[{"_1":2,"_138":-5,"_139":-5},"loaderData",{"_3":4,"_9":10},"root",{"_5":6,"_7":8},"locale","id","isCms",false,"routes/tags/$slug",{"_11":12,"_13":14,"_15":16,"_125":126,"_132":128,"_136":131,"_137":-5},"slug","cold-chain-product","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,"_122":123,"_68":124},"019bb758-e31b-70a3-add3-98467eb4fe4d","title","COVID-19 – BPOM keluarkan izin penggunaan vaksin Bio Farma","covid-19-191","main_id","019bb73f-28ac-70ed-836a-68ade28a117a","main_name","Nasional","main_slug","nasional","date","2021-02-17 16:53:30","author_id","019bb745-b426-73a2-9a49-5ddcb6765ea0","author_name","indowin","full_name","Indonesia Window","author_firstname","Indonesia","author_slug","indonesiawindow","content","Jakarta (Indonesia Window) – Badan Pengawas Obat dan Makanan (BPOM) pada Selasa (16/2) mengeluarkan Emergency Use Authorization (EUA) atau izin penggunaan masa darurat untuk vaksin COVID-19 yang diproduksi oleh perusahaan farmasi BUMN, Bio Farma.

Kepala BPOM Penny K Lukito mengatakan, pemberian EUA berdasarkan pada hasil evaluasi data hasil uji stabilitas, dokumen validasi proses produksi, validasi metode analisis, serta spesifikasi produk dan spesifikasi kemasan yang digunakan.

Vaksin dengan Nomor EUA2102907543A1 tersebut diberi nama Vaksin COVID-19, yang terbuat dari virus yang diinaktivasi.

Bahan baku vaksin tersebut didatangkan dari Sinovac Life Science China pada Desember 2020 sebanyak tiga juta dosis. Bio Farma lalu mem-filling dan mengemas vaksin ini.

“Tersedia dalam bentuk sediaan vial 5 ml, berisi 10 dosis vaksin per vial, dikemas dalam kotak berisi 10 vial, dan stabil disimpan pada suhu 2-8 derajat Celsius. Setiap vial dilengkapi dengan 2D Barcode yang menunjukkan identitas masing-masing vial dan berfungsi untuk melakukan tracking (pelacakan) dan mencegah peredaran vaksin palsu,” jelas Penny dalam keterangan tertulis pada Rabu.

“Vaksin COVID-19 yang diproduksi PT. Bio Farma sama kandungan dan profil khasiat serta keamanannya dengan vaksin CoronaVac yang diproduksi di Sinovac Beijing,” ungkap Penny.

Dia menambahkan, karena berbeda tempat produksi dan kemasan dari single dose menjadi multiple dose, maka sesuai peraturan, vaksin produksi Bio Farma wajib diregistrasi untuk mendapatkan Persetujuan Izin Edar.

Sebelum produk siap untuk digunakan, BPOM melakukan pengujian untuk pelulusan produk (lot release).

Sampai dengan 15 Februari 2021, BPOM telah menerbitkan sertifikat lot release untuk 5 batch vaksin, masing-masing sebanyak sekitar satu juta dosis.

“Dengan telah diberikan pelulusan produk, maka vaksin tersebut siap untuk digunakan dalam program vaksinasi,” ujarnya.

Penny menyatakan, mengingat vaksin merupakan produk rantai dingin (cold chain product) yang memerlukan suhu penyimpanan khusus, BPOM akan terus mengawal mutu vaksin pada jalur distribusi, mulai keluar dari industri farmasi hingga digunakan untuk vaksinasi.

Dia mengingatkan bahwa meskipun program vaksinasi telah dilaksanakan, Indonesia masih memerlukan jumlah vaksin yang cukup memadai untuk membentuk herd immunity (kekebalan kawanan) dan waktu untuk mencapai kondisi ini.

“Oleh karena itu, masyarakat harus tetap menjalankan protokol kesehatan, dengan terus menerapkan 5M, memakai masker, mencuci tangan, menjaga jarak, menghindari kerumunan, dan mengurangi mobilitas,” kata Kepala BPOM.

