KUALA LUMPUR: Nearly 1.3 million vials of Sinovac vaccines have completed the “fill and finish” production in the country and will be ready for rollout soon.
Health Minister Datuk Seri Dr Adham Baba said as of today (May 11), 1,284,147 vials have been bottled. It would take about 23 days to undergo laboratory testing until it obtains lot release approval.
“The final process, which is the lot release, is controlled by the National Pharmaceutical Regulatory Agency (NPRA).
“This process will take two to three days where more documents will be submitted,” he said at the Pharmaniaga Bhd (Pharmaniaga) “fill and finish” vaccine handover ceremony at the Health Ministry, today.
Dr Adham said Pharmaniaga had received 200 litres of Sinovac vaccines in bulk on Feb 27 with its production facility plant, Pharmaniaga LifeScience Sdn Bhd (PLS) surrendering the first four batches 73 days later.
The batches were manufactured for the purpose of process validation, and was part of the NPRA’s registration requirement.
It was later approved by the Drug Control Authority (DCA) on April 23 for commercialisation, with a total of 17 quality control tests being conducted, he added.
“A month after the vaccines were manufactured, several quality control tests were conducted again in April 2021.
“This is also in line with NPRA regulations to conduct stability tests on the first, third, sixth months and so on,” he said, adding that quality control tests were also conducted by third party agencies such as Sirim Bhd.
At the ceremony, Dr Adham received 290,480 doses of filled and finished Sinovac vaccine vials, presented by Pharmaniaga group managing director Datuk Zulkarnain Md Eusope.
These vaccines would be rolled out to vaccine storage centres and vaccination centres nationwide.
Meanwhile, Pharmaniaga in a statement said PLS is now at its full production cycle capacity and would be able to produce 2 million doses per month.
Zulkarnain said there were various stages involving pending test results and the lot release approval process for fill and finish manufacturing of the Covid-19 vaccine.
“We are very grateful to the authorities, especially NPRA for prioritising the vaccine evaluation and subsequent lot release approvals. Our appreciation also to DCA which gave the approval for the use of the vaccine.
“All vaccines produced will continue to be subjected to stringent tests and evaluation by authorities, and our highly skilled technical teams will continue to adhere to it.”
He said Pharmaniaga is also awaiting approval by the China Food and Drug Administration for the Sinovac Covid-19 vaccine for children aged 3 to 17 years and manufacturing of two doses per vial before submitting it to the NPRA for variation process.
The production capacity is also expected to increase by 4 million per month once the two-dose vial is approved.
The fill and finish Sinovac vaccine by PLS is the first vaccine being manufactured in the country.
It is the second source of the CoronaVac vaccine, registered under Sinovac Life Sciences Co Ltd China.-NST