3,000 volunteers in Phase 3 clinical trial for Covid-19 vaccine
KUALA LUMPUR,. A Phase 3 Covid-19 vaccine clinical trial will commence this Jan 21 at nine Health Ministry (MoH) hospitals by their respective Clinical Research Centres (CRC), said Prime Minister Tan Sri Muhyiddin Yassin.
In announcing this, 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 and Ethics Committee (MREC) and finally, the Clinical Trial Import License (CTIL) from NPRA were obtained on Jan 8, 2021,” he said in a special address broadcast live on local television stations yesterday.
Muhyiddin said the MoH’s National Pharmaceutical Regulatory Agency (NPRA) had also approved the registration of the Covid-19 vaccine produced by the pharmaceutical company, Pfizer, and Malaysia should receive the supply of Pfizer vaccine for the first phase at end of February.
He said as a preliminary preparation to ensure that the distribution of Covid-19 vaccine to the people would run smoothly when supplies were obtained, MoH had 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 would ensure that only vaccines meeting the safety, quality and effective characteristics would 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 had been set, even though the supply of vaccines would be received
He also assured all that the government would do its best to provide protection for all the people.
“I am also calling upon 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.