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M’sia to take part in phase three clinical trials for new Covid-19 vaccine from China, says Health DG – The Star Online

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PETALING JAYA: Malaysia will participate in phase three clinical trials for a new vaccine manufactured by Chinese firm Shenzhen Kangtai Biological Products Co Ltd, says the Health Ministry.

Health director-general Tan Sri Dr Noor Hisham Abdullah said the clinical study involving the inactivated vaccine was approved by the National Pharmaceutical Regulatory Agency (NPRA) on May 28.

Phase three clinical study of this vaccine will be conducted in eight research centres in Malaysia targeting the participation of 3,000 adults aged 18 years and above and is expected to take 15 to 19 months.

“The Health Ministry would like to inform that there is an addition of one clinical study, involving the product SARS-CoV-2 Vaccine (Vero Cells), Inactivated, 5μg/0.5mL manufactured by Shenzhen Kangtai Biological Products Co Ltd from China.

“Malaysia is one of the countries involved in this clinical study besides Colombia, Argentina, Pakistan, the Philippines and Ukraine.

“This vaccine has also been approved by China for emergency use on May 14,2021,” he said in a statement on Saturday (June 5).

Dr Noor Hisham said that clinical studies of Covid-19 vaccines conducted in Malaysia can provide clinical information related to the efficacy and safety of the vaccine,

as well as information on the suitability of the vaccine for Malaysians.

He added that this was an advantage needed by the government to reach the targeted herd immunity via the National Covid-19 Immunisation Programme which is currently going on full swing nationwide.

This is the second Covid-19 vaccine clinical trial that Malaysia is involved in.

In January, Malaysia started phase three clinical trials for a Covid-19 vaccine developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).

The trials involved nine government hospitals across Malaysia and 3,000 volunteers for a period of 13 months.

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