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İngiltere , Türk bilim insanı Prof. Dr. Uğur Şahin 'in kurucu ortağı olduğu Alman biyoteknoloji firması BioNTech'in Amerikan ilaç şirketi Pfizer ile geliştirdiği yeni tip koronavirüs (Kovid-19) aşısının yaygın kullanımına onay verdi.
İLK ÜLKE İNGİLTERE BBC'nin hab erine göre, İngiltere İlaç ve Sağlık Ürünleri Düzenleme Kurumu, "BNT162b2" aşı adayının yaygın kullanım için güvenli olduğunu bildirdi. Böylece İngiltere, Kovid-19'a karşı geliştirilen bir aşı adayına onay veren ilk ülke oldu.
Onayın ardından İngiltere'de gelecek haftadan itibaren yüksek öncelikli gurupların aşılanmasına başlanması bekleniyor. İngiltere daha önce aşıdan 40 milyon doz satın almak üzere ön anlaşma yapmıştı.
TESCİLLENEN İLK KOVİD-19 AŞISI Mesajcı Ribo Nükleik Asit (mRNA) temelli aşı adayı, dünyada tescillenen ilk Kovid-19 aşısı oldu. Aşı, 10 ay gibi kısa bir sürede klinik öncesi geliştirme çalışmaları ve 3 aşama klinik denemeleri tamamlayarak onay almayı başardı.
Aşı, formülündeki RNA bileşim sayesinde Kovid-19'u etkisiz kılan kan şekeri enzimleri ile alımlayıcı-bağlayıcı İmmünoglobulin G antikorlarını harekete geçirmeyi, hücre düzeyinde bağışıklık tepkisi yaratan CD4+ ve CD8+ glikoproteinlerini artırmayı amaçlıyor.
AB D'de Pfizer, Çin 'de Fosun Pharma ilaç firmalarının üretim lisansını aldığı aşı adayı için 1'inci ve 2'nci aşama klinik denemelerinin Almanya 'da yürütülmesinin ardından 27 Temmuz'da ABD, Arjantin ve Almanya'nın aralarında olduğu ülkelerde 30 bin sağlıklı gönüllünün katılması hedefiyle 3. aşama klinik denemeler başlatılmıştı.
VİRÜSE KARŞI YÜZDE 95 ETKİLİ Pfizer ve BioNTech, 18 Kasım'da 3'üncü aşama klinik denemelerini tamamladığını, aşı adayının virüse karşı bağışıklık sağlamada yüzde 95 etkili olduğunu bildirmişti.
Şirketler, aşı adayının acil kullanımına izin verilmesi için AB D Gıda ve İlaç İdaresi (FDA) ile Avrupa İlaç Ajansına (EMA) başvurularda bulunmuştu.
ÇOK SAYIDA ÜLKE ÖN ANLAŞMA YAPTI Şirketler, aşının tedariki için AB D, Avrupa Birliği (AB), İngiltere , Kanada ve Japonya ile anlaşmalar yaptı. ABD hükümeti, aşı adayının başarılı olması halinde 100 milyon doz aşı satın almak için 1,95 milyar dolar taahhüt ederken, AB Komisyonu aşıdan 300 milyon doz, İngiltere 40 milyon doz, Kanada 20 milyon doz, Japonya ise 120 milyon doz satın almak üzere ön sözleşme imzalamıştı.
TÜRKİYE 25 MİLYON DOZ ALMAYI PLANLIYOR Sağlık Bakanı Fahrettin Koca, 25 Kasım'da, Türkiye 'nin aşı adayından, 1 milyonu aralıkta olmak üzere kış aylarında 25 milyon doz satın almak üzere görüşmeler yürüttüğünü açıklamıştı.
Şirket, aşıdan 2020 sonuna kadar 100 milyon ve 2021 sonuna kadar ise yaklaşık 1,3 milyar doz üretmeyi planlıyor.
PROF. DR. UĞUR ŞAHİN'DEN İLK YORUM Prof. Dr. Uğur Şahin , dünya çapındaki klinik araştırmalar dışında kalan insanların Kovid-19'a karşı aşı olma fırsatına ilk kez sahip olacağını söyledi. Şahin, düzenleyici verilerin "bilimsel olarak titiz ve son derece etik bir araştırma ve geliştirme programının" sonucu olduğunu sözlerine ekledi.
Şirketler daha önce 2020 ve 2021'de İngiltere 'ye 40 milyon doz tedarik etmek için bir anlaşma imzalamıştı. Amerika Birleşik Devletleri de dahil olmak üzere diğer ülkeler, yıl sonundan önce çeşitli koronavirüs aşıları için onay almayı düşünüyor.