[{"_1":2,"_130":-5,"_131":-5},"loaderData",{"_3":4,"_9":10},"root",{"_5":6,"_7":8},"locale","id","isCms",false,"routes/tags/$slug",{"_11":12,"_13":14,"_15":16,"_117":118,"_124":120,"_128":123,"_129":-5},"slug","universitas-airlangga","ads",[],"posts",[17],{"_6":18,"_19":20,"_11":21,"_22":23,"_24":25,"_26":27,"_28":29,"_30":31,"_32":33,"_34":35,"_36":37,"_38":39,"_40":41,"_42":43,"_44":20,"_45":46,"_47":48,"_49":50,"_51":20,"_52":53,"_54":55,"_56":57,"_58":59,"_114":115,"_68":116},"019bb764-cbd9-73c9-9b25-6869ae49e1a9","title","COVID-19 – Izin penggunaan darurat vaksin Unair ditargetkan semester I 2022","covid-19-izin-penggunaan-darurat-vaksin-unair-ditargetkan-semester-i-2022","main_id","019bb73f-28ac-70ed-836a-68ade28a117a","main_name","Nasional","main_slug","nasional","date","2021-08-18 21:24:15","author_id","019bb745-b426-73a2-9a49-5ddcb6765ea0","author_name","indowin","full_name","Indonesia Window","author_firstname","Indonesia","author_slug","indonesiawindow","content","Jakarta (Indonesia Window) – Emergency Use Authorization (EUA) atau izin penggunaan darurat vaksin Merah Putih buatan peneliti Universitas Airlangga (Unair) ditargetkan terpenuhi pada semester pertama 2022, kata Kepala Badan Pengawas Obat dan Makanan (BPOM) Penny K Lukito.

Hal tersebut disampaikannya pada konferensi pers virtual penyerahan sertifikasi pemenuhan Cara Pembuatan Obat yang Baik (CPOB) kepada PT Biotis Pharmaceutical Indonesia, Rabu.

Vaksin Merah Putih tersebut merupakan produksi PT Biotis Pharmaceutical Indonesia bersama Universitas Airlangga.

Penny mengatakan para peneliti vaksin tersebut telah merampungkan uji praklinik tahap pertama transgenik dan kini memasuki tahap kedua uji praklinik pada monyet makaka.

Sebelum memperoleh EUA, lanjut dia, vaksin tersebut akan diuji coba pada manusia dalam waktu dekat.

Penny mengatakan BPOM bersama industri farmasi, peneliti dan sponsor terus melakukan pendampingan dalam pengembangan uji praklinik vaksin Merah Putih.

\"BPOM terus mendiskusikan konsep pengembangan rasional dari penelitian, desain setiap perencanaan praklinik dan uji klinik, serta aspek pengembangan mutu formula dan mutu obat,\" katanya.

Penny mengatakan seluruh vaksin harus diproduksi dalam skala laboratorium dengan mengikuti kaidah uji klinik yang baik.

\"Uji praklinik dan klinik ini akan menjadi data saintifik yang menjadi dasar dalam proses registrasi selanjutnya,\" terangnya.

Penny menambahkan sertifikat CPOB yang diberikan kepada PT Biotis Pharmaceutical Indonesia didasari atas sejumlah aspek penilaian, di antaranya desain fasilitas produksi, pelaksanaan inspeksi, asistensi, konsultasi, dan penyelesaian perbaikan.

Laporan: Redaksi","excerpt","Jakarta (Indonesia Window) – Emergency Use Authorization (EUA) atau izin penggunaan darurat vaksin Merah Putih buatan peneliti Universitas Airlangga (Unair) dit...","seo_kw","seo_title","","seo_description","Para peneliti vaksin telah merampungkan uji praklinik tahap pertama transgenik dan kini memasuki tahap kedua uji praklinik pada monyet makaka.","image","2021/08/BPOM-kepala_BPOM.jpg","image_alt","image_caption","Kepala Badan Pengawas Obat dan Makanan (BPOM) Penny K Lukito pada konferensi pers virtual penyerahan sertifikasi pemenuhan Cara Pembuatan Obat yang Baik (CPOB) kepada PT Biotis Pharmaceutical Indonesia, Rabu (18/8/2021). (BPOM/YouTube/tangkapan layar)\n","image_url","https://indonesiawindow.sgp1.cdn.digitaloceanspaces.com/2021/08/BPOM-kepala_BPOM.jpg","status","publish","tags",[60,76,82,89,95,102,109],{"_6":61,"_62":63,"_64":65,"_11":66,"_49":-5,"_67":-5,"_68":69,"_70":69,"_71":72},"019bb744-1c2f-71ec-b547-aa3d474813de","old_id",2509,"name","vaksin Merah Putih Indonesia","vaksin-merah-putih-indonesia","description","created_at","2026-01-13T12:10:52.000000Z","updated_at","pivot",{"_73":18,"_74":61,"_68":75,"_70":75},"post_id","tag_id","2026-01-13T12:46:34.000000Z",{"_6":77,"_62":78,"_64":79,"_11":80,"_49":-5,"_67":-5,"_68":69,"_70":69,"_71":81},"019bb744-1c35-7255-8df7-dd64d12cca43",2511,"uji klinis vaksin Merah Putih","uji-klinis-vaksin-merah-putih",{"_73":18,"_74":77,"_68":75,"_70":75},{"_6":83,"_62":84,"_64":85,"_11":86,"_49":-5,"_67":-5,"_68":87,"_70":87,"_71":88},"019bb744-6b7f-7108-9b2b-fd510dc95a46",9823,"izin penggunaan darurat","izin-penggunaan-darurat","2026-01-13T12:11:13.000000Z",{"_73":18,"_74":83,"_68":75,"_70":75},{"_6":90,"_62":91,"_64":92,"_11":93,"_49":-5,"_67":-5,"_68":87,"_70":87,"_71":94},"019bb744-6b86-72e0-8705-57b4c0b5956f",9825,"Emergency Use Authorization","emergency-use-authorization",{"_73":18,"_74":90,"_68":75,"_70":75},{"_6":96,"_62":97,"_64":98,"_11":99,"_49":-5,"_67":-5,"_68":87,"_70":87,"_71":100},"019bb744-6b8a-7026-8d59-696bf65d6d50",9827,"BPOM","bpom",{"_73":18,"_74":96,"_68":101,"_70":101},"2026-01-13T12:46:35.000000Z",{"_6":103,"_62":104,"_64":105,"_11":106,"_49":-5,"_67":-5,"_68":107,"_70":107,"_71":108},"019bb744-6fa7-71be-85d6-8ef75b1c6c58",10305,"Biotis Pharmaceutical Indonesia","biotis-pharmaceutical-indonesia","2026-01-13T12:11:14.000000Z",{"_73":18,"_74":103,"_68":101,"_70":101},{"_6":110,"_62":111,"_64":112,"_11":12,"_49":-5,"_67":-5,"_68":107,"_70":107,"_71":113},"019bb744-6fae-7116-9876-f28935e6a6f0",10307,"Universitas Airlangga",{"_73":18,"_74":110,"_68":101,"_70":101},"comments",[],"2021-08-18","pagination",{"_119":120,"_121":120,"_122":123,"_124":120,"_125":120,"_126":127},"count",1,"total","perPage",12,"currentPage","totalPages","links",{},"pageSize","error","actionData","errors"]