PUTRAJAYA: The Covid-19 vaccine phase 3 clinical trials by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) will begin today.

The Health Ministry, in a statement, said the vaccines will be delivered to each trial site in stages to conduct safety and effectiveness assessments on Covid-19 infection.

The phase 3 clinical test for the Covid-19 vaccine virtual launching ceremony was officiated by Health Minister Datuk Seri Dr Adham Baba at his office today.

It said the collaboration initiative between the government and the Chinese government through IMBCAMS serves to generate scientific evidence in the development of the SARS-CoV-2 vaccine. 

"It (development) must fully comply to the international standards, national Health Regulatory policies that are stable, Good Manufacturing Practices (GMP), Good Clinical Practice (GCP) and Helsinki Declaration which will be closely monitored by the National Pharmaceutical Regulatory Agency (NPRA) and the Medical Research and Ethics Committee (MREC) under the ministry.

"The clinical trial is a test against the Covid-19 vaccine using the inactivate vaccine platforms such as the platform used by Sinopharm (China), CoronaVac from Sinovac (China) and Covaxin from Bharat Biotech (India)," it said.

It also said phases 1 and 2 of the clinical trials developed by China recorded significant immune reactions against antigen SARS-CoV-2 and do not show any serious side effects that exceed more than 30 per cent as a whole for the period of 28 days after immunisation.

IMBCAMS has conducted field surveys and the ministry's clinical trial facilities and all nine hospitals under the ministry are fully prepared to implement the Phase 3 clinical study.

Meanwhile, it said the SARS-CoV-2 vaccine uses an inactive vaccine platform made from viruses that are killed through physical or chemical processes and does not have the potential to cause diseases.

It added the use of inactive vaccines, such as those for Hepatitis A, influenza, polio and rabies, usually do not provide a strong immunity as live vaccines, therefore, it requires several doses from to build up the immune response to Covid-19 infection.

It also said the vaccine trial was received on Jan 23 and the first group of participants are expected to receive the immunisation by end of January or early February.

It was reported that 50 per cent of the 3,000 volunteers would receive two doses of the inactive vaccine while the other half would receive two placebo doses.

The volunteers would be given two doses over an interval of 14 days on the upper arm muscles and are required to attend six visits within two months, followed for 13 months.

"The vaccine trial advertisement was published on the ministry and ICR social media platforms on Jan 15 with frequently asked questions (FAQ) while more than 7,000 members of the public have contacted the clinical trial site and expressed interest in participating in the study.

"Currently, the process of recruiting volunteers is still open to ensure that the 3,000 volunteers selected are able to meet the conditions and commitments for 13 months," he said.