Malaysia’s first Covid-19 vaccine trial to begin next month

 

Malaysia will undertake its first Covid-19 vaccine trial next month as part of a government-to-government agreement with China, said Prime Minister Muhyiddin Yassin.

He said the trial will be a Phase III trial on a vaccine candidate developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).

“This Phase III clinical trial will involve 3,000 participants and will assess the safety and efficacy of the vaccine in development,” he told a press conference in Putrajaya today.

He said the trial will be conducted by a local clinical research organisation and has already been registered in the National Medical Research Registry.

The study will take place at eight clinical research sites managed by the Health Ministry.

Before the study begins, however, he said the National Pharmaceutical Regulatory Agency will study the vaccine candidate’s safety profile before approving a clinical trial import licence.

In addition, the Medical Research Ethics Committee will be perusing the study’s research protocol to ensure it adheres to the Health Ministry guidelines. - Mkini