{"id":145672,"date":"2022-09-13T10:23:09","date_gmt":"2022-09-13T03:23:09","guid":{"rendered":"https:\/\/nawacita.co\/?p=145672"},"modified":"2022-09-13T10:23:10","modified_gmt":"2022-09-13T03:23:10","slug":"bpom-terbitkan-izin-vaksin-covovax-untuk-booster-usia-18-tahun-ke-atas","status":"publish","type":"post","link":"https:\/\/nawacita.co\/index.php\/2022\/09\/13\/bpom-terbitkan-izin-vaksin-covovax-untuk-booster-usia-18-tahun-ke-atas\/","title":{"rendered":"BPOM Terbitkan Izin Vaksin Covovax untuk Booster Usia 18 Tahun ke Atas"},"content":{"rendered":"

BPOM Terbitkan Izin Vaksin Covovax untuk Booster Usia 18 Tahun ke Atas<\/h1>\n

Jakarta, Nawacita<\/a><\/strong> | BPOM terbitkan izin Vaksin Covovax untuk penambahan posologi dosis booster<\/em>\u00a0homolog bagi sasaran vaksinasi kelompok dewasa usia 18 tahun atau lebih. Vaksin Covovax merupakan vaksin Covid-19 yang dikembangkan Novavax Inc, USA.<\/p>\n

“Dalam penggunaannya sebagai booster homolog, Vaksin Covovax diberikan dalam satu dosis (0,5 ml), sekurang-kurangnya enam bulan setelah dosis kedua vaksinasi primer dengan Vaksin Covovax,\u201d kata Kepala\u00a0BPOM\u00a0RI Penny K. Lukito di Jakarta, Selasa (13\/9\/2022).<\/p>\n

Vaksin Covovax dikembangkan dengan platform protein subunit glikoprotein spike menggunakan adjuvant Matrix-M1. Vaksin tersebut diproduksi oleh Serum Institute of India Pvt. Ltd, India dan didaftarkan di Indonesia oleh PT Indofarma.<\/p>\n

Vaksin Covovax merupakan satu dari 13 vaksin Covid-19 yang telah mendapatkan EUA di Indonesia pada 31 Oktober 2021, dengan indikasi untuk vaksinasi primer pada usia 18 tahun atau lebih. Setelah itu, BPOM mengeluarkan persetujuan perluasan EUA\u00a0vaksin Covovax\u00a0untuk penambahan indikasi vaksinasi primer pada anak usia 12 tahun atau lebih pada tanggal 28 Juni 2022.<\/p>\n

\"Vaksin<\/a>
Vaksin Covovax<\/figcaption><\/figure>\n

Dalam pemberian izin edar obat, termasuk EUA vaksin, BPOM mengutamakan aspek khasiat, keamanan, dan mutu. Selain itu, BPOM mengutamakan pertimbangan ilmiah berdasarkan rekomendasi Komite Nasional Penilai Khusus Vaksin Covid-19, Indonesia Technical Advisory Group of Immunization (ITAGI), dan asosiasi klinisi.<\/p>\n

\u201cPemberian EUA Vaksin Covovax sebagai booster homolog dilakukan setelah BPOM bersama para ahli melakukan evaluasi terhadap aspek keamanan, mutu dan khasiat berdasarkan data-data uji klinik yang juga menjadi acuan para ahli yang terlibat,\u201d katanya.<\/p>\n

Penny mengatakan, hasil evaluasi terhadap aspek keamanan dan khasiat pemberian dosis\u00a0booster<\/em> pada dewasa berdasarkan data studi klinik fase 1\/2 dan studi klinik fase 2a\/b yang dilakukan pada subjek usia 18 tahun atau lebih.<\/p>\n

“Hasil studi klinik tersebut memperlihatkan efektivitas pemberian\u00a0booster<\/em>\u00a0enam bulan setelah vaksinasi primer lengkap pada kelompok usia 18 tahun ke atas,” katanya.<\/p>\n

Baca Juga:\u00a0Vaksin Hirup Covid-19 Buatan CanSino Dapat Izin Penggunaan Darurat di China<\/a><\/strong><\/p>\n

Hasil studi juga menunjukkan profil keamanan yang serupa dengan profil keamanan pada pemberian vaksinasi dosis primer, serta dapat ditoleransi dengan baik. Studi klinik pertama pada subjek dewasa sehat menunjukkan titer antibodi Imunoglobulin G (IgG) pada 28 hari setelah pemberian\u00a0booster<\/em>\u00a0meningkat sebesar 33,7 kali lipat dibandingkan sebelum pemberian\u00a0booster<\/em>.<\/p>\n

Hasil pengukuran titer antibodi netralisasi juga menunjukkan peningkatan sebesar 95,6 kali dibandingkan sebelum pemberian\u00a0booster<\/em>. Dalam tahapan studi klinik kedua dengan pengukuran titer antibodi selama 35 hari setelah pemberian\u00a0booster<\/em>\u00a0menunjukkan peningkatan antibodi IgG sebesar 17,1 kali lipat dibandingkan sebelum pemberian\u00a0booster<\/em>\u00a0dengan\u00a0seroconversion rate<\/em>\u00a0100 persen.<\/p>\n

Hasil pengukuran titer antibodi netralisasi juga menunjukkan peningkatan sebesar 7,7 kali lipat dibandingkan sebelum pemberian booster dengan seroconversion rate 99,6 persen, kata Penny menambahkan.<\/p>\n

\u201cJadi, setelah EUA diberikan, BPOM juga memberikan edukasi kepada tenaga kesehatan dan masyarakat. Selanjutnya, BPOM juga akan terus mengevaluasi efektivitas dan keamanan Vaksin Covovax sebagai vaksin booster<\/em> homolog,\u201d ujarnya. rpblk<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

BPOM Terbitkan Izin Vaksin Covovax untuk Booster Usia 18 Tahun ke Atas Jakarta, Nawacita | BPOM terbitkan izin Vaksin Covovax untuk penambahan posologi dosis booster\u00a0homolog bagi sasaran vaksinasi kelompok dewasa usia 18 tahun atau lebih. Vaksin Covovax merupakan vaksin Covid-19 yang dikembangkan Novavax Inc, USA. “Dalam penggunaannya sebagai booster homolog, Vaksin Covovax diberikan dalam satu […]<\/p>\n","protected":false},"author":1459,"featured_media":145677,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[15857,46612,28669,40746,34563,46611],"class_list":{"0":"post-145672","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-nasional","8":"tag-bpom","9":"tag-bpom-terbitkan-izin-vaksin-covovax","10":"tag-covid-19","11":"tag-vaksin-booster","12":"tag-vaksin-covid-19","13":"tag-vaksin-covovax"},"yoast_head":"\nBPOM Terbitkan Izin Vaksin Covovax untuk Booster Usia 18 Tahun ke Atas - Nawacita<\/title>\n<meta name=\"description\" content=\"Jakarta, Nawacita | BPOM terbitkan izin Vaksin Covovax untuk penambahan posologi dosis booster\u00a0homolog bagi sasaran vaksinasi kelompok dewas\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nawacita.co\/index.php\/2022\/09\/13\/bpom-terbitkan-izin-vaksin-covovax-untuk-booster-usia-18-tahun-ke-atas\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BPOM Terbitkan Izin Vaksin Covovax untuk Booster Usia 18 Tahun ke Atas - 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