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TÜBİTAK COVID-19 Türkiye Platformu çatısı altında geliştirilen ve Dünya Sağlık Örgütünün aşı adayı listesinde yer alan virüs benzeri parçacıklara (VLP ) dayalı aşı, Faz 2 aşamasında gönüllülere uygulanmaya başlandı.
TÜBİTAK Başkanı Prof. Dr. Hasan Mandal , VLP temelli aşının, Faz-2 gönüllülerine uygulanması dolayısıyla Ankara Onkoloji Hastanesi'nde düzenlenen programa katıldı.
Bu haftanın ülkede yerli aşının gelişimi için önemli bir hafta olduğuna işaret eden Mandal, salı günü Erciyes Üniversitesinde TURKOVAC aşısının Faz-3 çalışmalarına başlandığını anımsattı.
Mandal, VLP aşısının Faz-1 çalışmasının tamamlandığını belirterek, "Sağlık Bakanlığının ilgili kuruluşu Türkiye İlaç ve Tıbbi Cihaz Kurumunca 2 gün önce Faz-2 çalışmasının başlatılması için onay verildi. Bugün de ilk gönüllülerimiz aşılanma sürecine başladılar." dedi. Platform olarak marttan itibaren başlatılan süreçte 436 araştırmacının 49 kurumdan bir araya gelerek 17 proje gerçekleştirdiklerinin altını çizen Mandal, bunların 7'sinin aşı projesi olduğunu ifade etti. Mandal, "Bu çalışmalardan en önde gideni VLP aşısı. VLP, virüsü taklit eden yenilikçi bir aşı grubu." diye konuştu.
Mandal, aşı çalışmasının Dünya Sağlık Örgütünün listesinde yer aldığına dikkati çekerek, VLP aşısının İngiliz mutantına karşı geliştirilen bir versiyonunun da Faz-2 aşamasında kullanılacağını bildirdi.
Faz-2 çalışmasının Faz-1'den farklı olarak 3 merkezde gerçekleştirileceğini belirten Mandal, Ankara Onkoloji Hastanesinin yanı sıra Kocaeli Üniversitesi Tıp Fakültesi ve Yedikule Göğüs Hastalıkları Hastanesinde çalışmaların gerçekleştirileceğini bildirdi. Mandal, inaktif aşısının da temmuzun ayının ortasında Faz-2 aşamasına gelmiş olacağını dile getirdi.
Mandal, VLP aşısının varyasyonlar için çok hızlı bir şekilde geliştirilebileceğini ifade etti.
Faz-1 aşamasında gönüllü olan tüm vatandaşlara teşekkür eden Mandal, ülkede yerli ve milli aşının geliştirilmesi için gönüllülerin çok önemli olduğunu söyledi.
"YAPTIĞIMIZ AŞI ADAYININ DİĞER VARYANTLARA OLAN ETKİNLİĞİNİ TEST ETMEYİ PLANLIYORUZ" ODTÜ'den Prof. Dr. Mayda Gürsel ile aşıyı geliştiren Bilkent Üniversitesinden Prof. Dr. İhsan Gürsel de aşının hem Vuhan hem de İngiliz varyasyonlarına göre tasarlandığına dikkati çekerek şunları kaydetti:
"Yaptığımız aşı adayının diğer varyantlara olan etkinliğini test etmeyi planlıyoruz. Aşılı olan gönüllülerin buna karşı etkisinin ne olduğunu öğreneceğiz. Virüs izole edilebilirse, bu tip çalışmalar ülkemizde gerçekleştirilebilirse, yurt dışına bu örnekleri göndermeden yapabilme ve sonuçları değerlendirme şansımız olur. Şu anda aşımızın Delta varyantıyla ilgili etkinliğini test etmedik. Aşının hatırlatma dozlarında da etkili olacağını düşünüyoruz. " Ankara Onkoloji Eğitim ve Araştırma Hastanesi Başhekimi Prof. Dr. Fevzi Altuntaş da Faz-2 çalışmasının yaklaşık 330 gönüllüyle gerçekleştirileceğini söyledi.
Şu ana kadar aşı çalışması planlamasında bir değişiklik olmadığını belirten Altuntaş, temmuz ayının sonunda Faz-2 çalışmasını bitirmeyi planladıklarını ifade etti.
Türkiye'nin ilk yerli aşısı Turkovac'ta Faz-3 çalışması, gönüllülerle devam ederken, Sanayi ve Teknoloji Bakanı Mustafa Varank'ın Faz-2 aşamasında gönüllü olduğu, virüs benzeri parçacıklara dayalı (VLP ) aşısının da mutasyonlara karşı yüksek oranda etkili olduğu belirtildi. Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Uzmanı Doç. Dr. Ümit Savaşçı, "Turkovac'tan sonra ikinci ve bence daha güzel haber; VLP aşısının mutasyonlara karşı çok yüksek oranda etkili olacağını düşünüyoruz. Bütün mutasyonlardan etkilenmeyecek şekilde 6 tane izotopu koruyucu etkisi var" dedi.
