KUALA LUMPUR, Jan 11 — The third phase of Covid-19 vaccine clinical study is scheduled to begin on January 21, Prime Minister Tan Sri Muhyiddin Yassin announced today.
In his live address today, Muhyiddin highlighted that Malaysia is the first country outside of China to conduct the study.
“I would also like to take this opportunity to announce that the Clinical Research Phase 3 of the Covid-19 vaccine will start on January 21, 2021 in nine Ministry of Health (MOH) hospitals under the management of the respective Clinical Research Centres (CRC).
“The first clinical study conducted in Malaysia is expected to involve 3,000 volunteers and Malaysia will be the first country outside China to study the inactivated Covid-19 vaccine candidate made by the Institute of Medical Biology Chinese Academy of Medical Sciences, China (IMBCAMS),” he said.
Muhyiddin said that all regulatory requirements including ethical approval from the Medical Review & Ethics Committee (MREC) and the Clinical Trial Import License (CTIL) from the National Pharmaceutical Regulatory Agency (NPRA) was obtained on January 8.
He said the NPRA, which falls under MOH had approved the registration of the Covid-19 vaccine produced by the pharmaceutical company, Pfizer, and that Malaysia is set to receive the first phase of the supply at the end of February.
“As a preliminary preparation to ensure the distribution of Covid-19 vaccine to the people of this country runs smoothly when supplies are obtained, MOH has developed the National Covid-19 Immunisation Programme Plan,” he added.
Muhyiddin said that in order to achieve herd immunity, as much as 60 to 70 per cent or between 20 and 23 million Malaysians need to be inoculated with the vaccine.
He said at the moment, the government has also signed an initial agreement with Pfizer, Covax and AstraZeneca to obtain the vaccine supply to cover 40 per cent of Malaysian population.
“The government is also in the process of final negotiations with Sinovac, CanSino and Gamaleya to secure an increased vaccine supply of more than 80 per cent of the country’s total population or 26.5 million.
“The government will ensure only vaccines that meet the safety, quality and effective characteristics will be registered and used in Malaysia. This evaluation process is made by the Product Evaluation Committee of the NPRA, for approval and the Drug Control Authority for the purpose of registration before the Covid-19 vaccine can be used in Malaysia,” he added.
