BERNAMA
27/01/2021
PUTRAJAYA, Jan 27 — Malaysia’s first Covid-19 vaccine clinical trial began today in nine hospitals, involving some 3,000 volunteers, Health Minister Datuk Seri Dr Adham Baba said.
The Phase 3 clinical trial of the vaccine developed and sponsored by China's Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) is being carried out with the objective of assessing its safety and effectiveness against COVID-19 infection.
The nine hospitals participating in the trial, coordinated by the Health Ministry's Institute of Clinical Research (ICR), are the Ampang Hospital; Sarawak General Hospital, Penang Hospital; Seberang Jaya Hospital; Sultanah Bahiyah Hospital; Raja Permaisuri Bainun Hospital; Taiping Hospital; Sungai Buloh Hospital and the Sultan Abdul Halim Hospital.
“It will involve 3,000 Malaysian volunteers over a period of 13 months,” he said in a statement in conjunction with the launch of the clinical trial held virtually at the ministry today.
Dr Adham said the clinical study was a test of the SARS-CoV-2 vaccine, using an inactive vaccine platform.
Dr Adham said Phases 1 and 2 of the clinical trial involved subjects in China and its findings showed significant immune response towards the SARS-CoV-2 antigen.
"It also does not show serious side effects, not exceeding 30 per cent overall for a period of 28 days after immunisation was carried out," he said.
He said the initiative is a collaboration between the Malaysian and Chinese governments through IMBCAMS and capable of playing a role in generating scientific evidence in the development of COVID-19 vaccines.
“This phase 3 trial is historic and meaningful to Malaysia, particularly in the field of medicine. In addition, IMBCAMS is very satisfied with the level and readiness of the ministry’s facilities in the field in terms of participation and implementation,” he said.
Dr Adham said the trial must meet international standards, national regulatory health policies, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and the Helsinki Declaration.
It will also be closely monitored by the National Pharmaceutical Regulatory Agency (NPRA) and the Medical Review and Ethics Committee of the Health Ministry, he added.