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Uzmanı Doç. Dr. Savaşçı, yaptığı açıklamada, Türkiye Bilimsel ve Teknolojik Araştırma Kurumu (TÜBİTAK ) Covid-19 Türkiye Platformu çatısı altında çalışmaları süren, yerli VLP temelli aşıda önemli gelişmenin yaşandığını söyledi. Doç. Dr. Savaşçı, Sanayi ve Teknoloji Bakanı Mustafa Varank'ın da Faz-2 aşamasında gönüllü olduğu VLP aşısına ilişkin "Çok zor geçen pandemi sürecinden sonra sevindiren gelişmeler de oluyor ülkemizde. 'Turkovac' dediğimiz yerli aşımızda şu anda Faz-3 çalışmaları tamamlanmak üzere. Etkinliği de Sinovac aşısı gibi yine etkinliği olacak bir aşımız. Yerli aşı olması bizim için çok önemli. Her zaman ulaşılabilir bir aşının olması bizim için anlamlıydı. Bizim için gurur kaynağı ancak daha da sevindiren haberimiz özellikle son dönemde herkesin biraz da Hindistan kaynaklı korkulu rüyası haline gelen delta mutasyonu, delta plus mutasyonuna karşı ve dünya üzerinde de insan çalışmaları anlamında etkili olabilecek, bu mutasyonlardan da insanları koruyabilecek virüs benzeri parçacık aşısı; TÜBİTAK ve özellikle de bakanımız sayın Varank'ın da gönüllü olduğu aşımız Faz-2 çalışmasında" dedi.
'GURUR KAYNAĞIMIZ OLACAK' Doç. Dr. Savaşçı, VLP aşısının bütün mutasyonlara karşı etkili olacağını kaydederek, "Dolayısıyla onun da sevindirici bir yönü var. Bütün bu mutasyonlardan etkilenmeyecek şekilde 6 tane izotopu koruyucu etkisi var. Dolayısıyla mutasyonlardan etkilenmeyecek. Kendi halkımızı koruduğumuz gibi bütün insanlığa da koruyucu bir çare olarak çıkabilecek aşımızda çalışmalar çok hızlı şekilde ilerliyor. Bu açıdan çok umutluyuz, gerçekten gurur kaynağımız olacak ve tüm dünyada da bu aşıyı hem ekonomik anlamda hem de sağlık anlamında güzel bir sunum elde edeceğimizi düşünüyoruz. Sonbaharda yetişirse VLP aşımız, bizim için insanlık için dünyamız için kurtarıcı aşı olarak görmekteyim. Bu teknolojinin dünyada uygulanırlığı sadece ülkemizde mevcut; dolayısıyla biz en önde gideceğiz bu anlamda" diye konuştu.
'ÇOK GÜÇLÜ VARYANTALARA KARŞI ETKİLİ' Doç. Dr. Savaşçı, VLP aşısı faz çalışmalarında şu ana kadar ciddi yan etkiye rastlanılmadığını belirterek, "Bakanımız da yaptırdı, herhangi bir yan etki açıklanmadı. Umduğumuz gibi koruyuculuk oranı yüksek olursa mekanizma olarak da en çok mutasyonun olduğu 6 tane epitopu da etkilemediği için çok güçlü varyantlara karşı etkili olabileceğini düşündüğümüz aşı yapısında olduğu için çok umutluyuz. Gurur kaynağımız Turkovac aşımızda üretim aşamalarının başlayacağı gibi bir ümide kapıldık. İkinci ve bence daha güzel bir haber de aslında VLP aşısının Faz-2 çalışmalarına geçip, Faz-3 çalışmalarından sonra da etkinlik yüksek olursa mutasyonlara karşı da çok yüksek oranda etkili olacağını düşünüyoruz. Diğer aşıların kullanılmadığı bir teknoloji VLP aşısı. Dolayısıyla daha etkili ve daha güzel koruma sağlayacaktır" dedi.
'BİONTECH VARYANTALARA KARŞI DAHA KORUYUCU' Doç. Dr. Savaşçı, dünyada kullanılan koronavirüs aşılarının, mutasyonlarla etkinliğinin düştüğüne dikkat çekerek, "Son çalışmalarda özellikle inaktif aşının etkinliği biraz düşük kalıyor. Zaten ilk dozda yüzde 25 etkinlik vardı, ikinci dozdan sonra yüzde 70'in üzerine çıkıyordu; ama varyantlara karşı ne yazık ki koruyuculu şüpheli boyutta. BioNTech aşısı halen koruyucu; ama ikinci dozdan sonra yüzde 95 civarında koruyan BioNTech aşısında da 'delta plus' dediğimiz mutasyon biraz daha bulaşıcı mutasyon, bunda da BioNTech aşısının etkinliğinin yüzde 70'lere kadar düştüğüne yönelik bazı çalışmalar, veriler elde etmeye başladık. Bu tabi bizi biraz endişeye sevk ediyor bu anlamda ama ülkemizde son dönemde BioNTech aşısı uygulandığı için sağlık çalışanlarında da BioNTech ve Sputnik V aşılanma programına geçileceği için sağlık çalışanları başta olmak üzere halkımızı bu anlamda korumuş olacağız" diye konuştu.