BioNTech şirketi, Avrupa İlaç Ajansı’na (EMA) yapılan başvuruyla ilgili açıklama yaptı.
Açıklamaya göre, halihazırda “Acil Kullanım İzni” için ABD Gıda ve İlaç Dairesine (FDA) başvuru yapıldı. Şirket, kısa süre önce ABD’de 12 ila 15 yaş grubundaki 2 bin 260 kişi üzerinde yaptığı klinik çalışmanın yüzde 100 etkinlik gösterdiğini duyurmuştu. Açıklamada yan etkilerin 16-25 yaş grubundakilere denk geleceği anlatıldı.
EMA’nın onay vermesi halinde, haziran ortasında 27 AB ülkesinde 12-15 yaş grubundaki çocuklara aşı yapılabilmesi planlanıyor.
Bilimsel değerlendirmeler bekleniyor
AB yetkilileri de BioNTech-Pfizer aşısının çocuklara da uygulanması için bilimsel değerlendirmelerin ve çalışmaların sonucunu bekledikleri bilgisini verdi.
AB ülkeleri için BioNTech-Pfizer aşısından 1,8 milyar doz daha satın almak üzere müzakereler yürüttüklerini hatırlatan AB Komisyonu sözcülerinden Eric Mamer, bu sayede EMA’dan onay çıkması halinde çocukları da aşılamak için yeterli doza sahip olacaklarını söyledi.
Mamer, AB Komisyonunun birlik sınırları içindeki çocuk nüfusunu aşılamada hesaba katmadığına yönelik eleştirileri reddetti.
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