KUALA LUMPUR – The Phase 3 Covid-19 vaccine clinical trial will start on January 21 at nine Health Ministry hospitals under their respective Clinical Research Centres (CRC), said Prime Minister Tan Sri Muhyiddin Yassin.
He said the first clinical trial in Malaysia is expected to involve 3,000 volunteers.
“Malaysia will be the first country outside China to conduct the trial of the inactivated Covid-19 vaccine candidate by the Institute of Medical Biology Chinese Academy of Medical Sciences, China (IMBCAMS).
"All regulatory requirements, including ethical approval from the Medical Review & Ethics Committee (MREC), and finally, the Clinical Trial Import Licence (CTIL) from NPRA, were obtained on January 8," he said in a special live address today.
Muhyiddin said the ministry's National Pharmaceutical Regulatory Agency (NPRA) has also approved the registration of the Covid-19 vaccine produced by the pharmaceutical company, Pfizer and Malaysia is expected to receive the supply of Pfizer vaccine for the Phase 1 at the end of next month.
He said as part of preliminary preparations to ensure the distribution of the Covid-19 vaccine runs smoothly, the ministry has developed the National Covid-19 Immunisation Programme.
"To achieve herd immunity, as much as 60% to 70% of the Malaysian population, or 20 to 23 million people, must be given the Covid-19 vaccine.
"Currently, the government has signed a preliminary agreement with Covax, Pfizer and AstraZeneca for the procurement of Covid-19 vaccines to obtain a guarantee of vaccine supply of 40% of the population coverage," he said.
The prime minister said the government is also in final negotiations with Sinovac, CanSino and Gamaleya to secure vaccine supplies exceeding 80% of the country's total population, or 26.5 million.
He said the government will ensure that only vaccines that meet safety, quality and effectiveness standards will be registered and used in Malaysia.
He said the evaluation process will be conducted by the NPRA for approval and the Drug Control Authority for the purpose of registration before the Covid-19 vaccine can be used.
At the end of his message, Muhyiddin also reminded the people to continue complying with all SOPs, even though the supply of vaccines will be received soon.
He also assured that the government will do its best to provide protection for all people.
"I am also calling on all of you to do your best to protect each other and the community. Only by uniting against this virus, can we win. InsyaAllah." – Bernama, January 11, 2021
