Perlombaan untuk otorisasi darurat agar tidak menciptakan ketegangan

Perlombaan untuk otorisasi darurat agar tidak menciptakan ketegangan – Pada hari Jumat, para pemimpin agensi mengadakan konferensi video empat jam untuk meyakinkan publik bahwa mereka teliti dalam meninjau data uji klinis dan rincian pembuatannya.

“Kami bekerja sepanjang waktu untuk mendapatkan lisensi vaksin Covid-19 pertama,” kata Direktur Eksekutif EMA Emer Cooke dalam pernyataan yang dikirim melalui email kunjungi bloomberg. “Warga Eropa telah memberi tahu kami bahwa mereka menginginkan persetujuan yang cepat, tetapi yang lebih penting mereka menginginkan evaluasi menyeluruh tentang manfaat dan risiko vaksin, sehingga mereka dapat yakin bahwa vaksin itu aman, efektif dan berkualitas tinggi.”

EMA sedang mempelajari data yang sama seperti mitranya di Inggris, Kanada, dan AS. Regulator menganalisis data pasien dari uji coba manusia skala besar yang dikirim dalam batch bergulir untuk melihat berapa banyak infeksi yang terjadi pada mereka yang menerima suntikan seperti plasebo dibandingkan dengan mereka yang diberi vaksin.

Karena virus menyebar begitu luas, BioNTech hanya membutuhkan waktu berminggu-minggu untuk mencatat jumlah kasus yang diperlukan untuk menentukan seberapa efektif suntikannya — proses yang biasanya memakan waktu bertahun-tahun.

Tetapi regulator juga mengajukan pertanyaan untuk memastikan vaksin tersebut secara umum aman dan efektif, dan dapat diproduksi dengan kualitas yang konsisten. Di bagian depan ini, EMA lebih lambat daripada Inggris, yang kepala pengaturnya mulai mengajukan pertanyaan lebih awal dalam proses dan lebih cepat membuat pertanyaan tindak lanjut, kadang-kadang dalam beberapa menit dari jawaban, kata orang-orang yang bekerja dengan kedua agensi baru-baru ini. Regulator yang berbeda juga menginginkan data diformat secara berbeda, sehingga menimbulkan penundaan.

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