{"id":195381,"date":"2020-08-04T06:32:15","date_gmt":"2020-08-03T23:32:15","guid":{"rendered":"https:\/\/setkab.go.id\/?p=195381"},"modified":"2020-08-04T06:35:35","modified_gmt":"2020-08-03T23:35:35","slug":"kemenkes-jelaskan-mekanisme-produksi-obat-dan-perkembangan-uji-klinis-vaksin-covid-19","status":"publish","type":"post","link":"https:\/\/setkab.go.id\/kemenkes-jelaskan-mekanisme-produksi-obat-dan-perkembangan-uji-klinis-vaksin-covid-19\/","title":{"rendered":"Kemenkes Jelaskan Mekanisme Produksi Obat dan Perkembangan Uji Klinis Vaksin Covid-19"},"content":{"rendered":"<div id=\"attachment_195385\" style=\"width: 650px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-195385\" class=\"size-full wp-image-195385\" src=\"https:\/\/setkab.go.id\/wp-content\/uploads\/2020\/08\/images-1-1.jpeg\" alt=\"\" width=\"640\" height=\"360\" \/><p id=\"caption-attachment-195385\" class=\"wp-caption-text\">Ilustrasi Vaksin.<\/p><\/div>\n<p style=\"text-align: justify;\">Kementerian Kesehatan (Kemenkes) melalui Pelaksana Tugas (Plt.) Kepala Badan Penelitian dan Pengembangan Kesehatan (Kabadan Litbangkes), Slamet, memberikan penjelasan terkait mekanisme produksi obat dan perkembangan uji klinis vaksin Covid-19. <!--more--><\/p>\n<div style=\"text-align: justify;\">Lebih lanjut, Plt. Kabadan Litbangkes menyampaikan secara garis besar proses produksi obat sebagai berikut:<\/div>\n<div><\/div>\n<div style=\"text-align: justify;\"><strong>Pertama<\/strong>, diawali dengan upaya penemuan bahan\/zat\/senyawa potensial obat melalui berbagai proses penelitian;<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\"><strong>Kedua<\/strong>, Bahan\/zat\/senyawa potensial obat tersebut harus melewati berbagai proses pengujian diantaranya adalah uji aktivitas zat; uji toxisitas in vitro dan in vivo pada tahap pra klinik; serta Uji Klinik untuk fase I, fase II dan fase III;<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\"><strong>Ketiga<\/strong>, proses izin edar;<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\"><strong>Keempat<\/strong>, diproduksi melalui cara pembuatan obat yang baik (GMP) dan dilakukan kontrol pada proses pemasaran.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">&#8220;Banyak lembaga internasional dan nasional sedang bekerja keras untuk mendapatkan obat ataupun vaksin Covid 19. Sebagian kandidat vaksin juga sudah memasuki tahap uji klinik tahap akhir,&#8221; kata Slamet.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Namun, diakui Slamet, hingga saat ini belum ada satu negara atau lembaga manapun di dunia yang sudah menemukan obat atau vaksin secara spesifik bisa menanggulangi Covid-19.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">&#8220;Saat ini beberapa negara termasuk Indonesia tergabung dalam <i>Solidarity Trial\u00a0<\/i>WHO, untuk mendapatkan bukti klinis yang lebih kuat dan valid terhadap efektivitas dan keamanan terbaik dalam perawatan pasien Covid-19,&#8221; jelas Slamet.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\"><b>Perkembangan Uji Klinis Tahap III Vaksin Covid-19<\/b><\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Sementara itu, Slamet sampaikan bahwa terkait perkembangan pembuatan vaksin Covid-19 yang diproduksi Sinovac dari Tiongkok saat ini akan dilakukan uji klinik fase 3 di <em>site<\/em> penelitian Fakulatas Kedokteran Universitas Padjadjaran (FK Unpad).<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">&#8220;Sesuai dengan standar internasional juga peraturan Badan POM untuk registrasi obat\/vaksin, maka protokol penelitian ini harus mendapatkan persetujuan etik dari <em>site<\/em> penelitian yang akan dituju, dalam hal ini Unpad,&#8221; katanya.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Komisi Etik Unpad, menurut Kabadan Litbangkes telah melakukan telaah protokol penelitian fase 3 vaksin tersebut.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Pada tanggal 27 Juli 2020, Slamet sampaikan bahwa Unpad mengumumkan persetujuan etik terhadap uji klinik ini. Artinya, Ia menambahkan bahwa data-data yang mendasari dilakukan uji klinik fase 3 dapat diterima secara ilmiah, risiko terhadap subjek dapat diminimalisasi dan manfaat diperkirakan dapat diperoleh.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">&#8220;Komisi Etik Universitas Padjajaran berkewajiban melakukan <em>monitoring<\/em> pelaksanaan penelitian,&#8221; jelasnya.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">Pemerintah mengimbau masyarakat untuk tidak mudah percaya akan informasi yang diragukan kebenarannya. Untuk itu, Slamet mengingatkan untuk melakukan saring sebelum <i>sharing<\/i>, bersikap kritis dan cari informasi dari sumber yang terpercaya.<\/div>\n<div style=\"text-align: justify;\"><\/div>\n<div style=\"text-align: justify;\">&#8221;Kepada seluruh pihak, khususnya tokoh publik, kami harap dapat memberikan pencerahan tentang Covid-19 kepada masyarakat dan bukan sebaliknya menimbulkan pro-kontra,&#8221; pungkas Slamet. (<strong>Humas Kemenkes\/EN<\/strong>)<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Kementerian Kesehatan (Kemenkes) melalui Pelaksana Tugas (Plt.) Kepala Badan Penelitian dan Pengembangan Kesehatan (Kabadan Litbangkes), Slamet, memberikan penjelasan terkait mekanisme produksi obat dan perkembangan uji klinis vaksin Covid-19.<\/p>\n","protected":false},"author":33,"featured_media":195385,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[55],"tags":[1341,983],"class_list":["post-195381","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-berita","tag-covid-19","tag-kesehatan"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.1 (Yoast SEO v26.1.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Kemenkes Jelaskan Mekanisme Produksi Obat dan Perkembangan Uji Klinis Vaksin Covid-19 - Sekretariat Kabinet Republik Indonesia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/setkab.go.id\/kemenkes-jelaskan-mekanisme-produksi-obat-dan-perkembangan-uji-klinis-vaksin-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kemenkes Jelaskan Mekanisme Produksi Obat dan Perkembangan Uji Klinis Vaksin Covid-19 - Sekretariat Kabinet Republik Indonesia\" \/>\n<meta property=\"og:description\" content=\"Kementerian Kesehatan (Kemenkes) melalui Pelaksana Tugas (Plt.) 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