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14 Ogos 2026, 1:29 am

Dr. Yasmin ketuai kajian klinikal vaksin Covid-19 Malaysia

PUTRAJAYA: Kajian klinikal vaksin kerjasama antara Malaysia dan Institut Perubatan Biologi Akademi Sains Perubatan China (IMBCAMS) dijangka bermula bulan depan, kata Ketua Pengarah Kesihatan, Tan Sri Dr. Noor Hisham Abdullah.

Bercakap kepada Mingguan Malaysia, beliau berkata, ujian itu akan dikoordinasi Institut Penyelidikan Klinikal (ICR) iaitu agensi di Institut Kesihatan Negara (NIH) di bawah Kementerian Kesihatan dan sebuah organisasi kontrak penyelidikan tempatan.

Katanya, sekumpulan pakar berpengalaman diketuai pakar perubatan penyakit berjangkit, Dr. Yasmin Mohamed Ghani dari Hospital Sungai Buloh akan mula merekrut seramai 3,000 peserta di lapan hospital kerajaan.

“Ini akan dijalankan dengan mengikut Protokol Penyelidikan Klinikal (CRP) dan mematuhi proses Amalan Klinikal Baik (GCP) yang diiktiraf Majlis Penyelarasan Antarabangsa (ICH).

“Ia seperti mana mendapat kebenaran bertulis dari peserta yang dimaklumkan tentang ujian klinikal (Informed Consent),” katanya.

Beliau memberitahu, lapan hospital yang akan terlibat ialah Hospital Ampang, Hospital Umum Sarawak, Hospital Sungai Buloh, Hospital Pulau Pinang, Hospital Seberang Jaya, Hospital Taiping, Hospital Sultanah Bahiyah dan Hospital Raja Permaisuri Bainun.

“Malaysia adalah satu destinasi utama ujian-ujian klinikal di rantau Asia Pasifik dan diiktiraf di peringkat global dalam pengendalian percubaan klinikal Fasa 1, 2 dan 3 sejak tahun 80-an.

“Percubaan klinikal tersebut diharap dijalankan seperti yang dijangkakan dan keputusan bakal menjawab keberkesanan dan keselamatan vaksin dari IMBCAMS,” katanya.

Dr. Noor Hisham berkata, kajian vaksin itu menggunakan platform Inactivated SARS-CoV-2 dan nama vaksin tersebut akan dimaklumkan kepada pihak IMBCAMS kelak.

Menurut beliau, percubaan klinikal itu adalah kajian terkawal dan merangkumi kajian keselamatan dan keberkesanan vaksin tersebut.

Katanya, bagi membolehkan percubaan klinikal di Malaysia dimulakan, beberapa langkah perlu diambil kira terlebih dahulu termasuk memperoleh kelulusan Jawatankuasa Etika Kajian Perubatan (MREC) dan Agensi Regulatori Farmaseutikal Kebangsaan (NPRA).

“Prosedur-prosedur ini adalah amat penting supaya setiap percubaan klinikal yang dijalankan di Malaysia adalah selamat dan mematuhi undang-undang negara,” katanya. -UTUSAN

Dr. Yasmin ketuai kajian klinikal vaksin Covid-19 Malaysia

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