Badan POM Terbitkan EUA Covovax sebagai Vaksin Alternatif Ke-11 dalam Penanganan Pandemi Covid-19

BADAN Pengawas Obat dan Makanan (Badan POM) secara resmi memberikan izin penggunaan darurat/emergency use authorization (EUA) kepada Vaksin Covovax. Covovax menjadi vaksin covid-19 ke-11 yang dapat digunakan di Indonesia.

Vaksin dengan teknologi platform rekombinan protein subunit glikoprotein spike menggunakan vaksin adjuvant Matrix-M1 ini diproduksi Serum Institute of India Pvt. Ltd., India (SII).

Evaluasi aspek keamanan, imunogenisitas, dan efikasi Vaksin Covovax mengacu pada data uji pre-klinik dan uji klinik yang dilakukan di Australia, Amerika Serikat, Meksiko, Inggris (United Kingdom/UK), dan Afrika Selatan.

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Untuk memastikan khasiat dan keamanan, Vaksin Covovax telah memenuhi persyaratan evaluasi yang dikeluarkan World Health Organization (WHO). SII juga telah melakukan uji klinik fase 2/3 di India.

“Sesuai persyaratan EUA, Badan POM telah melakukan evaluasi terhadap aspek keamanan, khasiat, dan mutu yang mengacu pada standar evaluasi vaksin covid-19, baik standar nasional maupun internasional, serta evaluasi terhadap pemenuhan Cara Pembuatan Obat yang Baik (CPOB) pada fasilitas produksi Vaksin Covovax di India,” papar Kepala Badan POM RI Penny K Lukito melalui siaran pers, Rabu (17/11).

Vaksin Covovax dapat digunakan untuk dewasa berusia 18 tahun ke atas dengan pemberian 2 kali suntik dan interval 21 hari.

“Dari hasil evaluasi tersebut, Vaksin Covovax dapat digunakan untuk dewasa berusia 18 tahun ke atas dengan dosis 5 μg /dosis, diberikan sebanyak 2 kali dengan interval pemberian 21 hari,” ujarnya.

Dari uji klinik Vaksin Covovax dalam aspek keamanan, kejadian efek samping yang dilaporkan umumnya bersifat ringan hingga sedang. Efek samping yang paling sering dilaporkan, yakni nyeri lokal, tenderness, sakit kepala, kelelahan/fatigue, nyeri otot/myalgia, dan demam.

Lebih lanjut, dari aspek khasiat atau efikasi Vaksin Covovax, hasil pengamatan 7 hari setelah pemberian dosis kedua pada dewasa usia 18 tahun atau lebih dengan status imun negatif (seronegatif)  berkisar antara 89,7%-90,4% pada semua kasus covid-19 dengan berbagai tingkat keparahan.

Sementara itu, pada kasus dengan tingkat keparahan sedang hingga berat, berkisar antara 86,9%-100%.

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Efikasi vaksin pada kelompok lanjut usia berdasarkan uji klinik fase 3 di Inggris ialah 88,9%. Di samping itu, hasil uji klinik fase 2/3 di India menunjukkan respons imun yang baik dari pengukuran 14 hari setelah pemberian Vaksin Covovax dosis kedua.

Terkait aspek mutu dan pemenuhan standar CPOB, hasil evaluasi Covovax, dari bahan awal, bulk antigen, hingga produk vaksin, termasuk evaluasi terhadap mutu, telah memenuhi syarat sesuai standar evaluasi mutu yang berlaku secara Internasional. Standar yang dimaksud, antara lain dari WHO, United States Food and Drug Administration (US-FDA), dan European Medicines Agency (EMA).

Badan POM sebagai regulator obat yang telah diakui WHO memiliki kemampuan untuk melakukan evaluasi obat dan vaksin. Pun sebagai National Regulatory Authority dengan sistem evaluasi obat dan vaksin yang baik (maturity level 4). Dengan begitu, Badan POM dapat menerbitkan EUA tanpa harus menunggu persetujuan atau dikeluarkannya EUA dari regulator lain untuk produk yang sama.

Sesuai dengan regulasi yang berlaku, Badan POM sebagai lembaga independen dan berbasis ilmiah mengambil semua keputusan pemberian izin edar obat, termasuk EUA, sepenuhnya berdasarkan standar internasional yang mengedepankan pemenuhan persyaratan aspek keamanan, khasiat, dan mutu produk.

Selain itu, juga melalui pertimbangan ilmiah berdasarkan rekomendasi Komisi Nasional Penilaian Obat dan Vaksin Covid-19, ITAGI (Indonesia Technical Advisory Group of Immunization), serta asosiasi klinisi, termasuk saat menerbitkan EUA Covovax.

“Karena itu, kami kembali menyampaikan apresiasi kepada semua pihak yang terlibat atas kerja samanya yang memungkinkan vaksin ini segera rilis ke masyarakat,” terang Penny.

Bersama dengan penerbitan EUA Covovax, Badan POM juga menerbitkan factsheet yang dapat diacu tenaga kesehatan dan tersedia informasi produk yang dikhususkan untuk masyarakat.

Factsheet tersebut berisi informasi lebih lengkap terkait dengan keamanan dan efikasi vaksin ini serta hal-hal yang harus menjadi kewaspadaan dalam penggunaan vaksin, termasuk monitoring kemungkinan efek samping atau Kejadian Ikutan Pasca-Imunisasi (KIPI) dan pelaporannya. Para tenaga kesehatan dan masyarakat dapat mengakses factsheet dan informasi produk vaksin covid-19 melalui website Badan POM.

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Terbitnya EUA Covavax semakin menambah alternatif vaksin yang dapat digunakan pada program Vaksinasi Covid-19 untuk dewasa 18 tahun ke atas.

Badan POM juga kembali mengimbau masyarakat untuk selalu menerapkan protokol kesehatan sebagai upaya kunci dalam memutus rantai penyebaran covid-19 selain mendorong untuk menyukseskan dan mengikuti program vaksinasi yang telah dicanangkan pemerintah.

“Masyarakat juga perlu bijak dan berhati-hati dalam mengonsumsi obat-obatan yang digunakan dalam penanganan covid-19 serta tidak mudah terpengaruh dengan promosi produk obat, obat tradisional, maupun suplemen kesehatan dengan klaim dapat mencegah atau mengobati covid-19,” tutup Kepala Badan POM. (RLS/J1)

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