Laporan: Redaksi","excerpt","Jakarta (Indonesia Window) – Badan Pengawas Obat dan Makanan (BPOM) pada Selasa (16/2) mengeluarkan Emergency Use Authorization (EUA) atau izin penggunaan masa...","seo_kw","seo_title","","seo_description","Sebanyak tiga juta dosis bahan baku vaksin didatangkan dari Sinovac Life Science China pada Desember 2020. Bio Farma lalu mem-filling dan mengemas vaksin ini.","image","2021/02/Kepala-BPOM_Setkab.jpg","image_alt","image_caption","Kepala Badan Pengawas Obat dan Makanan (BPOM), Penny K Lukito. (Sekretariat Kabinet RI)","image_url","https://indonesiawindow.sgp1.cdn.digitaloceanspaces.com/2021/02/Kepala-BPOM_Setkab.jpg","status","publish","tags",[60,76,83,90,97,104,111,117],{"_6":61,"_62":63,"_64":65,"_11":66,"_49":-5,"_67":-5,"_68":69,"_70":69,"_71":72},"019bb744-18c5-7396-94f9-e8e1164a7db3","old_id",2163,"name","herd immunity covid-19","herd-immunity-covid-19","description","created_at","2026-01-13T12:10:51.000000Z","updated_at","pivot",{"_73":18,"_74":61,"_68":75,"_70":75},"post_id","tag_id","2026-01-13T12:33:34.000000Z",{"_6":77,"_62":78,"_64":79,"_11":80,"_49":-5,"_67":-5,"_68":81,"_70":81,"_71":82},"019bb744-3281-70d6-9298-53840835606f",4367,"vaksin covid-19 Bio Farma","vaksin-covid-19-bio-farma","2026-01-13T12:10:58.000000Z",{"_73":18,"_74":77,"_68":75,"_70":75},{"_6":84,"_62":85,"_64":86,"_11":87,"_49":-5,"_67":-5,"_68":88,"_70":88,"_71":89},"019bb744-42fc-70bd-9202-20155a9c1eba",5707,"bahan baku vaksin covid-19","bahan-baku-vaksin-covid-19","2026-01-13T12:11:02.000000Z",{"_73":18,"_74":84,"_68":75,"_70":75},{"_6":91,"_62":92,"_64":93,"_11":94,"_49":-5,"_67":-5,"_68":95,"_70":95,"_71":96},"019bb744-49eb-702a-bdd1-20bbbed072f0",6429,"vaksin covid-19 CoronaVac","vaksin-covid-19-coronavac","2026-01-13T12:11:04.000000Z",{"_73":18,"_74":91,"_68":75,"_70":75},{"_6":98,"_62":99,"_64":100,"_11":101,"_49":-5,"_67":-5,"_68":102,"_70":102,"_71":103},"019bb744-4c8b-708f-a44a-01bfb8af20c1",6647,"bahan baku vaksin Sinovac","bahan-baku-vaksin-sinovac","2026-01-13T12:11:05.000000Z",{"_73":18,"_74":98,"_68":75,"_70":75},{"_6":105,"_62":106,"_64":107,"_11":108,"_49":-5,"_67":-5,"_68":109,"_70":109,"_71":110},"019bb744-506f-7097-a068-b297bf32c6d8",7041,"lot release vaksin covid-19","lot-release-vaksin-covid-19","2026-01-13T12:11:06.000000Z",{"_73":18,"_74":105,"_68":75,"_70":75},{"_6":112,"_62":113,"_64":114,"_11":115,"_49":-5,"_67":-5,"_68":109,"_70":109,"_71":116},"019bb744-5079-7002-86a6-30ae930e7555",7043,"Sinovac Life Science China","sinovac-life-science-china",{"_73":18,"_74":112,"_68":75,"_70":75},{"_6":118,"_62":119,"_64":120,"_11":12,"_49":-5,"_67":-5,"_68":109,"_70":109,"_71":121},"019bb744-5080-7148-9a76-7530e29edfa8",7045,"cold chain product",{"_73":18,"_74":118,"_68":75,"_70":75},"comments",[],"2021-02-17","pagination",{"_127":128,"_129":128,"_130":131,"_132":128,"_133":128,"_134":135},"count",1,"total","perPage",12,"currentPage","totalPages","links",{},"pageSize","error","actionData","errors"]