KUALA LUMPUR (June 5): The National Pharmaceutical Regulatory Agency (NPRA) has approved the clinical study of a new vaccine from China to be carried out in Malaysia.
In a statement today, health director-general Tan Sri Dr Noor Hisham Abdullah said the clinical study will involve the SARS-CoV-2 vaccine (Vero Cells), inactivated, manufactured by Shenzhen Kangtai Biological Products Co Ltd in China.
He said this Phase 3 clinical study will be conducted at eight research centres in Malaysia with target participants of 3,000 adults aged 18 years and above, and is expected to take 15 to 19 months.
Besides Malaysia, Dr Noor Hisham noted that other countries involved in this clinical study include Colombia, Argentina, Pakistan, the Philippines and Ukraine. The vaccine was also approved in China through its Emergency Use Approval on May 14, 2021.
"The clinical study of the Covid-19 vaccine conducted in Malaysia will provide clinical information related to the efficacy and safety of the vaccine, as well as information on the suitability of the vaccine to Malaysians.
"This is an advantage needed by the government in order to achieve the target of herd immunity through the National Covid-19 Immunization Program, which is being actively carried out throughout the country," he said.
As of yesterday, Malaysia has administered a total of 3.42 million doses of Covid-19 vaccine, whereby 2.29 million people have received their first dose and another 1.13 million people have completed two doses.