{"id":1966,"date":"2025-05-16T03:58:46","date_gmt":"2025-05-16T03:58:46","guid":{"rendered":"https:\/\/amanimanimun.com\/?p=1966"},"modified":"2025-05-16T03:58:46","modified_gmt":"2025-05-16T03:58:46","slug":"bpom-izinkan-uji-klinis-tahap-3-vaksin-tuberkulosis-m72","status":"publish","type":"post","link":"https:\/\/amanimanimun.com\/index.php\/2025\/05\/16\/bpom-izinkan-uji-klinis-tahap-3-vaksin-tuberkulosis-m72\/","title":{"rendered":"BPOM Izinkan Uji Klinis Tahap 3 Vaksin Tuberkulosis M72"},"content":{"rendered":"

AmanImanImun.com<\/strong> – Badan <\/span>Pengawas <\/span>Obat <\/span>dan <\/span>Makanan (<\/span>BPOM<\/span>)<\/span> telah <\/span>memberikan <\/span>lampu <\/span>hijau <\/span>untuk <\/span>pelaksanaan <\/span>uji <\/span>klinis <\/span>tahap <\/span>3 <\/span>vaksin <\/span>tuberkulosis (<\/span>TB) <\/span>M72<\/span> <\/a>di <\/span>Indonesia.<\/span><\/p>\n

Inisiatif <\/span>ini <\/span>bertujuan <\/span>untuk <\/span>menguji <\/span>efikasi <\/span>vaksin <\/span>sekaligus <\/span>membuka <\/span>jalan <\/span>bagi <\/span>pembaruan <\/span>metode <\/span>penanganan <\/span>TB <\/span>di <\/span>Tanah <\/span>Air, <\/span>sebuah <\/span>langkah <\/span>penting <\/span>dalam <\/span>upaya <\/span>melawan <\/span>penyakit <\/span>yang <\/span>menjadi <\/span>tantangan <\/span>global.<\/span><\/p>\n

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Kepala <\/span>BPOM, <\/span>Taruna <\/span>Ikrar, <\/span>menjelaskan <\/span>bahwa <\/span>Indonesia <\/span>menempati <\/span>posisi <\/span>kedua <\/span>dunia <\/span>sebagai <\/span>negara <\/span>dengan <\/span>jumlah <\/span>penderita <\/span>tuberkulosis <\/span>terbanyak, <\/span>hanya <\/span>kalah <\/span>dari <\/span>India. “<\/span>Jumlah <\/span>penderita <\/span>TB <\/span>di <\/span>Indonesia <\/span>mencapai <\/span>lebih <\/span>dari <\/span>satu <\/span>juta <\/span>orang, <\/span>bahkan <\/span>hampir <\/span>mendekati <\/span>dua <\/span>juta,” <\/span>ungkapnya <\/span>dalam <\/span>pernyataan <\/span>resmi <\/span>yang <\/span>dirilis <\/span>Kamis (<\/span>15\/<\/span>5\/<\/span>2025).<\/span><\/p>\n

Selama <\/span>ini, <\/span>pengobatan <\/span>TB <\/span>bergantung <\/span>pada <\/span>kombinasi <\/span>obat <\/span>isoniazid, <\/span>rifampicin, <\/span>dan <\/span>etambutol. <\/span>Namun, <\/span>pendekatan <\/span>ini <\/span>menghadapi <\/span>tantangan, <\/span>seperti <\/span>waktu <\/span>penyembuhan <\/span>yang <\/span>lama <\/span>dan <\/span>kemungkinan <\/span>resistensi. “<\/span>Gabungan <\/span>ketiga <\/span>obat <\/span>ini, <\/span>mungkin <\/span>karena <\/span>pemakaiannya <\/span>sudah <\/span>sangat <\/span>lama, <\/span>menyebabkan <\/span>sulitnya <\/span>pasien <\/span>sembuh <\/span>sepenuhnya,” <\/span>jelas <\/span>Taruna.<\/span><\/p>\n

