PETALING JAYA: Thousands of Malaysian volunteers are currently being screened for the Phase Three clinical trial of a Covid-19 vaccine from China, which will involve nine Health Ministry hospitals.
Malaysia is the first country outside China to trial the vaccine, developed by the Institute of Medical Biology Chinese Academy of Medical Sciences in China.
Prime Minister Tan Sri Muhyiddin Yassin previously said it would also be the first such trial in Malaysia.
A total of 3,000 participants will be selected for study, with applicants currently being screened for their suitability.
Some volunteers who reached out were asked to be on standby in case there is an opening.
According to an FAQ prepared by the Institute of Clinical Research, half the participants will receive the vaccine, developed using an inactivated virus, while the other half will receive a placebo.
The vaccines or placebos will be administered in two doses, on Day 0 and Day 14, and participants will not know which they have received in order to avoid bias in the study.
The study, the FAQ also reveals, will consist of a series of screening, consent, vaccination and follow-up visits.
“We will first check if you meet the criteria for this study. If you are eligible, and consent to participate, you will need to come to the hospital on the appointed date to receive two doses of the study vaccine or placebo.
“This study will take at least 12 months, involving six follow-up visits to the hospital and 24 phone calls, ” the FAQ said.
Participants are also required to undergo a throat and nasal swab, provide blood and urine samples, complete records, and inform the study team about symptoms that they have or medications that they are taking.
The study is open to healthy adults aged 18 years or older, excluding those who have had Covid-19.
“Individuals who have been infected and recovered from Covid-19 infection may have already developed immunity.
“Having volunteers who have recovered from Covid-19 may affect the results of the vaccine efficacy in the study, ” the FAQ stated.
The study has also been reviewed and approved by the Health Ministry’s Medical Research and Ethics Committee to ensure volunteer safety and that the benefits of the study outweigh the risks.
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