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MALAYSIA is now seeing the start of the first trial of the Covid-19 vaccine in the country.
“It is a phase 3 vaccine trial, conducted by the Institute of Medical Biology of the Chinese Academy of Medical Sciences. The trial request is currently underway for review and approval by the regulatory authority and the ethics committee before it is carried out in our hospitals here, ”says Dr. Akhmal Yusof, Executive Director of Clinical Research Malaysia (CRM).
CRM is a non-profit subsidiary of the Ministry of Health established as a comprehensive center to facilitate and conduct sponsored clinical research in the country.
In a written interview with the Sunday Star, Dr. Akhmal explains that these review processes are essential to ensure the safe conduct of any clinical trial in participants from Malaysia.
“In addition, this also gives us the opportunity to expand our role to assist in discussions with pharmaceutical and biotechnology companies on vaccine development and selection,” he says.
Since 2012, more than 1,400 globally sponsored clinical trials have been conducted in Malaysia, including new treatments for cancer, diabetes, and even vaccines. CRM has been in active engagements with industry players who are interested in conducting Covid-19 trials and vaccine studies here in Malaysia since April 2020 through scientific diplomacy promoted by the Ministry of Health; The Ministry of Science, Innovation and Technology and the Ministry of Foreign Affairs, says Dr. Akhmal.
Sponsored clinical research is research funded entirely by the pharmaceutical and biotechnology industry, in which the company develops the study drug or treatment.
“It is very gratifying to hear stories from some of our trial participants who have had a better quality of life thanks to access to these innovative treatments. Our clinical investigators have performed well in global trials and have been recognized for their achievements.
“As a result, we have positioned ourselves to conduct clinical research with speed, quality and reliability,” says Dr. Akhmal, adding that Malaysia as a nation has grown enormously from where we were a decade ago, in terms of our clinical research. capabilities and capabilities.
“In April 2020, Malaysia joined the World Health Organization’s international solidarity trial, evaluating some treatments in addition to standard of care, to identify potential treatments for the disease. This is one of the largest international randomized trials for Covid-19 treatments conducted, with nearly 12,000 patients enrolled from more than 30 countries. “
“While we wait for a Covid-19 vaccine to be obtained, distributed, and administered to our population, clinical research is an important step in ensuring that the vaccine meets the requirements of regulatory authorities looking at its safety, quality and efficacy. .
“Participants in clinical trials can also be the first to receive this vaccine, which can give them immune protection. It motivates me and the CRM team to know that each of us plays an important role in the clinical research ecosystem and the benefits that our patients can receive from the trials performed. “
In late November, Prime Minister Tan Sri Muhyiddin Yassin said that the government had started to implement an RM3bil plan to obtain enough Covid-19 vaccines to immunize 6.4 million people in Malaysia, as soon as the vaccine has been shown to be safe enough to be used. The first batch of vaccines is expected to be available early next year. – By Dina Murad
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