The Ministry of Health (MOH) is looking for healthy volunteers to join the Phase III clinical trial of a COVID-19 vaccine developed in China
The vaccine has been developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS), read a statement uploaded on the official Facebook page of MOH last night, 15 January.
It was also announced by Prime Minister Tan Sri Muhyiddin Yassin on 11 January, stating that the phase III COVID-19 vaccine clinical trial will start on 21 January at nine MOH hospitals.
The trial is expected to involve 3,000 volunteers, making Malaysia the first country outside China to conduct the trial of inactivated COVID-19 vaccine candidate made by IMBCAMS.
"All regulatory requirements including ethical approval from the Medical Review and Ethics Committee (MREC), and finally the Clinical Trial Import Licence (CTIL) from the National Pharmaceutical Regulatory Agency (NPRA), have been obtained on 8 January," read the MOH statement.
According to information shared by MOH, the vaccines will only be offered to healthy volunteers who are aged 18 years and above
Trial participants, however, may be at potential risk such as swelling, redness over the skin and or feeling pain, itch at the injection site after the injection, and fatigue, fever, diarrhoea, etc.
On the plus side, though, there are potential benefits such as gaining immunity towards COVID-19.
In light of MOH's announcement, Dr Khoo Yoong Khean, a healthcare administrator working in Singapore and the managing editor of The Malaysian Medical Gazette, took to his Twitter to highlight a few things
In his Twitter thread, Dr Khoo noted a few things for those who are interested to join the COVID-19 vaccine trial, stating that "human trials are not experimental" as the vaccine would have already gone through laboratory trials and pass an ethics board, as it has been announced by the ministry in its statement.
Other things to note, include:
- You may or may not get the vaccine (vaccine vs placebo dose)
- Is there a risk? Yes, this will be conveyed to you by the trial coordinator.
- Is there an advantage? Yes, you (might) get protected from the disease early.
- Will it affect my daily living? It might, trials usually have frequent follow-ups so it might disrupt your schedule.
- Can I leave the trial early? Yes, trials are voluntary. You can leave anytime but remember, follow-ups (to monitor health) will also be less.
Meanwhile, MOH has also shared a list of FAQ prepared by researchers for those interested in the COVID-19 vaccine study:
Last week, we spoke to Singapore-based Dr Khoo some common questions we had about the COVID-19 vaccines: