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Koronavirüs hapı Molnupiravir için AB'den açıklama var... İngiltere ilk ülke olmuştu - HAKANSEYHAN
Avrupa Birliği’nin (AB) ilaç düzenleyicisi Avrupa İlaç Ajansı (EMA), Amerikan ilaç şirketi Merck’in ürettiği “molnupiravir” adlı ilacın yeni tip koronavirüs (Kovid-19) tedavisinde acil durumlarda kullanılmasını tavsiye ettiğini duyurdu.
EMA, salgınla mücadeleye ilişkin çalışmalarındaki son durum hakkında basın toplantısı düzenledi.
Ajansın aşı stratejisinden görevli yetkilisi Marco Cavaleri, molnupiravirin virüsün vücutta yayılmasını azaltabileceği, hastaneye yatış ve ölüm oranlarında düşüş sağlayabileceği sonucuna varıldığını açıkladı.
Cavaleri, EMA’nın AB ülkelerine bu tedaviyi pazarlama iznini beklemeden, acil kullanımlar için hazırlamalarını tavsiye ettiğini duyurdu.
İNGİLTERE ONAYLAYAN İLK ÜLKE OLMUŞTU İngiltere’de bugün yeni tip koronavirüs tedavisinde Merck firmasının ürettiği ilacın kullanımına şartlı yetki verildi. İngiltere böylece Kovid-19’a karşı geliştirilen bir ilaca dünyada ilk onayı veren ülke oldu. Yetkililer, vatandaşların, Molnupiravir adlı ilaca ulusal bir çalışmayla kış aylarında erişebileceğini açıkladı.
İngiltere Sıhhat Bakanı Sajid Javid de “Bugün ülkemiz için zamanı bigün, bundan dolayı İngiltere şu anda dünyada Kovid-19 için evde alınabilecek bir antivirali onaylayan ilk ülke.” dedi.
Javid, İngiltere Ulusal Sıhhat Servisine (NHS) atıfta bulunarak yapmış olduğu açıklamada, “Molnupiravir’i mümkün olan en kısa sürede ulusal emek harcama kanalıyla hastalara dağıtma planı belirlemek için NHS ile beraber çalışıyoruz.” ifadelerini kullandı.
Doktorlar, tedavinin aşıya iyi cevap vermeyen kişiler için bilhassa mühim olacağını belirtiyor.
Şartlı yetkiyle Kovid-19 testi pozitif çıkan ve risk grubundaki 18 yaş üstü yetişkinlerin kullanımı için lisans alan ilacın, hastalığı evde hafifçe yada orta şiddette geçiren kişiler tarafınca 5 gün süresince günde iki doz kullanılması gerekiyor. Semptomları azaltan ve iyileşmeyi hızlandıran ilacın, hastanelerdeki olay yüklerini hafifletmesi ve zayıf sıhhat sistemlerine haiz daha yoksul ülkelerde salgını engellemeye destek olması umut ediliyor.
ABD Besin ve İlaç Dairesi de kasım sonunda ilacın güvenliğini ve etkinliğini incelemek suretiyle bağımsız uzmanlardan oluşan bir kurul toplayacağını duyurmuştu.
Moderna’nın takviye dozu delta varyantına karşı etkili Bugün açıklamada EMA’nın Moderna firmasının “Spikevax” adlı aşısının üçüncü dozunun 18 yaşından büyüklerde kullanımını tavsiye ettiğini anımsan Cavaleri, söz mevzusu takviye dozunun delta varyantına karşı 18 kat daha çok antikor ürettiğini gösterdiğini söylemiş oldu.
Cavaleri, birçok AB ülkesinin riskli kişilere yönelik takviye aşılamalara başladığını, bir sonraki adımda bunların nüfusun geneline yayılabileceğini belirtti.
Johnson and Johnson şirketinin ilaç kolu olan Janssen-Cilag International N.V. tarafınca üretilen “COVID-19 Vaccine Janssen ” aşısının 1. dozdan 6 ay sonrasında uygulanan takviye dozuyla ilgili veri beklediklerini belirten Cavaleri, “Comirnaty ” adlı aşının 5-11 yaşındaki çocuklarda kullanımını mevzusundaki değerlendirmenin aralıkta sonuçlanacağını bildirdi.
Cavaleri, Pfizer-BioNTech tarafınca geliştirilen aşının 5-11 yaş grubuna da uygulanması için meydana getirilen başvurunun değerlendirmesinin sürdüğünü kaydetti.
“Avrupa’da durum kaygı verici” EMA’nın klinik emekler ve üretimden görevli yetkisi Fergus Sweeney de “Avrupa’daki epidemiyolojik durum oldukca kaygı verici. Kış öncesinde vakalar artıyor, hastaneye yatış ve ölüm oranları artıyor.” diyerek aşılamanın önemini altını çizdi.
EMA’nın kararları AB üyesi ülkeler için tavsiye niteliği taşıyor. AB üyeleri aşılama uygulamalarında kendi kararlarını veriyor.
Başa dön tuşu