Vaksin <\/span>Bacillus <\/span>Calmette-<\/span>Gu\u00e9rin (<\/span>BCG) <\/span>yang <\/span>telah <\/span>digunakan <\/span>selama <\/span>ini <\/span>dinilai <\/span>kurang <\/span>efektif, <\/span>terutama <\/span>pada <\/span>orang <\/span>dewasa. <\/span>Oleh <\/span>sebab <\/span>itu, <\/span>vaksin <\/span>M72 <\/span>diharapkan <\/span>mampu <\/span>menawarkan <\/span>perlindungan <\/span>yang <\/span>lebih <\/span>baik. “<\/span>Dengan <\/span>teknologi <\/span>dan <\/span>hasil <\/span>baru <\/span>ini, <\/span>kami <\/span>berharap <\/span>dampaknya <\/span>dapat <\/span>bermanfaat <\/span>bagi <\/span>masyarakat <\/span>Indonesia <\/span>yang <\/span>menderita <\/span>tuberkulosis <\/span>dalam <\/span>jumlah <\/span>besar,” <\/span>tambahnya.<\/span><\/p>\n

Sebanyak <\/span>2.000 <\/span>peserta <\/span>dari <\/span>Indonesia <\/span>terlibat <\/span>secara <\/span>sukarela <\/span>dalam <\/span>uji <\/span>klinis <\/span>tahap <\/span>3 <\/span>ini, <\/span>yang <\/span>merupakan <\/span>bagian <\/span>dari <\/span>total <\/span>20.000 <\/span>peserta <\/span>global. <\/span>Proses <\/span>penelitian <\/span>menggunakan <\/span>metode <\/span>double-<\/span>blind, <\/span>di <\/span>mana <\/span>baik <\/span>peserta <\/span>maupun <\/span>peneliti <\/span>tidak <\/span>mengetahui <\/span>apakah <\/span>subjek <\/span>menerima <\/span>vaksin <\/span>atau <\/span>plasebo, <\/span>sehingga <\/span>memastikan <\/span>keilmiahan <\/span>penelitian.<\/span><\/p>\n

Taruna <\/span>juga <\/span>mengungkapkan <\/span>bahwa <\/span>produksi <\/span>vaksin <\/span>nantinya <\/span>akan <\/span>melibatkan <\/span>Biofarma, <\/span>dengan <\/span>pengawasan <\/span>ketat <\/span>dari <\/span>BPOM <\/span>untuk <\/span>menjaga <\/span>standar <\/span>good <\/span>manufacturing <\/span>practice (<\/span>GMP)<\/span><\/strong>.<\/span><\/p>\n

Direktur <\/span>Utama <\/span>Biofarma, <\/span>Shadiq <\/span>Akasya, <\/span>menyatakan <\/span>pentingnya <\/span>uji <\/span>klinis <\/span>ini. “<\/span>Selama <\/span>30 <\/span>tahun <\/span>terakhir <\/span>belum <\/span>ada <\/span>vaksin <\/span>TB <\/span>baru <\/span>yang <\/span>berhasil <\/span>dikembangkan. <\/span>Ini <\/span>merupakan <\/span>langkah <\/span>besar, <\/span>terutama <\/span>dengan <\/span>dukungan <\/span>Gates <\/span>Foundation <\/span>dan <\/span>BPOM, <\/span>untuk <\/span>memastikan <\/span>vaksin <\/span>ini <\/span>dapat <\/span>diproduksi <\/span>secara <\/span>lokal,” <\/span>ujarnya.<\/span><\/p>\n

