The Health Ministry said the Drug Control Authority (DCA) made the decision at a meeting yesterday.
“This conditional registration approval requires information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time.
“It is to ensure that the benefits outweigh the risks for the vaccines,” it said in a statement.
The ministry said it strove to combat the pandemic by ensuring an adequate supply of vaccines that had been evaluated for quality, safety and effectiveness by the National Pharmaceutical Regulatory Division and approved by the DCA.
PETALING JAYA: The Sinopharm and Johnson & Johnson Covid-19 vaccines have been granted conditional approval for use in the country’s National Covid-19 Immunisation Programme, says the Health Ministry.
In a statement, the ministry said the Drug Control Authority (DCA) made the decision at a meeting on Friday (July 16).
“This conditional registration approval requires information on the quality, safety and effectiveness of the vaccine product to be monitored and evaluated based on the latest data from time to time.
“It is to ensure that the benefit over risk for the vaccines remain positive,” it said.
The ministry said it strives to combat the pandemic by ensuring adequate supply of vaccines that have been evaluated for quality, safety and effectiveness by the National Pharmaceutical Regulatory Division and approved by the DCA.
PETALING JAYA: Three thousand Malaysian adults will be invited to participate in the 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 Division (NPRA) on May 28.
The third phase of the clinical study of this vaccine would be conducted in eight research centres in Malaysia targeting the participation of 3,000 adults aged 18 and above and was expected to take 15 to 19 months, he said.
“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.
Time interval between vaccination doses determined through data sent by vaccine manufacturer, says Khairy thestar.com.my - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thestar.com.my Daily Mail and Mail on Sunday newspapers.
Almost a million doses of Sinovac vaccine expected to be administered by end of April 01 Apr 2021 / 22:45 H. Pix for representational purpose only.
KUALA LUMPUR: Almost one million doses of the Sinovac vaccine from China are expected to be administered by the end of April, says Pharmaniaga Berhad (Pharmaniaga) managing director Datuk Zulkarnain Md Eusope.
He said this would be possible after the batch manufacturing process validation (PV) data and vaccine stability study data could be provided by mid-April to complete the registration application before it is approved by the National Pharmaceutical Regulatory Division (NPRA).
The first dose of the vaccine was given on March 18.