3,000 VOLUNTEERS IN PHASE 3 CLINICAL TRIAL FOR COVID-19 VACCINE - PM
11 JAN 2021
KUALA LUMPUR: A phase 3 COVID-19 vaccine clinical trial will start on Jan 21 at nine Health Ministry (MOH) hospitals by their respective Clinical Research Centres (CRC), said Prime Minister Tan Sri Muhyiddin Yassin. In announcing the matter, he said the first clinical trial conducted in Malaysia was expected to involve 3,000 volunteers.
“Malaysia will be the first country outside China to conduct the trial of inactivated COVID-19 vaccine candidate made 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 License (CTIL) from NPRA were obtained on January 8, 2021," he said in a special address broadcast live on local television stations today.
Muhyiddin said the MOH'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 first phase at the end of February.
He said as a preliminary preparation to ensure the distribution of COVID-19 vaccine to the people runs smoothly when supplies are obtained, MOH has developed the National COVID-19 Immunisation Programme Plan.
"To achieve herd immunity, as much as 60 to 70 per cent or 20 to 23 million of the Malaysian population 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 vaccine to obtain a guarantee of vaccine supply of 40 per cent of the population coverage," he said.
The Prime Minister said the government was also in the process of final negotiations with Sinovac, CanSino and Gamaleya to secure vaccine supply exceeding 80 per cent of the country's total population or 26.5 million.
He stressed that the government will ensure that only vaccines that meet the safety, quality and effective characteristics will be registered and used in Malaysia.
He said the evaluation process would be conducted by NPRA for approval and the Drug Control Authority for the purpose of registration before the COVID-19 vaccine could be used.
At the end of his message, Muhyiddin also reminded the people to continue complying with all the SOPs that have been set 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 the 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, we can win. Insya-Allah," he said. -Bernama