Selain <\/span>berkontribusi <\/span>pada <\/span>pengendalian <\/span>TB, <\/span>partisipasi <\/span>Indonesia <\/span>dalam <\/span>uji <\/span>klinis <\/span>ini <\/span>juga <\/span>memiliki <\/span>dampak <\/span>strategis <\/span>pada <\/span>sektor <\/span>farmasi <\/span>nasional. <\/span>Saat <\/span>ini, <\/span>94% <\/span>bahan <\/span>baku <\/span>obat <\/span>di <\/span>Indonesia <\/span>masih <\/span>diimpor. <\/span>Dengan <\/span>keterlibatan <\/span>dalam <\/span>pengembangan <\/span>vaksin <\/span>M72, <\/span>Indonesia <\/span>berpeluang <\/span>mendapatkan <\/span>hak <\/span>properti <\/span>intelektual <\/span>yang <\/span>memungkinkan <\/span>produksi <\/span>vaksin <\/span>secara <\/span>lokal. <\/span>Langkah <\/span>ini <\/span>tidak <\/span>hanya <\/span>mengurangi <\/span>ketergantungan <\/span>impor <\/span>tetapi <\/span>juga <\/span>memperluas <\/span>akses <\/span>masyarakat <\/span>terhadap <\/span>vaksin.<\/span><\/p>\n

Senior <\/span>CMC <\/span>Advisor <\/span>Vaccine <\/span>Development <\/span>Gates <\/span>Foundation, <\/span>Rasayam <\/span>Prasad, <\/span>menekankan <\/span>pentingnya <\/span>memperluas <\/span>akses <\/span>vaksin. “<\/span>Pengembangan <\/span>vaksin <\/span>saja <\/span>tidak <\/span>cukup, <\/span>akses <\/span>terhadap <\/span>vaksin <\/span>juga <\/span>harus <\/span>diperluas. <\/span>Indonesia <\/span>dapat <\/span>menjadi <\/span>hub <\/span>untuk <\/span>penyediaan <\/span>vaksin <\/span>global, <\/span>termasuk <\/span>untuk <\/span>tuberculosis, <\/span>campak, <\/span>rubella, <\/span>dan <\/span>penyakit <\/span>lainnya,” <\/span>ujar <\/span>Rasayam.<\/span><\/p>\n

Dengan <\/span>harapan <\/span>tinggi <\/span>dan <\/span>dukungan <\/span>dari <\/span>berbagai <\/span>pihak, <\/span>langkah <\/span>uji <\/span>klinis <\/span>vaksin <\/span>tuberkulosis <\/span>M72<\/span><\/strong> ini <\/span>menjadi <\/span>peluang <\/span>emas <\/span>untuk <\/span>mengendalikan <\/span>penyakit <\/span>yang <\/span>telah <\/span>lama <\/span>menjadi <\/span>momok <\/span>di <\/span>Indonesia <\/span>dan <\/span>dunia. <\/span>Apabila <\/span>berhasil, <\/span>vaksin <\/span>ini <\/span>tidak <\/span>hanya <\/span>akan <\/span>menyelamatkan <\/span>jutaan <\/span>nyawa <\/span>tetapi <\/span>juga <\/span>memperkokoh <\/span>posisi <\/span>Indonesia <\/span>dalam <\/span>kontribusi <\/span>pengembangan <\/span>kesehatan <\/span>global.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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AmanImanImun.com – Badan Pengawas Obat dan Makanan (BPOM) telah memberikan lampu hijau untuk pelaksanaan uji…<\/p>\n","protected":false},"author":3,"featured_media":1967,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[1,8],"tags":[142,564,562,563],"class_list":["post-1966","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home","category-vaksinasi","tag-bpom","tag-m72","tag-uji-klinis","tag-vaksin-tuberkulosis"],"yoast_head":"\nBPOM Izinkan Uji Klinis Tahap 3 Vaksin Tuberkulosis M72<\/title>\n<meta name=\"description\" content=\"BPOM resmi izinkan uji klinis tahap 3 vaksin tuberkulosis (TB) M72 di Indonesia untuk menguji efikasi vaksin\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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