Vaccine trials in Malaysia

Dr Akhmal: ‘While we wait for a Covid-19 vaccine to be procured, distributed, and administered to our population, clinical research is an important step to ensure that the vaccine fulfils the requirement of the regulatory authorities which looks at its safety, quality, and efficacy.’

MALAYSIA is now seeing the initiation of the first Covid-19 vaccine trial in the country.

“It is a Phase 3 vaccine trial, by the Institute of Medical Biology, Chinese Academy of Medical Sciences. The trial application is currently ongoing for review and approval by the regulatory authority and ethics committee before being conducted in our hospitals here, ” says Dr Akhmal Yusof, CEO of Clinical Research Malaysia (CRM).

CRM is a Health Ministry non-profit subsidiary set up as a one-stop centre to facilitate and conduct sponsored clinical research in the country.

In a written interview with Sunday Star, Dr Akhmal explains that these review processes are essential to ensure the safe conduct of any clinical trials on Malaysian participants.

“Additionally, this also provides us the opportunity to expand our role to help the discussions with pharmaceutical and biotech companies on vaccine development and selection, ” he says.

Since 2012, over 1,400 global sponsored clinical studies have been conducted in Malaysia, involving new treatments in cancer, diabetes and even vaccines as well. CRM has been in active engagements with industry players who are interested in conducting Covid-19 trial and vaccine studies here in Malaysia since April 2020 through Science Diplomacy advocated by the Health Ministry; Science, Innovation and Technology Ministry and Foreign Affairs Ministry says Dr Akhmal.

Sponsored clinical research is research that is wholly funded by the pharmaceutical and biotechnology industry, in which the study drug or treatment is developed by the company.

“It is very rewarding to hear stories of some of our trial participants who have led a better quality of life due to access to these innovative treatments. Our clinical investigators have performed well in global trials and have received recognitions to their accomplishment.

“As a result, we have positioned ourselves to be conducting clinical research with speed, quality, and reliability, ” says Dr Akhmal, adding that Malaysia as a nation has grown tremendously from where we were a decade ago, in terms of our clinical research capabilities and capacities.

“In April 2020, Malaysia joined the international World Health Organisation solidarity trial, evaluating a few treatments in addition to the standard of care, to identify potential treatments for the disease. This is one of the largest international randomised trials for Covid-19 treatments carried out, with almost 12,000 patients enrolled from over 30 countries.”

“While we wait for a Covid-19 vaccine to be procured, distributed, and administered to our population, clinical research is an important step to ensure that the vaccine fulfils the requirement of the regulatory authorities which looks at its safety, quality, and efficacy.

“Participants in clinical trials may also be the very first few to receive this vaccine which may confer immunity protection to them. It motivates me and the team at CRM knowing that each of us plays an important part in the clinical research ecosystem and the benefits our patients may receive from the trials conducted.”

In late November, Prime Minister Tan Sri Muhyiddin Yassin said the government has started rolling out a RM3bil plan to gain enough Covid-19 vaccines to immunise 6.4 million people in Malaysia, as soon the vaccine has been proven safe enough to be used. The first batch of vaccines is expected to be available early next year. – By Dina Murad