Discover and read the best of Twitter Threads about #EmergencyUseAuthorization

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#SahabatBPOM, Emergency Use Authorization (EUA) atau persetujuan penggunaan dalam kondisi darurat untuk vaksin COVID-19 dilakukan oleh semua otoritas regulatori obat di seluruh dunia untuk mengatasi pandemi COVID-19.
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Selaras dengan panduan WHO, EUA vaksin dapat ditetapkan dengan kriteria: pemerintah telah menetapkan keadaan kedaruratan kesehatan masyarakat, cukup bukti ilmiah keamanan dan khasiat vaksin, mutu memenuhi standar yang berlaku serta Cara Pembuatan Obat yang Baik,
memiliki kemanfaatan lebih besar dari risiko, serta belum ada alternatif pengobatan/penatalaksanaan yang memadai dan disetujui.
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Berdasar hasil evaluasi data keamanan vaksin Coronavac dari studi klinik fase 3 di Indonesia, Turki dan Brazil yang dipantau hingga periode 3 bulan
Read 7 tweets
FDA has issued first #EmergencyUseAuthorization for therapeutics to treat COVID-19 (rest have all been for in-vitro diagnostics, PPE, and other med devices). EUA issued to BARDA for hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile.
IMPT: Although some versions of chloroquine phosphate are approved by FDA for other indications, the CP covered by this EUA has NOT been approved at all. For hydroxychloroquine sulfate, the EUA appears to apply to approved versions (although of course not for COVID-19).
Oh, this is more IMPT: the actual authorization letter
fda.gov/media/136534/d…
Read 18 tweets

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