Malaysia's first Covid-19 vaccine trial to involve 3,000 people

Malaysia's first Covid-19 vaccine trial to involve 3,000 people

Malaysia is set to embark on its first Covid-19 vaccine trial, which would involve some 3,000 participants from eight hospitals under the Health Ministry.

Health director-general Datuk Dr Noor Hisham Abdullah said the trial would be a Phase 3 clinical trial on a vaccine that has been developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) in Beijing.

"At the moment, we have been informed that 12 (Covid-19) vaccines have undergone Phase 3 clinical trials. We have contacted 10 of the companies who are looking into the clinical trials.

"So far, we have not received any Phase 3 clinical trial reports.

"The Health Ministry, however, will embark on a Phase 3 clinical trial that is using the inactivated Covid-19 vaccine developed by (IMBCAMS)," he said at a press conference here today.

Dr Noor Hisham said the decision was made following the success of the vaccine's Phase 1 and Phase 2 clinical trials which showed good results as it is able to elicit adequate antibody response.

He said the study, which is expected to start by the end of the month, aims to further investigate the safety and efficacy of the vaccine in Malaysia, given the country's diverse population.

"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 what about in Malaysia. So that is the reason why it's good that we embark on this study."

The study, he said, has also been registered under the National Medical Research Registry and it will be conducted by a principal investigator from the ministry, with the assistance of a local clinical research organisation.

The clinical trial, he said, would be conducted in eight hospitals - Ampang Hospital, Sarawak General Hospital, Sungai Buloh Hospital, Penang Hospital, Seberang Jaya Hospital, Taiping Hospital, Sultanah Bahiyah Hospital, and the Raja Permaisuri Bainun Hospital.

"From the eight hospitals, we are estimating about 3,000 participants for this trial.

"On Dec 10, we will be reviewing (the study with) the medical research and ethics committee to look into the law and research ethics (of the clinical trial).

"Once approved, we can probably start the study at the end of the month or next year. That is the process that we have put in place." - Bernama