PUTRAJAYA: Malaysia’s first-ever Covid-19 vaccine trial has kicked off in nine of the country’s hospitals, with 3,000 volunteers taking part in the national study.
Health Minister Datuk Seri Dr Adham Baba described the Phase 3 clinical trial, which is sponsored by China’s Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) as “historic”.“This Phase 3 clinical trial marks a historic moment for Malaysia and it means a lot to the country, particularly in the field of health.
“This development is also very important to scientists and medical officers involved.
“On top of that, IMBCAMS has also expressed their satisfaction with the readiness level of our ministry’s facilities in implementing this initiative, ” said Dr Adham.
The clinical trial was officially launched by Dr Adham in a virtual ceremony that was also attended by Health Ministry officials as well as those representing IMBCAMS.
They included deputy director-general of health (research and technical support) Dr Hishamshah Mohd Ibrahim, Institute of Clinical Research (ICR) director Dr Kalaiarasu M. Periasamy and IMBCAMS research and development division director Dr Che Yanchun.
The trial is a collaboration between the governments of Malaysia and China through IMBCAMS.Before this, the institute had carried out Phase 1 and 2 trials in China. The same Phase 3 trials will also be carried out in Brazil.
The Phase 3 trial in Malaysia will be overseen by the ICR and involves 3,000 healthy local volunteers above the age of 18, for a period of 13 months. Half of the volunteers will receive two doses of inactivated vaccines, while the remaining half will get two doses of a placebo – which will resemble the vaccine but does not contain the SARS-CoV-2 antigen.
The participants will be given two doses on their upper arm in a 14-day interval.
They are then required to undergo six visitations in two months and a follow-up 13 months later.
The ministry said it had received 7,000 calls from members of the public who were interested to take part in the trial.
“Recruitment ads were published in the ministry’s and ICR’s social media platforms since Jan 15. Volunteer recruitment is still open.
“This is to ensure that the 3,000 volunteers chosen are those who fulfil the requirements and can commit themselves for 13 months, ” the ministry said.
The Phase 3 clinical trial received the ministry’s approval on Dec 14 through the Medical Review and Ethics Committee (MREC), as well as the National Pharmaceutical Regulatory Agency (NPRA) on Jan 8.
The research vaccines arrived on Jan 23 and have begun delivery to participating hospitals.
The ministry said the first batch of volunteers can expect to receive their first vaccine shots by the end of this month.
The hospitals involved in the clinical trial are Hospital Ampang, the Sarawak General Hospital, Penang hospital, Hospital Seberang Jaya, Hospital Taiping, Hospital Sungai Buloh, Hospital Sultanah Bahiyah in Alor Setar, Hospital Raja Permaisuri Bainun in Ipoh and Hospital Sultan Abdul Halim in Sungai Petani.
Under Malaysia’s Covid-19 vaccination plan, the country is expected to start its vaccine rollout in March.
The first batch of vaccines that will arrive in Malaysia is developed by American firm Pfizer and German company BioNTech, and can cover 12.5 million Malaysians. At the same time, the country is in the midst of negotiating deals with other companies like China’s Sinovac and the United Kingdom’s AstraZeneca-Oxford.
Malaysia aims to vaccinate 500,000 frontliners in March, followed by about 6.5 million elderly and sick people in May.
In August, the country hopes to vaccinate 16 million Malaysians aged 18 and above.
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