Türkiye'de de kullanılan aşılardan biri olan CoronaVac ile ilgili flaş bir gelişme yaşandı.
Dünya Sağlık Örgütü, Çin'in geliştirdiği Sinovac'ın koronavirüs aşısı CoronaVac için acil kullanım onayı verdiğini açıkladı.
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Türkiye'de de kullanılan aşılardan biri olan CoronaVac ile ilgili flaş bir gelişme yaşandı.
Dünya Sağlık Örgütü, Çin'in geliştirdiği Sinovac'ın koronavirüs aşısı CoronaVac için acil kullanım onayı verdiğini açıkladı.
TÜRKİYE'DE KAÇ KİŞİ AŞILANDI?
Türkiye'de 1 Haziran itibariyle Toplam yapılan aşı sayısı 29.239.788 oldu. Yapılan aşılarda 1.doz uygulanan kişi sayısı 16.659.967 olurken 2. doz uygulanan kişi sayısı ise 12.579.821 oldu.
TÜRKİYE'DE SINOVAC AŞISININ FAZ-3 SONUÇLARI
Türkiye'de Sağlık Bakanlığınca yeni tip koronavirüs (Kovid-19) ile mücadele kapsamında toplumsal bağışıklığın kazanılması için Çin'den getirilen Sinovac firmasının geliştirdiği CoronaVac aşısının Türkiye Faz-3 sonuçları Mart ayında belli oldu. Bu kapsamda, Hacettepe Üniversitesinden çalışma sonuçlarına ilişkin bilgi notu paylaşıldı.
Sağlıklı gönüllülerle yürütülen CoronaVac Faz-3 Klinik Çalışması ile Kovid-19 pandemisine karşı geliştirilen CoronaVac aşısının güvenliliği ve RT-PCR ile doğrulanmış semptomatik Kovid-19 hastalığına karşı koruyuculuğunun değerlendirilmesi amaçlandı.
Çalışmanın çift kör randomize plasebo kontrollü bir klinik araştırma olduğu belirtilen bilgi notunda, şunlar aktarıldı:
"Gönüllülerin bir kısmına gerçek aşı, diğer bölümüne ise plasebo verilmiştir. Bu, bilgisayar programı tarafından rastgele olarak grubun belirlenmesi işlemine randomizasyon adı verilmektedir. Hangi gönüllüye ne yapıldığını gönüllü ve araştırma ekibi bilmemektedir.
Çalışmanın protokolünde sağlık çalışanları (K-1 Kohortu) ve normal riskli gönüllüler (K-2 Kohortu) olmak üzere iki aşama olarak ve toplamda 12 bin 450 gönüllünün dahil edilmesi planlanmaktaydı. Sağlık çalışanlarından oluşan K-1 Kohortuna her 2 aşı uygulamasının 1 uygulaması gerçek aşı olurken, normal riskli gönüllüler bölümünde yapılan her 3 aşı uygulamasının 2 uygulaması gerçek aşı koluna randomize edilmiştir, yani gönüllülere gerçek aşı yapılma ihtimali üçte ikidir."
Klinik çalışmanın, 14 Eylül'de ilk gönüllünün dahil edilmesi ile başlatıldığı belirtilen bilgi notunda, "18-59 yaş arası gönüllüler gerçek aşı ve plasebo kolları olmak üzere iki ayrı kola dahil edilmiştir. Toplam 24 merkezden 10 bin 216 kişiye en az 1 doz gerçek aşı ya da plasebo uygulaması yapılmıştır. Bu gönüllülerden 6 bin 648'i gerçek aşı koluna dahil edilirken, 3 bin 568'i plasebo koluna dahil edilmiştir. Plaseboların tekrar gerçek aşı ile aşılanması ile toplam 25 bin 937 doz uygulama yapılmıştır. Dahil edilen gönüllülerin yüzde 57,8'i erkek iken, yüzde 42,24'ü kadındır. Ortanca yaş 45'tir." ifadelerine yer verildi.
"ÖLÜME RASTLANMAMIŞTIR"
"Çalışma kapsamında acil kullanım onayı nedeniyle körleme ilk olarak 14 Ocak 2021'de sağlık çalışanlarında kırılmaya başlanmıştır. Ardından merkezlerin kapasitesine göre gönüllülerin körlemeleri 12 Şubat 2021 tarihine kadar kırılmaya devam edilmiştir. 12 Şubat tarihinde tüm gönüllülerin körlüğü kırılmıştır." değerlendirmesinde bulunularak, şunlar kaydedildi:
"Bu tarihe kadar görülen semptomatik ve RT-PCR ile doğrulanmış COVID-19 vakaları ile aşının etkililiği, yüzde 83,5 olarak hesaplanmıştır. Hastanede yatışı engelleme oranı ise yüzde 100 olarak bulunmuştur. Çalışma süresince her iki kolda da ölüme rastlanmamıştır.
En sık görülen yan etkiler yorgunluk yüzde 9,8, baş ağrısı yüzde 7,6, kas ağrısı yüzde 3,8, ateş yüzde 2,5, titreme yüzde 2,4 ve lokal yan etkilerden en sık görüleni ise enjeksiyon yerinde ağrıdır. Bunun oranı da yüzde 1,6'dır.
İlk doz aşı sonrası ortanca takip süresi 70 gün, 2. doz aşıdan 14 gün sonrası için ortanca takip süresi 42 gündür."