STUDI LITERATUR PRODUKSI VAKSIN, TINGKAT EFEKTIFITAS DAN EFIKASI PLATFORM SUB UNIT PROTEIN DARI VIRUS SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV 2)

SITI SHYNTIANA NURROHMAHWATI, - (2022) STUDI LITERATUR PRODUKSI VAKSIN, TINGKAT EFEKTIFITAS DAN EFIKASI PLATFORM SUB UNIT PROTEIN DARI VIRUS SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV 2). Skripsi thesis, Sekolah Tinggi Farmasi Indonesia.

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Abstract

Vaksin dari platform subunit protein Covid-19 adalah vaksin yang zat aktif nya menggunakan bagian protein patogen yang spesifik (antigen). Sudah banyak vaksin platform subunit protein dari berbagai negara namun informasi mengenai produsen, drug substance, drug product, tingkat keefektifitasan dan efikasi dari platform subunit protein ini belum banyak diketahui. Studi literatur ini bertujuan untuk memberikan informasi mengenai produksi dan status produk vaksin, drug substance, drug product serta hasil keefektifitasan dan efikasi dari vaksin subunit protein Covid-19. Metode yang digunakan dalam studi literatur ini adalah kriteria inklusi dengan tinjauan penelitian dan artikel literatur yang berkaitan dengan produksi, drug substance dan hasil uji klinis yang terkandung dalam vaksin platform subunit protein Covid-19 dan kriteria eksklusi dengan teknologi produksi vaksin platform subunit protein non covid-19 dan teknologi produksi vaksin covid-19 non platform subunit protein. Berdasarkan hasil studi literatur platform subunit protein vaksin yang diproduksi oleh Coalition For Epidemic Preparedness Innovations (CEPI), Finlay Institut Iran dan Anhui Zhifei. Dengan semua status produk ditahap uji klinis fase III. Vaksin yang sudah mendapatkan izin edar diantaranya vaksin Novavax, vaksin FINLAY-FR-1 dan vaksin Zifivax. Sebagian besar drug substance yang digunakan yaitu protein spike RBD dan adjuvant aluminium dengan metode produksi DNA rekombinan. Hasil efektifitas dan efikasi masingmasing vaksin terhadap virus SARS-CoV-2 yaitu Novavax 90,4%, FINLAY-FR-1 92% dan Zifivax 81,76% . --- The vaccine from the Covid-19 protein subunit platform is a vaccine whose active substance uses a specific part of the pathogenic protein (antigen). There have been many protein subunit platform vaccines from various countries but information about the producer, drug substance, drug product, level of effectiveness and efficacy of this protein subunit platform is not widely known. This literature study aims to provide information on the production and status of vaccine products, drug substances, drug products and the effectiveness and efficacy of the Covid-19 protein subunit vaccine. The method used in this literature study is inclusion criteria with a review of research and literature articles related to production, drug substance and clinical test results contained in the Covid-19 protein subunit platform vaccine and exclusion criteria with non-covid-19 protein subunit platform vaccine production technology. 19 and non-platform protein subunit Covid-19 vaccine production technology. Based on the results of a literature study of the vaccine protein subunit platform produced by the Coalition For Epidemic Preparedness Innovations (CEPI), Iran's Finlay Institute and Anhui Zhifei. With all product status in phase III clinical trials. Vaccines that have received marketing authorization include Novavax vaccine, FINLAY-FR-1 vaccine and Zifivax vaccine. Most of the drug substances used are spike protein RBD and aluminum adjuvant with recombinant DNA production method. The results of the effectiveness and efficacy of each vaccine against the SARS-CoV-2 virus were Novavax 90.4%, FINLAY-FR-1 92% and Zifivax 81.76%.

Item Type: Thesis (Skripsi)
Uncontrolled Keywords: Drug substance, Drug product, status vaksin --- Drug substance, Drug product, vaccine status
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Divisions: Program Studi S1 Farmasi
Depositing User: pustakawan - -
Date Deposited: 14 Sep 2024 14:15
Last Modified: 14 Sep 2024 14:15
URI: http://repository.stfi.ac.id/id/eprint/1251

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