PUTRAJAYA – Phase 3 clinical trial for a Covid-19 vaccine from China will be conducted in eight hospitals under the Ministry of Health (MoH), said Health director-general Tan Sri Dr Noor Hisham Abdullah.
He said the clinical trial centres involved are Hospital Ampang (Kuala Lumpur), Sarawak General Hospital, Hospital Sungai Buloh (Selangor), Hospital Pulau Pinang, Hospital Seberang Jaya (Penang), Hospital Taiping (Perak), Hospital Sultanah Bahiyah (Kedah) and Hospital Raja Permaisuri Bainun (Perak).
“So far, MoH has not received any phase 3 clinical reports but will embark on a phase 3 clinical trial for a Covid-19 vaccine. The vaccine is an inactivated virus vaccine that is developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) in Beijing (China).
“We want to see whether the vaccine is effective in terms of safety and efficacy in our population. It might work in other populations but how about in Malaysia? So, I think it's good that we can embark on this study.
“We hope that on Dec 10, the Medical Research Ethical Committee (MREC) will look into the law and research ethics. Once approved, we can probably start the study by the end of this month or next year,” he told a press conference on Covid-19 here today.
Dr Noor Hisham added that the study aims to further investigate the safety and efficacy of the vaccine. The study is currently registered with the National Medical Research Register (NMRR) and will be conducted by Principal Investigators (PI) from MoH with the assistance of a local Clinical Research Organisation (CRO).
He said the data for the phases 1 and 2 clinical trials in China showed that the vaccine is safe and can elicit good and adequate antibody response to combat the virus.
At the moment, he said, the National Pharmaceutical Regulatory Agency (NPRA) is looking into the safety profile of the vaccine before authorising a Clinical Trial Import Licence (CTIL), which is required to bring in pharmaceutical products for clinical trials.
On another issue, the MoH is considering to shorten the quarantine period for travellers entering Malaysia.
“We are still following the old policy of 14-day quarantine where they will be tested on day one and day 13 or if they have symptoms during the quarantine.
“However, we are reviewing more data to determine whether we can actually shorten the quarantine as we are aware some countries do the quarantine for 7-10 days,” he said.
“Certainly when we shorten to 10 days, the risk will be probably about five per cent so we must manage the risks. Hence, we are reviewing the data before we can change any policy,” he added. – Bernama, December 4, 2020
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