KUALA LUMPUR, Jan 27 — The Health Ministry announced the commencement of local phase three clinical trials for a Covid-19 vaccine today, with the goal of assessing the vaccine’s safety and efficacy against the coronavirus.
In a statement, the ministry said the initiative is a joint effort between Malaysia and China via the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS), with the study playing a role in generating scientific evidence in assessing a vaccine for the SARS-CoV-2 coronavirus.
The trial was launched virtually by Health Minister Datuk Seri Dr Adham Baba at his office in Putrajaya today.
The first and second phases of the trials were carried out in China, and their findings revealed a significant immune reaction towards SARS-CoV-2 antigens.
No serious side effects were also seen, accounting for fewer than 30 per cent of the trial’s participants in the following 28 days after immunisation began.
Minor side effects reported in the first and second phases include redness, itchiness at the inoculation spot, fever, coughing, lethargy, diarrhoea, nausea, and allergic reactions, among others.
Nine hospitals nationwide will be involved in the clinical trials, under the auspices of the ministry’s Clinical Research Institute. It will include 3,000 local volunteers above the age of 18 over the course of 13 months.
Approximately 50 per cent of these volunteers will receive two doses of the inactive vaccine, while the remaining 50 per cent will receive two doses of a placebo resembling the vaccine but without containing the SARS-CoV-2 antigen.
The vaccines and placebos will be administered over the course of a fortnight, with the inoculation on the arm muscle. Participants are required to attend six appointments within a period of two months, with follow-ups throughout the 13 months.
The hospitals have all been deemed ready following a field evaluation and ministry clinical trial facilities by IMBCAMS.
The third-phase clinical trial was earlier approved by the ministry via the Medical Review and Ethics Committee on December 14 last year. Subsequently the National Pharmaceutical Regulatory Agency also approved the trials on January 8.
The vaccines for the trial were received on Sunday (January 23) and will be dispatched to the testing sites in stages starting today, while the first participants are expected to begin by the end of the month or early next month.
The third-phase clinical trials on the vaccine will use an inactive vaccine platform, similar to those used by China’s Sinopharm, Sinovac’s CoronaVac, and India’s Bharat Biotech’s Covaxin.
The inactive platform consists of dead virus through a chemical or physical process in which the virus is no longer capable of causing infection. Inactive vaccines usually do not grant a strong immunity compared to their active counterparts, requiring several doses to be administered from time to time to build the body’s immune system against Covid-19.
IMBCAMS will also carry out the third-phase clinical trial of the vaccine simultaneously in Brazil.
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