NPRA approves clinical study of another COVID-19 vaccine - Health DG
Bernama
June 5, 2021 17:10 MYT
June 5, 2021 17:10 MYT
Dr Noor Hisham said the vaccine was also approved by China through its Emergency Use Approval on May 14. - BERNAMA filepic
KUALA LUMPUR: The National Pharmaceutical Regulatory Agency (NPRA) has approved a clinical study of another COVID-19 vaccine, said Health director-general Tan Sri Dr Noor Hisham Abdullah.
He said the clinical study involving the SARS-CoV-2 Vaccine (Vero Cells), inactivated, 5ug/0.5mL, manufactured by Shenzhen Kangtai Biological Products Co., Ltd. in China was approved on May 28.
He said the Phase 3 clinical study to be conducted at eight research centres in Malaysia with a target participants of 3,000 adults aged 18 years and above, is expected to take 15 to 19 months.
"Apart from Malaysia, other countries involved in the clinical study are Colombia, Argentina, Pakistan, the Philippines and Ukraine.
"The vaccine was also approved by China through its Emergency Use Approval on May 14," he said in a statement here today.
Dr Noor Hisham said the clinical study conducted in the country could provide clinical information on the effectiveness, safety and suitability of the COVID-19 vaccine to Malaysians.
He said this was an advantage needed by the government in efforts to achieve the herd immunity target through the National COVID-19 Immunisation Programme which is being actively carried out nationwide.
-- BERNAMA