bekliyoruz."
"YERLİ VLP AŞISI, ELİMİZDE ÖNEMLİ BİR GÜÇ" Prof. Dr. Altuntaş, yerli VLP aşısı nın etkisine ilişkin olarak şunları söyledi:
"Yerli VLP aşımız büyük umut vadediyor. İnşallah eylülde de Faz-3 aşamasına geçeceğiz. Faz-3 aşamasının olumlu sonuçlanmasıyla erken kullanım onayı umut ediyoruz. Yerli VLP aşımızın belli bir mesafe katetmesiyle yine bu yılın sonuna doğru veya gelecek yılın başlarında yaygın kullanıma geçeceğini, erken kullanım için izin alabileceğini, veriler uygun olursa tahmin ediyoruz. Yerli VLP aşısının, özellikle bu mutantların, varyantların yaygın olduğu ve önümüzdeki süreçlerde de değişeceğini öngörürsek elimizde önemli bir güç olduğunu söyleyebilirim."
"YERLİ VLP AŞIMIZ ÖZELLİKLE FAZ-3 AŞAMASINDA DELTA VARYANTLARINA KARŞI UYARLANIP TEST EDİLECEKTİR" Yerli VLP aşı sının Faz-2 aşamasında Wuhan ve İngiliz tipi varyantlarına karşı test edildiğini anımsatan Altuntaş, "Yerli VLP aşısı varyantlara karşı hızla uyarlanabilir, hızla dizayn edilebilir, bu da pandemide önemli bir güçtür. Yerli VLP aşımız özellikle Faz-3 aşamasında Delta varyantlarına karşı uyarlanıp test edilecektir." dedi.
18 yaş üzeri sağlıklı, Covid-19 geçirmemiş ve aşılanmamış kişiler gönüllü olabilecek
Faz-3 aşamasının hızla bitmesi için sağlıklı gönüllülerin buna sahip çıkması gerektiğine işaret eden Altuntaş, "18 yaşın üzerinde olan sağlıklı ve Kovid geçirmemiş, aşı olmamış kişilerin yine yerli aşımıza müracaatları önemli tabii. Tabii ki Faz-3 aşamasında çeşitli gruplar, çeşitli alt analizler olabilir. Daha önce aşı olanların bir grubuna bu yerli VLP aşısı da uygulanabilir, onu zamanla, gelecek ay herhalde göreceğiz." değerlendirmesini yaptı.